U.S. FDA approves Pfizer’s COVID-19 booster vaccine for kids ages 5-11

The U.S. Food and Drug Administration (FDA) authorized Tuesday single booster doses of Pfizer-BioNTech’s COVID-19 vaccine for children ages five to 11.

Children within that age bracket will be able to get a booster dose at least five months after their first two doses of the Pfizer vaccine after the FDA amended its emergency use authorization for it.

“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 Robert M. Califf said in a statement.

“The FDA is authorizing the use of a single booster dose of the Pfizer-BioNTech COVID-19 Vaccine for children 5 through 11 years of age to provide continued protection against COVID-19.”

Califf said vaccination is the most effective way to prevent COVID-19 and potentially severe consequences, including hospitalization and death.

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The FDA previously approved a booster dose for individuals 12 to 15 years old in January, while the first two doses for those five to 11 were approved in October 2021.

6:39 U.S. FDA has now approved Pfizer’s COVID-19 booster shot for 12- to 15-year-olds

The agency has determined that the benefits of a booster dose for the young age category outweigh the potential risks.

The FDA came to its conclusion on the booster’s effectiveness for kids after studying antibody responses in 67 participants who received a booster dose seven to nine months after the first two-dose series.

“The antibody level against the SARS-CoV-2 virus one month after the booster dose was increased compared to before the booster dose,” the FDA said in a statement.

To determine the safety of the booster dose on children, the FDA did a study of about 400 kids who received the dose five to nine months after the first series. That study found the most common side effects were pain, redness and swelling at the injection site, as well as fatigue, headache, muscle or joint pain, and chills and fever.

It is unclear how many parents of children in the age group will opt for a third dose, though, as only 28.8 per cent of kids five to 11 are fully vaccinated in the U.S., according to the U.S. Centers for Disease Control and Prevention.

Children under five are not yet eligible for a COVID-19 vaccine in the U.S.