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HomeHealthFDA authorizes bivalent COVID-19 boosters for children ages 5 to 11

FDA authorizes bivalent COVID-19 boosters for children ages 5 to 11

Children ages 5 to 11 are now eligible to receive a COVID-19 booster aimed at both the original virus that causes COVID-19 and the omicron BA.4 and BA.5 variants.

The Food and Drug Administration authorized the boosters Wednesday morning from both Pfizer-BioNTech and Moderna. Approval from the Centers for Disease Control and Prevention is expected to quickly follow.

The vaccines should soon become available at area pharmacies and pediatricians’ offices.

Children are less likely than adults to become severely ill and die of COVID-19 infections or to suffer from long COVID-19.

But that risk isn’t zero. Because COVID-19 vaccines have been found to be extremely safe, pediatricians strongly recommend that nearly all children receive the two-dose primary series as well as a booster.

“Since children have gone back to school in person and people are resuming pre-pandemic behaviors and activities, there is the potential for increased risk of exposure to the virus that causes COVID-19,” said Dr. Peter Marks, who heads the FDA’s vaccine division, in a statement. “We encourage parents to consider primary vaccination for children and follow up with an updated booster dose when eligible.” 

White House COVID-19 coordinator Dr. Ashish Jha has urged everyone to get a bivalent booster shot by Oct. 31, ahead of the holidays and an expected winter surge in cases.

It takes about two weeks for vaccines to become fully effective after a shot.

“Don’t wait,” Jha said in a White House briefing Tuesday. “Get your new flu shot and get your new COVID shot today. If Americans did that, we could save hundreds of lives each day this winter.”

Adults are told to wait three months after an infection before getting a booster. Children are to wait at least two months after a previous infection or COVID-19 vaccine to get the booster, the FDA said.

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While the first two vaccine doses were protective early in the pandemic, studies showed a third shot was needed to provide strong protection against severe disease from the omicron variant, which first appeared around last Thanksgiving.  

Officials have said it’s OK to get a COVID-19 booster at the same time as an annual flu shot.

Although a previous infection with COVID-19 is believed to be protective against re-infection, as with vaccines, that protection isn’t perfect and fades over time, particularly in the face of new variants. 

The new shot is considered a “bivalent” vaccine, because it targets both the original virus and the variants that have been most common since early summer.

BA.4 and BA.5 now account for about 80% of the variants seen in the United States, a figure that has fallen in recent weeks. BA.4.6 is now the second-most common variant (BA.5 is first), and BA.7 is gaining ground as well. It’s not clear whether vaccines and treatments will respond differently to those newer variants.

Pfizer and its partner, BioNTech, said they are prepared to immediately ship the boosters, following final quality control checks. 

“Pfizer has the capacity to ship up to 6 million pediatric doses in the first seven calendar days,” company spokesperson Steve Danehy said in a statement, “without any impact to distribution output of the doses for individuals 12 years and older.”

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