E-Paper
Coxavin gets DCGI nod for use among 12-18 age group
The decision came shortly before Prime Minister Narendra Modi addressed the nation and announced that the government was opening vaccinations to children between the ages of 15 and 18 from January 3 next year.
New Delhi The Drugs Controller General of India (DCGI) on Saturday approved Covaxin for use in children between the ages of 12 and 18, a significant step towards opening vaccinations to the age group that has so far remained ineligible in India’s immunisation programme against Covid-19.
The decision came shortly before Prime Minister Narendra Modi addressed the nation and announced that the government was opening vaccinations to children between the ages of 15 and 18 from January 3 next year.
“Covaxin receives approval for emergency use in children 12-18 years of age... We have documented excellent safety and immunogenicity data readouts in children,” the maker of the vaccine, Bharat Biotech, said in a statement.
India previously approved ZyCoV-D, a vaccine made by Zydus Cadila, for those between the ages of 12 and 18 (there are around 150 million), although vaccinations in children did not begin after the move.
The move comes amid concerns of the spread of Omicron, a highly transmissible variant of the coronavirus. Children are likely to remain less at risk due to their inherent immunity advantage, experts have said, but a highly transmissible virus will breach deeper into the population, posing a greater threat to any child with compromised immunity.
The approval from DCGI came nearly 10 weeks after the subject expert committee of the Central Drugs Standard Control Organisation (CDSCO) recommended Covaxin’s use in children based on clinical trial data submitted by the Hyderabad-based company. The panel recommended the use of the vaccine in those aged between two and 18.
Covaxin is one of the two Covid-19 vaccines that are the mainstay in India’s Covid-19 immunisation programme; the other vaccine is Oxford-AstraZeneca’s Covishield, which is being locally manufactured by the Serum Institute of India.
“The Drugs Controller General of India took his time to approve the vaccine for paediatric use after carefully scrutinising the data and looking at some additional data from around the world where vaccination in children has begun. It is a sensitive matter, which is why it made sense to be thorough before granting approval,” a senior official in the ministry of health and family welfare said on condition of anonymity.
For a vaccine to be included formally in the government’s coronavirus immunisation campaign for children or adults, DCGI’s approval is mandatory. Six Covid-19 vaccines have been granted emergency use authorisation by the national drugs regulator so far based on the recommendations of the subject expert committee.
Experts welcomed the approval and said it was high time children were vaccinated against Covid-19.
“Children may not get severe disease but there will always be the risk of others getting infected through children, especially elders and those at high risk in the family,” said Dr Vikas Maurya, director and head of the respiratory medicine department, Fortis Healthcare.
