E-Paper
SEC recommends Covaxin, Covishield for full market authorisation: Report
On January 14, the subject expert committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) sought more data from the two respective manufacturers for regular market approval.
The subject expert committee (SEC) of the Central Drugs Standard Control Organisation (CDSCO) on Wednesday recommended regular market approval for Covaxin and Covishield, the two most widely used jabs in the national vaccination drive against Covid-19, news agency PTI has reported, citing official sources.
Also Read | Serum Institute of India applies for full approval of Covishield Covid vaccine
The development comes just days after the SEC, on January 14, sought more data from the two manufacturers--Hyderabad-based Bharat Biotech (Covaxin) and Pune-based Serum Institute of India (Covishield)--for approval for full market authorisation.
Also Read | Govt seeks more data for full market clearance to Covishield, Covaxin
A full market authorisation is granted when a vaccine is deemed safe and effective for most people who are inoculated with it. Such an approval is authorised after submission and review of full data from phase 1, 2 and 3 trials of the jab.
On the other hand, an emergency use authorisation (EUA) is given after studying data from phase 1 and 2, when regulators conclude that benefits of a vaccine far outweigh risks. All Covid-19 vaccines currently in use in India, including Covaxin and Covishield, have emergency use authorisation (EUA) from the Drugs Controller General of India (DCGI).
On January 3 last year, both jabs received EUA; the nationwide inoculation drive began on January 16. Bharat Biotech's Covaxin is India's first indigenous vaccine against Covid-19, while Serum Institute locally manufactures Britain's AstraZeneca-Oxford jab as ‘Covishield.’
More than 1.58 billion (158 crore) doses have been administered nationally thus far, of which, according to the Union health ministry's dashboard, more than 7.6 million were administered in the last 24 hours. The vaccination drive, for the most part, was open for those aged 18 and above; however, on January 3 this year, it was expanded to include the 15-18 age group as well.
From January 10, healthcare workers, frontline workers and senior citizens with comorbidities became eligible for a ‘precautionary’ or booster shot.
Also Read | Home vaccinations for teens, third dose beneficiaries soon: Centre
Both announcements were made by Prime Minister Narendra Modi in an address to the nation last Christmas Day.
