The Drugs Controller General of India (DCGI) has finally approved the Covid19 vaccines, developed by the Serum Institute of India (SII) and Bharat Biotech, for emergency use.

This has been confirmed by Prime Minister Narendra Modi.

The Subject Expert Committee (SEC) of Central Drugs Standard Control Organisation (CDSCO) met on January 1-2, 2021 and made recommendations in respect of proposal for restricted emergency approval of COVID19 virus vaccine of SII and Bharat Biotech.

Confirming the approval of DCGI, PM Modi tweeted on Sunday: “A decisive turning point to strengthen a spirited fight! DCGI granting approval to vaccines of @SerumInstIndia and @BharatBiotech accelerates the road to a healthier and COVID-free nation. Congratulations India.”

“It would make every Indian proud that the two vaccines that have been given emergency use approval are made in India! This shows the eagerness of our scientific community to fulfil the dream of an Aatmanirbhar Bharat, at the root of which is care and compassion,” the PM added.

The Union health ministry in a statement on Sunday said: “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.”

Also read: Bharat Biotech’s Covid19 vaccine Covaxin gets nod for emergency use, AIDAN asks DCGI to withdraw approval

“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%.”

The health ministry said SII 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, it added.

Also read: Expert panel recommends Serum Institute’s Covid19 vaccine Covishield for emergency use

The ministry said 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,” the ministry said.

All these data has been shared by the firm with CDSCO. Phase I and Phase II clinical trials were conducted in approximately 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 ministry stated.

The clinical trial ongoing within the country by the firm will continue, it added.

“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 ministry said.

The firm has sought permission to conduct Phase-III clinical trial in 26000 Indian participants, which has been recommended by the Subject Expert Committee, it said.

“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,” the ministry stated.

“After adequate examination, CDSCO has decided to accept the recommendations of the Expert Committee and accordingly, vaccines of M/s Serum and M/s Bharat Biotech are being approved for restricted use in emergency situation and permission is being granted to M/s Cadila Healthcare for conduct of the Phase III clinical trial,” the ministry further said.


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