Covid vaccine: Expert panel asks for more data on Covaxin, Covishield before granting licences
NEW DELHI: The subject expert committee of the Central Drugs Standards Control Organisation on Covid-19 on Wednesday demanded more data related to the safety and immunogenicity of two coronavirus vaccines that were evaluated.
The vaccines that were considered for emergency use authorisation (EUA) included Covaxin by Bharat Biotech and Covishield by Serum Institute of India, developed by AstraZeneca-Oxford University.
These companies, along with US-based Pfizer, have applied to the CDSCO for EUA of their respective Covid-19 vaccines in India over the last few days.
"Today was the first meeting to consider the approvals of the three Covid19 vaccines but representatives from Pfizer could not participate," a source in the drug regulator told The New Indian Express.
"Data related to the vaccines by other two companies were discussed but additional information has been sought before a conclusive recommendation can be made to the Drug Controller General of India," he said, and added that the matter is still under review.
A top official in the Union Ministry of Health and Family Welfare said that a series of meetings could be held before the committee submit its recommendations, based on which the DCGI would take a final decision.
The next meeting date on the vaccines however is yet to be decided.
"In no country, the regulator approves a major intervention like a vaccine until its fully satisfied with data submitted," the official further said, adding that the regulator could wait for a decision by the Medicines and Healthcare Products Regulatory Agency in the UK on Covishield.
Covaxin, as of now, is in the final stage of the trial in India but even the recruitment of all 26,000 volunteers has not been completed yet.
On the other hand, Covishield, which has been tested on volunteers across six countries, is also being tested on 1600 Indians as part of phase 2 and 3 clinical trials.
An interim analysis of the vaccine in the UK and Brazil has shown it to be about 70% effective in preventing Covid-19 on average but no efficacy data from India is available.