By Priyanka Sharma
New Delhi [India], January 1 In a major development related to the COVID vaccine, the Subject Expert Committee of Drugs Controller General of India (DCGI) has recommended granting permission for Emergency Use Authorisation (EUA) with certain conditions to COVID-19 vaccine being manufactured by Serum Institute of India.
Government sources on Friday said that SEC meeting was held here today to review the application submitted by two compes - SII and Bharat Biotech- who had applied to get the emergency use authorisation (EUA) for their vaccine candidates.
"In the meeting, an expert panel has recommended to DCGI to grant its approval to Serum Institute of India's COVID-19 vaccine for EUA in India with certain conditions," a government source said.
The SEC has issued several regulatory conditions to the Serum Institute of India that it should submit safety, efficacy and immunogenicity data from the ongoing clinical trials in India and in other countries.
"SII also should submit the safety data including the data on adverse event following immunisation (AEFI)," the source said.
The COVID-19 vaccine being manufactured by SII has been developed by AstraZeneca and Oxford University.
Another source said that while considering the application of Bharat Biotech company, the SEC after detailed evaluation recommended that the pharma major should submit additional data of phase 2 and the safety and efficacy data from its ongoing phase 3 trials respectively. "The SEC has also asked the Bharat Biotech to appoint more volunteers for the ongoing phase 3 clinical trial," another source said.
The application submitted by Pfizer was not discussed in the SEC meeting, the sources said.
( With inputs from ANI )
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