However, final US approval by the drug regulator and the inclusion of the vaccine in Covid’s national immunization program for the pediatric population will take a few more days, as the data presented by the company will be further evaluated. top government sources said Tuesday.
“The committee of experts in the field (SEC) has only partially recommended USA for Covaxin. The recommendations are given along with many conditions. The application is still under evaluation and it will take a few more days before we reach a final conclusion, “said a senior regulatory official.
Once the Comptroller General of Drugs of India grants final regulatory approval to Covaxin for emergency restricted use in the age group 2-18 years, the National Technical Advisory Group on Immunization (NTAGI) for Covid-19 will also assess the data before including it in the national program.
In addition to Covaxin, Zydus cadila‘s ZyCov-D USA has been granted for children over 12 years of age. Serum Institute of India is conducting phase II and III trials for Covovax in children ages 7-11. Given that Covaxin is likely to receive EUA soon, the availability of vaccines for children is likely to improve, with the hope that vaccination will go beyond the initial plan to cover children with comorbidities.
There are about 44 million million children in the country. While Zydus Cadila’s ZyCoV-D has already been approved for emergency use in children older than 12 years, a final approval for Covaxin will be significant because it will help increase supplies to cover the pediatric population. The government has yet to start vaccinating children with anti-Covid hits under the national program.
The conditions prescribed by the Committee of Experts in the Art include the continuation of the clinical trials of Bharat Biotech. The company has also been asked to send updates to the prescribing information, the package insert, the summary of product characteristics and a fact sheet. You will also need to submit adverse event data and analysis every 15 days for the first two months and then monthly.
“The company must present a risk management plan,” the SEC’s recommendations said.
Bharat Biotech said the data has been thoroughly reviewed by the drug regulator and the SEC, which have provided positive recommendations.
“This represents one of the first approvals worldwide for Covid-19 vaccines for the age group 2-18 years … We now await further regulatory approvals from the CDSCO prior to product launch and market availability of Covaxin for Children, “the company said.
Hyderabad-based Bharat Biotech, which completed phase 2/3 trials of Covaxin for use in children between the ages of 2 and 18, had submitted the data to the Central Drugs Standard Control Organization (CDSCO) for verification and subsequent approval for the US earlier this month.
The SEC reviewed the data and deliberated on the US application on Monday.
“After detailed deliberation, the committee recommended granting marketing authorization for the vaccine for the 2- to 18-year-old age group for restricted use in emergency situations subject to certain conditions,” the SEC said in its recommendations.
The recommendations have been submitted to DCGI for final approval.