FDA advisers debate criteria for approving a coronavirus vaccine for young children

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Fri, 2021-06-11 10:25 — mike kraft

FDA advisers debate standards on a coronavirus vaccine for young children Executives from Pfizer and Moderna have said that data showing whether their vaccines are effective in younger children are expected by fall. Carolyn Y. Johnson Washington Post

With coronavirus vaccines available to adolescents and adults, regulators are now turning their attention to younger children and the level of proof needed before authorizing shots for children as young as 6 months.

On Thursday, many members of a panel that advises the Food and Drug Administration on vaccines argued that faster authorization should be an option because of uncertainties about virus variants and a potential fall surge in cases.

The discussion was not centered on a particular vaccine, and it unfolded as Pfizer-BioNTech and Moderna conduct trials of their vaccines in children.

The Pfizer-BioNTech vaccine is already authorized for adolescents as young as 12, and Moderna announced Thursday it had submitted an application to the FDA for authorization for adolescents. Executives from Pfizer and Moderna have said that data showing whether their vaccines are effective in younger children is expected by fall.

The timeline is welcome news to many families eager to go back to normal and gain confidence about in-person school.

But the expert discussion included many points of disagreement and often strayed into currently unanswerable questions about the future, reflecting how the question about vaccines for children may become emotional and tricky in the fall. Because covid-19, the disease caused by the virus, rarely results in serious illness in young children, several of the advisers argued that a longer and more conventional review of the vaccine should take place.

But A. Oveta Fuller, associate professor of microbiology and immunology at the University of Michigan Medical School, said that as the country opens up, she fears that unvaccinated children who have been largely insulated from the virus would begin to bear the burden of disease.

“We haven’t seen it for the children because they have been isolated, or there are other mitigations,” Fuller said at the meeting of vaccine advisers. As mitigation measures are relaxed, she said, the virus could take root in unvaccinated populations. “I think we are in an emergency situation, and we will be going into winter.” ...

The role that children play in transmission is still poorly understood, but Hannah Kirking, a medical epidemiologist at the respiratory viruses branch of the Centers for Disease Control and Prevention, presented unpublished data that suggests children of all ages play a role similar to adults in transmission and infection. ...

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