Experts noted that two doses of Covaxin could be administered to children within a gap of 28 days
Representational photo.
Experts noted that two doses of Covaxin could be administered to children within a gap of 28 days
The Subject Expert Committee (SEC) of the Central Drugs Standards Control Organisation (CDSCO) has submitted its recommendation to the Drugs Controller General of India (DCGI) for granting emergency use authorisation (EUA) to Bharat Biotech’s Covaxin for 2-18-year-olds.
Bharat Biotech had submitted data from clinical trials in this age group to the CDSCO and the latter and the SEC had thoroughly reviewed it and provided their positive recommendations
According to a senior Central Government official, the Hyderabad-based Bharat Biotech had completed Phase-2 and Phase-3 trials of Covaxin on children below 18 in September and submitted the trial data. The trials were done on the age groups of 2-6, 6-12 and 12 -18.
Experts noted that two doses of Covaxin could be administered to children within a gap of 28 days. For adults, the government has set 4-6 weeks between the two shots.
“This represents one of the first approvals worldwide for COVID-19 vaccines for the 2-18 age group,” a Bharat Biotech statement noted. The company was awaiting further regulatory approvals from the CDSCO prior to product launch and market availability of the vaccine, it added.
Experts noted that two doses of Covaxin could be administered to children within a gap of 28 days Representational photo. Experts noted that two doses of Covaxin could be administered to children within a gap of 28 days The Subject Expert Committee (SEC) of the Central Drugs Standards Control Organisation (CDSCO) has submitted its recommendation to the Drugs Controller General of India (DCGI) for granting emergency use authorisation (EUA) to Bharat Biotech’s Covaxin for 2-18-year-olds.Bharat Biotech had submitted data from clinical trials in this age group to the CDSCO and the latter and the SEC had thoroughly reviewed it and provided their positive recommendationsAccording to a senior Central Government official, the Hyderabad-based Bharat Biotech had completed Phase-2 and Phase-3 trials of Covaxin on children below 18 in September and submitted the trial data. The trials were done on the age groups of 2-6, 6-12 and 12 -18.Experts noted that two doses of Covaxin could be administered to children within a gap of 28 days. For adults, the government has set 4-6 weeks between the two shots.“This represents one of the first approvals worldwide for COVID-19 vaccines for the 2-18 age group,” a Bharat Biotech statement noted. The company was awaiting further regulatory approvals from the CDSCO prior to product launch and market availability of the vaccine, it added. Our code of editorial values