An expert panel of India’s central drug authority has recommended granting Emergency Use Authorisation (EUA) for Biological E’s COVID-19 vaccine Corbevax for children in the five to 11 years’ age group with certain conditions, official sources said recently. 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 EUA application for use of Covaxin among those aged two to 11 years, they said.
The SEC has also recommended the grant of EUA to Cadila for their ZyCoV-D vaccine for an additional dose of 3 mg with a two-jab inoculation schedule 28 days apart for those aged 12 years and above, another source said. Currently, ZyCoV-D is approved for a 2 mg 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 (EUL) by the Drugs Controller General of India (DCGI) for the age group of 12 to 18 years on 24th December, 2021. An official source 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. Biological E has also presented updated safety data for vaccination in the age group of 12 to 14 years from the immunisation programme. “The SEC noted that the interim safety and immunogenicity data of phase-II/III clinical trial in subjects of five to less than 12 years is comparable to that higher age groups. It also noted the safety data of vaccination in the age group of 12 to 14 years. “After detailed deliberation, it has recommended approval of the vaccine for five years and above for restricted use in an emergency situation with the condition to submit ongoing clinical trial data,” an official source said.
Edits by EP News Bureau
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