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Govt. panel recommends emergency use authorisation for Corbevax for 5 to 11 years age group

Govt. panel recommends emergency use authorisation for Corbevax for 5 to 11 years age group

The Hindu
Thursday, April 21, 2022 05:51:31 PM UTC

SEC has also recommended the grant of EUA to Cadila for their ZyCoV-D vaccine

An expert panel of India's central drug authority has recommended granting emergency use authorisation for Biological E's COVID-19 vaccine Corbevax for children in the five to 11 years age group with certain conditions, official sources said on Thursday.

The Subject Expert Committee (SEC) on COVID-19 of the CDSCO has, on the other hand, sought more data from Bharat Biotech to review its emergency use authorisation (EUA) application for use of Covaxin among those aged two to 11 years, they said.

The SEC has also recommended the grant of emergency use authorisation (EUA) to Cadila for their ZyCoV-D vaccine for an additional dose of 3mg with a two-jab inoculation schedule 28 days apart for those aged 12 years and above, another source said.

Presently, ZyCoV-D is approved for a 2mg three-dose vaccination schedule.

Biological E's Corbevax is being used to inoculate children against COVID-19 in the age group of 12 to 14 years. Covaxin has been granted Emergency Use Listing by the DCGI for the age group of 12 to 18 years on December 24, 2021.

An official source on Thursday said Biological E had submitted updated safety data two to three months after the second dose in the proposed five to 11 years age group along with safety data available from the doses used uptil in the higher age group.

It has also submitted immunogenicity data and virus neutralising antibody data against variants of concern, including Delta and Wuhan strains, for its proposal for grant of restricted use in an emergency situation in the age group of five to 12 years, the source said.

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