Experts hail Covaxin approval for 2-18 year olds, favour use on children with comorbidities first

Children in India now have a choice in terms of COVID-19 vaccines with Bharat Biotech becoming the second company after Zydus Cadila to offer a vaccine for children. Off course, the Zydus Cadila vaccine, is a first in the world DNA vaccine and is for adolescents and older (12 years and above), the just approved vaccine from Bharat Biotech is for 2 to 18 year olds.

In a rather vaguely worded statement from the company, Bharat Biotech explains the approval it has received with a sequence of events that led to it stating that it “has submitted data from clinical trials in the 2-18 years age group for COVAXIN (BBV152) to CDSCO (Central Drugs Standard Control Organisation). The data has been thoroughly reviewed by the CDSCO and Subject Experts Committee (SEC) and (they) have provided their positive recommendations.”

Describing it as one that “represents one of the first approvals worldwide for COVID-19 vaccines for the 2-18 age group, the note from Bharat Biotech concludes by thanking the various regulatory entities – the Drug Controller General of India (DCGI), Subject Experts Committee, and the CDSCO and says, “we now await further regulatory approvals from the CDSCO prior to product launch and market availability of COVAXIN for Children.”

While most experts welcomed it though some were waiting for details on how the vaccine for children compares with the Covaxin for adults in terms of its immunogenicity data (data on the immune response) and details on the composition. Some believe that the amount of antigen carried in the vaccine for children may be less than the load of around 6 microgram of antigen per dose in the case of adults but then details on this are still awaited as also on when the company can make the vaccine now available, though the early sense from the spokesperson seems to be that since it is similar, it should not take long to launch it.

Happy that the vaccine has been approved, Dr Gagandeep Kang, a highly regarded virologist from India and the professor at the Christian Medical College, Vellore, focused on the key priority says, “it should be used in children with comorbidities.”

Calling it a “welcome development”, K V Balasubramaniam, an independent consultant and former managing director of Indian Immunologicals Ltd, says, “I would any day bet on an inactivated vaccine or a sub-unit protein vaccine for safety reasons for children rather than say a DNA vaccine where the long-term safety has still to be proved or even a viral vector vaccine (like say Covishield), which may have a component of reactive genecity (chances of reactions from the vaccine like for instance, case of people getting fever or body aches in the immediate period after the vaccine shot).”

Covaxin is an inactivated vaccine while the vaccine from Biological E is a sub-unit protein vaccine. It is still under trials and is for those who are 5 years of age and more.