The SEC (Subject Expert Committee) has granted emergency approval to Covaxin, Bharat Biotech’s. Vaccine can be used for children of the age group 2-18 years.
In September, Phase-2 and Phase-3 trials are completed of covaxin on children below the age of 18 years. In the starting of October, the data of trials are submitted to DCGI (Drugs and Comptroller General of India) .
The expert panel said in a statement, “After detailed deliberation, the committee recommended for grant of market authorization of the vaccine for the age group of 2 to 18 years for restricted use in emergency situation.”
This vaccine made in India will be given in two doses, 20 days gap is mandatory between first and second dose.
Bharat Biotech said in a statement, that the clinical trial data it had submitted was thoroughly reviewed by the Central Drugs Standard Control Organisation (CDSCO) and SEC, who provided their positive recommendations.
The vaccine developer, said, “This represents one of the first approvals worldwide for Covid-19 vaccines for the 2-18 age group. Bharat Biotech sincerely thank the DCGI, Subject Experts Committee, and CDSCO for their expedited review process. We now await further regulatory approvals from the CDSCO prior to product launch and market availability of Covaxin for children.”
Meanwhile, Covaxin approval from WHO is yet pending. Reportedly, Bharat Biotech has submitted all the required documents.
India has also granted approval to the use of ZyCov-D’s Covid-19 vaccine for children between the ages of 12 to 18. This vaccine is developed by pharmaceutical firm Zydus Cadila and is the first DNA vaccine to be approved in the world.