US: FDA panel approves Pfizer COVID-19 vaccine for kids aged 5-11

The benefits “clearly outweigh” risks of rare side effects, the panel noted

pfizer-vaccine-covid-19-vaccine-reuters Representational image | REUTERS

A panel of advisers for the US Food and Administration (FDA) on Tuesday recommended the Pfizer-BioNTech COVID-19 vaccine for kids aged five to 11.

Data from the company's clinical trials found that a paediatric dose of the vaccine—one third of that given to adults and adolescents—was safe and 90 per cent effective. The advisers took into account the vaccine’s effectiveness, the effects of the pandemic on kids’ social and educational lives and also the potential risk of a rare heart-related side effect. "The virus is not going away. We have to find a way to live with it and I think the vaccines give us a way to do that," said FDA adviser Jeannette Lee of the University of Arkansas.

The benefits of vaccination “clearly outweigh” the risks of myocarditis and pericarditis, FDA scientists concluded in an analysis. Statistical models developed by FDA scientists showed the vaccine would prevent far more COVID-19 hospitalisations in this age group than would potentially be caused by that very rare side effect—heart inflammation.

 The FDA isn't bound by the panel's recommendation and is expected to make its own decision within days, the AP stated in a report. If the FDA goes ahead and authorises the kid-size doses, the Centres for Disease Control and Prevention (CDC) will have to decide whether to recommend the shots and which youngsters should get them.

Full-strength shots made by Pfizer and its partner BioNTech already are recommended for everyone 12 and older. 

Earlier, top FDA vaccine scientist Peter Marks said younger children were "far from being spared harm of COVID-19," adding that, in this group, there had been 1.9 million infections and 8,300 hospitalisations, roughly a third of which required intensive care. A study of elementary schoolchildren found the Pfizer shots are nearly 91 per cent effective at preventing symptomatic infection.    

Moderna also is studying its vaccine in young children, and Pfizer has additional studies under way in those younger than 5.

-with AP inputs