NEW DELHI: More than two months after an expert panel endorsed Covaxin for kids, the Drug Controller General of India on Saturday approved the Covid19 vaccine by Bharat Biotech for the 12-17 age group in India.
However, the country's highest drug regulator has permitted the vaccine only for adolescents and not for kids under 12, as recommended by the subject expert committee on Covid19 in October.
Earlier, the Hyderabad based vaccine maker had said that it had submitted data from clinical trials in the 2-18 years age group for Covaxin to the regulator which was thoroughly reviewed by the Central Drugs Standard Control Organization and the subject expert committee.
“This represents one of the first approvals worldwide for Covid-19 vaccines for the 2-18 age group,” the company had said . “We now await further regulatory approvals from the CDSCO prior to product launch and market availability of Covaxin for Children.
Raches Ella, clinic lead of Covid vaccines at the company had also said in a tweet that Covaxin has been “reported to be safe and immunogenic” in a pediatric cohort and “the approval in children will help expedite the reopening of schools”.
Now, Covaxin has become the second vaccine, after Zydus Cadila’s ZyCoV D, to be permitted for under 18 population group in India even though the country is yet to clearly spell out its policy on Covid vaccination for minors.
Approved for adolescents aged 12-17 years of age in August by the DCGI, along with adults, ZyCoV D however is still to be rolled out for any population group in the country.
Meanwhile, Officials in the CDSCO said that though the amount of Covaxin recommended for minors remains the same—0.5 ml—as it is for adults and will also be administered in two doses- 28 days apart- there will be slight difference in the approach.
“It has been discussed that for adolescents, vaccines can be supplied in pre-filled syringes—instead of vaccines being taken out of vials at the time of administration,” said an official.
This, officials said, was recommended in order to ensure that exactly the specified quantity of vaccines are administered in kids as the higher quantity may lead to adverse effects.