Provide more safety data on Covid-19 vaccine: SEC to Serum, Bharat Biotech

The Central Drugs Standard Control Organisation's Subject Expert Committee on Wednesday asked the Serum Institute of India and Bharat Biotech to submit more data and information to get emergency use authorisation (EUA) for their Covid-19 vaccine candidates.

According to the minutes of the meeting, the committee recommended the Serum Institute of India to submit the updated safety data of the Phase 2/3 clinical trials, immunogenicity data from the clinical trial in UK and India, and outcome of the assessment of UK-MHRA for grant of EUA.

During the meeting, the SII presented their proposal for grant of EUA of COVISHIELD, along with the interim safety data from Phase 3 clinical trial and interim safety and efficacy results of Phase 2/3 and Phase 3 clinical trials carried out in UK, other countries and India, before the committee.

In the case of Bharat Biotech, the firm presented their proposal for grant of EUA, along with the interim safety and immunogenicity data of Phase 1 and 2 clinical trial carried out in the country before the committee.

"Serum Institute of India has been asked for an updated safety data of phase 2 and 3 clinical trial in the country and immunogenicity data from the clinical trial in the United Kingdom and India. While considering the application of Bharat Biotech company, the SEC after detailed evaluation recommended that the pharma major should submit the safety and efficacy data from its ongoing phase 3 clinical trial in India for more analysis," a source said.

The application submitted by the Pfizer was not discussed at the SEC meeting as the company has requested for more time for giving its presentation, sources said.

America's Pfizer was the first to apply on December 4, followed by Pune-based SII and Hyderabad-based Bharat Biotech who applied on December 6 and 7, respectively. Pfizer has, however, requested more time to make presentation before the committee.

Emergency Use Authorisation is a mechanism to facilitate the availability and use of medical countermeasures, including vaccines, during public health emergencies. Such an approval was given to Covid-19 drugs - remdesivir and favipiravir in June and itolizumab in July.

On Tuesday, the Union Health Ministry informed that as many as eight Covid-19 vaccine candidates are under different stages of clinical trials which could be ready for authorization in near future.

Theus includes Astrazeneca and Oxford University developed and Serum Institute of India manufactured Covishield, Covaxin by Bharat Biotech, ZyCoV-D by Zydus Cadila, Russian vaccine candidate Sputnik-V, NVX-CoV2373 by SII, HGCO19 by Geneva, and two unlabeled vaccines - the Recombinant Protein Antigen based vaccine by Biological E Ltd, and Inactivated rabies vector platform by Bharat Biotech.