Europe approves Pfizer-BioNTech COVID-19 vaccine for kids from 5 to 11

November 25, 2021, 1:33 PM UTC

The European Union’s drugs regulator backed expanded use of the COVID-19 vaccine made by Pfizer Inc. and BioNTech SE for younger school-age children, saying its benefits outweigh its risks. 

A European Medicines Agency committee recommended extending use of the vaccine for children from 5 to 11 years old on Thursday. The two-shot regimen for younger kids is one-third the dose that’s given to people ages 12 and older. 

The decision comes as a fourth wave of the pandemic sweeps across Europe, tilting countries closer to lockdown ahead of the Christmas holiday season. Authorities are pushing adults who’ve already been fully vaccinated to get booster shots and warning that immunization alone won’t be enough to curb the wave of infections. 

It will probably take a few weeks to ship the lower-dose shots for children, with distribution likely starting around Dec. 20, German Health Minister Jens Spahn said on Monday, prior to the agency’s recommendation. That’s a contrast to the U.S., where millions of kids’ doses were shipped in the days following the Food and Drug Administration’s Oct. 29 authorization. 

In the U.K., most children ages 12 to 15 are being offered a single dose of Covid vaccine, and authorities have held off on approving the shot for younger kids. 

Health officials are monitoring the risk of myocarditis, an inflammatory heart condition that’s a very rare side effect after vaccination. Cases have occurred mostly in younger men, and more frequently after the second dose. The benefit of the shot in preventing Covid and its complications outweigh the risks, in particular for children with conditions that increase the risk of becoming seriously ill, the EMA said. 

The current wave of the pandemic in Europe has increasingly affected children, either because they’re directly infected or because their school and day-care classes are sent into quarantine. Though Covid doesn’t usually hit children as hard as it does adults, it can spread via children to more vulnerable people. 

The EMA committee’s recommendation will be sent to the European Commission for final approval. 

Pfizer and BioNTech are studying the vaccine for use in even younger children, with data from a trial in kids ages two to five expected this year, the companies said on Thursday. Results from a study of babies ages six months to two years old should come in the first quarter of 2022.

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