An Indian government body has recommended the restricted use of homegrown Covid-19 jab Covaxin for those aged between two and 18 years.
A subject expert committee on coronavirus vaccines gave its approval for “restricted use in emergency situations” on Tuesday after Covaxin producer Bharat Biotech submitted trial data last week. The final approval now lies with the Drugs Controller General of India (DCGI), which is believed to only be a formality.
Two doses of Covaxin will be administered to children with a gap of 28 days. For adults, the government has set a gap of four to six weeks between two shots.
If approved, this would be the first vaccine for children under 12, and the second vaccine for teenagers.
Bharat Biotech has not yet made public the test results of the trials carried out on children but the company has said that its trials included 1,000 children. The Covaxin vaccine tested on children is the same formulation as those on adults, but separate trials were required.
This is the first time that children in the 2 to 12 age group will be covered under the vaccination programme in India, and will be a major boost to the country’s efforts to open up educational institutes.
India is trying to vaccinate children with severe co-morbidities first, according to Dr NK Arora, the chief of India’s vaccine task force.
“We are trying to identify [children] at highest risk... within the next couple of weeks, the list will be in the public domain. We are also making arrangements so these children do not have to travel [too far] to get the vaccine...” he told news agency ANI earlier this month.
Covaxin, developed by Hyderabad-based Bharat Biotech, was also the first India-made vaccine to receive emergency authorisation for adults, along with Serum Institute’s locally-made version of AstraZeneca — Covishield. However, Covaxin’s first approval was marked by a controversy for a rushed nod as its data for third trial was not out when approval was granted and was only submitted later.
The World Health Organisation is yet to grant emergency use authorisation to Covaxin for adults. Bharat Biotech had reportedly submitted all documents required for listing to the WHO, but the international body is yet to come to a decision. So far, Covaxin is only approved in nine countries, including India, Nepal and Iran.
In India so far, only one vaccine has received emergency authorisation for children between 12-18 years of age — Zydus Cadila’s three-dose DNA jab ZyCOV-D, which is also an indigenously produced jab. The approval was granted in August and it was the first DNA jab in the world to receive emergency approval for Covid-19.
Ahmedabad-based pharma company Zydus Cadila is also carrying out trials for children in the 2-12 age group, and it could soon apply for approval.
A third potential candidate for vaccines for children is Serum Institute’s Novavax, for which the DCGI last month cleared trials for children between seven and 11 years.
The Serum Institute of India, considered world’s largest manufacturer of vaccines, is already mass-producing Covishied — a locally made version of Oxford-AstraZeneca vaccine — for India and Covax alliance.
In the US, Pfizer has applied for approval for its vaccines for children.
In May, the European Medicines Agency approved the Pfizer vaccine for 12 to 15-year-olds and the UK began vaccinating children aged between 12 and 15 in September.