As India's vaccination drive has so far expanded to include people in the age group of over 18 years, there's no vaccine against COVID for children yet. But that could change soon as vaccine manufacturers are conducting trials in children aged below 18. Bharat Biotech is commencing Covaxin trials in the 2-18 years of age group in the next 10-12 days, according to VK Paul, member of NITI Aayog (Health).
"Covaxin has been approved by the Drugs Controller General of India (DCGI), for Phase II/III clinical trials in the age group of 2 to 18 years. I have been told that trials will begin in the next 10-12 days," Paul said during a press conference on Tuesday.
Covaxin trials in 2-18 age group for Phase II/III was approved by the Drugs Controller General of India (DGCI). The approval was based on recommendations by the SEC of the Central Drugs Standard Control Organisation's (CDSCO). The trials are expected to be conducted with a group of 525 healthy participants at various age group.
Vaccinating children is crucial
Inoculating children has been requested by many experts so schools can be safely reopened. Bharat Biotech had proposed clinical trials in children aged between 5 and 18 years in February, but it was rejected.
"After detailed deliberation, the committee recommended that the firm should submit efficacy and safety data of the ongoing Phase III clinical trial in adults along with the age subgroup analysis. The design of the trial should be revised to Phase II/III. Sample size and other consequential changes should be made to the protocol, accordingly. Accordingly, the firm shall submit revised clinical trial protocol for review of the committee," Bharat Biotech was told in a meeting on February 24.
Once the trial is over, it may take some weeks for the company to apply for Emergency approval and soon ship Covaxin to distribution centres. Bharat Biotech has announced last month to enhance its capacity to produce about 700 million doses of Covaxin annually, which falls far below the demand for the vaccine in Covid-battered country that is struggling to fight the disease.
