Explained | Why DCGI set aside emergency approvals of Serum Institute, Bharat Biotech COVID vaccines

Three pharma companies have applied for emergency use authorisation of their COVID-19 vaccines in India

The subject experts committee (SEC) constituted by the Drug Controller General of India (DCGI), which reviewed the emergency use applications of Serum Institute of India and Bharat Biotech for their COVID-19 vaccines, has sought more data from both the companies for further consideration of their applications. The committee couldn't take up Pfizer's emergency approval request because the US-based drug maker sought more time.

You can read more about emergency use approvals here

Serum Institute

According to DCGI, Serum Institute has presented its proposal for grant of emergency use authorisation of its 'Covishield' vaccine, along with the interim safety data from Phase II/III clinical trial carried out in India and the interim safety and efficacy results of Phase II/III and Phase III clinical trials carried out in UK, other countries and India before the committee.

The SEC noted that as per the condition of the permission to conduct phase II/III clinical trial in the country, the clinical data generated in the trial shall be considered along with the data from the Oxford clinical trial outcome. Serum Institute has submitted the safety data till November 14,

"After detailed deliberation, the committee recommended that the firm should submit the following data/information for updated safety data of the Phase II/III clinical trial in the country, immunogenicity data from the clinical trial in UK and India and the outcome of the assessment of UK MHRA for grant of EUA," DCGI said.

Currently Serum Institute's partners AstraZeneca-University of Oxford have filed for grant of emergency use authorization, which is currently under evaluation with MHRA. The Phase II/III clinical trial of Serum Institute for 'Covishield' are still ongoing in India as we speak.

Bharat Biotech

Bharat Bitoech presented its proposal for grant of emergency use for its Covaxin, along with the interim safety and immunogenicity data of Phase I and II clinical trial carried out in the country before the committee.

After detailed deliberation, the SEC recommended that Bharat Biotech should present the safety and efficacy data from the ongoing Phase III clinical trial in the country for further consideration.

Pfizer