Covaxin for children? Making trial data public will create trust in paediatric-use vaccines

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October 18, 2021 5:13 AM

As the drugs regulator mulls over approval for Covaxin, Bharat Biotech needs to keep in mind that its case is helped with trial data put in the public domain for independent experts to examine.

With very few Covid-19 vaccine candidates having received any form of approval for paediatric use across the globe—even those that have are restricted to a clutch of developed jurisdictions.With very few Covid-19 vaccine candidates having received any form of approval for paediatric use across the globe—even those that have are restricted to a clutch of developed jurisdictions.

A subject expert committee of the Central Drugs Standard Control Organization has recommended the grant of accelerated approval to Covaxin for use among 2-18 year olds. The recommendation is based on safety and efficacy data submitted by Bharat Biotech from a trial involving 525 children across three age groups 2-6 years, 6-12 years and 12-18 years. Though the Drugs Controlled General of India is yet to give approval, this is a promising first step.

With very few Covid-19 vaccine candidates having received any form of approval for paediatric use across the globe—even those that have are restricted to a clutch of developed jurisdictions. But, with the ever-present threat of virulent and infectious variants, many countries are looking at vaccine options for children. In Israel, a spike of cases among children post the opening of schools led the government to approve vaccination for minors. Till date, 84% of the country’s 16–19 year olds and 53.7% of 12–15 year olds have been fully vaccinated.

The US has granted emergency use approval to Pfizer and Moderna for 12-15-year-olds and is likely to do this for younger age groups soon, against a backdrop of a spike in cases among children— according to government data, as many as 750,000 children have been infected within the last month. While Covid-19 mortality among children has been relatively much lower among children, the risks for children with co-morbidities remain high; moreover, the shadow of long Covid and the risks of associated immunopathologies reported across the world among children from the viral infection would make a vaccine for the young an imperative.

Most important, with the need to reopen schools a badly felt need across geographies, the transmission risk for the adult population from unvaccinated children is too significant to ignore. Cases among children have risen in some parts of India, but on the whole, remain a small fraction of the overall number of infections reported. However, the country’s under-18 population is estimated to be be 30% of the population—and only a mere 20% of the population has received full vaccination (two doses) so far. And with the clamour for reopening of schools growing—a non-negotiable if the future of lakhs of children from poor households is not to be put in jeopardy—it is hard to imagine stalling for paediatric Covid-19 vaccines for too long.

As the drugs regulator mulls over approval for Covaxin, Bharat Biotech needs to keep in mind that its case is helped with trial data put in the public domain for independent experts to examine. To be sure, keeping the data for the regulator’s eyes only is the company’s privilege and there is no requirement to make the data public. But, an avoidable controversy had marred the accelerated approval given to the vaccine for adult use, stoked by trial data remaining unpublished at the time.

Indeed, to engender wide trust in paediatric use of the vaccines, not just Bharat Biotech, but others in the line—Serum Institute, Pfizer, Zydus Cadilla—must consider putting trial data out in the open, in the formal peer-reviewed process. The government, for its part, needs to carefully strategise the roll-out of any paediatric-use vaccine it approves; it could perhaps start with a focus on children with co-morbidities.

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