Centre's Principal Scientific Adviser congratulates India as it approves 2 COVID vaccines

As India approved 2 COVID-19 vaccines, Principal Scientific Adviser to the Government of India K Vijay Raghavan on Sunday congratulated India and said vaccinations against Coronavirus will begin soon. The Principal Scientific Adviser said that this is a result of focused work by scientists, national laboratories, government agencies, regulators, health care workers, and most importantly, all our people who have waited patiently following all COVID appropriate behaviour.

Stating that there are full vaccination measures in place across the country, VK Vijay Raghavan said, "all should follow these protocols systematically and fully. Everyone will get their turn. We should start by ensuring that those who look after us, health- and frontline workers are first safe."

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India approves 2 COVID vaccines for emergency use

In a massive development, the Drugs Controller General of India (DCGI) on Sunday approved Serum Insititute's 'Covishield' for emergency use, along with Bharat Biotech's 'Covaxin'. Addressing a presser, the DCGI VG Somani said that the Subject Expert Committee of Central Drugs Standard Control Organisation (CDSCO) met on January 1 and 2 and made recommendations in respect of a proposal for Restricted Emergency Approval of COVID-19 virus vaccine of Serum Institute of India and Bharat Biotech as well as Phase III clinical trial of Cadila Healthcare Ltd. The nod by India comes days after the United Kingdom's approval to Oxford-AstraZeneca's Coronavirus Vaccine which is being manufactured and marketed in India by Serum Institute under the name Covishield.

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Here is the full DCGI statement:

The Subject Expert Committee of Central Drugs Standard Control Organisation (CDSCO) met on 1st and 2nd January, 2021 and made recommendations in respect of a 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.
The Subject Expert Committee consists of domain knowledge experts from the fields of pulmonology, immunology, microbiology, pharmacology, paediatrics, internal medicine, etc.

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. After detailed deliberations Subject Expert Committee has recommended for the grant of permission for restricted use in emergency situation subject to certain regulatory conditions. The clinical trial ongoing within the country by the firm will continue.

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 a well-established track record of safety and efficacy in the country & globally.

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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. 

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 an emergency situation in the 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 Cadila Healthcare Ltd., has developed a Novel Corona Virus-2019-nCov-Vaccine using DNA platform technology. The firm initiated Phase-I/II clinical trial in India in more than 1000 participants which is ongoing. The interim data suggest that the vaccine is safe and immunogenic with three doses when administered intradermally. Accordingly, the firm has sought permission to conduct Phase-III clinical trial in 26000 Indian participants, which has been recommended by the Subject Expert Committee.
M/s Serum and M/s Bharat Biotech vaccines have to be administered in two doses. All three vaccines have to be stored at 2-8° C. 

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