New Delhi: Union Health Minister Harsh Vardhan on Sunday (January 3, 2020) called it a ‘watershed moment in India’s famed battle against COVID-19’ after Serum Institute of India’s COVISHIELD and Bharat Biotech’s COVAXIN get a nod for restricted use.

“A watershed moment in India’s famed battle against COVID-19 under the charismatic leadership of Hon’ble PM Sh Narendra Modi Ji! Our wait for COVID19 vaccine is over with COVISHIELD from @SerumInstIndia & COVAXIN from @BharatBiotech approved for emergency use in India,” said Harsh Vardhan.

He added, “These vaccines are a fitting tribute to our corona warriors! My heartfelt gratitude to all healthcare professionals & frontline workers for their exemplary efforts during these unprecedented times. Congratulations to all the scientists & researchers for their untiring efforts.”

The Health Minister also said, “It’s now time to reap the benefits of the robust supply chain infrastructure we’ve put in place for quick & equitable distribution of the vaccine. Urge all citizens to entrust the stringent protocols followed for ensuring safety, efficacy & immunogenicity of the approved vaccines.

Notably, the Subject Expert Committee of Central Drugs Standard Control Organisation (CDSCO) met on January 1 and January 2, 2021, 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.

Serum Institute of India, Pune 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,” said the Ministry of Health and Family Welfare.

The Ministry of Health and Family Welfare added that 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 and after detailed deliberations, Subject Expert Committee recommended for the grant of permission for restricted use in an emergency situation subject to certain regulatory conditions. 

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

On the other hand, 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.

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 have 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.

Serum and Bharat Biotech COVID-19 vaccines have to be administered in two doses and have to be stored at 2-8° C.





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