Covaxin gets expert panel nod for emergency use among kids

Covaxin gets expert panel nod for emergency use among kids

Sushmi.Dey@timesgroup.com

New Delhi:13.10.2021

The central drug regulator’s expert panel has recommended granting marketing authorisation with certain conditions to Bharat Biotech’s Covaxin for restricted emergency use (EUA) in children and adolescents in the age group of 2 to18 years.

However, the final approval of EUA from the drug regulator and inclusion of the vaccine in the national Covid immunisation programme for the paediatric population will take a few more days as data submitted by the company will be further evaluated, top government sources said on Tuesday.

“The Subject Expert Committee (SEC) has only partly recommended EUA for Covaxin. The recommendations are given along with many conditions. The application is still under evaluation and will take a few more days before we arrive at a final conclusion,” a top regulatory official said.

Once the Drugs Controller General of India grants the final regulatory approval to Covaxin for restricted emergency use in the 2-18 age group, the National Technical Advisory Group on Immunisation (NTAGI) for Covid-19 will also evaluate the data before including it in the national programme.

Besides Covaxin, Zydus Cadila's ZyCov-D has been granted EUA for children above 12.

No domestic flight cap from Oct 18

The Centre on Tuesday allowed airlines to operate at full pre-Covid flight capacity in the domestic sector from next Monday (October 18). Following strong recovery in air traffic, the aviation ministry on Tuesday decided to lift variable capacity deployment ceilings in place since May 25, 2020. The ongoing festive season will now see more flights well before Diwali. P 14

Vax availability for kids to improve with nod to Covaxin

Serum Institute of India is carrying out phase II and III trials for Covovax among children 7-11 of age. With Covaxin likely to receive EUA soon, availability of vaccines for children is likely to improve holding out hope that vaccination will move beyond the initial plan to cover children with comorbidities.

There are around 44 crore children in the country. While Zydus Cadila’s Zy-CoV-D has already been approved for emergency use in children above 12 years of age, a final approval to Covaxin will be significant because it will help increase supplies to cover the paediatric population. The government is yet to start inoculating children with anti-Covid jabs under the national programme.

The conditions prescribed by Subject Expert Committee includes continuation of clinical trials by Bharat Biotech. The firm has also been asked to submit updates prescribing information, package insert, summary of product characteristics as well as fact-sheet. It will also have to submit adverse event data and analysis every 15 days for first two months and monthly thereafter.

“The firm should submit risk management plan,” the SEC recommendations said.

Bharat Biotech said the data have been thoroughly reviewed by the drug regulator and SEC which have provided positive recommendations.

“This represents one of the first approvals worldwide for Covid-19 vaccines for the 2-18 age group…We now await further regulatory approvals from the CDSCO prior to product launch and market availability of Covaxin for Children,” the company said.

Full report on www.toi.in