Demystifying and Enhancing Awareness on Covid-19 Vaccination

ONLINE SEMINAR ON

DEMYSTIFYING AND ENHANCING AWARENESS ON COVID-19 VACCINATION

BACKGROUND MATERIAL

6TH FEBRUARY, 2021

4.00 PM - 6.00 PM

Organised by

WATERFALLS INSTITUTE OF TECHNOLOGY TRANSFER

In Association with THE MADRAS CHAMBER OF COMMERCE & INDUSTRY

ONLINE SEMINAR ON DEMYSTIFYING AND ENHANCING AWARENESS ON COVID-19 VACCINATION

BACKGROUND MATERIAL

6TH FEBRUARY, 2021

4.00 PM - 6.00 PM

Organised by

WATERFALLS INSTITUTE OF TECHNOLOGY TRANSFER

In Association with THE MADRAS CHAMBER OF COMMERCE & INDUSTRY

C O N T E N T S

INVITATION … … … 1

PREFACE … … … 2

1. INTRODUCTION: COVID-19 & VACCINES 4 1.1 About COVID-19 4 1.2 Executive Summary (Covid 19 Vaccine – Operational Guidelines) 5 1.3 Introduction to Vaccines for Covid-19 8 1.4 Development of COVID-19 Vaccine 9 1.5 COVID-19 vaccine development in India 11 1.6 Communication Strategy 11 1.7 Contents of COVID-19 Vaccine(s) – Operations Guidelines 13 1.8 Contents COVID-19 Vaccine(s) – Communication Strategy 15 1.9 List of Awareness Material (Ministry of Health) 17 2. DEMYSTIFYING THE CONCEPTS ABOUT COVID-19 AND 20 VACCINATION 2.1 India’s Vaccination Drive 20 2.2 US COVID-19 Vaccination Program 21 2.3 FAQ and Answers on Vaccines for Covid-19 22 2.4 Myths on Vaccines 27 2.5 WHO Conversation in Science 39 3. VACCINE MANUFACTURING 40 3.1 Types of Covid-19 Vaccines 40 3.2 Vaccine Manufacturing 44 3.3 Indian Vaccine Development & Manufacturers 47 3.4 Emergency use Authorisation : Covid-19 Vaccine 50 3.5 Indian Vaccines: How the Globe Views It 52 4. INTELLECTUAL PROPERTY RIGHTS AND COVID 19 VACCINES 54 4.1 Patent Ownership of Covid-19 Vaccines 54 4.2 COVID-19 Patent Ban (South Africa/Indian) 56 4.3 Looking into Future of Patent Ban /Waiver 58 Annexure 4.1 : A note on International development regarding Access 61 to Medicine to address the COVID-19 ( A note from Dr. K.S. Kardam) 5. ABOUT THE SPEAKERS 63

P R E F A C E

This background material is prepared for the online Seminar being planned for 6th February, 2021, jointly organised by Waterfalls Institute of Technology Transfer and Madras Chamber of Commerce and Industry. The subject of the Seminar is “Demystifying and Enhancing Awareness on Covid-19 Vaccination”. No doubt at all, the subject is rapidly evolving and this material assembled in later part of January 2021 would be impacted by newer information that would become available by the time the seminar takes place in the first week of February 2021.

No originality whatsoever is implied by the Institute for the material assembled here; all credit is in fact due to several agencies and organisations for publishing very valuable information from time to time. Material put out by only a few organisations are included here after being abridged and edited in this backgrounder such as; the Ministry of Health and Family Welfare of the Govt. of India, World Health Organisation, Geneva Switzerland, leading Vaccine Manufactures, some medical centres and few others; the reader is urged to refer to the original material of such organisations to form a firm view on an issue, this backgrounder serving only as an indication for further study and examination.

Chapter I. Introduction to Covid 19 and Vaccine is mainly from the Website of the Ministry of Health and Family Welfare of the Govt. of India under the “Resources” section, “Training Material” lists several links. Two of them dealing with vaccines is picked up; they are (i) Covid 19 Vaccines: operational guidelines uploaded on 28-12-2020. The Contents page and Executive Summary is given in this Chapter; and (ii) Covid 19 Vaccines: Communication strategy uploaded on 30-12-2020. The introduction and Contents page is also extracted for presentation in this Chapter. This chapter also gives a list of Awareness material on a wide range of topics by the Ministry of Health and Family Welfare.

Chapter 2. contains material which will help to Demystify the concept about Covid-19 and vaccination. Section 2.1 give a brief overview of India’s vaccination drive, perhaps the largest in the history of the world. Section 2.2 similarly gives the US program on vaccination. In fact the largest impact of Covid-19 in terms of persons infected are USA and India and as such their vaccination program have many similar features with 2 vaccines in each country. Section 2.3 provides answers to the frequently asked questions on Vaccines for Covid-19. Section 2.4 provides explanations and clarifications on many myths relating to Covid-19 vaccines and vaccination. It will be seen that many items of myths relates to perception and misinformation in USA; similar myths exists in India too, but here the correct information has not yet been collected and clarified. Perhaps this could be done as India’s’ vaccination drive advances and the items reported in Phase I of the Vaccination could be brought out; this would be of use in enhancing awareness in the later phases of the vaccination program. Section 2.5 gives a list of subject items (Episodes) covered in the WHO series in “conversation in science”, which incidentally have cleared some myths and provided clarification relating to covid-19. 4

The third Chapter is focussed on Vaccine Manufacture, which will be of special interest to industry, showing how the recent advances in science is impacting this segment of the Industry particularly to meet the demands in the pandemic period. Section 3.1 provides an introduction to the different types of Covid-19 vaccines, and Section 3.2 points out the problem in the manufacturing vaccine to provide the large number of doses in an affordable manner. Section 3.3 provides insights to the Indian Vaccine development. Section 3.4 explains the process to obtain an Emergency use approval (EUA). Section 3.5 points out the praise showered on India in raising to the occasion in combating the pandemic and the success of the “vaccine diplomacy”.

The Chapter 4 deals with the Intellectual property rights relating to vaccine manufacture and it impacts on the availability and accessibility issues and eventually leading to affordability. Section 4.1 points out the ownership issues relating to Patents rights, reorganising the large investments made by the pharmaceutical industrial giants and risks associated with such investment. However, the large investments provided by the public (the Government) is often ignored or forgotten.

Section 4.2 deals with a proposal moved at the WTO by India and South Africa to temporarily ban the IPR on inventions relating to Covid-19 medicines and vaccines. Section 4.3 after an analysis of the proposal peeps into the future as to what may happen.

An Annexure (4.1) to this Chapter is a note by Dr K S Kardam titled “A note on International development regarding Access to Medicine to address the COVID-19”

Chapter 5 is a short two page note giving a brief thumb nail sketch of the speakers taking part in this Seminar.

In the Seminar ahead, our experts will throw more information to clarify the issues and they will answer questions lingering in the minds of the audience.

I wish to thank several of our experts in providing me information relating to this backgrounder. Special thanks are also due to the Staff of Waterfalls Institute of Technology Transfer and the Madras Chamber of Commerce and Industry for their efforts in planning the Seminar.

Chennai Dr.K.V. Swaminathan 03- February, 2021 (Founder Chairman)

1. INTRODUCTION: COVID-19 & VACCINES

1.1 About COVID-19

Coronavirus disease (COVID-19) is an infectious disease that has spread rapidly throughout the world. In March 2020, the World Health Organization (WHO) declared the COVID-19 outbreak a pandemic. The pandemic has severely impacted health systems, economic and social progress throughout the world. From a few thousand confirmed COVID-19 cases in January 2020, cases continue to grow globally; as of 26 January 2021, there have been 100,280,252 confirmed cases of COVID-19, including 21,49,387 deaths. (www.worldmeters.info/coronovirus)

COVID-19 is caused by a newly discovered coronavirus now named as the Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2). Coronaviruses (CoV) are zoonotic, and are transmitted between animals and humans. Coronaviruses cause diseases such as the Middle East Respiratory Syndrome (MERS) and Severe Acute Respiratory Syndrome (SARS) and more mild illnesses including the common cold. The most common signs of infection with COVID-19 include fever, dry cough, shortness of breath or difficulty in breathing, and tiredness or fatigue. Most people (~80%) experience mild disease and recover without requiring hospitalization. However, globally, around 20% of people who contract COVID-19 become more seriously ill and have trouble in breathing. In more severe cases, the infection can cause pneumonia, severe acute respiratory syndrome, kidney failure and even lead to death.

In India, 1,06,77,710 confirmed COVID-19 cases and over 1,53,624 deaths have been reported as of 26th January 2021. While strong measures were adopted and some progress was made in containing the spread through better public health interventions, diagnostics and treatments, scientists across the world have accelerated the process to develop a safe and effective vaccine that will break the chain of transmission.

The Ministry of Health and Family Welfare in their Website has provided very valuable information concerning the theme of the Seminar planned for 6 February 2021. In particular two recent documents contains information about vaccines and vaccination; (i) Loaded on 28- December 2020 is titled “Covid-19 Vaccines – Operational Guidelines; (ii) Loaded on 30 December 2020 is titled “Covid-19: Communication Strategy”. Section 1.2 of this Backgrounder is the Executive Summary of the first publication covering operational guidelines. Section 1.7 and Section 1.8 gives the contents of these to publications.

Table 1.4 gives details about the impact of Covid-19 on the world and 10 countries who had felt the impact severely, of which India ranks 2.

The Ministry have also provided valuable awareness material in the website. Section 1.9 gives a list of such awareness Material.

1.2 Executive Summary (Covid 19 Vaccine – Operational Guidelines) Coronavirus disease (COVID-19), is an infectious disease caused by a newly discovered coronavirus (SARS-CoV-2), which has spread rapidly throughout the world. In March 2020, the World Health Organization (WHO) declared the COVID-19 outbreak a pandemic. The pandemic has severely ravaged health systems, and economic and social progress globally.

In India, 96,06,810 confirmed COVID-19 cases and over 1,39,700 deaths have been reported as of 4 December 2020. COVID-19 most commonly manifests as fever, dry cough, shortness of breath and tiredness. Most people (~80%) experience mild disease and recover without hospitalization, while around 20% may become more seriously ill.

While countries, including India, have taken strong measures to contain the spread of COVID-19 through better diagnostics and treatment, vaccines will provide a lasting solution by enhancing immunity and containing the disease spread. In response to the pandemic, the vaccine development process has been fast-tracked. Globally, over 274 candidate vaccines are in different stages of development as of 4 December 2020. The majority of vaccines in clinical evaluation as of 4 December 2020 will require a two dose schedule to be administered two, three or four weeks apart, and is need to be administered through the intramuscular route.

Anticipating that the COVID-19 vaccine may soon be available, the Government of India (GoI) is preparing for its it to be introduced in the country so that it can be expeditiously rolled out when available. One of the milestones in this direction has been the constitution of a National Expert Group on Vaccine Administration for COVID-19 (NEGVAC). The NEGVAC will guide all aspects of the COVID-19 vaccine introduction in India. High-level coordination at the national, state and district levels must be established for effective cooperation and collaboration among the key departments. 19 ministries at national level, 23 departments at state/ district and numerous developmental partners are involved in planning the COVID-19 vaccine introduction; their roles have been described in these operational guidelines.

The Successful introduction of the COVID-19 vaccine will largely depend upon the quality of training conducted for enumerators for beneficiary listing, health functionaries for vaccination activities, social mobilizers for all mobilization activities and communication training for all workers involved in the process of vaccination. As demonstrated during recent experiences with pneumococcal conjugate vaccine (PCV) introduction and polio supplementary immunization activities (SIAs) conducted during the COVID-19 pandemic, national and state training of trainers (ToT) may be successfully conducted on virtual platforms and cascaded to district and sub-district levels using a mix of virtual and face-to-face training. The COVID-19 vaccine will be introduced once all training is completed in the district/block/planning unit.

COVID-19 vaccine will be offered first to healthcare workers, frontline workers and population above 50 years of age, followed by population below 50 years of age with associated comorbidities based on the evolving pandemic situation, and finally to the remaining population based on the disease epidemiology and vaccine availability. The priority group of above 50 years may be further subdivided into those above 60 years of age and those between 50 to 60 years of age for the phasing of roll out based on pandemic situation and vaccine availability. The latest electoral roll for the Lok Sabha and Legislative Assembly election will be used to identify the population aged 50 years or more.

The COVID-19 Vaccine Intelligence Network (Co-WIN) system, a digital platform will be used to track the enlisted beneficiaries for vaccination and COVID-19 vaccines on a real-time basis. At the vaccination site, only pre-registered beneficiaries will be vaccinated per the prioritization, and there will be no provision for on-the-spot registrations. Based on the numbers of registered beneficiaries and the priority accorded, vaccination sessions will be planned with the following considerations:

• One session for 100 beneficiaries;

• While most of the healthcare and frontline workers would be vaccinated at fixed session sites that may be government health facilities above PHCs or private health facilities identified by district administration, vaccination of other high-risk populations may require outreach session sites, and mobile sites/teams; and

. State/UT can identify specific days for vaccination;

. The entire vaccination process will be broadly similar to the election process.

. The vaccination team will consist of five members as follows:

. Vaccinator Officer–Doctors (MBBS/BDS), staff nurse, pharmacist, auxiliary nurse midwife (ANM), lady health visitor (LHV); anyone authorized to administer an injection may be considered as a potential vaccinator;

. Vaccination Officer 1: At least one person (Police, home guard, civil defense, national cadet corps (NCC), national service scheme (NSS), endr yuva kendra sangathan (NYKS) who will check the registration

status of a beneficiary at the entry point and ensure the regulated entry to the vaccination session; . Vaccination Officer 2: Is the verifier who will authenticate/verify the identification documents; and

. Vaccination Officer 3 & 4 are the two-support staff who will be responsible for crowd management and ensure 30 minutes of waiting time by beneficiary post-vaccination. Support staff will provide information, education and communication (IEC) messages and support to vaccinator as well as the vaccination team.

Essential health services including existing routine immunization sessions should not be impacted or interrupted.

Vaccine safety need to be ensured during storage, transportation and delivery of vaccine with sufficient police arrangements so that there are no leakages in the delivery system.

Safety precautions, including infection prevention and control practices, safe injection practices and waste disposal, will be followed during vaccination sessions. As large population groups will be vaccinated over a short period with a new vaccine, monitoring the safety of these vaccines will be critical. The existing adverse events following immunization (AEFI) surveillance system will be utilized to monitor adverse events and understand the safety profile of the vaccines. To ensure confidence in the vaccine and the immunization programme during COVID-19 vaccine introduction, states/UTs must rapidly detect and promptly respond to all AEFIs. The reporting of AEFI through surveillance and action for events following vaccination (SAFEVAC) has been integrated with Co-WIN software and every AEFI to be reported at the district level and facilitate the referral mechanisms in case any AEFI needs to be put in place.

Requirements for management of the cold chain for COVID-19 vaccination will vary depending on the type of COVID-19 vaccine, as different vaccines have different storage temperature ranges. Cold chain assessments and gap analysis have been completed, and there are plans in place for supplying additional cold chain equipment where required. States/UTs must ensure adequate cold chain storage capacity for the COVID-19 vaccine campaign. Cold chain handlers, and vaccinators at all levels will be trained on procedures for vaccine and logistics management as well as infection prevention and control precautions.

Every effort is being made to ensure that everyone in the country has access to timely, accurate and transparent information about the COVID-19 vaccine(s). This requires a meticulous, structured, informative and clear communication strategy to create adequate awareness, ensure accurate knowledge, generate and manage adequate demand, facilitate eagerness and address vaccine hesitancy and confidence, and mitigate for unintended situations (e.g. AEFI clusters, delay in vaccine roll-out for certain population categories) to ensure the smooth introduction and roll-out of COVID-19 vaccine(s). Key communication and demand generation strategies include advocacy at national, state, district and sub-district levels; capacity building, media engagement, social mobilization and partnership, community engagement and empowerment is included at family and community levels. Key

areas to be addressed in the communication plan includes information on COVID-19 vaccine, vaccine eagerness, vaccine hesitancy and COVID-19 appropriate behavior.

A vaccination programme of this scale will require close monitoring and supportive supervision at all levels to identify bottlenecks and challenges faced at the ground level. Each step-in the vaccine introduction will be monitored. This includes:

• Tracking the progress of introduction activities – beneficiary registration training, vaccine logistics availability, and task forces. This will be supported by partners through tracking mechanisms;

• Readiness assessment before vaccine introduction – field visits and desk review of data at national and state levels;

• Concurrent monitoring of vaccination activities – daily evening meetings, standardized monitoring tools, mobile-based apps, real-time data from the planning unit to the national level; and

• Knowledge management – the best practices and innovations at all levels would be shared to improve the implementation in the next phase of scale-up.

1.3 Introduction to Vaccines for Covid-19

The overarching goal is for COVID-19 vaccines to contribute significantly to the equitable protection and promotion of human well-being among people globally. Global equitable access to a vaccine, particularly protecting health care workers and those most-at-risk is the only way to mitigate the public health and economic impact of the pandemic and is the current priority. The vaccine is to be used in conjunction with other control measures. In the longer term, the vaccine is intended to be used for active immunization of people at-risk to prevent COVID-19. While countries, including India, have taken strong measures to contain the spread of COVID-19 through better diagnostics and treatment, vaccines will provide a solution by enhancing immunity and containing the disease spread.

Scientists throughout the world have accelerated the process to develop safe and effective COVID-19 vaccines. Vaccines aim to expose the body to an antigen and provoke an immune response that can block or kill the virus if a person becomes subsequently infected, without causing the disease. As part of the global efforts for rapid development of a safe and effective COVID-19 vaccine, various scientific techniques like the use of different viruses or viral parts10 are being developed. The COVID-19 vaccines under development use one of the following techniques:

Virus vaccines

These vaccines use the virus itself in a weakened or inactivated form. Vaccines against measles and polio (oral) are made in this manner. There are two types of virus vaccines under development against coronavirus, weakened virus and inactivated virus vaccines.

Viral-vector vaccines

In the development of these vaccines, a virus (such as adenovirus or measles), is genetically engineered to produce coronavirus proteins in the body, but the virus is weakened and cannot cause disease. The two types of viral-vector vaccines under development are replicating viral vector (can replicate within cells) and non-replicating viral vector (cannot replicate within cells).

Nucleic-acid vaccines

In these vaccines, nucleic acid (DNA or RNA) is inserted into human cells. These human cells then produce copies of the virus protein which produces an immune response. The two types of nucleic-acid vaccines under development are DNA vaccine and RNA vaccine.

Protein-based vaccines

These vaccines use virus protein fragments or protein shells which are injected directly into the body. The two types of protein-based vaccines being developed against the coronavirus are the protein subunit vaccines and virus-like particle vaccines.

1.4 Development of COVID-19 Vaccine

The Development of a vaccine is a time-consuming process that includes the following phases:

Table.1.1. Phases of vaccine development

Phases of vaccine development/trial Purpose

Pre-clinical Vaccine development in laboratory Phase 1 Clinical trial (8-10 participants) For testing vaccine safety Phase

2 Clinical trial (50-100 participants) For testing vaccine immunogenicity i.e. production of antibodies against virus

Phase 3 Clinical trial (30,000-50,000 For testing actual protection offered by the participants) vaccine

The vaccine development process has been fast-tracked and multiple platforms are under development. Among those with the greatest potential for speed are DNA and RNA-based platforms, followed by those for developing recombinant- subunit vaccines. RNA and DNA vaccines can be made quickly because they require no culture or fermentation, instead use synthetic processes. 12

Per the tracker developed by the Vaccine Centre at the London School of Hygiene and Tropical Medicine, a total of 274 candidate vaccines are in different stages of development as of 4 December 2020, preclinical (215), phase I (25), phase I/II (17), phase II (5), phase II/III (1), phase III (10) and licensed (1).

Table 1.2: Progress on COVID-19 Vaccine Development (Source: Vaccine Centre of London School of hygiene and Tropical Medicine, accessed 4 December 2020).

Types of COVID-19 vaccines Pre- Phase Phase Phase Phase Phase Licensed clinical I I/II II II/III III Live-attenuated 3 1 Virus Vaccine Inactivated 11 1 2 1 4 Replicating viral vector 18 1 2 1 Viral vector Vaccine Non-replicating viral 26 6 4 vector DNA vaccine 16 2 5 Nucleic acid vaccines RNA vaccine 29 2 2 1 1 1 Protein subunit 64 9 5 2 1 Protein based vaccine Virus like particle 17 1 1 Unknown - 31 3 Total 215 25 17 5 1 10 1

With multiple COVID-19 vaccines under development, key characteristics regarding dosage, storage requirements, efficacy, route of administration, etc., currently remain unknown. However, a recent landscape document by WHO details 51 vaccines in clinical evaluation. The landscape document, as of 2 December 2020, indicates that most vaccines will require a two-dose schedule to be administered two, three or four weeks apart, and will be administered through-the intramuscular IM route.

Vaccine specifications

In June 2020, the United Nations Children’s Fund (UNICEF) gathered information on vaccine specifications from 26 vaccine developers and manufacturers (10 manufacturing in China, 6 in India, 3 in the United States of America, 2 each in Belgium, Russia and Japan, 1 each in France, South Korea, Switzerland and the United Kingdom).

From the results, which were made public on 31 August 2020, characteristics of the COVID-19 vaccines under development from these 26 developers are:

Of the four vaccines with preliminary efficacy data available as of 4 December 2020, all are intramuscular (IM) injections with 2-dose courses.

• The University of Oxford/AstraZeneca vaccine can be stored, transported and handled at +2o to 8oC.

• BioNTech/Fosun Pharma/Pfizer vaccine has a recommended temperature condition of -80oC and can be stored for five days at +2o to 8oC.

• The Moderna/NIAID vaccine remains stable at -20oC for up to six months and remains stable at +2o to 8oC for 30 days and the Gamaleya institute, Sputnik-V vaccine can be stored at +2o to 8 oC.

1.5 COVID-19 vaccine development in India

There are 9 COVID-19 vaccine candidates in different phases of development in India, of these 3 are in pre-clinical phase whereas 6 are under clinical trials.

Table.1.3. Indian landscape of COVID-19 vaccines under development

1.6 Communication Strategy

The communication strategy that supports the COVID-19 vaccines rollout in India seeks to disseminate timely, accurate and transparent information about the vaccine(s) to alleviate apprehensions about the vaccine, ensure its acceptance and encourage uptake.

The strategy will also serve to guide national, state and district level communication activities, so that the information on the COVID-19 vaccines and vaccination process reaches all people, across all states in the country.

To support and encourage appropriate uptake of the vaccines by:

Managing and mitigating any potential disappointment expressed by unmet demand for the vaccine or ‘eagerness’ amongst people.

Addressing vaccine ‘hesitancy’ that could arise because of apprehensions around vaccine safety, efficacy; and any other myths and misconceptions.

Provide information on potential risks and mitigate unintended crisis (e.g. AEFI clusters, delay in vaccine rollout for certain population categories) during the introduction and rollout.

The strategy also seeks to build trust and enable greater confidence in the COVID-19 vaccine amongst all people by employing transparency in communication, while also managing any mis/disinformation and rumours around it.

Table 1.4 TOP 10 COUNTIRES IMPACTED BY COVID-19 (Numbers as of 01, February 2021)

No. Country Total Cases Total deaths Recovered Active Per million Cases Population Cases Deaths 1. USA 26,767,229 452,279 16,403,843 9,911,107 80,590 1,362 2. India 10,758,619 154,428 10,434,983 169,208 7,752 111 3. Brazil 9,204,731 224,534 8,027,042 953,155 43,125 1,052 4. Russia 3,868,087 73,619 3,318,173 476,295 26,499 504

5. UK 3,817,176 106,158 1,673,936 2,037,082 56,057 1,559 6. France 3,197,114 76,057 224,406 2,896,651 48,917 1,164 7. Spain 2,830,478 58,319 N/A N/A 60,525 1,247

8. Italy 2,553,032 88,516 2,010,548 453,968 42,262 1,465 9. Turkey 2,477,463 25,993 2,362,415 89,055 29,191 306

10. Germany 2,225,659 57,777 1,935,600 232,282 26,514 688

Total World 103,569,867 2,238,898 75,193,856 26,132,615 13,287.0 287.2

(Source: https://www.worldometers.info/coronavirus/)

1.7 Contents of COVID-19 Vaccine(s) – Operations Guidelines

CONTENTS

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1.8 Contents COVID-19 Vaccine(s) – Communication Strategy

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Table 1.9 Awareness Material (Ministry of Health & Family Welfare - GOI)

04.01.2021 Audio visual on Dr Guleria, Director, AIIMS sharing FAQs on COVID 19 vaccine rollout Episode 1/3 Episode 2/3 Episode 3/3 17.12.2020 FAQs on COVID 19 Vaccine for Healthcare providers and Frontline workers – English - Hindi 17.12.2020 FAQs on COVID 19 Vaccine for General Public - English - Hindi 12.10.2020 Encouraging youth to advocate against stigma and discrimination during COVID-19 - English 12.10.2020 Encouraging youth to advocate against stigma and discrimination during COVID-19 - Hindi 15.07.2020 Patients, their families and health care providers stand together to counter stigma and discrimination associated with COVID19 15.07.2020 A/V on 15 COVID Appropriate Behaviours - English 15.07.2020 A/V on 15 COVID Appropriate Behaviours - Hindi 03.07.2020 Hindi Video on supporting COVID recovered patients 03.07.2020 Hindi Video on COVID Appropriate Behaviours during COVID-19 03.07.2020 Hindi Video on extending support towards persons returning home during COVID-19 03.07.2020 Hindi Video on showing respect to healthcare workers 03.07.2020 Hindi Video on showing respect to sanitation workers 03.07.2020 Video on health care workers’ helping us fight the battle against COVID-19 03.07.2020 Heartfelt thanks to Corona Warriors 03.07.2020 Video on showing support for persons in quarantine / isolation 02.07.2020 A/V on thanking Corona Warriors 02.07.2020 Video on Home Isolation for very mild/ pre-symptomatic COVID-19 patients 22.06.2020 A/V on COVID Appropriate Behaviours (1/5), (2/5), (3/5), (4/5) & (5/5) 18.06.2020 An Illustrative Guide on COVID Appropriate Behaviours -English, Hindi 18.06.2020 A/V on "Quit using spit as it can increase the risk of spread of COVID-19" - (English) 18.06.2020 A/V on "Quit using spit as it can increase the risk of spread of COVID-19" - (Hindi) 16.06.2020 Guide to address stigma associated with COVID-19 - English 16.06.2020 Guide to address stigma associated with COVID-19 - Hindi 12.06.2020 Guidelines for Hotels on preventive measures to contain spread of COVID-19 12.06.2020 Guidelines for Offices on preventive measures to contain spread of COVID-19 12.06.2020 Guidelines for Religious Places on preventive measures to contain spread of COVID-19 12.06.2020 Guidelines for Restaurants on preventive measures to contain spread of COVID-19 12.06.2020 Guidelines for Shopping Malls on preventive measures to contain spread of COVID-19 08.06.2020 A/V on the need to address Stigma and Discrimination associated with COVID-19 08.06.2020 A/V on COVID Appropriate Behaviours - (English) 08.06.2020 A/V on COVID Appropriate Behaviours - (Hindi) 28.05.2020 RAP video to advocate no spitting

27.05.2020 Video on Caring and Sharing, the new normal 16.05.2020 NO Spitting in public places (Video) 15.05.2020 Guidelines for Home Isolation of very mild / pre-symptomatic COVID-19 cases (Video) 05.05.2020 Thematic Bank of COVID19 Creatives 1. What is Corona Virus and how does it transmits 2. Handwashing 3. COVID Appropriate Behaviours Pack 1.0 4. COVID Appropriate Behaviours Pack 2.0 5. Home Quarantine 6. Myth Busters 7. All India National Helpline 1075 8. No Spitting 9. Stigma and Discrimination 10. Thank you COVID Warriors 29.04.2020 Awareness Material for front line workers of COVID-19 – Hindi 29.04.2020 Awareness Material for front line workers of COVID-19 – Punjabi 29.04.2020 Awareness Material for front line workers of COVID-19 - Bengali 29.04.2020 Awareness Material for front line workers of COVID-19 - Marathi 29.04.2020 Awareness Material for front line workers of COVID-19 - Telgu (Telangana) 29.04.2020 Awareness Material for front line workers of COVID-19 - Telgu (Andra Pradesh) 29.04.2020 Awareness Material for front line workers of COVID-19 - Malayalam 29.04.2020 Awareness Material for front line workers of COVID-19 - Kannada 29.04.2020 Awareness Material for front line workers of COVID-19 - Tripura 29.04.2020 Awareness Material for front line workers of COVID-19 - Tamil 29.04.2020 Awareness Material for front line workers of COVID-19 - Gujrati 29.04.2020 Awareness Material for front line workers of COVID-19 - Odia 20.04.2020 Audio Visual on Addressing Stigma Related to COVID-19 18.04.2020 Information for general public on use of necessary medicines for COVID19 (Poster) 18.04.2020 Information for general public on use of necessary medicines for COVID19 - Audio Visual 11.04.2020 Video on use of reusable face cover (English) - Part 1 11.04.2020 Video on use of reusable face cover (English) - Part 2 08.04.2020 Video on Salutations to Coronavirus Warriors - I 08.04.2020 Video on Salutations to Coronavirus Warriors - II 08.04.2020 Know how to use your own Homemade Reusable Face Cover 07.04.2020 Know how to use your own Homemade Reusable Face Cover 04.04.2020 Video on Lockdown - Staying Active at Home 02.04.2020 Aarogya Setu App for staying informed and alert against COVID19. Government initiative to develop a digital Bridge to fight against COVID_19. Download Today! Play Store APPIOS APP 31.03.2020 Handling Public Grievances pertaining to COVID-19 in M/o Health & Family Welfare 29.03.2020 Video from experts from AIIMS, New Delhi sharing basic steps on hand washing to fight against COVID-19 – English

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2. DEMYSTIFYING THE CONCEPTS ABOUT COVID-19 AND VACCINATION

2.1 India’s Vaccination Drive

India started the world's largest Covid-19 vaccination drive, inoculating 3 crore people on priority. On 16 January, 2021- the first day of the drive - over 3 lakh healthcare workers were to be administered the vaccine against Covid-19. (Actual about 2.0 lakh were vaccinated).

A total of 3,006 session sites across all states and union territories will be virtually connected during the launch at 10.30 am by Prime Minister Narendra Modi and around 100 beneficiaries will be vaccinated at each session site. As India begins its journey into what the Health Ministry has called 'the beginning of the end”.

(i) What are the Vaccines approved by India, and their prices?

The vaccines Covishield, developed by the Serum Institute of India, and Covaxin from Bharat Biotech have been approved by the Indian government. These have already been delivered to all states and union territories. A dose of Covishield and CoVaxin may cost in the range of ₹200 to 295 in India. Serum Institute chief has also said that the jab may cost Rs.1,000 in the private market.

(ii) Are there any side-effects to the Vaccines?

The Health Ministry has cautioned about mild side effects following vaccination for both the vaccines. In case of Covishied, some mild adverse effects may occur like injection site tenderness, injection site pain, headache, fatigue, myalgia, malaise, pyrexia, chills and arthralgia and nausea. Some mild adverse effects in case of Covaxin include injection site pain, headache, fatigue, fever, body ache, abdominal pain, nausea and vomiting, dizziness-giddiness, tremor, sweating, cold, cough and injection site swelling. Paracetamol may be used to provide symptomatic relief from post vaccination adverse reactions.

(iii) Who is in the Priority Group ?

Healthcare workers will receive the jab first because they are at high risk of contracting the infection. Next, come the frontline workers, the vaccination of whom will help in reducing the societal and economic impact by reducing COVID-19 mortalities. And lastly, persons over 50 years of age and persons under 50 years with comorbid conditions will be inoculated, due to there being high mortality in the category.

(iv) What about the Co-win Application ?

Co-WIN is an online platform designed by the Centre for monitoring COVID-19 vaccine delivery. The Health Ministry has said it will form the foundation for the anti-coronavirus inoculation drive. The App is also designed to enable citizens to self-register for the vaccination process. However, that will take some time as the vaccination drive will start for frontline workers and other vulnerable citizens. The government had explained that the Co-WIN app comes with five modules, namely - Administrator module, Registration module, Vaccination module, Beneficiary Acknowledgement module, and Report module - to ensure smooth tracking and registration for COVID-19 vaccine in the country. The mobile app is also an upgraded version of the eVIN (Electronic Vaccine Intelligence Network) and it will be available to download for free via the Google 23

Play Store and Apple App Store. The App may also launch on Jio phones that run on KaiOS. 2.2 US COVID-19 Vaccination Program (Information provided by the Centers for Disease Control and Prevention)

Now that there are authorized and recommended vaccines to prevent COVID- 19 in the United States, here are 8 things one need to know about the new COVID- 19 Vaccination Program and COVID-19 vaccines. Vaccination started in US in December 2020.

(i) The safety of COVID-19 vaccines is a top priority.

The U.S. vaccine safety system ensures that all vaccines are as safe as possible.

CDC has developed a new tool, v-safe, as an additional layer of safety monitoring to increase our ability to rapidly detect any safety issues with COVID-19 vaccines. V-safe is a new smartphone-based, after-vaccination health checker for people who receive COVID-19 vaccines.

(ii) COVID-19 vaccination will help protect one from getting COVID-19. Two doses are needed.

Depending on the specific vaccine, a second shot 3-4 weeks after your first shot is needed to get the most protection the vaccine has to offer against this serious disease.

(iii) CDC is making recommendations for who should be offered COVID-19 vaccine first when supplies are limited.

To help guide decisions about how to distribute limited initial supplies of COVID-19 vaccine, CDC and the Advisory Committee on Immunization Practices have published recommendations for which groups should be vaccinated first.

(iv) There is currently a limited supply of COVID-19 vaccine in the United States, but supply will increase in the weeks and months to come.

The goal is for everyone to be able to easily get vaccinated against COVID-19 as soon as large enough quantities are available. Once vaccine is widely available, the plan is to have several thousand vaccination providers offering COVID-19 vaccines in doctors’ offices, retail pharmacies, hospitals, and federally qualified health centers.

(v) After COVID-19 vaccination, one may have some side effects. This is a normal sign that the body is building protection.

The side effects from COVID-19 vaccination may feel like flu and might even affect ability to do daily activities, but they should go away in a few days.

(vi) Can a COVID-19 vaccine make one sick with COVID-19?

No. None of the COVID-19 vaccines contain the live virus that causes COVID- 19 so a COVID-19 vaccine cannot make one sick with COVID-19.

(vii) The first COVID-19 vaccines are being used under Emergency Use Authorizations (EUA) from the U.S. Food and Drug Administration (FDA). Many other vaccines are still being developed and tested.

If more COVID-19 vaccines are authorized or approved by FDA, the Advisory Committee on Immunization Practices (ACIP) will quickly hold public meetings to review all available data about each vaccine and make recommendations for their use in the United States.

All ACIP-recommended vaccines will be included in the U.S. COVID-19 Vaccination Program. CDC continues to work at all levels with partners, including healthcare associations, on a flexible COVID-19 vaccination program that can accommodate different vaccines and adapt to different scenarios. State, tribal, local, and territorial health departments have developed distribution plans to make sure all recommended vaccines are available to their communities.

(viii) COVID-19 vaccines are one of many important tools to help stop this pandemic.

It’s important for everyone to continue using all the tools available to help stop this pandemic as we learn more about how COVID-19 vaccines work in real- world conditions. Cover your mouth and nose with a mask when around others, stay at least 6 feet away from others, avoid crowds, and wash your hands often.

2.3 FAQ and Answers on Vaccines for Covid-19

(i) How do vaccines work?

Vaccines stimulate the human body’s own protective immune responses so that, if a person is infected with a pathogen, the immune system can quickly prevent the infection from spreading within the body and causing disease. In this way, vaccines mimic natural infection but without actually causing the person to become sick.

For SARS-CoV-2, antibodies that bind to and block the spike protein on the virus’s surface are thought to be most important for protection from disease because the spike protein is what attaches to human cells, allowing the virus to enter the cells. Blocking this entrance prevents infection.

Not all people who are infected with SARS-CoV-2 develop disease (Covid-19 is the disease caused by the virus SARS-CoV-2). These people have asymptomatic infection but can still transmit the virus to others. Most vaccines do not completely prevent infection but do prevent the infection from spreading within the body and from causing disease. Many vaccines can also prevent transmission, potentially leading to herd protection whereby unvaccinated people are protected from infection by the vaccinated people around them because they have less chance of exposure to the virus.

(ii) What are the different types of vaccines in use or in development and why are there so many? Several different types of vaccines against SARS-CoV-2, the virus that causes the disease Covid-19, are in use or in development. Some are based on traditional methods for producing vaccines and others on newer methods. One of the more traditional ways of making a viral vaccine is to inactivate (kill) the virus with chemicals, such as is done with the flu vaccine, inactivated polio or hepatitis A vaccines, so that the virus can no longer multiply. Several inactivated SARS-CoV-2 vaccines are in development. Other vaccines are based on just a part of the bacteria or virus, typically one or more proteins, such as the vaccines for whooping cough (pertussis) and hepatitis B virus. For SARS-CoV-2 vaccines that focus on a part of the virus.

Newer vaccine types include what are called viral vector vaccines, in which the SARS-CoV-2 gene for the spike protein is inserted into another harmless virus to deliver the gene to human cells where the spike protein is produced. The spike protein then stimulates immune responses. The most common viral vectors are adenoviruses, which typically cause common cold-like symptoms in people but are further weakened for vaccines so they cannot cause any disease at all. Several adenovirus vector vaccine for SARS-CoV-2 are in advanced clinical testing (phase 3 clinical trials), such as the vaccine produced by Johnson & Johnson that may be protective following a single dose.

Finally, instead of using a viral vector, the gene for the spike protein can be used directly as a vaccine in the form of DNA or messenger RNA (mRNA). These are the most novel SARS-CoV-2 vaccines. Several mRNA vaccines are in advanced clinical testing.

Many manufactures around the world are working on this global problem. This means that there will likely be multiple different types of SARS-CoV-2 vaccines and they may work differently in different people. Hopefully, some will work well in older adults and in people with underlying conditions that impair their immune system, as these groups are more likely to get sick and die from Covid-19.

(iii) How do we know if a vaccine is safe and effective? The safety and efficacy of a vaccine are determined through clinical trials. Clinical trials are studies that are typically conducted in three phases to assess the safety and efficacy of vaccines in increasingly larger numbers of volunteers.

Phase 1 clinical trials assess the safety and dosage of a vaccine in a small number of people, typically a dozen to several dozen healthy volunteers. Whether a vaccine stimulates immune responses is often assessed in a phase 1 study but this is better assessed in phase 2 studies, which typically involve hundreds of people including some special groups such as children, people with pre-existing conditions such as heart disease, and older adults. Vaccine safety is also assessed in phase 2 studies, in which adverse events not detected in phase 1 trials may be identified because a larger and more diverse group of people receive the vaccine. However, only in much larger phase 3 clinical trials can it be demonstrated whether a vaccine is actually protective against disease and safety is more fully assessed.

Phase 3 clinical trials often include thousands of volunteers, and for Covid-19 vaccines involve tens of thousands (30,000 to 45,000 people in some of the phase 3 trials). In phase 3 trials, participants are randomized to receive either the viral vaccine or a placebo vaccine (sometimes a vaccine against another disease or a harmless substance like saline). Randomization is a process to determine who receives the vaccine and who receives the placebo without any bias, like flipping a coin. To further prevent any bias in interpreting the study data, participants and most of the investigators will not know if an individual received the vaccine or placebo. The participants are then followed to see how many in each group get the disease. If the vaccine is efficacious, many fewer people who received the viral vaccine will get the disease compared to those who received the placebo vaccine. It takes time for cases of disease to accumulate so that we can be confident there is a true difference between the two groups, and this is why these phase 3 trials often take a long time. Assessing safety is also a major goal of phase 3 trials, both short-term (e.g., fever, tenderness, muscle aches) and long-term safety (e.g., autoimmune conditions or enhanced disease following infection).

After a vaccine is approved and in more widespread use, it is critically important to continue to monitor for both safety and effectiveness. Some very rare side effects may only be detectable when large numbers of people have been vaccinated. Safety concerns that are discovered at this late stage could lead a licensed vaccine to be withdrawn from use, although this is very rare.

(iv) When will a vaccine be available ?

Vaccines for SARS-CoV-2 will be available when they are demonstrated to be safe and efficacious in large phase 3 clinical trials, have been approved by regulatory authorities (the Food and Drug Administration in United States), and have been manufactured and distributed to places where people can be vaccinated.

To demonstrate efficacy, sufficient differences in disease must be observed between those who received the viral vaccine and those who received the placebo or comparison vaccine in a phase 3 clinical trial. This depends on the likelihood of infection in places where the studies are conducted but can take from several months to years. Once sufficient data are available to be confident that the vaccine is efficacious, and no evidence of serious adverse events is identified, a rigorous and transparent approval process should take place.

Manufacturing capacity has already been developed for some vaccines and vaccine distribution systems are being put in place. However, because of limited quantities of vaccine, some groups of people will be offered the vaccine first, likely health care workers, other essential personnel, and those most vulnerable to severe disease and death.

(v) How is the process for approving a vaccine moving so quickly ?

Traditionally, it has taken many years to develop a vaccine, confirm its safety and efficacy, and manufacture the vaccine in sufficient quantities for public use. This timeline has been substantially shortened for SARS-CoV-2 vaccines in development. There are several ways this has been made possible. First, some 27

clinical trials have combined phases 1 and 2 to assess safety and immune responses. Second, because of the high number of new cases of Covid-19 in many places, differences in disease risk between those who received the viral vaccine and those who received the placebo or comparison vaccine can be measured more quickly than in the absence of a pandemic. Third, the United States government and others heavily invested in building the manufacturing capacity to produce large numbers of vaccine doses before the findings of the phase 3 trials were available. Typically, vaccine manufacturers wait until the phase 3 trial is completed and shows safety and efficacy before making such a large investment in manufacturing capacity. None of these factors that contribute to the accelerated development of a vaccine for SARS-CoV-2 imply that safety, scientific or ethical integrity are compromised, or that short-cuts were made.

(vi) What is an emergency use authorization?

Drugs and vaccines have to be approved by the Food and Drug Administration (FDA) to ensure that only safe and effective products are available to the American public. In situations when there is good scientific reason to believe that a drug is safe and is likely to treat or prevent disease, the FDA may authorize its use even if definitive proof of the efficacy of the drug is not known, especially for diseases that cause high mortality.

Emergency use authorizations were granted by the FDA Commissioner for chloroquine and hydroxychloroquine (later revoked) and for the use of convalescent plasma to treat hospitalized patients with Covid-19. Many are concerned that Emergency Use Authorization for a vaccine could be issued prematurely, before sufficient safety and efficacy data have been generated through phase 3 clinical trails.

It is important to emphasize that the bar for ensuring safety of a vaccine is higher than for a therapeutic to treat an ill person. Vaccines are given to potentially millions of healthy people, unlike drugs for sick people, and loss of trust in a vaccine for SARS-CoV-2 could spill over into loss of trust in other vaccines, seriously jeopardizing public health.

(vii) How long will it take for the general public to be vaccinated after a vaccine is approved? It is not clear at this point in time when vaccines will be available, but a reasonable guess may be at least six months to one year after approval. The timeline depends on how rapidly vaccine doses can be produced and distributed. Importantly, the public will need to trust a vaccine and be willing to be vaccinated to have a public health impact. Building trust in a vaccine for SARS-CoV-2, particularly in communities with long-standing mistrust of the government and scientific experiments, is critical.

(viii) Should children get the vaccine? Children will not be a priority group for a vaccine early in vaccine deployment but will likely be eligible as vaccine availability improves. The major vaccine clinical trails are currently focussed on enrolling adults, and as they expand, the inclusion of children in vaccine clinical trials will produce data on safety and

efficacy that can be applied to children. While children are less likely to develop severe disease and die from Covid-19, there are several reasons for ensuring that eventually there is a vaccine that is safe and effective for children. Although rare, some children may develop severe disease or die from Covid- 19. Children have also developed a severe inflammatory syndrome, called multisystem inflammatory syndrome in children. Children may be important transmitters of SARS-CoV-2 and vaccinating them with a vaccine that reduces transmission could be important in controlling the pandemic. Finally, having a safe vaccine for children will build confidence towards opening up schools and learning centers for in-person educational processes.

(ix) How long will protection last following vaccination? We do not yet know how long protection lasts following vaccination but it will be critically important to measure long-term protection (at least two years) in the phase 3 trials and in other groups prioritized for early vaccination. We are still learning about the duration of protection following infection with SARS-CoV-2 and it is too early to tell how long protection will last. There have already been cases where individuals have been shown to be infected twice but most often the second illness was mild or without any symptoms. This is what we would expect with an immune response that protects against disease but not infection.

There are ways to potentially make protection following vaccination more durable than following natural infection, such as with an adjuvant, an ingredient used in some vaccines that helps create a stronger immune response, or with booster doses of vaccine. These strategies to enhance vaccines may be particularly important for vulnerable populations, such as the elderly and those with underlying diseases, who are at particular risk of severe Covid-19 but are also less likely to develop a protective immune response to a vaccine.

(x) If I already had Covid-19, should I still get a vaccine?

When people recover from some viral infections, such as measles or mumps, they are protected against reinfection and would not need to be vaccinated. However, for other diseases, such as pneumococcal pneumonia or influenza, it is important to be vaccinated (or revaccinated) despite having disease because the vaccine protects against several strains or types of the pathogen and thus can still be valuable. There is no evidence that there are significant differences in SARS-CoV-2 to warrant vaccination for this reason, but we do not yet know how long people are protected after having Covid-19 and so do not yet know if these people should be vaccinated. If protection only lasts for several months, vaccination could be of benefit.

(xi) Can someone get Covid-19 from the vaccine?

No, it is not possible to get Covid-19 from vaccines. Vaccines against SARS- CoV-2 use inactivated virus, parts of the virus (e.g., the spike protein), or a gene from the virus. None of these can cause Covid-19.

(xii) Should I get the vaccine for influenza (flu shot)?

Yes, it is very important to get the influenza vaccine, particularly this season when both influenza viruses and SARS-CoV-2 can infect people. We still do not 29

know how these two viruses will interact but people can get infected with both viruses and this will likely cause more severe disease and possibly death. Reducing the number of people who get severe influenza and require hospitalization will also help ensure that the health care system, hospitals and intensive care units will not be overwhelmed should there be an increase in Covid-19 cases this fall and winter.

(xiii) Will we still need to wear a masks and practice physical distancing once a vaccine is available?

We will still need to wear masks and practice physical distancing until a large proportion of the population is vaccinated and we are sure the vaccine provides long-term protection. Initially, we will not have enough vaccine to vaccinate everyone who wants the vaccine and the virus will still be transmitted.

Although the phase 3 clinical trials were designed to determine whether vaccinated individuals are protected against disease, it will also be important to understand whether vaccinated individuals are less likely to transmit the virus. This is likely but not ensured. If a vaccine not only protects against disease but reduces transmission, and continues to do so for many years, we are likely to reach a state of herd protection when masks and physical distancing will no longer be required. Herd protection is achieved when a sufficient proportion of the population is made non-infectious through vaccination or natural infection so that the likelihood of an infectious individual transmitting to a susceptible individual is very low.

2.4 Myths on Vaccines

Vaccine Myths Demystified

Vaccines are widely considered one of the greatest inventions of mankind.

The World Health Organization (WHO) estimates that vaccines prevented over 10 million deaths between 2010 and 2015, and many millions more were protected from illness.

Despite this, there are growing anti-vaccination and vaccine hesitancy movements in the world.

There is a lot of misinformation and misconceptions about vaccines that contribute to this growing problem. The facts behind some of the most common vaccine myths are indicated in what follows. Three papers were referred to in this (i) 10 Common Myths busted; [University of Maryland Madical Systems, as of 16-12- 2020] (1-10); (ii) Mayo Clinic Health Systems as of 08-12-2020. ; (iii) Health guard as of 16-01-2021.

Myth 1: One can delay routine vaccinations until the coronavirus pandemic is over. Adult vaccines and childhood vaccines are essential for maintaining health and wellness.

Both the American Academy of Pediatrics and the Centers for Disease Control and Prevention recommend staying up-to-date on routine vaccinations during the pandemic. Delaying vaccination can be harmful to health and the health of the community. Myth 2: Vaccines can make one sick.

Vaccines will not make a person sick.

Some people can experience mild side effects from some vaccines, such as soreness at the injection site or a low-grade fever, but they dissipate quickly. According to WHO, serious side effects from vaccines rarely occur. In fact, many adverse effects are so rare that their risk cannot be accurately assessed statistically.

Myth 3: Vaccines contain toxic ingredients.

Dosage is everything when it comes to toxicity.

Any substance—even water—can be toxic in large doses. Some vaccines contain ingredients like formaldehyde and aluminum, but these trace amounts are so small that they're not considered toxic or harmful.

The gelatin and egg proteins featured in some flu vaccines can cause allergic reactions in very rare cases. Those affected typically have a history of severe allergies to gelatin or eggs.

Myth 4: Vaccines can overload your immune system.

Children often require a lot of vaccinations within a short period of time. Luckily, there is no need to worry.

The immune system is resilient and isn't negatively affected by receiving simultaneous vaccines. There's also no evidence that spacing out vaccines is safer for children. In fact, delaying childhood vaccinations can cause community outbreaks of preventable diseases like measles or chickenpox. A 2015 study showed that only 1% of pediatricians thought vaccines should be spread out.

Myth 5: Natural immunity is healthier and more effective than vaccine-induced immunity.

Vaccines allows to build immunity without the damaging effects.

These diseases can cause serious health problems and even be life- threatening. For example, Haemophilus influenzae type b (Hib) can cause intellectual disability and measles can lead to death. All of these effects can be avoided by simply getting vaccinated.

When administered properly and in the recommended quantities, all vaccines provide the protection that is needed. In some cases, a single

natural infection can invoke a greater immune response than a single vaccine, which is why some vaccines require multiple doses. However, this makes no difference when it comes to preventing infection.

Myth 6: If everyone around is immune, then I don't need to be vaccinated.

Getting vaccinated is like wearing a mask – it isn't just about protecting that person, but also his community.

Most vaccine-preventable diseases spread through person-to-person contact. When one person in a community gets the disease, it can easily spread to other people. When more people are vaccinated, the fewer chances a disease will spread.

Myth 7: We don't get vaccine-preventable diseases in the United States.

Diseases that were once common in the United States, like measles or polio, are now rare or even eliminated completely because generations of people were vaccinated to protect themselves and their communities.

In our globalized world, the potential exposure to vaccine-preventable diseases is only a plane ride away. As the coronavirus pandemic has painfully reminded us, if one country has an outbreak, it's the world's concern. In all of human history, smallpox is the only disease to be eradicated from the plant completely.

Failing to get vaccinated can put yourself and your entire community at risk.

Myth 8: The flu vaccine will protect against COVID-19.

There is no evidence to support the claim that the flu vaccine protects against coronavirus.

However, it's still important to get both of these vaccines. In fact, getting flu vaccine is even more important in 2020. If you fail to get your flu vaccine, you could potentially be infected with coronavirus and the flu at the same time, putting strain on both your health and our health care system.

Myth 9: Vaccines can cause autism.

Vaccines don't cause autism.

This claim stems from a discredited and retracted study that linked the measles, mumps and rubella (MMR) vaccine to autism. Unfortunately, this flawed study has kicked off a resilient storm of misinformation.

Hundreds of studies across the globe have shown time and time again that there is no connection, but a 2016 national study revealed 16.5% of parents or primary caregivers of autistic children believed vaccines caused their child's autism.

Myth 10: Vaccines are used to microchip people.

The internet can be beneficial for learning more about health, but it can also be fertile ground for misinformation -- particularly during the coronavirus pandemic. 33

There are some claims that vaccines are or will be used to microchip people so they can be tracked or controlled through 5G cell phone towers. This is not only false, but impossible. Evidence suggests that this conspiracy theory was spread by people seeking to sow disinformation and confusion among Americans.

Myth 11: The COVID-19 vaccine is not safe because it was rapidly developed and tested.

Fact: Many pharmaceutical companies invested significant resources into quickly developing a vaccine for COVID-19 because of the world-wide impact of the pandemic. The emergency situation warranted an emergency response but that does not mean that companies bypassed safety protocols or didn't perform adequate testing.

Mayo Clinic will recommend the use of those vaccines that we are confident are safe. While there are many COVID-19 vaccine candidates in development, early interim data are encouraging for the Pfizer vaccine which likely is to be the first authorized for emergency use by the FDA in the late December/early January timeframe. This vaccine was created using a novel technology based on the molecular structure of the virus. The novel methodology to develop a COVID-19 vaccine allows it to be free from materials of animal origin and synthesized by an efficient, cell-free process without preservatives. This vaccine developed by Pfizer/BioNTecH has been studied in approximately 43,000 people.

To receive emergency use authorization, the biopharmaceutical manufacturer must have followed at least half of the study participants for at least two months after completing the vaccination series, and the vaccine must be proven safe and effective in that population. In addition to the safety review by the FDA, the Advisory Committee on Immunization has convened a panel of vaccine safety experts to independently evaluate the safety data from the clinical trial. Mayo Clinic vaccine experts also will review the available data. The safety of COVID-19 vaccine will continue to be closely monitored by the Centers for Disease Control and Prevention (CDC) and the FDA.

Myth 12: I already had COVID-19 and I have recovered, so I don't need to get a COVID-19 vaccine when it's available.

Fact: There is not enough information currently available to say if or for how long after infection someone is protected from getting COVID-19 again. This is called natural immunity. Early evidence suggests natural immunity from COVID-19 may not last very long, but more studies are needed to better understand this. Mayo Clinic recommends getting the COVID-19 vaccine, even if you’ve had COVID-19 previously. However, those that had COVID-19 should delay vaccination until about 90 days from diagnosis. People should not get vaccinated if in quarantine after exposure or if they have COVID-19 symptoms./p>

Myth13: There are severe side effects of the COVID-19 vaccines.

Fact: There are short-term mild or moderate vaccine reactions that resolve without complication or injury. The early phase studies of the Pfizer vaccine show that it is safe. About 15% of people developed short lived symptoms at the site of the injection. 50% developed systemic reactions primarily headache, chills, fatigue or muscle pain or fever lasting for a day or two. Keep in mind that these side effects are indicators that your immune system is responding to the vaccine and are common when receiving vaccines.

Myth 14: I won't need to wear a mask after I get vaccinated for COVID-19.

Fact: It may take time for everyone who wants a COVID-19 vaccination to get one. Also, while the vaccine may prevent you from getting sick, it is unknown at this time if you can still carry and transmit the virus to others. Until more is understood about how well the vaccine works, continuing with precautions such as mask-wearing and physical distancing will be important.

Myth 15: More people will die as a result of a negative side effect to the COVID- 19 vaccine than would actually die from the virus.

Fact: Circulating on social media is the claim that COVID-19's mortality rate is 1%-2% and that people should not be vaccinated against a virus with a high survival rate. However, a 1% mortality rate is 10 times more lethal than the seasonal flu. In addition, the mortality rate can vary widely and is influenced by age, sex and underlying health condition.

While some people who receive the vaccine may develop symptoms as their immune system responds, remember that this is common when receiving any vaccine and not considered serious or life-threatening. You cannot get COVID-19 infection from the COVID-19 vaccines; they are inactivated vaccines and not live viruses.

It's important to recognize that getting the vaccine is not just about survival from COVID-19. It's about preventing spread of the virus to others and preventing infection that can lead to long-term negative health effects. While no vaccine is 100% effective, they are far better than not getting a vaccine. The benefits certainly outweigh the risks in healthy people.

Myth 16: The COVID-19 vaccine was developed to control the general population either through microchip tracking or "nanotransducers" in our brains.

Fact: There is no vaccine microchip, and the vaccine will not track people or gather personal information into a database.

This myth started after comments made by Bill Gates from The Gates Foundation about a digital certificate of vaccine records. The technology he was referencing is not a microchip, has not been implemented in any manner and is not tied to the development, testing or distribution of COVID- 19 vaccines.

Myth 17: COVID-19 vaccines will alter DNA of the person.

Fact: The first COVID-19 vaccines to reach the market are likely to be messenger RNA (mRNA) vaccines. According to the CDC, mRNA vaccines work by instructing cells in the body how to make a protein that triggers an immune response. Injecting mRNA into your body will not interact or do anything to the DNA of your cells. Human cells break down and get rid of the mRNA soon after they have finished using the instructions.

Myth 18: COVID-19 vaccines cause infertility or miscarriage. Fact: No, COVID-19 vaccines have not been linked to infertility or miscarriage.

A sophisticated disinformation campaign has been circulating online, claiming that antibodies to the spike protein of COVID-19 produced from these vaccines will bind to placental proteins and prevent pregnancy. This disinformation is thought to originate from internet postings by a former scientist known to hold anti-vaccine views.

These postings are not scientifically plausible, as COVID-19 infection has not been linked to infertility. Also, no other viral infection or vaccination- inducing immunity by similar mechanisms has been shown to cause infertility. Antibodies to the spike protein have not been linked to infertility after COVID-19 infection. There is no scientific reason to believe this will change after vaccination for COVID-19.

While there are no formal studies, the best evidence comes from women who got sick with COVID-19 while pregnant. While data clearly indicate pregnant women are at higher risk of hospitalization due to COVID-19 infection, there is no evidence of increased miscarriage rates.

During natural infection, the immune system generates the same antibodies to the spike protein that COVID-19 vaccines would. Thus, if COVID-19 affected fertility, there already would be an increase in miscarriage rates in women infected with COVID-19. This has not happened.

Myth 19: I am allergic to eggs so I shouldn't get the COVID-19 vaccine.

Fact: Neither the Pfizer/BioNTech COVID-19 vaccine nor the Moderna COVID-19 vaccines contain egg nor were eggs used the development or production of either vaccine. However, those with severe allergic reactions to eggs or any other substance (i.e., anaphylaxis) are encouraged to remain after vaccination for 30 minutes for observation.

Myth 20: COVID-19 vaccines must be stored at extremely low temperatures because of preservatives in the vaccines.

Fact: Pfizer/BioNTech and Moderna have reported that their vaccines contain no preservatives.

Different vaccines have different storage requirements. For instance, the Pfizer/BioNTech vaccine must be stored at minus 94 degrees Fahrenheit (minus 70 degrees Celsius), while Moderna has said that its vaccine needs to be stored at minus 4 degrees Fahrenheit (minus 20 degrees Celsius). Both of these vaccines use messenger RNA, or mRNA, to teach cells how to make a protein that will trigger an immune response to COVID-19. However, messenger RNA is fragile and can break down easily. Storing messenger RNA vaccines, like these COVID-19 vaccines, in an ultracold environment keeps them stable and safe. One should not worry about these temperatures. Vaccines are thawed before injection.  The remaining Myths 21-26 are from Health Guard, last updated on 16 January, 2021

MYTH 21: COVID-19 vaccines are not being tested against a placebo in clinical trials.

THE FACTS: The final phase of clinical testing for COVID-19 vaccine candidates are Phase 3 trials, in which the vaccine is given to tens of thousands of patients. Researchers then compare how many patients become infected with COVID-19 compared to a separate group of patients who received a placebo, to determine the vaccine’s efficacy and safety. All 10 vaccine candidates that have begun Phase 3 trials as of Nov. 3, 2020, are being tested against a placebo, according to the World Health Organization.

MYTH 22: Dr. Anthony Fauci will personally profit from a COVID-19 vaccine.

THE FACTS: There is no evidence that Fauci, director of the U.S. National Institute of Allergy and Infectious Diseases (NIAID), has personal investments in vaccines being developed for COVID-19. Fauci’s agency is working with pharmaceutical company Moderna. but PolitiFact found no record of a business relationship between Fauci and Moderna in an April 2020 search of the U.S. Securities and Exchange Commission’s database.

MYTH 23: A new law in Colorado will force parents into a government-run re- education program if they refuse to give their children a COVID-19 vaccine.

THE FACTS: The School Entry Immunization Bill, signed into law by Colorado’s governor in June 2020, does not make any reference to COVID- 19 or a COVID-19 vaccine. The law did toughen the state’s process for obtaining a religious or personal belief vaccine exemption, requiring parents requesting such an exemption to either submit a form signed by a health care provider, or complete what the law calls an “online education module” about vaccine science, produced by the Colorado Department of Public Health and Environment.

MYTH 24: The COVID-19 vaccine has been proven to cause infertility in 97 percent of its recipients.

THE FACTS: This claim appears to have originated with British YouTuber Zed Phoenix, who claimed that an unnamed source at pharmaceutical company GlaxoSmithKline told him that 61 of the 63 women tested with a COVID-19 vaccine became infertile and that a separate, male-specific vaccine “resulted in decreased testicular size, drop of testosterone levels, and marked atrophy of the prostate.” Phoenix’s statements about the alleged effects of these vaccines appear to have been taken verbatim from an unrelated 1989 study from the National Institute of Immunology in New Delhi, India, according to Reuters. This research examined the use of anti-fertility vaccines on baboons in discussing future treatment options for human cancer patients whose tumors are affected by fertility hormones. None of the COVID-19 vaccine candidates are gender-specific or are in any way related to fertility.

MYTH 25: COVID-19 vaccines will contain aborted human fetaltissue.

THE FACTS: Existing vaccines for diseases such as chickenpox and rubella are produced using cell lines descended from fetuses aborted decades ago. According to a June 2020 article published in Science magazine, at least five COVID-19 vaccine candidates are using fetal cell lines: one descended from a fetus aborted in 1972 and another from an abortion performed in 1985.

However, no additional fetal cells are required for the production of any of these vaccines, including those being developed for COVID-19, and no actual fetal tissue is present in these vaccines. The National Catholic Bioethics Center, which consults with the Vatican and Catholics on medical ethics issues and opposes abortion, has stated, “The cells in these lines have gone through multiple divisions before they are used in vaccine manufacture. After manufacture, the vaccines are removed from the cell lines and purified. One cannot accurately say that the vaccines contain any of the cells from the original abortion.”

MYTH 26 : The COVID-19 vaccine being developed by Oxford University and AstraZeneca will turn people into monkeys.

THE FACTS: This false claim is based on the fact that Oxford and AstraZeneca’s vaccine relies on a modified chimpanzee adenovirus intended to generate an immune response to the virus that causes COVID-19. According to The Times of London, the claim is being promoted through memes and video clips as part of a disinformation campaign involving officials in Russian state agencies, specifically targeted at countries where Russia wants to sell its own COVID-19 vaccine.

MYTH 27 : Government food stamps will be denied to those who refuse COVID-19 vaccines.

THE FACTS: The pseudoscience and conspiracy-oriented website Natural News first reported that President-elect Joe Biden’s COVID-19 task force had announced such a policy. However, the article relied on outdated and inaccurate information. Dr. Luciana Borio, a member of the task force, helped write a report from the Johns Hopkins Center for Health Security in July 2020 that mentioned government food stamps in a larger discussion 39

about COVID-19 vaccines. However, the report was not part of the task force, and it did not advocate the denial of food stamps to people who decline to take a COVID-19 vaccine. The report’s lead authors said in a statement to FactCheck.org in November 2020 that they “do NOT advocate that such social supports ever be withheld in connection with an individual’s vaccination status.”

MYTH 28: The U.K. Medicines and Healthcare products Regulatory Agency (MHRA) will use artificial intelligence to monitor the safety of COVID-19 vaccines because the agency knows that vaccines are extremely dangerous.

THE FACTS: It is true that MHRA has awarded a contract to the company Genpact to create an artificial intelligence tool to monitor reports of adverse effects to COVID-19 vaccines. However, the agency states that this is not evidence of foreknowledge of dangers posed by vaccines. Moreover, an adverse event report does not prove that the event or reaction was caused by a vaccine.

In a November 2020 statement to NewsGuard, the MHRA said, “We have a range of resources and technology to support the safety monitoring of any COVID-19 vaccination programme. The use of AI will be one element of that. We take every report of a suspected side effect seriously and we combine the review of these individual reports with statistical analysis of clinical records.”

The agency continued: “Based on the available published reports from the Phase One and Two clinical trials, we don’t currently anticipate any specific safety concerns with COVID-19 vaccines. We expect the general safety profile to be similar to other types of vaccines. A COVID-19 vaccine will only be deployed once it has been proven to be safe and effective through robust clinical trials and approved for use.”

MYTH 29: A document on the FDA website shows that two participants died as a result of “serious adverse events” from an experimental COVID-19 vaccine.

THE FACTS: There were two deaths among the 21,000 people in the trial who received Pfizer and BioNtech’s COVID-19 vaccine, but the U.S. Food and Drug Administration did not attribute those deaths to the vaccine.

According to a December 2020 FDA document describing the circumstances of the deaths, “one experienced a cardiac arrest 62 days after vaccination #2 died 3 days later, and the other died from arteriosclerosis 3 days after vaccination #1.” The document also said in the case of the second death, the participant had “baseline obesity and pre-existing atherosclerosis,” or a narrowing of the arteries.

There were also four deaths reported among the 21,000 trial participants who received a placebo. The deaths “represent events that occur in the general population of the age groups where they occurred, at a similar rate,” according to the FDA document.

To determine the safety of the vaccine, the trial recorded what are called “serious adverse events,” defined by the U.S. National Library of Medicine as any medical event that results in death, hospitalization, or interferes substantially with normal life functions. The FDA document said among the serious events reported in the Pfizer/BioNTech trial, it considered only two as possibly related to the vaccine: a shoulder injury and swollen lymph nodes, a common and typically benign condition.

MYTH 30: The virus mutates so fast that a vaccine will never work.

THE FACTS: Available evidence suggests that the COVID-19 virus is genetically stable and mutates slowly. For example, scientists say that the COVID-19 virus mutates twice as slowly as does the seasonal flu virus, which requires a new vaccine every year, according to Emma Hodcroft, a molecular epidemiologist at the University of Basel, Switzerland, who was cited in a September 2020 Nature article.

Experts say that COVID-19’s relatively slow rate of mutation suggests that at least for the short term, a vaccine would be effective. Trevor Bedford, an infectious-disease expert at the Fred Hutchinson Cancer Research Center in Seattle, told Business Insider in November 2020: “It will take the virus a few years to mutate enough to significantly hinder a vaccine.”

MYTH 31: The head of research at Pfizer said the company’s COVID-19 vaccine contains a protein called syncytin-1 that will result in female sterilization.

THE FACTS: This claim was based on a petition to the European Medicines Agency from a doctor named Michael Yeadon, apparently the aforementioned “head of Pfizer research.” In fact, Yeadon had left the company in 2011, according to a December 2020 article by The Associated Press.

The petition speculated that the vaccine may create an immune response against a protein vital for the formation of the placenta during pregnancy. However, the vaccine does not contain syncytin-1 and there is no evidence connecting the COVID-19 vaccine to infertility.

Moreover, there is no evidence that the spike protein in the virus that causes COVID-19 and that is being targeted by the vaccine will create an immune response against syncytin-1, scientists say. “Any hint of similarity between syncytin-1 and the SARS-CoV-2 spike protein (which is used as part of the vaccine) is extremely remote,” Brent Stockwell, a biological sciences and chemistry professor at Columbia University, told PolitiFact in December 2020. “There are hardly any parts of the two proteins that are even vaguely similar, and they are far more distinct than would be needed for cross- reactivity of immune responses.” In a December 2020 statement to The Associated Press, Pfizer spokesperson Jerica Pitts said the company’s COVID-19 vaccine had not been found to cause infertility. “It has been incorrectly suggested that COVID-19 vaccines will cause infertility because of a shared amino acid sequence in the spike protein of SARS-CoV-2 and a placental protein,” she

said. “The sequence, however, is too short to plausibly give rise to autoimmunity.”

MYTH 32: COVID-19 vaccine injections, shown during press events being delivered to health care workers, are fabricated, using syringes with “disappearing needles.” THE FACTS: These claims were made in Twitter posts and YouTube clips, using real videos from press events where health care workers received COVID-19 vaccines. One tweet that promoted this claim, using BBC footage of a worker receiving a COVID-19 vaccine injection, attracted 394,000 views between Dec. 16 and 17, 2020.

According to the BBC and Vice News, the injections of the COVID-19 vaccine shown in these videos were delivered using retractable syringes, not “disappearing needles,” where the needlepoint automatically retracted into the barrel of the syringe once the dose of medication was delivered. Retractable syringes are typically used to reduce needlepoint injuries, such as a nurse or a lab worker accidentally puncturing their skin with a used needle and potentially exposing themselves to infection.

Retractable syringes have been in use for years before the COVID-19 vaccine was introduced. A patent for a “retractable needle hypodermic syringe” was granted in the U.S. in 1992.

MYTH 33 : A nurse in Alabama died hours after receiving the COVID-19 vaccine.

THE FACTS: According to fact-checking website LeadStories.com, this claim first appeared in screenshots of a text message conversation shared on Facebook on Dec. 15, 2020, by a Facebook account using the name Danielle Tyler. Facebook posts that shared the screenshots claimed that a 42-year-old nurse who received the COVID-19 vaccine was “found dead eight hours later.” The source for this claim, according to the Facebook posts, was “not an internet rumor, my FB friend’s friend’s aunt.” In a Dec. 16, 2020, statement to LeadStories.com, the Alabama Department of Public Health said it “has reached out to all hospitals in the state which administered the COVID-19 vaccine and confirmed there have been no deaths of vaccine recipients. The posts are untrue. No person who received a COVID-19 vaccine in Alabama has died.” The emergency use authorization for the first COVID-19 vaccine, developed by Pfizer and BioNTech, requires that serious adverse events following vaccination, including deaths, have to be reported to the Vaccine Adverse Event Reporting System (VAERS), which is co-operated by the U.S. Food and Drug Administration and the U.S. Centers for Disease Control and Prevention. In an Dec. 16, 2020, email to PolitiFact, CDC spokesperson Kristin Nordlund said, “I can confirm that as of 4 p.m. ET today that VAERS has received no reports of death after COVID-19 vaccines.”

MYTH 34: The COVID-19 vaccines violate the Nuremberg Code, which bans medical experiments from being performed on humans without their consent. THE FACTS: The Nuremberg Code created a set of medical research ethics principles for what it calls “permissible medical experiments.” According to a June 2020 article by FactCheck.org, the code was created in response to Nazis performing medical experiments on concentration camp prisoners without their consent. Vaccines that have gone through multiple rounds of testing in clinical trials and have then been approved for widespread use by regulators are not in violation of the Nurenberg Code’s principles. For example, the COVID-19 vaccine developed by Pfizer and BioNTech was authorized for emergency use by the UK Medicines and Healthcare Products Regulatory Agency and the U.S. Food and Drug Administration in 2020 only after it went through multiple clinical trials to demonstrate its safety and efficacy, with the final Phase 3 trial involving 43,000 patients. “The Nuremberg Code is about doing human experiments, not vaccination,” Dr. Jonathan Moreno, professor of bioethics at the University of Pennsylvania, told Agence France-Presse in a May 2020 article. “The Nuremberg Code is perfectly compatible with vaccination.”

MYTH 35: The COVID-19 vaccines will cause “pathogenic priming” or “disease enhancement,” meaning that vaccinated individuals will be more likely to develop severe cases of COVID-19 if they are infected with the COVID-19 virus. THE FACTS: COVID-19 vaccines went through multiple clinical trials to determine their safety and efficacy before being authorized for emergency use by regulators. The final phase 3 trials for two COVID-19 vaccines authorized in the U.S. as of January 2021 — one developed by Moderna and another from Pfizer and BioNTech — involved a combined 36,000 people receiving one of the two vaccines. Contrary to the claim that the vaccines cause more severe cases of COVID- 19, out of the 36,000 people who received the vaccines, only two developed severe cases, according to the results of the Moderna and Pfizer/BioNTech vaccines’ clinical trials, which were both published in the New England Journal of Medicine in December 2020. Both vaccines were found to be approximately 95 percent effective in preventing COVID-19. In a November 2020 article published on fact-checking website Health Feedback, Walter Orenstein, a professor at the Emory University School of Medicine in Atlanta, stated that “thus far, there are no data supporting vaccination as a cause of vaccine-induced enhanced disease.”

MYTH 36: The COVID-19 vaccine can cause people to develop COVID-19.

THE FACTS: None of the vaccines authorized for widespread use in the U.S. or Europe as of January 2021 contain the live virus that causes COVID-19 virus. “This means that a COVID-19 vaccine cannot make you sick with COVID-19,” the U.S. Centers for Disease Control and Prevention stated on its website. However, the CDC did note that the available vaccines require two doses, and it will take some time after vaccination for the body to build immunity against the COVID-19 virus. “That means it’s possible a person could be infected with the virus that causes COVID-19 just before or just after vaccination and still get sick,” the CDC stated. “This is because the vaccine has not had enough time to provide protection.”

COVID-19 cases among fully vaccinated individuals are still possible, because none of the available vaccines have been found to be 100 percent effective in preventing symptomatic cases of COVID-19. Additionally, the vaccines might not prevent asymptomatic infection, meaning vaccine recipients might be able to get infected, show no symptoms, and unwittingly spread the virus, according to the Children’s Hospital of Philadelphia.

2.5 WHO Conversation in Science

WHO in a series provided answers, explanations and clarification to several questions on the basis of science related to Covid-19. This series is intended to protect the reader. The clarifications were provided by WHO experts. Table 2.1 gives the list of 21 such episodes and the WHO expert who provided the clarifications. Interviewer was Ms. Vismita Gupta Smith. The experts were (i) Dr.Soumya Swaminathan, Chief Scientist ; (ii) Dr. Sylvie Briand, Director of the Department of Global Infectious Hazard Preparedness; (iii) Dr. Maria Van Kerkhove, Infectious Disease Epidemiologist, Technical lead for COVID-19 ; (iv) Dr. Maria Neira ; (v) Dr. Hanan Balkhy ; (vi) Dr. Katherine O’Brien ; (vii) Dr.Mariangela Simao ; (viii) Dr. Janet Diaz ; (ix) Dr. Peter Ben Embarek.

Six out of 21 Episodes dealt with Vaccines; three deal with myths and science ; 2 on Air flow and Ventilation ; and the remaining on general topics such as herd Immunity, How the Virus infects, Serology Covid-19 tests, immunity after recovery and differences between Covid-19 and Flu. Table 2.1 Topics & Speakers of the Episodes for Science for Covid-19

Sl.No. Topics Speaker 1. Herd Immunity Dr. Soumya Swaminathan 2. How it infects – Sars-Cov-2 Dr. Maria Van Kerkhove 3. Myths vs Science Dr. Sylvie Briand 4. Reopening Schools Dr. Maria Van Kerkhove 5. Vaccines Dr. Soumya Swaminathan 6. Flu & Covid-19 Dr. Sylvie Briand 7. Serology Surveys Dr. Soumya Swaminathan 8. Myth vs Sceicne Dr. Sylvie Briand 9. Air Poultion – Covid-19 Dr. Sylvie Briand 10. Ventilation & Covid-19 Dr. Maria Neira 11. Antibiotics & Covid-19 Dr. Hanan Balkhy 12. Safe celebration during the Pandemic Dr.Soumya Swaminathan 13. Vaccine Trials Dr. Katherine O’Brien 44

14. COVID-19 Tests Dr. Hanan Balkhy 15. Vaccine Distribution: privitization Dr. Katherine O’Brien 16. How do vaccines work Dr. Katherine O’Brien 17. Vaccine Approvals Dr. Mariangela Simao 18. Immunity after recovery Dr. Maria Van Kerkhove 19. Prolonged Symptoms after Covid-19 Dr. Janet Diaz 20. Origins of Sars. Cov – Virus Dr. Peter Ben Embarek 21. Variants & Vaccines Dr.Soumya Swaminathan ------

3. VACCINE MANUFACTURING

3.1 Types of Covid-19 Vaccines

(source: https://coronavirus.jhu.edu/vaccines/report/types-of-covid-19-vaccines)

This primer of 05-10-2020 outlines key terms and concepts related to COVID- 19 vaccines and is intended for members of the general public, policy makers, educators, and key stakeholders.

[ (Authors: William Moss, (Executive Director) & Lois Privor-Dumm, (Director of Adult Vaccines and Senior Advisor for Policy, Advocacy & Communications) John Hopkins Coronovirus Resource Center ]

(a) Introduction

Several different types of vaccines against SARS-CoV-2, the virus that causes the disease Covid-19, are in development. Some are based on traditional methods for producing vaccines and others use newer methods.

For SARS-CoV-2, antibodies that bind to and block the spike protein on the virus’s surface are thought to be most important for protection from disease because the spike protein is what attaches to human cells, allowing the virus to enter. Blocking this entrance prevents infection and thus disease and transmission to others.

(b) Desired Vaccine Characteristics

The ideal SARS-CoV-2 vaccine would:

1. be safe and associated with only mild, transient side effects (e.g. soreness and low-grade fever); 2. confer long-lasting protection (more than a season) in a high proportion of vaccine recipients (e.g. >80%), particularly in vulnerable populations such as the older adults and those with other underlying medical conditions or risk factors such as obesity; 3. protect not only against disease but prevent virus transmission to others; 4. be administered as a single dose; 5. be able to be produced quickly and in large quantities; 6. be easily stored (e.g., not at ultra-low temperatures, in packaging that does not require a lot of space); 7. can be easily transported (e.g., outside of the cold-chain or even through the mail); and 8. can be easily administered (does not require special devices, self-administered or administered by those who do not require much training).

The initial SARS-CoV-2 vaccines will not have all of these characteristics. Different types of vaccines will have different characteristics with different tradeoffs. The most important characteristics are that a SARS-CoV-2 vaccine be safe, shortly after vaccination and in the long term, and protect a substantial proportion of those vaccinated against moderate to severe disease, particularly those in the most vulnerable groups.

Several inactivated SARS-CoV-2 vaccines have been developed, including those by Sinovac Biotech, Sinopharm, the Wuhan Institute of Biological Products, and Bharat Biotech. Inactivation of viruses is a well-established method to produce vaccines and several inactivated virus vaccines are widely used, including vaccines against influenza, polio, hepatitis A, and rabies viruses. The virus is inactivated so that it can no longer replicate or multiply. The immune system is exposed to viral proteins but the inactivated virus cannot cause disease. The inactivated virus stimulates the body’s immune system to produce antibodies so when a person is exposed to the natural virus, antibodies are called to action to fight the virus.

Production of inactivated virus vaccines requires the ability to cultivate or grow the virus in large quantities. Because viruses cannot replicate outside of host cells, vaccine viruses need to be cultured in continuous cell lines or tissues. Influenza virus, for example, is typically grown in eggs to produce the inactivated influenza vaccine. The virus is then purified and concentrated before inactivation with chemicals. Inactivated vaccines typically do not provide immune responses as strong as attenuated (i.e., modified or weakened viruses so they do not cause disease) viral vaccines and may require booster doses to achieve and sustain protection.

Inactivated virus vaccines have been produced for many decades and the manufacturing procedures are well established and relatively straightforward, although there are challenges to producing safe and effective inactivated virus vaccines. First, the inactivation process has to sufficiently inactivate all of the virus without changing viral proteins so much that they induce weak immune responses. Second, the inactivation process cannot alter the virial proteins in a way that results in an abnormal or altered immune response and enhanced disease after exposure to the natural virus. As with all vaccines, the immunogenicity of new inactivated virus vaccines must be rigorously tested to ensure safety and efficacy.

(d) Protein-Based Vaccines

Many vaccines for SARS-CoV-2 in development include only viral proteins and no genetic material, including those by Novavax, Sanofi and GlaxoSmithKline, SpyBiotech, and others. Some use whole viral proteins and others just pieces of viral proteins. For SARS-CoV-2 vaccines, this means either the spike protein on the surface of the virus or a portion of the spike protein called the receptor-binding domain, which binds to host cells (i.e., the cells where viruses can replicate). These protein-based, or subunit, vaccines work much like inactivated vaccines by exposing the immune system to viral proteins and inducing protective immune responses without causing disease. In the case of protein-based vaccines, this is because no genes necessary for virus replication are included in the vaccine.

Protein-based vaccines have been widely used and have a long history of safety and effectiveness. Examples include vaccines for hepatitis B virus, shingles, and the bacteria that cause whooping cough (pertussis). There are different ways of producing recombinant viral proteins, including production of the virus protein in yeast or insect cells. Protein-based vaccines also can be packaged in different ways and combined with vaccine adjuvants (additives in small quantities) that improve or enhance immune responses. The Novavax SARS-CoV-2 vaccine, for example, uses nanoparticles of cholesterol, phospholipid, and saponins from the soap bark tree to deliver viral proteins to cells of the immune system and stimulate strong immune responses.

The addition of adjuvants to vaccines is another common way of enhancing the immune responses to virus proteins. Protein-based vaccines sometimes do not induce strong CD8 T cell responses, the cells that destroy virus-infected cells, and adjuvants can help correct this. Aluminum-containing adjuvants have been used in vaccines since the 1930s in small enough quantities to not cause any harm. Other adjuvants include different lipid formulations and a synthetic form of DNA that mimics bacterial and viral genetic material. Vaccine adjuvants will likely be important to induce strong and durable protection in older adults whose immune systems are less responsive as they age. Vaccines with adjuvants can cause more local reactions, such as redness, swelling, and pain at the injection site, and more systemic reactions such as fever, chills, and body aches, than non-adjuvanted vaccines.

(e) Viral Vector Vaccines

Viral vector vaccines use another non-replicating virus to deliver SARS-CoV-2 genes, in the form of DNA, into human cells where viral proteins are produced to induce protective immune responses. This viral DNA is not integrated into the host genome (i.e.., all of the body’s DNA) but is transcribed or copied into messenger RNA and translated into proteins. Current SARS-CoV-2 viral vectored vaccines use non-replicating human or chimpanzee adenoviruses, including those by AstraZeneca with the University of Oxford, Johnson & Johnson, CanSino Biologics, and the Gamaleya Research Institute, part of Russia’s Ministry of Health.

Adenoviruses are a group of approximately 50 common viruses that can cause cold-like symptoms, fever, sore throat, diarrhea, and pink eye. The human adenovirus vectors used for SARS-CoV-2 are weakened forms of adenovirus 5 and adenovirus 26. The weakened vectors do not replicate because important genes have been deleted. These vaccines will likely require at least two doses, although there is some hope that a single dose may induce protective immune responses.

Viral vectors have been studied for several decades for gene therapy, to treat cancer, and for research into molecular biology as well as for vaccines. Viral vectors other than adenoviruses include retroviruses and the vaccinia virus that was used to prevent smallpox. In July 2020, the European Commission approved use of an adenovirus 26 vaccine for Ebola that was manufactured by Johnson & Johnson, the first adenovirus vectored vaccine approved for use in humans, and the same vaccine platform used by Johnson & Johnson for their SARS-CoV-2 vaccine. Large-scale production of viral vector vaccines requires cultivation of the viral vector, such as adenovirus, in cell cultures and virus purification.

Most people have been exposed to multiple adenoviruses and thus have pre- existing immunity that could impair vector entry into host cells. This is a potential limitation of viral vector vaccines using human adenoviruses. The AstraZeneca and University of Oxford vaccine uses a chimpanzee adenovirus as vector, thus minimizing the risk of pre-existing immunity to the vector that might reduce vaccine efficacy.

(f) Genetic Vaccines

Instead of using a viral vector to deliver SARS-CoV-2 virus genes to human cells, the genes can be administered directly as either DNA or RNA. Several of the SARS-CoV-2 vaccines furthest along in phase 3 trials are messenger RNA (mRNA) vaccines that deliver the spike protein gene, including those by Moderna, BioNTec with Pfizer, CureVac, and Imperial College London. Once the genetic sequence of the SARS-CoV-2 virus was known in January 2020, it was relatively straightforward to generate genetic vaccine candidates. mRNA vaccines are easier to develop and manufacture compared to other vaccine types as they do not require cultivating viruses in cells. This is why they were some of the first SARS-CoV-2 vaccines to enter human trials. However, no mRNA vaccine has previously been licensed and approved for humans and most experience with this technology in humans has been for the treatment of cancer.

mRNA vaccines are taken up into cells, but do not need to enter the nucleus to trick the body into producing viral proteins, which then induce immune responses. RNA is particularly potent at inducing innate immune response, the earliest type of response to a pathogen that prevents spread within the body. mRNA is used by the cell as a template to build a protein through the process of translation.

Early phase 1 and 2 studies of SARS-CoV-2 mRNA vaccines show these vaccines induce immune responses likely to be protective, including in older adults. However, until phase 3 clinical trials are completed, the safety, efficacy, and duration of protection from mRNA vaccines will not be known and at least two doses will be required.

(g) Advantages and Disadvantages of Different Vaccine Types

Until completion of the phase 3 clinical trials, we will not know the safety and efficacy of the different types of SARS-CoV-2 vaccines and their relative advantages and disadvantages. It will be important to not only monitor short-term vaccine safety, such as soreness and fever, but the risk of long-term adverse events such as enhanced disease following exposure to natural infection and autoimmune diseases. Of particular interest will be vaccine effectiveness in vulnerable populations such as older adults and those with underlying medical conditions, including diabetes, HIV infection, and chronic heart, kidney, and lung diseases. Protein-based vaccines with adjuvants may be the most likely to induce protective immune responses in elderly adults with weakened immune systems. These different vaccine types will not be interchangeable. Once a vaccine is selected, the same vaccine must be used for a second dose if required.

Many of the vaccines furthest along in development are those for which vaccine delivery platforms existed. mRNA vaccines were developed rapidly after the SARS- CoV-2 genome was sequenced and manufacturing capacity can be rapidly scaled- 49

up. However, some mRNA vaccines have stringent cold chain requirements. The Pfizer and BioNTech mRNA will need to be stored at -70oC until about 48 hours prior to use, when it can be refrigerated, because of the instability of RNA, while the Moderna mRNA vaccine may require storage at -20oC until about one week prior to use. Freezers with the capacity to hold large volumes of vaccine at this temperature will be needed and are not currently part of the existing vaccine supply cold chain.

3.2 Vaccine Manufacturing

(a) Vaccine Manufacturing to Create Immunity

(Source: https://bioscience.lonza.com/lonza_bs/US/en/vaccine-manufacturing) 30-01-2021

Vaccine manufacturing has been widely popular ever since Pasteur developed the rabies vaccine in 1885. Since then vaccine manufacturing has continued to be popular due to the defense that vaccines provide against certain viruses. The human immune system is constantly defending itself against a barrage of viruses and we simply lack the capacity to recognize and fight against these ever changing pathogens. Vaccines are designed to help mobilize the host’s immune system to prevent virus infections and break the chain of transmission.

Vaccine development and manufacturing has led to vaccines against Hepatitis A and B, influenza, measles, mumps and polio just to name a few. Immunizations have helped many childhood diseases that caused a large number of deaths historically, to be extremely rare with only a few or no cases a year.

Tactics for vaccine manufacturing rely on two main types of vaccines:

- Active immunity: Induced after injecting of a modified version or part of the pathogen into the recipient by stimulating an immune response against the infectious agent. This provides long term protection from the virus in question.

- Passive immunity: Induced after injecting antibodies or secondary agent directed against the pathogen into the recipient. While this is a short term protection from the pathogen, depending on the virus this may be all that is needed.

Vaccine manufacturing relies on processing a virulent parental virus in four different ways:

1. Attenuation 2. Inactivation 3. Fractionation 4. Cloning

Vaccine manufacturing that uses attenuated (live) viruses stimluates an immune response due to viral replication. The infection induces mild or inapparent disease in comparison with the wild virus. An example of a vaccine made via attenuation of the pathogen is the intranasally administered influenza vaccine. The virus only replicates in the nasopharynx which produces protective immunity to the influenza virus.

(i) Vaccine Manufacturing Process

Vaccine manufacturing comprises several stages. In the first step, the antigen inducing the immune response is produced. Since viral antigens are normally presented by the native virus, vaccine manufacturing has historically depended on virus growth in cultured primary cells, continuous cell lines or chicken eggs (depending on the tropism) for the production of whole viral particles. Moreover, the growth of bacteria-specific viruses in bacteria grown in bioreactors can be employed for the manufacturing of bacteriophages for Phage-Display and more recently for the development of bacterial vaccines. Nowadays further development of recombinant protein production technology allows expression of the isolated antigenic peptide in organisms such as bacteria, yeasts and mammalian cell lines, increasing consistency of upstream and downstream processes.

In a second step, the viral particles are collected and further processed. Non- attenuated viruses may need to be inactivated through chemical or physical methods, but generally no further purification is required. Recombinant proteins on the other hand require further purification steps (downstream) including ultrafiltration and column chromatography.

In its final step, the vaccine is formulated by adding adjuvant, stabilizers, and preservatives as needed. The adjuvant enhances the immune response against the antigen, stabilizers increase the storage life, and preservatives allow the use of multidose vials.

Vaccine manufacturing is evolving. Cultured mammalian cells are expected to become increasingly important over conventional options that use chicken eggs. Vaccine manufacturing is relying on mammalian cells due to greater productivity and low incidence of problems with contamination versus vaccine manufacturing using eggs. Recombinant technology that produces genetically detoxified vaccine is expected to grow in popularity for the production of bacterial vaccines that use toxoids. Combination vaccines are expected to reduce the quantities of antigens they contain, and thereby decrease undesirable interactions, by using pathogen-associated molecular patterns.

There are many cost pressures when manufacturing vaccines. Producing a vaccine in eggs has been the historical practice with vaccine manufacturing using cell lines being a more recent endeavor. Having a critical cell number, producing the most vaccine possible, and reducing variables or tedious downstream activities is a must for vaccine manufacturing.

While some manufacturers have successfully produced vaccines for decades, others have faltered or failed, and relatively little information is available in the literature on the challenges, complexity and cost of vaccine manufacturing.

Regulatory authorities license not only a specific biological entity, but also the processes by which that entity is produced, tested, and released for use. Subtle changes in the production process may alter the final product and change its purity, safety, or efficacy.

Many vaccine patents protect the manufacturing process rather than the antigen that is produced by the process. Emphasis on process development is a major success factor in being first to market with new biopharmaceuticals and 51

inadequate process development is often implicated in late stage product development failures. Anyone looking to develop a new vaccine must keep commercial production in mind to help stop late stage product development failures. An emphasis on process development is a major factor to accelerate time to market. Serum free media helps to reduce variables and provide a consistent performing product for vaccine manufacturing. Moving away from serum use increases reproducibility and viral titers. Using a serum free medium that is also protein free facilities easier downstream processing which reduces workload and costs which are increasing concerns in vaccine manufacturing. Getting rid of the high cost of serum, large processing time for egg based cultures, and providing a regulatory friendly product for easy insertion into any vaccine manufacturing workflow are all benefits of using serum free media for vaccine production.

(b) Accelerating Vaccine Manufacturing (source: https://www.genengnews.com/insights/a-shot-in-the-arm-for-vaccine- manufacturing/) April 1, 2019

Vaccines of recent orgin, which include synthetic, recombinant, and DNA vaccines, embody the latest insights of molecular genetics and related disciplines; but there are hurdles to realize their full potential. The problem isn’t in research and development, which has progressed quickly. It is, rather, in production, which simply hasn’t kept pace.

However, there are signs that innovation in vaccine production is shifting into high gear. For example, vaccine manufacturers are beginning to leverage process technology that already benefits the broader biotechnology industry. Like producers of biologics, producers of vaccines must coordinate subprocesses and maintain aseptic conditions. Shared problems may call for common solutions—continuous processing and disposable system components. Also, vaccine-specific innovations, as per example cell culture bases system are being adopted.

(i) Speeding up Delivery

Vaccine firms, want new production methods out of a desire for efficiency. More effective platforms have the potential to reduce the cost of goods and shorten time to market. Sanofi, sees the need to accelerate production in line with growing demand as a major manufacturing innovation driver.

The need for faster production has also been recognized by technology suppliers. “Speed is paramount when dealing with disease outbreaks”. “There are two critical elements: identifying a suitable antigen to induce a specific immune response, and the capability to make it or its vector available in a short time frame.”

One of the solutions has been to develop what are called turnkey facilities. These complete, out-of-the-box manufacturing platforms reduce production lead times. Immunization groups, like UNICEF are also calling for faster production technologies,

(ii) Cost reduction

Innovation also gives vaccine firms a chance to reduce costs.

In monoclonal antibody (mAb) production, many operations have been standardized. CHO-based expression systems, for example, are used by many developers, and the technologies required to use them are widely available. Vaccine production has not seen such standardization.

Lack of standardization means higher production costs and, ultimately, higher prices. This is a problem because, to be of maximum benefit, vaccines need to be accessible to as many people as possible.

Continuous manufacturing approaches are starting to break through in mAb processing. There is much promise for their application in viral vaccine manufacturing,” she notes, “both in cell culture and in downstream processing. The application of membrane chromatography together with a continuous multicolumn chromatography approach can help improve throughput. Furthermore, new initiatives—such as the development of novel ligands to address selectivity limitations and enable affinity purification—are emerging. Together with high-surface- area supports, these initiatives should offer further process improvements.”

(iii) Batch Size

The fact that vaccines are made in smaller batch sizes—relative to other biopharmaceuticals—is also shaping how production systems evolve. “Vaccine batches are smaller than typical batches seen with recombinant proteins and mAb. “Depending on the vaccine, the production runs during a limited time per year, Consequently, facilities configured for multiproduct manufacturing have been standard for a long time, which is why single-use systems have been so heavily adopted by vaccine manufacturers. Single-use technologies are also helping the vaccine industry to address another of its biggest challenges, namely, the need for sterile filtration. Sterilization is challenging in vaccine manufacturing, particularly if the product involved requires an alum-based adjuvant. The size of the alum component makes sterile filtration impossible, which means many final vaccine production steps need to be done in aseptic conditions.

One way around this, it appears will be to use disposable technology: “As many process steps are run in aseptic conditions, manufacturers have turned to single- use, closed systems. Here the assurance of sterility remains of high importance and can be addressed by the use of very sensitive integrity test methods such as helium integrity testing in addition to a strong Quality by Design approach.”

Manufacturing innovation will revitalize the vaccine sector. “Innovation drives significant improvements in discovery, development, manufacture, and delivery of vaccines. New technologies improve and will continue to control of these complex manufacturing processes and increase robustness and accelerate quality controls.

3.3 Indian Vaccine Development & Manufacturers

India holds the second largest group of people who were affected with Covid-19 (as on of 30 January, 2021) the figure was 10,734,026 with USA leading at 26,512,193: the world total was 102,674,752. In other words India had about 10.5% of the persons affected in the globe and about 40% of the number of persons affected in USA. 53

The Number of persons infected in India relation to the population, 7734 person were infected per million; this is only about 9.5% of the rates of USA.

The deaths arising from this infection is at 154,184 in India compared to USA at 447,459 ie. Indian fatality is …. of that of USA. The death per million population of India is 111 one of the lowest in the world, compared 1347 of USA.

Thus the Indian population has resisted the infection quite well thanks to the precaution taken, including lockdowns in the early days. (March-May 2020).

Several types of treatment have been tried over the year 2020 and efforts were on throughout the world to find a suitable vaccine to prevent the infection. Around the middle of July 2020 seven Indian pharmaceuticals were with race to develop a vaccine for Covid-19.

Bharat Biotech, Serum Institute, ZydusCadila,Panacea Biotec, Indian Immunologicals, Mynvax and Biological E.

Vaccines normally require years of testing and additional time to produce at scale, but scientists were hoping to develop a coronavirus vaccine within months because of the pandemic.

Bharat Biotech had received approval to conduct phase I and II clinical trial for its vaccine candidate Covaxin, that has been developed and manufactured in the company's facility in Hyderabad. It started human clinical trials in July 2020.

Hyderabad-based Bharat Biotech also started human trials of its vaccine Covaxin at Rohtak's Post-Graduate Institute of Medical Sciences in July 2020. The phase I and II clinical trials of the vaccine for SARS-CoV-2 by Bharat Biotech have been approved by the Indian drug regulator after pre-clinical studies demonstrated safety and immune response. The company has developed the vaccine in collaboration with the Indian Council of Medical Research (ICMR) and the National Institute of Virology (NIV)

Leading vaccine major Serum Institute of India had planned to develop a COVID-19 vaccine by the year-end.

They were working on the AstraZeneca Oxford vaccine which is undergoing phase III clinical trials. In addition to this, they had planned to start human trials in India in August 2020. They had expected that the AstraZeneca Oxford vaccine will be available towards the end of last year,"

The company was also developing a live attenuated vaccine with US-based biotech firm Codagenix, which was undergoing pre-clinical trials.

"Serum Institute of India has entered a manufacturing partnership with AstraZeneca to produce and supply 1 billion doses of the COVID-19 vaccine being developed by Oxford University."

"Apart from AstraZeneca Oxford vaccine and Codagenix, SII was associated with multiple institutions worldwide as manufacturing partners for vaccine candidates that are being developed. Including Austria's Themis along with two others,"

These vaccines will be for India and middle and low income countries across the world (GAVI countries).

Pharma major ZydusCadila had said that it is looking to complete clinical trials of its COVID-19 vaccine candidate ZyCoV-D in seven months. The company had started clinical trials of its COVID-19 vaccine candidate with the first human dosing in July 2020.

Panacea Biotec in June had said that it was setting up a joint venture firm in Ireland with US-based RefanaInc to develop a vaccine for COVID-19. The company in partnership with Refana aims to manufacture over 500 million doses of COVID-19 candidate vaccine, with over 40 million doses expected to be available for delivery early next year.

Indian Immunologicals, a subsidiary of National Dairy Development Board (NDDB), has inked an agreement with Australia's Griffith University to develop a vaccine for coronavirus.

Others like Mynvax and Biological E are also working to develop vaccines for COVID-19.

By December 2020, the position had advanced and the Indian scene was approximately as follows:

Serum Institute of India (SII): The world's largest vaccine producer will manufacture (1) AstraZeneca Plc's Covishield and another formulation developed by US rival (2) Novavax Inc. Organizations such the GAVI vaccine group and the Bill & Melinda Gates Foundation are backing both candidates for large-scale distribution around the globe.

SII has secured funding from GAVI and the Gates Foundation to deliver up to 200 million doses of both vaccines for India and other low-and middle-income countries.

AstraZeneca said in June it had licensed SII to supply 1 billion doses of its vaccine to more than 60 low and middle-income countries. (3) SII is also working on developing in-house vaccines and has partnered with U.S. biotech firm (4) Codagenix and Austria's Themis to potentially manufacture their COVID-19 vaccine candidates.

SII has already made and stockpiled more than 50 million doses of COVISHIELD and aims to ramp up production to 400 million doses by mid-2021. It has already applied for emergency use authorization of the vaccine in India.

The company could sell the vaccine at ₹250 ($3.39) per dose to the Indian government and ₹1,000 on the country's private market. By comparison, the Pfizer's supply deal with the US government amounts to $39 for a two-dose course, while Moderna plans to charge between $25 and $37 per dose. 55

The world's largest vaccine manufacturer, the Serum Institute of India (SII), has sought the Drugs Controller General of India's (DCGI) permission to conduct a small domestic trial of the Novavax coronavirus vaccine that was found to be 89.3% effective in a UK trial. This is nearly as effective in protecting against the more highly contagious variant first discovered in Britain, as per a preliminary analysis.

Novavax is reportedly stockpiling Covid-19 vaccines at six operating manufacturing sites and said it expects a total of eight plants in seven countries to produce at the rate of 2 billion doses per year, including from the SII, a major player in the fight against coronavirus.

Bharat Biotech: Based in the southern Indian city of Hyderabad, the company is developing a whole-virion inactivated vaccine called COVAXIN in partnership with state-run Indian Council of Medical Research and Institute of Virology.

It recently applied for emergency use authorisation in the country and is in talks with more than 10 countries in South America, Asia and Eastern Europe to sell it there.

It has not issued any production or price forecasts.

The company is also conducting pre-clinical studies of another vaccine with the (5) Thomas Jefferson University of the United States.

Biological E. Ltd: The firm started phase I and phase II trials of its vaccine candidate in November. It is being developed in partnership with the (6) Baylor College of Medicine in Houston and Dynavax Technologies.

The Hyderabad-based company's trial will test two doses of the vaccine in about 360 healthy subjects and it expects results by February.

(7) Cadila Healthcare Ltd: ZydusCadila is developing an indigenous DNA- based vaccine, ZyCoV-D. Zydus plans to complete late-stage trials for ZyCoV-D by February or March, and could produce up to 100 million doses a year initially.

Hetero Biopharma: Another Hyderabad-based private pharmaceutical company, Hetero will manufacture more than 100 million doses of the (8) Russian Sputnik V COVID-19 vaccine a year, under a deal inked with the Russian Direct Investment Fund. (RDIF)

Dr. Reddy's Laboratories Ltd: The drugmaker is conducting clinical trials of Sputnik V in India and expects late-stage trials to be completed by March 2021. It will also distribute the finished vaccine in India once approved but there is no current plan for it to produce it.

3.4 Emergency use Authorisation : Covid-19 Vaccine

In USA two vaccines – the Pfizer/BioNTech mRNA vaccine and the Moderna mRNA vaccine – was reviewed for Emergency Use Authorization (EUA) by the FDA in December 2020.

An EUA is not FDA approval, but it permits the use of a product during a public health emergency.

EUAs are not new, and are not just for vaccines – but the FDA has issued specific guidance for EUAs for COVID-19 vaccines.

1. What is an Emergency Use Authorization, or EUA?

An Emergency Use Authorization (EUA) allows the U.S. Food and Drug Administration (FDA) to make a product or drug – whether new or not yet proven for a given use – available during an emergency, provided there are data to suggest that it is reasonably safe and effective. The basic requirements for an EUA are:

1. a public health threat exists;

2. there is reason to believe that the product will be effective in diagnosing, preventing, or treating the illness;

3. the known or potential benefits outweigh the risks; and

4. there are no adequate, approved, available alternatives.

2. How did EUAs come to be? What was the first EUA?

The authority to grant EUAs dates back to federal laws passed in 1938 and the Project BioShield Act of 2004, which was part of bioterrorism preparedness activities following 9/11. The first EUAs for the civilian population were granted in response to pandemic influenza in 2009, including an EUA for the use of oseltamivir (Tamiflu) in infants.

3. Have EUAs been issued for products to treat or prevent COVID-19?

The FDA has granted EUAs for a number of diagnostic tests for COVID-19, personal protective equipment, medical devices, drugs (e.g., remdesivir), and biological products (e.g., convalescent plasma).

4. Have there been EUAs for vaccines before?

An EUA was issued for anthrax vaccine in 2005. EUAs granted for the Pfizer/BioNTech and Moderna COVID-19 vaccines, are the first EUAs issued for vaccines for civilian populations.

5. Are there additional requirements for COVID-19 vaccine EUAs?

Yes, the FDA released specific guidance in October 2020 on the EUA process for COVID-19 vaccines. The FDA specified a minimum vaccine efficacy of 50%, which is substantially exceed by both the Pfizer/BioNTech and the Moderna COVID-19 mRNA vaccines. In addition, the FDA specified a minimum period of safety follow-up before EUA submission, and that companies must provide plans for continued safety follow-up. The FDA also requires that vaccine

companies provide data on the production of the vaccine, including the manufacturing process and quality controls, and the supply chain.

6. What is the process for reviewing applications for COVID-19 vaccine EUAs?

Applications for both the Pfizer/BioNTech and Moderna vaccines were submitted to the FDA, which has had an opportunity to review and analyze the data provided by the companies. This information will be made publicly available. The Vaccines and Related Biological Products Advisory Committee (VRBPAC), an independent group of scientists, will review the data and make recommendations to the FDA about issuing EUAs for these vaccines. The Vaccines and Related Biological Products Advisory Committee (VRBPAC) review of the Pfizer/BioNTech vaccine was on December 10th and of the Moderna vaccine on December 17th.

7. If an EUA is issued, is it the same as FDA approval? Does it mean that the vaccine trials end?

An EUA is not a license. The vaccine trials will continue in order to learn as much as possible about the long-term safety and efficacy of the Covid-19 vaccines. This information could be used to support future applications to the FDA to license the vaccines.

8. What is the process in India for EUA ?

In India the Drug Standard Control Organisation (DSCO) has the power to grant EUA. Unlike the US FDA, India follows the accelerated approval process. India has granted approvals for two Covid-19 vaccines on 2 January, 2021.

(i) Covisheild manufactured by Serum Institute of India, Pune. This is the vaccine developed by Astra-Zenice with Oxford University. (ii) The Covaxin manufactured by Bharat Biotech in Hyderabad.

3.5 Indian Vaccines: How the Globe Views It

https://www.bmj.com/content/372/bmj.n196 had assessed, as of 28 January, 2021 as follows:

India’s huge immunisation drive began on 16 January 2021. The health ministry is aiming to vaccinate four priority groups: healthcare workers, people over 50, public workers, and those under 50 with comorbidities—with the former two groups to be inoculated first in an initial rollout to 30 million people

As of end of January 2021 3.744 million people had been vaccinated.

The vaccines are being provided free to frontline workers—with no choice as to which one recipients receive. They are paid for by the Indian government, which says that the two approved vaccines cost them a quarter of the price on the global market, making them the cheapest in the world. Covishield is priced at Rs200 and Bharat Biotech’s Covaxin will cost Rs295 for a single dose. Furthermore, Bharat

Biotech is providing the government with 1.65 million free doses of Covaxin, reducing costs further.

But when the vaccines reach the private market, prices are expected to be much higher. Covishield will likely be around five times higher at Rs1000- per dose. There are no measures in place to keep they will be affordable for those who need it.

With the world’s second largest population, at 1.36 billion. India is a huge market for vaccines. With one of the largest pharmaceutical manufacturing capacities in the world, India seems well placed to deal as both importer and exporter.

On 22 December, US pharmaceutical company Ocugen signed a letter of intent to codevelop Bharat Biotech’s vaccine for the American market. And in the wake of mixed efficacy results for the Chinese Sinovac vaccine, Brazil has looked to India for both Covaxin and Covishield stocks. On 23 January, two million doses of Covishield, requested by the Brazilian president, had already been delivered, and a memorandum has been signed by private Brazilian clinics for five million doses of Covaxin to be delivered by March. Meanwhile, India is donating 800 000 doses of Covishield to be divided between Bangladesh, Bhutan, Myanmar, Nepal, the Philippines, and Seychelles as a goodwill gesture, with Afghanistan, Sri Lanka, and Mauritius also in line for donations.

India’s biotech companies are also expected to produce 300 million doses of Russia’s Sputnik V vaccine. Sputnik V also cleared Indian safety trials in mid- January, paving the way for phase III clinical trials and possible local rollout. This may prove crucial as the powdered version of the vaccine can be stored at refrigerator temperatures, making it more suitable for India’s climate.

As per a PTI report updated on 29 January, 2021

The UN Secretary-General also expressed hope that India will have all instruments necessary to play a major role in ensuring a global vaccination campaign becomes possible as the world fights the pandemic.

United Nations: India's vaccine production capacity is one of the best assets the world has today, UN chief Antonio Guterres has said as he applauded India for supplying COVID-19 doses to nations around the world to combat the catastrophic global health crisis. India has one of the most advanced pharmaceutical industries. India played a very important role in the production of generics for use that was a very important element of democratisation of access to medicines all over the world. -----

4. INTELLECTUAL PROPERTY RIGHTS AND COVID 19 VACCINES

4.1 Patent Ownership of Covid-19 Vaccines

There are now quite a few patents in force covering processes used in the manufacture if Covid-19 vaccines. For example on mRNA vaccines US:10,703,789, US. 10,702,600, US 10,577,403 are a few held by Moderna Inc. All major vaccine producers hold patents over the vaccine manufacturing processes and only when they agree to licence, the non patent owning manufacturer have a chance to start production.

The following information is extracted from an article by Adyasha Samal on “SPICY IP” dated 20 December, 2020. As at the end of 2020 a few firms have obtained approval [EAU] to make and make them available for vaccination.

While this may appear to be the light at the end of the tunnel, the focus now shifts towards equally challenging issues of availability, accessibility, and affordability of vaccines.

On 9th November, US Pharma giant Pfizer and German biotech firm BioNTech became the first to announce that ‘BNT162b2,’ the vaccine developed through their collaborative efforts, had shown over 90% effectiveness after the conclusion of Phase III trials. They will be supplying 50 million doses of one of the first ever messenger RNA-based vaccines by the end of 2020 and 1.3 billion doses by 2021. While no safety hazards have been noted, the vaccines will require ultra-cold storage at below -70 degree Celsius temperature and will only survive for 24 hours at refrigerator temperature (2-8 degrees Celsius). It is priced at a hefty price of $39 (nearly INR 3000). UK has given an emergency approval to this vaccine in December 2020.

US-based Moderna declared that its mRNA-1273, another mRNA-based vaccine, had shown 95% effectiveness. It is set to be priced at $25-37 (approx. INR 1900-2800) per dose depending on quantities purchased. Similar to Pfizer- BioNTech, this vaccine will have to be stored frozen at -20 degrees Celsius. However, it may be kept at refrigerator temperature for a month making downstream transportation relatively easier.

The highly anticipated AstraZeneca-Oxford vaccine, AZD1222, claims adequate efficacy as per interim data, a figure that is estimated to increase to 90% if the dosage is altered. Unlike the other two vaccines, this one utilizes a genetically modified common-cold virus. What makes the Oxford vaccine an attractive candidate is its price, which, following a no-profit pledge by AstraZeneca, is to be capped at $3 (approx. INR 222) per dose. It is also capable of storage at normal refrigerator temperature giving it a logistical edge over the other two.

Public Funding and Patent Ownership

Patent ownership can drastically influence global access to healthcare. Since the beginning of the COVID-19 pandemic, concerns have been raised regarding the implications of enforcement of patents held over potential COVID-19 treatments.

This has brought the patent landscape of the vaccine-manufacturing companies under scrutiny. It is reported that 13 patents are claimed by BioNTech on its vaccine technology. However, the status of rights over the vaccine is complicated. While the development of most vaccines has been significantly funded by governments, Pfizer has claimed that they have taken no money, neither from the US government nor from anyone else (perhaps as an explanation behind why it has not made any no- profit or non-patent enforcement pledges like other developers). Although this is true on the face of it, it is not to be forgotten that their Mainz-based partner BioNTech, who supplied the mRNA technology, received EUR 375 million from the German government and another EUR 100 million in loan from the European Investment Bank. More importantly, BNT162b2 was created using ‘spike protein technology,’ reportedly developed by scientists from the US government’s National Institute of Health (NIH). Former US Vice President Mike Pence went so far as to call the vaccine a ‘public-private partnership.’ If this is correct, in future, the ‘March-in rights’ under the Bayh-Dole Act could technically allow the US government to stake claim on what is being called taxpayer-funded technology. Aside from this, Pfizer and BioNTech have been sued for patent infringement by San Diego-based Allele Biotech for using the latter’s mNeonGreen fluorescent protein in developing the vaccine. As the companies stand poised to make $13 billion from their vaccine by next year, these multiple claims over the ownership of the technology can lead to complicated battles between the public and private players involved.

Moderna, which has received huge sums from the US government, has so far published seven US patents it claims protect its vaccine. In October, 2020 Moderna pledged to not enforce its COVID-19 vaccine patents while the pandemic lasts, and to willingly license the same afterwards. While this is a responsible step indeed, Moderna is embroiled in its own set of patent-ownership controversies. The company has been accused of failing to disclose vast amount of funds received from US Defense Advanced Research Projects Agency (DARPA) for its vaccine patent filings. Moreover, Moderna too has utilized US government’s NIH protein in its vaccine. It is also presently embroiled in patent disputes with other third parties such as Arbutus Biopharma over the sub-licensing of platform technology which has been utilized to develop the new vaccine. The company though, has emphatically declared that it is not aware of ‘any significant intellectual property impediments’, in commercializing mRNA-1273 with regard to Arbutus.

The developers of the Oxford vaccine, which has relied on the UK government’s funds and other donations, had been lauded initially for suggesting a possible open licensing framework. In April, Oxford entered into an exclusive licensing agreement with AstraZeneca. While they too have pledged to sell the vaccine at cost price till the pandemic lasts, AstraZeneca’s definition of “pandemic” has recently been called into question.

Bilaterail Pre-purchase Agreement

The equitable distribution of vaccines depends largely on the availability of vaccines in sufficient quantities. The past few months have seen frenzied attempts at vaccine stockpiling by higher-income countries through numerous bilateral pre-purchase agreements. According to reports now, 82% of the Pfizer’s vaccine stocks to be made available till the end of 2021 have been pre-booked by the UK (40 million), US (100 + 500 million), EU (200 million), Japan, and Canada, which 61

represent 14% of world population. Moderna is not far behind, with 78% of its vaccines sold to (largely the same) countries representing 12% of the people. AstraZeneca too has committed 100 million doses to the UK. The logistical challenge is an even greater one. Several countries across the Global South have ill-equipped healthcare systems, to sustain vaccine storage at ultra-cold temperatures. Also, cross-country cold storage transportation requires timely infusions of dry ice to maintain temperature, which is all the more difficult to ensure in tropical regions.

Patent Waiver Proposal

As the physical procurement of vaccines clearly presents a multilayered challenge, an alternative way of ensuring wider, equitable distribution is by sharing technological know-how with local manufacturers across the world to pump up total supply. Earlier, an attempt by WHO to facilitate a COVID-19 Technology Access Pool for the sharing of know-how and IP in order to allow companies to manufacture vaccines and treatments had fizzled out with only 40 countries (excluding India) joining the Solidarity Call for Action – most of which were lower income countries. In October, when India and South Africa made a proposal to the WTO to allow the suspension of patents linked to Covid-19 treatment till global immunity is achieved here, this proposal was widely supported by other lower and middle income countries, WHO, and leading UN experts. At the same time, the higher income countries, which have reportedly already pre-booked 51% of the world’s vaccine supply, refused to concede.

4.2 COVID-19 Patent Ban (South Africa/Indian)

The Lancet in their World report dated 5 December, 2020 has covered this topic.

South Africa and India have called for the World Trade Organization (WTO) to suspend intellectual property (IP) rights related to COVID-19 to ensure that not only the wealthiest countries will be able to access and afford the vaccines, medicines, and other new technologies needed to control the pandemic. The pharmaceutical industry and many high-income countries (HICs) staunchly oppose the move, which they say will stifle innovation when it is needed most.

Without special measures, proponents argue, rich countries will benefit from new technologies as they come onto the market, while poor nations continue to be devastated by the pandemic. The proposal states that IP rights such as patents are obstructing affordable COVID-19 medical products. A temporary ban would allow multiple actors to start production sooner, instead of having manufacturing concentrated in the hands of a small number of patent holders.

WTO decisions are normally reached through consensus. Dozens of low- income and middle-income countries (LMICs) support the proposal. However, HICs including the UK, the USA, Canada, Norway, and the EU have rejected it outright, saying that the IP system is required to incentivise new inventions of vaccines, diagnostics, and treatments, which might dry up in its absence. They dismiss the claim that IP is a barrier to access, and argue that equitable access can be achieved

through voluntary licensing, technology transfer arrangements, and the donor-funded COVAX Advance Market Commitment for vaccines.

An EU spokesperson said: “There is no evidence that IP rights in any way hamper access to COVID-19-related medicines and technologies.” The UK Government declared that the world urgently needs access to these new products to fight the pandemic, “which is why a strong and robust multilateral IP system that can meet this challenge is vital”. The UK, by far the largest funder of the COVAX Facility, urges other countries to contribute more.

The patent waiver proposal was presented to the WTO's Trade-Related Aspects of Intellectual Property (TRIPS) Council on Oct 16, 2020, and discussed again at a council meeting on Nov 20. There, the South African Government responded to objections, pointing to examples of how IP has created barriers to access. Manufacturers of monoclonal antibody therapeutics that are under patent protection, such as Regeneron and Eli Lily, have locked up most of their capacity in bilateral deals. “Disparity in access is certain unless concrete steps are taken to address intellectual property barriers”, South Africa's statement reads. For vaccines, South Africa cites the legal battle in India between Médecins Sans Frontières (MSF) and Pfizer over its pneumococcal vaccine, where a patent has blocked development of alternative versions of the vaccine. In South Korea, Pfizer sued SK Bioscience, which had developed a pneumococcal conjugate vaccine (PCV), forcing the Korean developer to close production of PCV-13. South Africa argues that a similar situation will arise with COVID-19 vaccines unless steps are taken to address the IP barriers.

John-Arne Røttingen, who chairs the WHO Solidarity Trial of COVID-19 treatments, agrees that technology transfer is crucial, but says that voluntary mechanisms are a better way to achieve this. The patent waiver, he says, is the “wrong approach” to the problem because COVID-19 therapeutics and vaccines are complex biological products in which the main barriers are production facilities, infrastructure, and know-how. “IP is the least of the barriers”, he says.

Røttingen, recently appointed as Norway's Global Health Ambassador, says waiving IP might help in producing small molecular weight substances. “But if you want to establish a biological production line, you need a lot of additional information, expertise, processes, and biological samples, cell lines, or bacteria” to be able to document to regulatory agencies that you have an identical product. Instead, he says, individual companies should be pressured to allow non-exclusive licences and technology transfer of their products, along the lines of the agreements that AstraZeneca and Novavax have established with the Serum Institute of India for vaccines. This partnership model would be much faster, he says. “Instead of going for an unreachable, ‘ideal’ solution that will not fly, they should identify where the barriers are and work on those.”

MSF has been advocating for a waiver on COVID-19 patents for several months, arguing that it is justified on emergency health grounds and necessary for LMICs that cannot afford to pay HIC prices for vaccines and treatments.

Yuanqiong Hu, Senior Legal and Policy Adviser at the MSF Access Campaign, says the India–South Africa proposal would also make it easier for non-patent holders to produce necessary medical equipment like ventilators, masks, and protective gear. Regarding the need for technology transfers, she says, it is not an 63

“either/or” question. Governments need the full package of toolkits, including technology transfer deals and legal measures such as the patent ban.

She says voluntary transfer via company-led initiatives has delivered limited results. AstraZeneca's vaccine manufacturing agreements with Indian and Brazilian companies lack transparency about costs, and Pfizer and BioNTech, whose vaccine candidate has shown promising results, have shown no sign of licensing or technology transfer of their patented products, she says. Pfizer told The Lancet that it will consider all viable options to ensure vaccines get to those who need them, but “a one-size-fits-all model disregards the specific circumstances of each situation, each product and each country“.

The co-sponsors of the patent waiver proposal say COVAX, funded through donations from HICs, is insufficient for ensuring timely and equitable access to COVID-19 products. COVAX aims to procure 2 billion doses of vaccine and to share them equally between HICs and LMICs. However, according to data collected by Duke University, the COVAX Facility has reserved only 700 000 vaccine doses so far. By comparison, HICs have reserved 6 billion doses for themselves through bilateral deals with pharmaceutical companies. Low-income countries, meanwhile, with a combined population of 1·7 billion people, have not yet signed a single bilateral vaccine deal.

4.3 Looking into Future of Patent Ban /Waiver

A recent article is published in Down to Earth on 11 January. 2021 “Dummy’s guide to how trade rules affect access to COVID-19 vaccines”. The original article appeared in www.theconversation.com. Extracts from this article presented below throws light on the ‘patent ban’ and what can happen in the future.

What difference the Patent Law would make ?

The waiver would allow WTO members to choose to neither grant nor enforce certain sections of the TRIPS agreement. This would allow WTO member states to collaborate on manufacturing, scaling up and supplying COVID-19 medical tools equitably.

The waiver would be temporary, in effect only until the WHO declares global herd immunity. It would apply only to those drugs, vaccines and medical technologies related to the prevention, containment or treatment of COVID-19. It would be optional; countries could elect not to abide by the waiver.

WTO member states arguing against the waiver maintain that existing TRIPS flexibilities already allow countries experiencing a public health emergency to issue compulsory licences to domestic pharmaceutical companies to produce generic (and less costly) equivalents. This is true, but the process is cumbersome and does not yet apply to trade secret know-how and cell lines needed to copy vaccines and biologic medicines.

Compulsory licences must be issued on a country-by-country, case-by-case basis. Some compulsory licences require prior negotiations with rights holders and some are only for public, non-commercial use. Moreover, even for a single medicine, compulsory licences might need to be issued in the country that produces the active 64

pharmaceutical product, the country that produces the finished product, and the country that imports and uses the medicine.

The rules covering export of a compulsory-licensed product to a country lacking its own production capacity are so complex that this flexibility has only been used once.

Role played by Pharma Companies

Powerful pharmaceutical industries have secured bilateral agreements for vaccines or other COVID-19 health products.

It is reasonable to infer that domestic lobbying by pharmaceutical companies may be at play, or that support for these industries for some countries has simply become accepted practice. The pharmaceutical industry itself has been vocal in opposing any efforts to undermine the patent system, arguing that intellectual property “is the blood of the private sector”.

Pharmaceutical companies have long argued the need to be rewarded for their risks in researching new discoveries. But what of the $12 billion plus that governments have directly contributed to vaccine discovery and expanded manufacturing?

It is true that private funding for the Pfizer / BioNTech vaccine was four times that of public funding. But governments have also entered into $24 billion of advance purchases agreements, including an estimated $21 billion in 2021 for the Pfizer vaccine, sales of which are expected to generate a 60%-80% profit margin.

What developing countries can do ?

Negotiations at the TRIPS Council in January and February may well produce a draft text or declaration on the waiver. When, and if, the waiver or declaration text makes it to the WTO General Council in March, both developing and developed countries should vote in support of it. WTO member state decisions are usually made by consensus. But in the absence of one, they can be passed with a three- fourths majority (123 of 164 members).

Between now and then government leaders of developing countries and others who support the waiver should contact non-supportive member states directly, making their arguments in favour of it. Emphasis should be placed on:

 the extent of public financing for COVID-19 medical discoveries,  the degree of UN and broader civil society support for the waiver, including support from global public health leaders,  the slow roll-out of vaccines to developing countries in its absence,  the inequalities this will worsen as some countries are able to access vaccines and treatments and so recover more rapidly than others, and  most countries’ already stated acknowledgement that until everyone receives the vaccine everyone remains at risk.

If the waiver fails, developing countries should explore a collaborative effort to make use of TRIPS Article 73 (Security Exceptions). A legal interpretation of this article suggests that the pandemic satisfies the conditions set out in the article and its conditions could achieve much the same outcome as the proposed waiver.

Invoking Article 73 might be challenged and have to undergo a formal dispute settlement process. Nonetheless, it is a strategy that merits consideration.

Finally, there is an urgent need to clarify public interest and public health exceptions to TRIPS intellectual property rights. Compulsory licensing for all applicable intellectual property rights should be improved so that full technology transfer and access to vaccines, therapeutics and diagnostics can be more easily guaranteed in the future.

This body of work should proceed quickly this year so that the world can better address predictable pandemic threats and global health needs, now and in the future.

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Annexure 4.1

A note on International development regarding Access to Medicine to address the COVID-19 (By Dr K.S.Kardam)

On 11 March 2020, the World Health Organization (WHO) declared the coronavirus disease 2019 (COVID-19) to be a global pandemic, after having announced a related public health emergency of international concern (PHEIC) on 30 January 2020.

The threat posed by COVID-19 on global health and the economic downturn resulting thereof necessitates the development of health technologies (such as medicines and vaccines). A global effort to invent new health technologies or the likely application of existing technologies is also underway since the outbreak of the pandemic. Even though the race to develop these technologies can be hailed as a pivotal undertaking, the development of health technologies alone may not expedite equitable access to the outcome of such development. Particularly, the lack of access to health technologies may befall if the conventional model of health technology pricing, which is derived from monopoly rights created by IP protection, is set. However, legal as well as policy tools can be used to overcome such hurdles and ensure global access to health technologies.

Accordingly, the annual meeting of the World Health Assembly (WHA) of the World Health Organization (WHO) held on 18-19 May 2020 discussed the global response to COVID-19 and adopted Resolution WHA73.1 on “COVID-19 Response”. The Resolution reaffirms the role of WHO as the directing and coordinating authority on international health work and it recognizes that all countries should have timely and affordable access to diagnostics, therapeutics, medicines and vaccines as well as to essential health technologies and equipment to respond to COVID-19. However, the Resolution does not define concrete actions to address the pandemic. Though the Resolution makes a commitment of ensuring access to medical products, vaccines and equipment for all countries in a timely manner, there are no concrete actions defined. In order to ensure global equitable access, WHO Members should make full use of the flexibilities of the Agreement on the Trade-Related Aspects of Intellectual Property Rights (TRIPS) and also enhance transparency of costs of research and development (R&D), openness and sharing of data, tools and technologies, and build more capacity through technology transfer.

In July 2020, South Africa called for a “more holistic approach to TRIPS flexibilities” in combating the ravaging Covid-19 pandemic to prevent world’s leading pharmaceutical companies from securing billions of dollars of public funds and to avoid adopting predatory pricing policies for new therapeutics and vaccines.

Thereafter several other developing countries have expressed serious concerns at the World Trade Organization about rising “vaccine nationalism” and attempts to restrict affordable access to vaccines and therapeutics for combating the Covid-19

pandemic, as the worsening health crisis has continued to ravage countries around the world. In the WTO TRIPS Council meeting held on 15-16 October 2020, two very important submissions were submitted. The first was from India and South Africa (IP/C/W/66) that calls for a waiver of several provisions in the TRIPS agreement as a necessary response to the worsening COVID-19 pandemic.

The second was from the Least Developed Countries group requesting for an extension to the transition period for implementing the core provisions of the TRIPS Agreement by 12 years, from 1 July 2021 to 2033 when the current transition period ends.

The waiver proposal requests the Council for TRIPS to recommend, as early as possible, to the General Council that the obligations of Members to implement or apply Sections 1, 4, 5 and 7 of Part II of the TRIPS Agreement or to enforce these Sections under Part III of the TRIPS Agreement, shall be waived in relation to prevention, containment or treatment of COVID-19, for certain years from the decision of the General Council.

As the deaths worldwide from COVID-19 passed the 2 million mark due to enveloping shortages of vaccines, the proponents of a TRIPS waiver for temporarily suspending key provisions in the WTO’s TRIPS Agreement in combating the worsening pandemic have called for text-based negotiations at the WTO so as to ensure an early agreement on the waiver.

At an informal TRIPS Council meeting held on 19 January, the proponents warned that any delay in agreeing to the waiver proposal will not only multiply deaths globally due to the IPR barriers, but also expected to protect tens of billions of dollars of monopoly profits of the international pharmaceutical behemoths which are currently virtually holding governments to ransom on the supply of vaccines.

The continued opposition to the waiver from developed countries led by the United States as usual expected to put profits and patents before saving people and lives, the negotiator, suggesting that the new Biden Administration in Washington must demonstrate political will so as to ensure an early outcome on the waiver.

Despite a groundswell of support from international civil society organizations, governments, and even several multilateral organizations, the opponents to the waiver continued turning a deaf ear to the concerns raised about IPR barriers, insisting that the TRIPS Agreement is sacred to them as it provides the flexibilities and protects innovation and balance between rights and obligations, said another negotiator, who asked not to be quote.

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5. ABOUT THE SPEAKERS

1. Ms. Jayanthi Venkatesan, Executive Member of the Waterfalls Institute of Technology Transfer, Chennai. She is a Corporate Trainer, Director IIT Study Circle Coimbatore an Executive Director of GUIDE. Visiting faculty on Management Studies at several institution and colleges. A popular compere covering conferences, seminars and fashion shows.

2. Mr. P.V. Jaishankar, Chairman, Waterfalls Institute of Technology Transfer (WITT) Chennai. Graduate from IIT (BHU) and PG from IIM Ahmedabad. Certified CEO/Executive Coach, primarily connected with Health Care/IT industries. Over 35 years experience in providing software solutions to Institutions like Banks and Hospitals.

3. Dr. J. Manivannan, Managing Director, Kauvery Hospitals and General Committee member of MCCI. A trained anaesthesiologist, Dr Manivannan’s vision of making Great Healthcare affordable became a reality in 1999, when he co-founded Kauvery Hospitals, a 1200-bed Tertiary hospital group. Under Dr. Manivannan’s leadership, Kauvery Hospital has successfully emulated the Japanese system of lean methodologies in every aspect of healthcare. His focus on implementation of 5S practices has helped Kauvery Hospital win several awards in 5S, Quality Circle initiatives.

4. Padma Shri Dr. Sneh Bhargava is the Chairperson for the event. An internationally respected luminary in radiology, and the first lady director of the All India Institute of Medical Sciences (AIIMS), New Delhi (and the only one in its 60 year history). Dr.Sneh Bhargava has served as Chair of the hospital board of directors. She established the Medical Education & Technology Center at AIIMS, designed to enable medical students to learn to teach in medicine, and is also the professor emeritus of the Department of Radiology at AIIMS. She has received numerous Lifetime Achievement awards and the Millennium Award 2000 from Indian Radiology and Imaging Association, apart from the Padma Shri for her distinguished contributions to Medicine.

5. Dr. Srikant Tripathy, former Director, Indian Council for Medical Research. Dr.Tripathy is currently the Director of Medical Research at the Dr. D.Y. Patil Medical College, Hospital & Research Centre at Pune – earlier, he was the Director at ICMR-National Institute for Research in Tuberculosis.

6. Dr. Prasad Kulkarni, Executive Director, Serum Institute of India. The Serum Institute of India is the largest producer of vaccines in the world and is also at the forefront in rolling out the Covisheild vaccine in India. A specialist in Clinical Pharmacology, Dr. Kulkarni’s focus at the Serum Institute has been on clinical development of new vaccines and therapeutic large molecules several of which are licensed and WHO

pre-qualified. A Fellow of the American College of Clinical Pharmacology, he has to his credit over 70 publications on International journals and has been a referee to many medical journals globally. He is also a faculty at CMC, Vellore since 2010.

7. Dr. Nitin Bansal, Consultant – Infectious Diseases at Rajiv Gandhi Cancer Institute, New Delhi. A post-doctoral Fellow in Infectious Diseases from Apollo Hospitals, Chennai, Dr. Bansal is currently in charge of the Covid Unit at RGCI and has over 20 publications in National & International journals.

8. Dr. K.S. Kardam. With a doctorate In Intellectual Property Law, Dr. Kardam headed the Patent office at New Delhi and was the Senior Joint Controller of Patents & Designs. He has been part of the Task Force constituted for Traditional Knowledge Digital Library and has represented India on many occasions at the WIPO. Dr. Kardam has published several papers and delivered talks at National & International seminars in the area of IPR.

9. Dr. K.V. Swaminathan is a retired technocrat, who founded the WITT institution in New Delhi in the 1990s. Healthcare is a subject of particular focus for him and he is part of the Governing Council of Sitaram Bhartia Hospital and former Chairman of Rajiv Gandhi Cancer Institute & Research Centre, both at New Delhi. Prior to that, he was the Advisor in the Ministry of Science & Technology, the Controller- General of Patents & Trademarks and the Director of UN Asian and Pacific Centre for Transfer of Technology (APCTT), New Delhi.

10. Mrs. K. Saraswathi, is the first woman Secretary-General of the Madras Chamber of Commerce and Industry (MCCI), Chennai in its 187 years. Graduate in Spl. Economics and PG in Mathematical Economics and MBA in operations Management, has over 25 years experience in Industry & Trade development areas. Had coordinated Science, Innovation and Research activities between UK & India as Senior Trade and Investment Adviser with British Deputy High Commission. ------