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Search 3rd January, 2021 Spotlight News Analysis here: http://www.newsonair.com/Main_Audio_Bulletins_Search.aspx

Topic: General Studies 2:

• Government policies and interventions for development in various sectors and issues arising out of their design and implementation

In News: The Subject Expert Committee of Central Drugs Standard Control Organisation (CDSCO) met on 1st and 2nd January, 2021 and made recommendations in respect of proposal for Restricted Emergency Approval of COVID-19 virus vaccine of M/s Serum Institute of India and M/s Bharat Biotech as well as Phase III clinical trial of M/s Cadila Healthcare Ltd.

India moved a step closer to getting a vaccine against the novel coronavirus as two candidates — Hyderabad-based Bharat Biotech’s Covaxin and the Serum Institute of India’s Covishield — have been recommended by a government-appointed panel to the DCGI for emergency use in the last two days.

As per an official release, the Subject Expert Committee (SEC) made its recommendations in respect of the accelerated approval process request of the SII, Bharat Biotech International Ltd as well as about phase-III trials of Cadila Healthcare Ltd.

• The DCGI formally announced the approval of Bharat Biotech’s Covaxin and the Serum Institute of India’s Covishield for ‘restricted use’ in the country
• DCGI VG Somani said both the drug firms have submitted data on their trial runs and both have been granted permission

The Announcement

The overall efficacy of the Oxford-AstraZeneca Covid-19 vaccine was 70.42%, while Bharat Biotech’s Covaxin was “safe and provides a robust immune response. The Subject Expert Committee (SEC) has reviewed the data on safety and immunogenicity of the vaccine and recommended for grant of permission for restricted use in emergency situation in public interest as an abundant precaution, in clinical trial mode, to have more options for vaccinations, especially in case of infection by mutant strains. The clinical trial ongoing within the country by the firm will continue.

M/s Serum Institute of India, Pune has presented a Recombinant Chimpanzee Adenovirus vector vaccine (Covishield) encoding the SARS-CoV-2 Spike (S) glycoprotein with technology transfer from AstraZeneca/Oxford University. 

• The firm submitted safety, immunogenicity and efficacy data generated on 23,745 participants aged ≥ 18 years or older from overseas clinical studies. The overall vaccine efficacy was found to be 70.42%. 
• Further, M/s Serum was granted permission to conduct Phase-II/III clinical trial on 1600 participants within the country. 
• The firm also submitted the interim safety and immunogenicity data generated from this trial and the data was found comparable with the data from the overseas clinical studies.

M/s Bharat Biotech has developed a Whole Virion Inactivated Corona Virus Vaccine (Covaxin) in collaboration with ICMR and NIV (Pune), from where they received the virus seed strains.

• This vaccine is developed on Vero cell platform, which has well established track record of safety and efficacy in the country & globally.
• The firm has generated safety and immunogenicity data in various animal species such as mice, rats, rabbits, Syrian hamster, and also conducted challenge studies on non-human primates (Rhesus macaques) and hamsters. All these data has been shared by the firm with CDSCO.
• Phase I and Phase II clinical trials were conducted in approx.800 subjects and the results have demonstrated that the vaccine is safe and provides a robust immune response.  
• The Phase III efficacy trial was initiated in India in 25,800 volunteers and till date, ~22,500 participants have been vaccinated across the country and the vaccine has been found to be safe as per the data available till date.

M/s Serum and M/s Bharat Biotech vaccines have to be administered in two doses. All the three vaccines have to be stored at 2-8° C.

Why was it necessary?

• Because a COVID-19 vaccine will involve two jabs spaced at least four weeks apart, and will need to be administered to potentially over a billion Indians, it requires more planning, personnel and logistical arrangements.
• India’s priority list of beneficiaries includes healthcare workers, municipal workers, police personnel, those over 50 years of age, and younger people with identified co-morbidities. 
• This, the government has calculated, works out to 300 million people, and given the pace of vaccine production and administration, it will be August till all on the priority list are inoculated. 
• With at least two vaccines on the EUA list, the whole exercise involves an unprecedented level of digitisation (Co-WIN Application).
• The purpose of the dry run was to assess operational feasibility of using Co-WIN application in field environment, to test the linkages between planning, implementation and to identify the challenges and guide way forward prior to actual implementation. 
• This is also expected to give confidence to programme managers at various levels

Must Read: Vaccine Development for COVID-19

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