The Subject Expert Committee (SEC) on Covid-19 of the Central Drugs Standard Control Organisation (CDSCO) on Saturday again deliberated on the emergency use authorisation (EUA) application of the Hyderabad-based pharmaceutical firm after it submitted additional data, facts and analysis subsequent to Friday’s review meeting, reported PTI quoting a source.
Both Covaxin and Covishield are now awaiting a final marketing approval from the Drugs Controller General of India (DCGI).
Covaxin will be the first indigenously developed vaccine to be given emergency approval in India.
It was developed by Bharat Biotech in collaboration with the Indian Council of Medical Research (ICMR).
Covishield, on the other hand, is developed by AstraZeneca and Oxford University and is being manufactured locally by the Serum Institute.
SII, the world’s biggest producer of vaccines, has already stockpiled about 50 million doses of Covishield.
On Friday, the SEC had approved Covishield with certain conditions.
The panel said that every recipient of the vaccine will be given a factsheet about the vaccine prior to vaccination.
The manufacturer may also be asked to report adverse events every 15 days.
India’s regulator has also received an emergency-use application for the Covid-19 vaccine made by Pfizer Inc with Germany’s BioNTech – the first shot to secure regulatory approval in the West.
Meanwhile, a nationwide dry run to assess the preparedness on field for the vaccination process was conducted on Saturday.
The exercise was held in all state capitals in at least three session sites.
Earlier today, Union health minister Harsh Vardhan said that Covid-19 vaccines will be provided free of cost to all Indians.
(With inputs from agencies)