Approval to pharma companies SII and Bharat Biotech has been given after thorough consultations with domain experts

National drug regulator, Drug Controller General of India on Sunday announced that the Central Drugs Standard Control Organisation has decided to accept the recommendations of its Subject Expert Committee (SEC), and approved the Covid-19 vaccine of both Serum Institute of India (SII) and Bharat Biotech for restricted use in the country.

The subject expert committee of CDSCO consisting of domain knowledge experts from the fields of pulmonology, immunology, microbiology, pharmacology, paediatrics, internal medicine met on January 1 and 2.

After adequate examination CDSCO accepted recommendations in respect of proposal for Restricted Emergency Approval of COVID-19 vaccine of SII and Bharat Biotech as well as Phase III clinical trial of M/s Cadila Healthcare Ltd, the Health Ministry said.

The SEC reviewed data on safety and immunogenicity.

According to Health Ministry’s press release, SSI 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 generated data on 23,745 participants and the overall vaccine efficacy was found to be 70.42 per cent.

Whereas Bharat Biotech has developed a whole virion inactivated Coronavirus vaccine (Covaxin) in collaboration with ICMR and NIV (Pune), from where they received the virus seed strains. This vaccine is developed on the Vero cell platform, which has a well established track record of safety and efficacy in the country and 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.

Phase-I and Phase-II clinical trials were conducted in approx.800 subjects. 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, according to the Health Ministry.