Emergency approval not recommended to Covaxin, Govt panel asks Bharat Biotech to give more data
New Delhi, Jan 01: The Central Drugs Standard Control Organisation (CDSCO) expert panel set up by Drugs Controller General of India (DCGI) to examine vaccine proposals, recommended 'interim efficacy analysis for Covaxin'.
The vaccine was developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
The Subject Expert Committee (SEC) on COVID-19 of the CDSCO asked the firm to expedite volunteer recruitment for the ongoing clinical trial and said it may conduct interim efficacy analysis for further consideration of restricted emergency use approval for its vaccine Covaxin, they stated.
The SEC, which earlier had sought additional safety, immunogenicity and efficacy data from SII and Bharat Biotech, deliberated on their applications seeking emergency use authorisation (EUA) for their shots on Wednesday, and met again on Friday to review the matter.
The SEC noted that the ongoing clinical trial is a large one with 25,800 subjects of which 22,000 have been enrolled, including subjects with comorbid conditions, which has demonstrated safety till date but efficacy is yet to be demonstrated. "After detailed deliberation, the committee recommended that the firm should try to expedite the recruitment and may perform interim efficacy analysis for further consideration of restricted emergency use approval," an official source said.
While granting emergency use approval for the Oxford-AstraZeneca vaccine, Covishield, the panel imposed certain regulatory provisions, including that the shot is indicated for active immunisation in individuals of 18 years or more to prevent the disease and that it should be administered intramuscularly in two doses at an interval of 4 to 6 weeks.
The Oxford-AstraZeneca vaccine, Covishield, has been developed in collaboration with Serum Institue of India (SII).
The decision to approve the Oxford shot clears the vaccine's rollout in India ahead of a country-wide dry run scheduled for Saturday.