In a move that could mitigate the vulnerability of children to the SAR-COV-2 virus, the Drug Controller General of India gave a restricted emergency use authorisation to three vaccines — Bharat Biotech’s Covaxin, Biological E’s Corbevax and Zydus Cadila’s ZyCov-D — for various age groups of children.
The DCGI’s nod to these vaccines came amid reports of schools recording a spurt in Covid-19 cases among children in tier-I cities across the country. While COVAXIN has received the EUA for 6-12-year-old children, the age group for Corbevax is 5- 12.
Meanhwhile, ZyCoV has received the EUA from the apex drug regulator of India for children above 12 years.
“It’s a welcome move,” said Chairman and Managing Director of Medanta Naresh Trehan, responding to the significant development.
“This was a vulnerable group. Now even elders will be safe. It’s not that you can take short cuts in vaccines. Safety and efficacy checks have been done,” Trehan said.
Bharat Biotech has been asked to submit safety data, including the data on adverse event with due analysis every 15 days for the first two months and monthly thereafter up to 5 months by the DCGI.
Last week, the expert panel of India’s apex drug regulator recommended grant of emergency use authorisation to Covid vaccine Corbevax for those in the 5-12 years age bracket.
According to a source familiar with the development, the Subject Expert Committee had recommended the DCGI grant the emergency use authorisation to Hyderabad-based Biological E’s Corbevax for this age. However, the emergency use authorisation may be the subject to certain conditions, the source added.
Earlier in the day, the panel held a meeting to discuss the recommendations on restricted emergency use of Bharat Biotech’s Covaxin and Biological E’s Corbevax vaccines among children aged 5-12.
The SEC has sent the recommendations to the DCGI. After the DCGI’s nod to the recommendation, the Union Health Ministry may give final approval to begin the vaccination for this age group.
Corbevax vaccine is India’s first indigenously-developed protein sub-unit vaccine against Covid-19. This vaccine is currently being administered to children in the age group 12-14 years.
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