Corbevax: Official sources stated on Thursday that an expert panel of India’s central drug administration has recommended awarding an emergency use license for Biological E‘s COVID-19 vaccine Corbevax for children aged five to eleven with specified circumstances.
The CDSCO’s COVID-19 Subject Expert Committee (SEC) has, on the other hand, requested more data from Bharat Biotech in order to examine their emergency use authorization (EUA) application for the use of Covaxin in children aged two to eleven years, they stated. According to another source, the SEC has also suggested that Cadila be granted an emergency use authorization (EUA) for its ZyCoV-D vaccine for an additional dose of 3mg with a two-jab inoculation schedule 28 days apart for people aged 12 and up.
ZyCoV-D is now approved for a two-mg-three-dose immunization schedule. Children aged 12 to 14 years are being inoculated against COVID-19 using Biological E’s Corbevax. On December 24, 2021, the DCGI issued Covaxin Emergency Use Listing for the age group of 12 to 18 years.
Biological E has submitted revised safety data of Corbevax
On Thursday, an official source said that Biological E has submitted revised safety data two to three months after the second dose of Corbevax in the recommended five to 11-year-old age range, as well as safety data from doses used up to the older age group.
For its proposal for restricted use in an emergency circumstance in the age bracket of five to twelve years, it has also presented immunogenicity data and virus-neutralizing antibody data against variants of concern, including the Delta and Wuhan strains, according to the source.
Biological E has also submitted updated safety data from the immunization program for vaccination in the age group of 12 to 14 years.
“The SEC acknowledged that the Phase 2/3 clinical trial’s interim safety and immunogenicity data in participants aged five to less than 12 years is equivalent to that of older age groups.” It also mentioned vaccine safety statistics for children aged 12 to 14.
Emergency use of Corbevax
“It has recommended approval of the vaccine for restricted use in an emergency situation for 5 years and above with the condition of submitting ongoing clinical study data,” an official source stated.
On March 16, India began immunising youngsters aged 12 to 14. The nationwide immunisation campaign began on January 16 of last year, with healthcare personnel being the first to be vaccinated. Frontline employees were first vaccinated on February 2 of last year. The next phase of COVID-19 vaccination began on March 1 of last year for persons over the age of 60 and those aged 45 and up who have certain co-morbid disorders.
From April 1 of last year, India mandated vaccination for all people above the age of 45. From May 1 of last year, the government decided to broaden its vaccination campaign by enabling anybody above the age of 18 to be inoculated against the viral disease. The latest round of vaccinations for adolescents aged 15 to 18 years old began on January 3.
From January 10, India began giving vaccine precaution doses to healthcare and frontline workers, as well as individuals aged 60 and older with comorbidities. From April 10, private vaccination clinics were permitted to administer COVID-19 precaution doses to anybody over the age of 18.