Lok Sabha Secretariat (LARRDIS)

BACKGROUND NOTE on “Status of COVID - 19 Vaccine production in India”

(For the use of the Standing Committee on Chemicals and Fertilisers)

October 2020

______The brief note is intended to serve only as a background aid to the Standing Committee on Chemical and Fertilisers. It is for restricted circulation and not for publication in any form. [Prepared by the Educational & Scientific Affairs Wing of the R&I Division. Officers associated with the preparation - Babulal Naik, Additional Director;Ms. Namita Kumari, RO; supervised by Shri Pradosh Panda, Director. Feedback is welcome and may be sent to [email protected]]

Status of COVID - 19 vaccine production in India LARRDIS October 2020

Introduction

India has the world's second largest coronavirus cases after the United States. However, after 8 months since the pandemic hit the country, the rising per day COVID cases curve has started to decline, especially at a time when a possible launch of coronavirus vaccine is being hoped by many by early 2021. COVID-19 is a new strain of coronavirus that has not been previously identified in humans. The COVID-19 is the cause of an outbreak of respiratory illness first detected in Wuhan, Hubei province, China. Since December 2019, cases have been identified in a growing number of countries. The Indian government and private firms have stepped up efforts to develop a vaccine to halt the spread of COVID-19 which has claimed over 118,567 lives till 25th October 2020 in the country1.

Source : Ministry of Health and Family Welfare dated 27 th Oct 2020

The whole world is waiting eagerly for an effective vaccine to fight the coronavirus pandemic. It has not only claimed lives, but also impacted people, both physically and mentally. Globally, India is renowned to be a leading vaccine producer and has manufactured several vaccines in the past, which experts believe gives India an edge over its competitors.There are more than 170 vaccines in progress right now, but closer home we have our hopes pinned on India’s first vaccine called .2Covaxin is the first indigenous vaccine developed by India against COVID-19 and is derived from a

1 https://www.worldometers.info/coronavirus/country/india/ 2 https://timesofindia.indiatimes.com/life-style/health-fitness/health-news/indias-first-coronavirus-vaccine-here-is- everything-we-know-about-its-development/articleshow/78613573.cms Page 2

Status of COVID - 19 vaccine production in India LARRDIS October 2020 strain of SARS-CoV-2 isolated by ICMR-National Institute of Virology, Pune. A number of companies and independent medical groups are involved in the development of a COVID-19 vaccine.Many more developments and announcements are taking place in the production of a homegrown vaccine. PM CARES Fund has extended support to the tune of ₹ 100 crore for coronavirus vaccine development efforts. According to the World Health Organization’s latest count, 13 experimental vaccines are being tested in humans and more than 120 others are in earlier stages of development even as the infections near nine million, including 468,484 deaths. Even as the Covid-19 pandemic has set off an unprecedented response among the global scientific community to find a vaccine, the race is set to kick up a notch from next month as three candidates — the ones developed by Moderna Inc, China’s Sinovac Biotech and UK’s Oxford- AstraZeneca — are set to enter late-stage trials.3

Source: https://www.worldometers.info/coronavirus/country/india/

3 https://indianexpress.com/article/explained/how-close-are-we-to-coronavirus-covid-19-vaccine-what-is-the- testing-process-6471283/ Page 3

Status of COVID - 19 vaccine production in India LARRDIS October 2020

Source: https://www.worldometers.info/coronavirus/country/india/ The Department of Biotechnology has been made a central coordination agency to identify pathways for vaccine development.4 Recently, Our Prime Minister in an address to the 2020 summit of the Grand Challenge on COVID-19 Vaccine development stated that India has one of the highest recovery rates of COVID-19 infections at 88 percent and the country is at the "forefront" of vaccine development. This meeting brought together policymakers and scientific leaders for a deepened scientific collaborations in solving global health problems, with great emphasis on COVID-19 with an "India for the World" framing.5 What is COVID -19

In February 2020, the World Health Organization coined the official name for the disease-causing the 2019 novel coronavirus outbreak. The new virus and disease were unknown before the outbreak began in Wuhan, China, in December

4 https://www.ndtv.com/india-news/coronavirus-pandemic-covid-19-vaccine-development-at-early-stage-in-india- breakthrough-unlikely-within-a-year-experts-2234047 5 Oct 20, 2020 07:33 AM IST | Source: Moneycontrol.com Page 4

Status of COVID - 19 vaccine production in India LARRDIS October 2020

2019.The new name of this disease is coronavirus disease 2019, abbreviated as COVID-19. In COVID-19, ‘CO’ stands for ‘corona,’ ‘VI’ for ‘virus,’ and ‘D’ for disease.6 Coronaviruses (CoV) are a large family of viruses that can cause illness ranging from the common cold to a more severe disease such as Middle East Respiratory Syndrome (MERS-CoV) and Severe Acute Respiratory Syndrome (SARS-CoV). Coronaviruses are zoonotic, meaning they are transmitted between animals and people. In March 2020, the WHO declared the COVID-19 outbreak a pandemic. Detailed investigations found that SARS-CoV was transmitted from civet cats to humans and MERS-CoV from dromedary camels to humans. Several known coronaviruses are circulating in animals that have not yet infected humans. Novel (meaning new) coronavirus (nCoV) is a new strain that had not been previously identified in humans. On 31 December 2019, WHO was informed of cases of pneumonia of unknown etiology (unknown cause) detected in Wuhan City, Hubei Province of China. A novel coronavirus (2019-nCoV) was identified as the causative virus by Chinese authorities on 7 January, 2020.

Available evidence on the 2019-nCoV virus and previous experience with other

6 https://know.rx.health/support/solutions/articles/48001160489-what-is-covid-19- Page 5

Status of COVID - 19 vaccine production in India LARRDIS October 2020 coronaviruses (MERS-CoV and SARS-CoV) and other respiratory viruses (e.g avian influenza) suggest that there may be zoonotic transmission associated with the 2019-nCoV.

The virus that causes COVID-19 and the one that caused the outbreak of Severe Acute Respiratory Syndrome (SARS) in 2003 are related to each other genetically, but the diseases they cause are quite different. SARS was more deadly but much less infectious than COVID-19. There have been no outbreaks of SARS anywhere in the world since 2003.7

The different phases of vaccine testing

Pre-clinical tests: In this stage, scientists test the vaccine in the laboratory using cells or animals. Phase I trials: This is the first step where the experimental vaccine is given to humans and examines the safety, dosage, and possible side effects. This stage typically takes around two months and involves small numbers of participants, usually 20 to 100 healthy volunteers. Phase II trials: In this stage, several hundred individuals are enrolled for testing and they are split into groups age-wise such as children and elderly. This stage studies the candidate vaccine’s immunogenicity, proposed doses, schedule of immunisations and method of delivery. Phase III trials: In this stage, the candidate vaccine is tested in hundreds to thousands of volunteers for its ability to prevent infection in humans in real-life situations (outside of laboratory conditions). During a pandemic, a vaccine may receive emergency use authorisation before a formal green signal. Approval: After Phase III trials, the developer submits a license application to the

7 https://www.mohfw.gov.in/ Page 6

Status of COVID - 19 vaccine production in India LARRDIS October 2020 regulatory authority in their respective country. The regulator then inspects the factory where the vaccine will be made and approves its labelling.8

The Global Progress for Severe Acute Respiratory Syndrome-Coronavirus-2 Vaccines 9

The first coronavirus vaccine trial has been started by the Kaiser Permanente Washington Health Research Institute. This vaccine is known as mRNA-1273 and was developed by the National Institute of Allergy and Infectious Diseases scientists and their collaborators at the biotechnology company Moderna, Inc., based in Cambridge, Massachusetts. The Coalition for Epidemic Preparedness Innovations supported the manufacturing of the vaccine candidate for the Phase 1 clinical trial.10,11Recently, another adenovirus containing S-protein vaccine came for clinical trial in record time. This vaccine developed by a research group in Jenner Institute at Oxford University in partnership with the UK-based global biopharmaceutical company AstraZeneca. Many academic and industry-based research groups are working on recombinant protein-based approach and mainly focusing on S-protein, viral vector-based vaccines, DNA vaccines, live attenuated vaccines ( with Codagenix), and inactivated virus vaccines. The major concerns about the current vaccine designs are whether they will be effective due to the high frequency of glycosylation and mutations in the S-

8 https://indianexpress.com/article/coronavirus/covid-19-vaccine-front-runners-oxford-moderna-pfizer- russia-covaxin-update-6586833/ 9 10 NIH Clinical Trial of Investigational Vaccine for COVID-19 Begins | NIH: National Institute of Allergy and Infectious Diseases. Available from: https://www.niaid.nih.gov/news-events/nih-cli nical-trial-investigational-vaccine-covid-19-begins. [Last accessed on 2020 Apr 29]. 11 Moderna Ships mRNA Vaccine Against Novel Coronavirus (mRNA-1273) for Phase 1 Study. Moderna, Inc. Available from: https://investors.modernatx.com/n ews-releases/news-release-details/moderna-ships-m rna-vaccine-against-novel-corona virus-mrna-1273 Page 7

Status of COVID - 19 vaccine production in India LARRDIS October 2020 protein, as well as the potential antibody-dependent enhancement. In vaccine development process, appropriate animal models are very critical to test protective responses. SARS-CoV2 does not grow in wild-type animals and induce mild disease in transgenic animals expressing ACE2.12Another suitable model will be nonhuman primate, for which pathogenicity studies are going on at a primate center of Texas Biomedical Research Center at San Antonio, USA. If a vaccine with optimal efficacy is generated, the next challenge will be the large-scale production of vaccine with good manufacturing practice to ensure the quality and safety. COVID-19 Vaccine Development Scenario in India

The Central Drugs Standard Control Organisation (CDSCO) has granted test license permission for manufacture of COVID-19 Vaccine for preclinical test, examination and analysis to the following manufacturers in India.

1. M/s Serum Institute of India Pvt., Ltd., Pune 2. M/s Ltd., Ahmadabad 3. M/s International Ltd., Hyderabad 4. Biological E Ltd., Hyderabad 5. M/s Reliance Life Sciences Pvt Ltd., Mumbai 6. M/s Aurbindo Pharma Limited, Hyderabad 7. M/s Gennova Biopharmaceuticals Limited, Pune

The Indian Council of Medical Research (ICMR), an autonomous organisation under the Department of Health Research, has informed that the

12 Verdecchia P, Cavallini C, Spanevello A, Angeli F. The pivotal link between ACE2 deficiency and SARS-CoV-2 infection. Eur J Intern Med 2020 ;S0953-6205(20)30151-5. Available from: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7167588/. Page 8

Status of COVID - 19 vaccine production in India LARRDIS October 2020

following companies are conducting clinical trials for COVID-19 vaccines in India.

(i) An inactivated whole virion candidate vaccine (BBV152) for SARS-CoV-2 has been developed by Bharat Biotech International Ltd (BBIL) using the virus isolate (NIV-2020-770) provided by ICMR-National Institute of Virology (NIV), Pune. Characterization of the vaccine candidate has been undertaken at ICMR- NIV followed by safety and tolerability studies in small animals like rats, mice and rabbits. Status of clinical trials is as follows:

 Phase I - clinical trials along with parallel studies in large animals have been completed. The trial has revealed excellent safety of the candidate vaccine. Immunogenicity testing is in progress.

 Phase II clinical trials are ongoing.

(ii) A DNA vaccine (ZyCov-D) has been developed by Cadila Healthcare Ltd. Pre- clinical toxicity studies were conducted in small animals: mice, rats, rabbits and guinea pigs. The vaccine has been found to be safe and immunogenic. Cadila has partnered with ICMR for conduct of parallel pre-clinical studies in large animals. Status of clinical trials is as follows:

 Phase I clinical trials have been completed. The trial has revealed excellent safety of the candidate vaccine. Immunogenicity testing is in progress.

 Phase II clinical trials are ongoing.

(iii) Serum Institute of India (SII) and ICMR have partnered for clinical development of two global vaccine candidates:

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Status of COVID - 19 vaccine production in India LARRDIS October 2020

 ChAdOx1-S, which is a non- replicating developed by University of Oxford/AstraZeneca. This vaccine is undergoing phase III clinical trials in Brazil. Phase II/III bridging studies have been initiated by ICMR at 14 clinical trial sites. ICMR-National Institute for Research in Tuberculosis (NIRT), Chennai is the lead institution.

 ICMR and SII have also partnered for clinical development of a glycoprotein subunit nanoparticle adjuvanted vaccine developed by Novavax from USA. The trial will be initiated in second half of October after the vaccine is manufactured by SII. The trial is led by ICMR-National AIDS Research Institute (NARI), Pune.As per details provided by Department of Biotechnology (DBT)/Department of Science and Technology (DST), more than 30 vaccine candidates have been supported which are in different stages of development. The ICMR has allocated Rs.25 crore for various studies and other research activities pertaining to vaccine development.The Science and Engineering Research Board (SERB), a statutory body under the Department of Science and Technology, has supported 3 projects under COVID-19 on vaccine research under Intensified Research in High Priority Areas (IRHPA). The sanctioned expenditure is Rs.22,27,579/- and the committed expenditure is Rs.3,20,78,161/.The Department of Biotechnology is also supporting 8 proposals by Industry and academia for candidate vaccine development and associated research resources at a total cost of Rs. 75 crore.13

Initiatives taken by the Government for the COVID-19 Vaccine

Vaccine development goes through various complex pathways and is a time taking procedure and the government and the Industry are trying their best to make available a safe and effective vaccine for COVID-19 at the earliest. The

13 https://pib.gov.in/PressReleasePage.aspx?PRID=1654450 dated 15 SEP 2020 Page 10

Status of COVID - 19 vaccine production in India LARRDIS October 2020

Government has constituted a high-level National Expert Group on vaccine administration for COVID-19 which is chaired by Member, Niti Aayog and co- chaired by Secretary, Ministry of Health & Family Welfare. The expert committee is addressing issues related to vaccine delivery, selection of suitable vaccines, procurement, prioritization of groups, logistics, Cold chain requirements, finance and National / International equity. 14 Thirty different Indian companies are trying to produce a vaccine to fight the infection, out of which WHO has given approvals to seven vaccine candidates, which are in different stages of testing and clinical studies now.15

 COVAXIN, developed by Hyderabad-based Bharat Biotech International Limited (BBIL), in collaboration with ICMR and NIV, Pune was the first vaccine to get regulatory approvals for clinical trials. The vaccine makes use of an inactive version of a virus to spike up production of antibodies in the host body and just recently initiated phase I and II of testing. Over 385 people have been recruited so far and top hospitals across the country have been selected for conducting the trials.

14 https://pib.gov.in/PressReleasePage.aspx?PRID=1654450 15 https://timesofindia.indiatimes.com/life-style/health-fitness/health-news/coronavirus-vaccine-status-in-india- stages-of-covid-19-vaccine-development-in-india Page 11

Status of COVID - 19 vaccine production in India LARRDIS October 2020

COVAXIN has got the nod from the Drugs Controller General of India (DCGI) to conduct phase 3 clinical trials. The development has come after Bharat Biotech Ltd, a Hyderabad based company presented its data from Phase 1 and 2 along with animal challenge data in two species including NHP on the Inactivated Coronavirus Vaccine (BBV152) along with the proposal to conduct event driven Phase 3 clinical trial to assess the efficacy of the vaccine in the SEC meeting to examine COVID-19 related proposals under accelerated approval process made in its 118th meeting at CDSCO.16 After detailed deliberation and based on the available evidences, the committee recommended for grant of permission to conduct Phase III clinical trial subject to the condition that the Primary efficacy endpoint for symptomatic cases should be amended as below:  Once a suspect case is confirmed the Phase I will evaluate the clinical information to classify it as a symptomatic case.  Two, criteria must be met for a participant to be a confirmed symptomatic case. Either criteria A or B with positive RT-PCR confirmation.  Criteria A: One or more - Shortness of Breath/Difficulty in breathing, New onset Anosmia/Aguesia, Oxygen saturation of <94 per cent or escalation in supplemental O2, Pneumonia diagnosed by chest X ray or CT scan, Evidence of Shock, ICU Admission/Death OR  Criteria B: Two or more - Fever, Chills, New cough, Myalgia/Fatigue, Headache, Sore throat, Nausea/Vomiting, Diarrhea, Congestion/ Runny Nose.  The events not meeting the primary endpoint shall be categorized as secondary endpoints.  Ahmedabad-based pharma giant, Zydus Cadila announced the start of phase I of its testing process of its novel vaccine candidate earmarked ZyCOV-D last week. Extensive research for the same was

16 https://www.indiatvnews.com/news/india/covaxin-coronavirus-vaccine-bharat-biotech-dcgi-approval-phase-3- clinical-trials-india Page 12

Status of COVID - 19 vaccine production in India LARRDIS October 2020

done in coordination with medical laboratories in the USA and Europe for the same. The company is testing two versions of its vaccine, one which makes use of molecular DNA to elicit an immune response, while the other uses a live measles viral strain to provide protection. Development of the vaccine was accelerated after authorities saw a positive response in pre-clinical research and animal studies.While human clinical trials are currently going on.  Another prime vaccine maker based out of India, Indian Immunologicals Limited (IIL) is overseeing the development of a vaccine in partnership with Griffith University, Australia. The vaccine model, though still in its nascent stage makes use of an innovative codon-deoptimization technology which directly targets the cells infected by SARS-COV-2. Pre-clinical trials and studies are still going on for the same.  Bengaluru-based medical pharmaceutical startup, Mynvax made news months back when it announced work on a COVID vaccine which uses a very different approach involving a protein-based vaccine. The same has been done in collaboration with the Indian Institute of Science (Bengaluru). While scientists are still conducting pre-clinical trials, the company has applied for a Rs 15 crore grant for further research from the Biotechnology Industry Research Assistance Council (BIRAC).

 British-Swedish pharma major Astra Zeneca is currently involved in the development of the much talked about adenovirus vector vaccine with the University of Oxford. The vaccine prototype is currently in phase III of testing. The company has tied up with Pune based Serum Institute of India (SII) to mass-produce the vaccine once the company gets required approvals and licensing from medical boards. On August 3, the Drugs Controller General of India (DCGI) has given approval to Pune- based Serum Institute of India (SII) to conduct clinical trials of Oxford University-Astra Zeneca COVID-19 vaccine in India. Astra Zeneca is in process of human trials of its vaccine in India. The vaccine, which has so far been found to be safe and effective is expected to be made available for the masses by the end of 2020.

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Status of COVID - 19 vaccine production in India LARRDIS October 2020

 Delhi-based biotechnology company, Panacea Biotech Limited has signed a partnership with a US-based pharma company, Refana Inc to develop, manufacture and distribute an experimental COVID-19 vaccine which is currently in works. An agreement has also been signed up with a firm in Ireland regarding the same. The vaccine prototype, which will make use of an inactivated virus strain has shown effective results in the pre-clinical trials conducted in the US. Toxicology studies and animal trials will be conducted in labs across Delhi and Punjab, following which, the company aims to proceed to human trials in the month of October.  The most recent entrant in the vaccine race, Hyderabad-based Biological E is working on developing a novel COVID-19 preventing vaccine which is still in its pre-clinical level. Further updates regarding the same are still awaited.

Some Other Developments in the COVID-19 Vaccine Production.  Bharat Biotech and the US –based Flugen, along with virologists at the University of Wisconsin –Madison , have begun the development and testing of a vaccine against COVID-19 called CoroFlu.17  In partnership with Cadila Pharmaceuticals of India ,the US-based Novavax is using the virus-like particles (VLP) platform which has been previously used for the papilloma virus vaccine.The Vaccine is undergoing trials in the US and Australia.18  IIT-Indore’s COVID-19 vaccine enters animal trial phase stage at the National Centre for Cell Science in Pune.  Oxford-AstraZeneca’s COVID-19 vaccine will be ready by December, the Serum institute of India says oxford - AstraZeneca’s potential COVID-19

17 https://gulfnews.com/world/3-leading-covid-19-vaccines-from-india-1.1596549088057?slide=4 18 https://gulfnews.com/world/3-leading-covid-19-vaccines-from-india-1.1596549088057?slide=4 Page 14

Status of COVID - 19 vaccine production in India LARRDIS October 2020

vaccine will be ready by December and available in market by March 2021 after procuring a license.19  Bharat Biotech is looking to raise manufacturing capacity above 500 million doses. It is one of three companies conducting advanced stage trials in India for its COVID-19vaccine candidate. The pharma company has a manufacturing capacity of 150 million doses per year.  Serum Institute of India (SII) and the Brihanmumbai Municipal Corporation have completed phase II trials of Oxford-AstraZeneca’Scovid-19 Vaccine.20  Bharat Biotech partners with Washington University for an intransal vaccine. According to founder Kiran Majumdar Shaw intranasal vaccine will be easier to deliver. Bharat Biotech gets nod to conduct phase 3 trial of its COVID-19.

 Dr.Reddy’s Laboratories and Russian Direct Investment Fund, Russia’s sovereign wealth fund, on October 17, 2020 announced that they have received approval from the Drug Controller General of India to conduct an

adaptive phase 2/3 human clinical trial for Sputnik V vaccine in India.

Way Forward in the COVID-19 Vaccine Production21 Recently our Prime Minister directed that the country should make use of experience gained in successful conduct of elections and disaster management for the vaccine delivery system. He said that in a similar manner the vaccine delivery and administration systems should be put in place. Three vaccines are in advanced stages of development in India, out of which 2 are in Phase II and one is in Phase-

19 https://www.businessinsider.in/india/news/covid-19-vaccine-updates-in-india-oxfords-vaccine-to-be-available-in- indian-market-by-march-bharat-biotech-to-develop-an-intranasal- vaccine/articleshow/78741876.cms?utm_source=contentofinterest&utm_medium=text&utm_campaign=cppst 20 https://www.businessinsider.in/india/news/covid-19-vaccine-updates-in-india-oxfords-vaccine-to-be-available-in- indian-market-by-march-bharat-biotech-to-develop-an-intranasal- vaccine/articleshow/78741876.cms?utm_source=contentofinterest&utm_medium=text&utm_campaign=cppst 21 https://www.indiatvnews.com/news/india/pm-modi-use-poll-experience-for-vaccine-delivery-system-657813 Page 15

Status of COVID - 19 vaccine production in India LARRDIS October 2020

III. Indian scientists and research teams are collaborating and strengthening the research capacities in neighbouring countries - Afghanistan, Bhutan, Bangladesh, Maldives, Mauritius, Nepal and Sri Lanka. There are further requests from Bangladesh, Myanmar, Qatar and Bhutan for clinical trials in their countries. In an effort to help the global community, the Prime Minister further directed that we should not limit our efforts to our immediate neighbourhood but also reach out to the wider world in providing vaccines, medicines and IT platforms for vaccine delivery systems. National Expert Group on Vaccine Administration for Covid-19 (NEGVAC) in consultation with state governments and all relevant stakeholders have prepared and presented a detailed blueprint of vaccine storage, distribution and administration.The Expert Group in consultation with the States is working actively on vaccine prioritisation and distribution of vaccines. The Prime Minister further directed that keeping in view the geographical span and diversity of the country, the access to the vaccine should be ensured speedily. Every step in the logistics, delivery, and administration should be put in place rigorously. It must include advanced planning of cold storage chains, distribution network, monitoring mechanism, advance assessment, and preparation of ancillary equipment required, such as vails, syringes etc. It should involve the participation of states, UTs, district level functionaries, civil society organisations, volunteers, citizens, and experts from all necessary domains. The entire process should have a strong IT backbone and the system should be designed in such a manner so as to have a lasting value to our healthcare system.Two PAN-India studies on the genome of SARS-CoV-2 (Covid-19 virus) in India conducted by ICMR and Department of Biotechnology (DBT) suggest that the virus is genetically stable and there is no major mutation in the virus.

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Electronic Vaccine Intelligence Network (eVIN) has ensured essential immunization services during the COVID pandemic 22 The Electronic Vaccine Intelligence Network (eVIN) is an innovative technological solution aimed at strengthening immunization supply chain systems across the country. This is being implemented under National Health Mission (NHM) by the Ministry of Health and Family Welfare. eVIN aims to provide real- time information on vaccine stocks and flows, and storage temperatures across all cold chain points in the country.

Source: Newspaper Indian Express dated This robust system has been used with the requisite customization during the COVID-19 pandemic for ensuring continuation of the essential immunization services and protecting our children and pregnant mothers against vaccine preventable diseases. eVIN combines state-of-the-art technology, a strong IT infrastructure and trained human resource to enable real time monitoring of stock and storage temperature of the vaccines kept in multiple locations across the country. eVIN has reached 32 States and Union Territories (UTs) and will soon be

22 https://pib.gov.in/PressReleasePage.aspx?PRID=1643172 Page 17

Status of COVID - 19 vaccine production in India LARRDIS October 2020 rolled-out in the remaining States and UTs of Andaman & Nicobar Islands, Chandigarh, Ladakh and Sikkim. At present, 23,507 cold chain points across 585 districts of 22 States and 2 UTs routinely use the eVIN technology for efficient vaccine logistics management. Over 41,420 vaccine cold chain handlers have been introduced to digital record-keeping by training them on eVIN. Nearly 23,900 electronic temperature loggers have been installed on vaccine cold chain equipment for accurate temperature review of vaccines in storage. The Electronic Vaccine Intelligence Network has helped create a big data architecture that generates actionable analytics encouraging data-driven decision-making and consumption based planning that helps in maintaining optimum stocks of vaccines leading to cost savings. Vaccine availability at all times has increased to 99% in most health centers. An activity rate of more than 99% reflects high adoption of the technology across all health centers where eVIN is currently operational. While instances of stock-outs have reduced by 80% , the time taken to replenish stocks has also decreased by more than half, on an average. This has ensured that every child who reaches the immunization session site is immunized, and not turned back due to unavailability of vaccines.

Parliamentary Discussion upon COVID-19 Vaccine Development

Union Minister of Health and Family Welfare Harsh Vardhan on (October 4, 2020) stated that the central government is planning to receive and utilize 400- 500 mllion COVID-19 vaccine doses which will cover around 20-25 crore people by July 2021. Health Ministry is currently preparing a format in which States will submit lists of priority population groups to receive the vaccine, especially health workers engaged in the management of COVID-19. The list of frontline health workers will include both government as well as private-sector

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Status of COVID - 19 vaccine production in India LARRDIS October 2020 doctors, nurses, paramedics, sanitary staff, ASHA workers, surveillance officers and many other occupational categories who are involved in tracing, testing and treatment of patients. This exercise is targeted to be completed by the end of this October and the States are being closely guided to also submit details about cold chain facilities and other related infrastructure which will be required down to the block level. The Centre is also working on plans for building capacities in HR, training, supervision etc on a massive scale and roughly estimates to receive and utilise 400-500 million doses covering approximately 20-25 crore people by July 2021. He further informed that the Government is also keeping an eye on immunity data with regard to COVID-19 disease while finalizing these plans. A high-level committee under the chairmanship of Niti Aayog Member (Health) VK Paul which is drawing up the entire process. Vaccine procurement is being done centrally and each consignment will be tracked real- time until delivery to ensure it reaches those who need it most.These Committees are working on understanding the timelines of availability of various vaccines in the country, obtaining commitments from vaccine manufacturers to make the available maximum number of doses for India inventory & supply chain management and also on prioritisation of high-risk groups. All vaccines that have proven to be safe, immunogenic and efficacious in clinical trials outside India need to undergo bridging studies to prove their safety and immunogenicity in the Indian population as well although these studies can be conducted with much smaller sample size and end quickly. All proposed clinical trials in India are designed using set principles and are stringently reviewed by the Subject Expert Committee set up by the Drug Controller General of India. Recently, the DCGI has also formulated draft

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Status of COVID - 19 vaccine production in India LARRDIS October 2020 guidelines on regulatory requirements for licensure of COVID-19 vaccines in India. for quick control of a pandemic, it is desirable to have a single-dose vaccine. However, it is often difficult to achieve desired levels of immune protection using a single dose. He added, two-dose vaccines are suitable for attaining the desired immunogenicity as the first dose gives some immune protection, and the second dose augments it further.23

https://www.oneindia.com/india/health-minister-releases-covid-19-management- protocol-based-on-ayurveda-yoga-3159471.html https://timesofindia.indiatimes.com/india/health-ministry-guidelines-for-co- infection-management-of-covid-19-with-seasonal-epidemic-prone- diseases/articleshow/78636762.cms https://www.financialexpress.com/lifestyle/health/indias-contribution-will-be- critical-to-fighting-covid-19-health-minister-harsh-vardhan/2111141/ https://www.hindustantimes.com/india-news/health-minister-releases-covid-19- management-protocol-based-on-ayurveda-yoga/story- vE3G18zHrydrw9ZzthM0kM.html

23 https://zeenews.india.com/india/union-health-minister-harsh-vardhan-reveals-who-will-receive-covid-19-vaccine- first-in-india-2314638.html Page 20

Status of COVID - 19 vaccine production in India LARRDIS October 2020 https://timesofindia.indiatimes.com/india/health-ministry-guidelines-for-co- infection-management-of-covid-19-with-seasonal-epidemic-prone- diseases/articleshow/78636762.cms https://www.oneindia.com/india/health-minister-releases-covid-19- management-protocol-based-on-ayurveda-yoga-3159471.html https://www.firstpost.com/health/india-will-grant-emergency- authorisation-for-covid-19-vaccine-depending-on-data-availability- health-minister-8904631 https://www.financialexpress.com/lifestyle/health/indias-contribution- will-be-critical-to-fighting-covid-19-health-minister-harsh- vardhan/2111141/ https://www.firstpost.com/health/india-will-grant-emergency- authorisation-for-covid-19-vaccine-depending-on-data-availability- health-minister-8904631.html

Conclusion In the future, the next coming months will be very critical to develop an effective vaccine or therapeutic options to battle with this pandemic. Lesson from this pandemic is that it would be the right time to consider investing in the development of better vaccine technologies that help to develop a protective

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vaccine as quickly as possible. In addition, we need to develop a better emergency plan that would allow us to produce and distribute vaccines within a short time frame.

Contact us : E-mail: [email protected] Phone : 011 -23034762/5038

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Contact us : E-mail: [email protected] Phone : 011 -23034762/5038