The Central Drugs Standard Control Organization (CDSCO) has asked Serum Institute of India and Bharat Biotech to reappear in front of the Subject Expert Committee (SEC) with more data about its COVID-19 vaccine to receive emergency use authorization (EUA).
In the SEC meeting held on December 9, the experts felt that the data provided by both the vaccine manufacturers was not adequate to provide EUA.
After the meeting, several news organisations reported that the EUA requests were rejected/ unapproved but the Ministry of Health and Family Welfare took to Twitter to call a graphic by NDTV sharing these news as fake. The minutes of the SEC meeting were not in the public domain, then.
Also Read:Health Ministry Refutes Media Reports Of Serum, Bharat Biotech EUA Rejected
Once the minutes were uploaded on the CDSCO website, it was clarified that the requests are currently on hold and unapproved. The SEC has asked the companies to provide more data, trial information and documents about its COVID-19 vaccine candidates
Documents Required From Serum Institute of India
The SEC has asked SII to present the Oxford trial clinical data from the UK along with the data from the ongoing clinical trials in the country. The company, however, presented data only till November 14.
Serum now has to provide details of the updated safety data from the Phase II/III trials in the country along with the immunogenicity (Vaccine eliciting an immune response) data from both UK and India.
As the proposal for the EUA of the vaccine is under evaluation by the British Medicines and Healthcare products Regulatory Agency (MHRA), Serum also has to provide the outcome of this assessment once decided.
Documents Required From Bharat Biotech
Bharat Biotech is creating an indigenous inactivated virus vaccine with the help of the strain isolated by the National Institute of Virology. It has not provided any interim results on efficacy and immunogenicity from its Phase III trials but did so from its Phase I and II trials.
The expert committee recommended that the firm come back to the committee to present the safety and efficacy data from the ongoing Phase III clinical trial in the country for further consideration.
While Indian rules do not have an exact provision for emergency use authorization, the rules of the Drugs and Cosmetics Act highlight provisions for accelerated review and expeditious