Biological E gets CDSCO panel nod for Corbevax EUA for 5-11 years old
Biological E's Corbevax is being used to inoculate children against COVID-19 in the age group of 12 to 14 years.
New Delhi: 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.
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 2/3 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 5 years and above for restricted use in an emergency situation with the condition to submit ongoing clinical trial data," an official source said.
India began inoculating children aged 12-14 on March 16.
The countrywide vaccination drive was rolled out on January 16 last year with healthcare workers getting inoculated in the first phase. Vaccination of frontline workers started from February 2 last year.
The next phase of COVID-19 vaccination commenced on March 1 last year for people over 60 years of age and those aged 45 and above with specified co-morbid conditions.
India launched vaccination for all people aged more than 45 years from April 1 last year. The government then decided to expand its vaccination drive by allowing everyone above 18 years of age to be inoculated against the viral disease from May 1 last year.
The next phase of vaccination commenced on January 3 for adolescents in the age group of 15-18 years.
India began administering precaution doses of vaccines to healthcare and frontline workers and those aged 60 and above with comorbidities from January 10.
Precaution doses of COVID-19 vaccines to all aged above 18 years were allowed at private vaccination centres from April 10.
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