FDA Approves COVID-19 Booster Shots For 12- To 15-Year-Olds

The agency also shortened the amount of time that people 12 and older need to wait before receiving a booster shot, from six months to five.

The Food and Drug Administration has authorized children ages 12 to 15 to receive a third dose of Pfizer-BioNTech’s coronavirus vaccine, with the booster shot approval coming as COVID-19 cases among children continue to skyrocket.

The FDA’s authorization, announced Monday, has not yet been approved by the Centers for Disease Control and Prevention. Booster shots for 16- and 17-year-olds were authorized by the FDA on Dec. 9, and the CDC approved that authorization the same day.

The FDA on Monday also announced that certain children ages 5 to 11 may receive a third vaccine dose if they are immunocompromised. The agency reasoned that such children may not respond adequately to only two doses.

The agency also shortened the amount of time that people 12 and older need to wait before receiving a booster shot, from six months to five.

A woman prepares a COVID-19 vaccination at a vaccination clinic in Fairfax, Virginia, on May 13, 2021.
A woman prepares a COVID-19 vaccination at a vaccination clinic in Fairfax, Virginia, on May 13, 2021.
ANDREW CABALLERO-REYNOLDS via Getty Images

Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said these decisions were based on evidence showing that a third vaccine dose “may help provide better protection against both the delta and omicron variants.”

“In particular, the omicron variant appears to be slightly more resistant to the antibody levels produced in response to the primary series doses from the current vaccines,” he said.

There were also no new safety concerns found from administering these boosters, the FDA said.

Roughly 62% of children between 12 and 17 have received at least one dose of a COVID-19 vaccine, and 52% are fully vaccinated, according to the American Academy of Pediatrics. The Pfizer-BioNTech vaccine is the only one authorized for children 5 to 17 years old.

Pediatric COVID-19 cases have been soaring in recent weeks. Total cases increased by 50% during the first week of December, according to the AAP. There was another 58% increase in cases from the week prior during the week of Dec. 21 to Dec. 27, The Associated Press reported, citing the CDC.

Severe illness in children due to COVID-19 fortunately appears to be uncommon.

A recent CDC report examining children over the age of 5 who were hospitalized for COVID-19 at six hospitals in July and August found that two out of three of them had at least one underlying health condition, the most common of which was obesity. Less than 1% of the children who were eligible for the COVID-19 vaccine had been vaccinated.

As far as pediatric deaths go, there have been just over 1,000 attributed to COVID-19, out of the roughly 6.8 million positive pediatric cases reported since the start of the pandemic, according to data released by the CDC.

Dr. David Rubin, a researcher at Children’s Hospital of Philadelphia, has said the recent rise in pediatric hospitalizations is largely due to children becoming infected with both the delta variant and the more contagious omicron variant, which in a matter of weeks became the nation’s dominant variant.

“I think the important story to tell here is that severity is way down and the risk for significant severe disease seems to be lower,” Rubin told The New York Times.

Data also suggests that children’s reactions to COVID-19 vaccines are mild to moderate.

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