FDA Advisers Deciding on Pfizer/BioNTech COVID-19 Vaccine in Children

An expert panel will weigh authorization of Pfizer Inc and BioNTech’s COVID-19 vaccine for children aged 5 to 11 on Tuesday as it prepares to vote on a recommendation for the U.S. Food and Drug Administration.

The panel’s vote is an important regulatory step in getting the vaccine into the arms of millions of children in the United States where schools are largely open for in-person learning.

The FDA need not follow the advice of its outside experts, but usually does.

Only a few other countries including China, Cuba and the United Arab Emirates have cleared COVID-19 vaccines for children in this age group and younger.

The advisers are expected to pay close attention to the rate of rare cases of heart inflammation called myocarditis that have been linked to both the Pfizer/BioNTech and Moderna vaccine, particularly in young men.

Pfizer and BioNTech are seeking clearance for a lower, 10 microgram dose version of the vaccine in children, versus 30 micrograms for everyone over the age of 12. The shot has been authorized for ages 12-15 since May and cleared for everyone over 16 since December.

The companies have said their vaccine showed 90.7% efficacy against the coronavirus in a clinical trial of children aged 5 to 11.

After the FDA, a panel to the U.S. Centers for Disease Control and Prevention will make a recommendation on the administration of the vaccine. The director of the agency will make the final call.

“If all goes well, and we get the regulatory approval and the recommendation from the CDC, it’s entirely possible if not very likely that vaccines will be available for children from 5 to 11 within the first week or two of November,” top U.S. infectious disease expert Anthony Fauci said on Sunday.

FDA staff, in documents posted before the meeting, said the likely vaccine benefits in that age group clearly outweigh the potential harms, including the rare risk of heart inflammation.

If the number of myocarditis cases in the younger age group turns out to be similar to that in 12- to 15-year-olds, the hospitalizations prevented for COVID-19 would outnumber those prevented for myocarditis in most scenarios analyzed, FDA staff reviewers said.

While children rarely become seriously ill or die from COVID-19, some develop complications, and COVID-19 cases in unvaccinated children have risen due to the contagious Delta variant.

Pediatric vaccinations are an important public health tool to prevent infectious diseases, even ones that do not cause high rates of mortality or hospitalization for children. (Reporting by Manas Mishra in Bengaluru; Editing by Caroline Humer and Richard Chang)

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