Lok Sabha Secretariat (LARRDIS) New Delhi 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 It is for restricted circulation and not for publication in any form.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 Covaxin.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- 3 AstraZeneca — are set to enter late-stage trials. 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 (Serum Institute of India 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-