The Subject Expert Committee (SEC) of the Central Drugs Standards Control Organisation (CDSCO) met on January 1 and 2 to deliberate on Restricted Emergency approval of COVID-19 virus vaccine.
On January 1, the SEC reviewed Bharat Biotech’s request for approval for Covaxin. The minutes from the SEC’s meeting of January 1 stated while the data generated (Bharat Biotech’s Covaxin) so far demonstrates a strong immune response to both antibodies as well as T cell and in-vitro viral neutralization. However, efficacy is yet to be demonstrated. The Bharat Biotech was told to “expedite the recruitment” of volunteers for the ongoing phase 3 human trials. The SEC also told Bharat Biotech “interim efficacy analysis for further consideration”, according to an Indian Express (IE) report.
However, on January 2, the SEC made recommendations for the consideration and final decision of the DCGI. “Grant of permission for restricted use in an emergency situation in the public interest as an abundant precaution, in clinical trial mode, especially in the context of infection by mutant strains, to M/s Bharat Biotech International Ltd., Hyderabad,” the Ministry of Health and Family Welfare said in a statement.
The minutes from the SEC’s meeting of January 2 stated Bharat Biotech had presented the “safety and efficacy data from non-human primate challenge study where the vaccine has been found to be safe and effective.”
“As already noted by the committee, this vaccine is Inactivated Whole Virion, CoronaVirus Vaccine having the potential to target mutated coronavirus strains,” the IE report says. The minutes also revealed that “updated data” and “justification” were presented by Bharat Biotech.
On January 3, the Ministry of Health and Family Welfare announced that Emergency Use Authorization (EUA) has been granted to Serum Institute of India’s Covishield and Bharat Biotech’s Covaxin. “The 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 the case of infection by mutant strains. The clinical trial ongoing within the country by the firm will continue,” the Ministry of Health and Family Welfare said in a statement.