FDA Authorizes COVID Booster for Kids Ages 5 to 11


The US Food and Drug Administration on Tuesday gave emergency use authorization for a booster dose of Pfizer and BioNTech’s COVID-19 vaccine for children ages 5 to 11, at least five months after their second shot. 

Kids age 12 and older are already eligible for a third shot, or booster dose. Before boosters start rolling out to the younger age group, they will need a recommendation from the US Centers for Disease Control and Prevention. The CDC’s independent advisory committee has a public meeting scheduled for Thursday, presumably to vote on whether to recommend the booster. 

Like the first two doses of the primary vaccine series for kids 5 to 11, Pfizer’s booster is one-third the dose given to those age 12 and older. 

The FDA said the authorization was based on immune response data from the ongoing randomized trial that supported the October authorization for the primary vaccine for younger kids. Antibody responses were evaluated in 67 children who received a booster dose seven to nine months after getting their second shot. Safety of the booster shot was evaluated in about 400 children. Side effects of the booster in children were similar to common side effects in adults, including pain at the injection site, fatigue, headache and fever. 

“While it has largely been the case that COVID-19 tends to be less severe in children than adults, the omicron wave has seen more kids getting sick with the disease and being hospitalized, and children may also experience longer term effects, even following initially mild disease,” FDA Commissioner Dr. Robert M. Califf said in a statement. 

Roughly 1 million people in the US have died from COVID-19 since the pandemic began in early 2020. 

The FDA didn’t hold a meeting with its independent advisory committee prior to this authorization, which it has typically done before authorizing COVID-19 vaccines or boosters for specific age groups. Pfizer’s request for emergency use authorization “did not raise questions that would benefit from additional discussion by committee members,” the FDA said, noting that it will make documents related to the request available on its website. 

Children under age 5 still aren’t able to get vaccinated against COVID-19. The FDA has loosely scheduled three dates next month — June 8, 21 and 22 — to discuss Moderna’s and Pfizer’s requests for authorization for babies and younger children.

Only 29% of children 5 to 11 have received the first two shots of COVID-19 vaccine, according to The New York Times. 

The information contained in this article is for educational and informational purposes only and is not intended as health or medical advice. Always consult a physician or other qualified health provider regarding any questions you may have about a medical condition or health objectives.


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