Covaxin final approval for 2-18 years old under expert opinion and evaluation: Report
The vaccine, developed by Hyderabad-based Bharat Biotech, was granted clearance by the Subject Expert Committee (SEC) of the drug regulator on October 12.
October 14, 2021 / 05:07 PM IST
The final approval for emergency use of COVID-19 vaccine Covaxin on children aged between 2 and 18 is "under expert opinion and evaluation", news agency ANI reported on October 14 citing government sources.
The vaccine, developed by Hyderabad-based Bharat Biotech, was recommended for emergency use on minors by the Subject Expert Committee (SEC) of the Drugs Controller General of India (DCGI) on October 12.
The final nod from the DCGI is, however, awaited. With the drug regulator's clearance, Covaxin would become the first vaccine in India to be granted emergency use authorisation for use on children.
The government sources also told ANI that pharmaceutical firm Biological E will submit final data related to its COVID-19 vaccine Corbevax by November-end.
The vaccine, last month, received DCGI's approval to conduct phase 2/3 study to evaluate the “safety, reactogenicity, tolerability and immunogenicity” of Corbevax in children and adolescents.
Biological E had also received approval for phase 3 comparator safety and immunogenicity trial in adults after a review of phase 1 and 2 clinical trials data by a subject expert committee, the Ministry of Science and Technology said on September 3.
On September 2, Niti Aayog member (health) Dr VK Paul said that results of Phase 3 trials of Corbevax were awaited and the company had committed to supply a significant quantity of the vaccine by the end of the year, ANI had reported.
“Stockpile is being produced. We should wait for the results. We hope it’ll be in the next month or two. They’ve made a broad commitment that they’ll supply a significant amount by year-end,” Dr Paul had said.