New Delhi: An expert committee of the Central Drugs Standard Control Organisation (CDSCO) sought Wednesday additional safety and efficacy data for COVID-19 vaccine candidates of Serum Institute of India (SII) and Bharat Biotech. This decision was taken after the expert committee deliberated upon their applications seeking emergency use authorisation for the shots, officials said.
The application by the Indian arm of US pharmaceutical firm Pfizer was not taken up for deliberation Wednesday. Pfizer has sought more time for making a presentation before the committee, sources said.
While considering Serum Institute’s application, the subject expert committee (SEC) on COVID-19 has recommended that the firm should submit an updated safety data of phases 2 and 3 clinical trials in India, immunogenicity data from the clinical trial in the UK and India, along with the outcome of the assessment of the UK Medicines and Healthcare products Regulatory Agency (MHRA) for grant of emergency use authorisation.
As for Hyderabad-based Bharat Biotech, ‘after detailed deliberation, the committee recommended that the firm should present the safety and efficacy data from the ongoing phase 3 clinical trial in India for further consideration’, the recommendations by the SEC said.
“The SEC on COVID-19 of the CDSCO held a detailed deliberation on both the applications for around four hours. The recommendations by the SEC have been approved by the Drugs Controller General of India (DCGI),” an official source informed.
Bharat Biotech had applied to the DCGI for emergency use authorisation for its indigenously developed COVID-19 vaccine Covaxin December 7, while the Pune-based Serum Institute of India (SII) sought the nod for the Oxford COVID-19 vaccine, Covishield, December 6. Pfizer had applied for emergency use authorisation (EUA) for its vaccine on December 4.
SII presented their proposal for grant of EUA along with interim safety data from phases 2 and 3 clinical trials carried out in India and the interim safety and efficacy results of phases 2 and 3 trials and phase 3 clinical trial carried out in the UK, other countries and India before the committee.
The committee noted that as per the condition of the permission to conduct phases 2 and 3 clinical trials, the clinical data generated in the trial shall be considered along with the data from the Oxford clinical trial outcome, the recommendations of the SEC meeting stated.
Further the firm stated that the proposal for grant of EUA is currently under evaluation with MHRA. It is also noted that the phases 2 and 3 clinical trials are still ongoing in the country, the source said. The firm has also submitted the safety data till November 14 only.
Bharat Biotech on the other hand presented their proposal for grant of EUA of its COVID-19 vaccine Covaxin along with the interim safety and immunogenicity data of phases 1 and 2 clinical trials carried out in the country before the committee.
Covaxin has been indigenously developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).