India approves Serum-Oxford, Bharat Biotech COVID vaccines for emergency use

Two of the leading coronavirus vaccine contenders in India have been granted approval for restricted use. Oxford-AstraZeneca's coronavirus vaccine Covishield, manufactured by Serum Institute of India and Bharat Biotech's COVID vaccine Covaxin have been approved for emergency use authorisation. The Drug Controller General of India VG Somani said that the Central Drugs Standard Control Organisation (CDSCO) gave its approval followed by the recommendation of the Subject Expert Committee (SEC) that recommended both the vaccines for emergency use.

"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," said the DCGI.

It said that the Oxford vaccine has been found to be 70.42 per cent efficient. "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 degree Celsius," said the DCGI. The third vaccine that is being referred to is Cadila Healthcare's candidate that has been approved for Phase 3 clinical trials.

The CDSCO met on January 1 and 2 and made recommendations for restricted emergency approval of the vaccines. The SEC consists of experts from fields of pulmonology, immunology, microbiology, pharmacology, paediatrics, internal medicine and more.

The DCGI said that the vaccine candidate presented by Serum Institute is a  Recombinant Chimpanzee Adenovirus vector vaccine. "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 trials 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 the Subject Expert Committee has recommended for the grant of permission for restricted use in emergency situations subject to certain regulatory conditions. The clinical trial ongoing within the country by the firm will continue," it said.

The Bharat Biotech vaccine, developed in collaboration with ICMR and NIV (Pune) is a Whole Virion Inactivated coronavirus vaccine. "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," it said.

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