Home / News / World /  DGCI to review applications for full market approval of Covaxin, Covishield today
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The Drugs Controller General of India (DCGI) headed Subject Expert Committee will review applications of Bharat Biotech and SII for full market approval to Covaxin and Covishield on Friday, according to sources.

The move comes after the Hyderabad-based vaccine manufacturer Bharat Biotech on Thursday announced that its indigenously developed Covid-19 vaccine Coavaxin is now a universal vaccine for adults and children.

"COVAXIN is now a universal vaccine for adults and children. Our goals of developing a global vaccine against Covid-19 have been achieved and all product development for licensure has been completed," said Bharat Biotech.

Earlier, Hyderabad-based Hyderabad-based vaccine manufacturer had claimed that its Covid vaccine Covaxin can neutralise both Delta and Omicron variants of coronavirus.

In a statement, Bharat Biotech said, "Results from a study conducted at Emory University demonstrating that sera from subjects who received a booster dose of Covaxin (BBV152) six months after getting a primary two-dose series of Covaxin, neutralized the SARS-CoV-2 Omicron and Delta variants."

It also mentioned that earlier studies demonstrated the neutralizing potential of Covaxin against SARS-CoV-2 Variants of Concern Alpha, Beta, Delta, Omicron, Zeta and Kappa.

Meanwhile in a related development last month, the Drugs Controller General of India (DCGI) has granted emergency use authorisation to Bharat Biotech's Covaxin for children above 12 years with certain conditions, sources said on Saturday.

The Subject Expert Committee on COVID-19 of the CDSCO on October 12 after deliberating Bharat Biotech's EUA application had recommended granting emergency use approval to Covaxin for use in the 12-18 years age group with certain conditions.


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