Children as young as 6 can now receive the Moderna booster, and children as young as 5 can now receive the Pfizer booster.
Previously, the Moderna booster was available to adults and the Pfizer booster was available to those 12 and older.
FDA officials suggested the emergency use authorizations were granted because the vaccines protect against hospitalization and severe illness.
“Vaccination remains the most effective measure to prevent the severe consequences of COVID-19, including hospitalization and death,” Dr. Peter Marks, a top FDA official, said in a statement.
But there’s no human data that supports the claim for the updated shots.
“Remarkable that FDA based this recommendation in children of this age group, on no evidence whatsoever relevant to the currently circulating BA.5 strain. Zero. Not even 8 mice,” Dr. Harvey Risch, a professor emeritus of epidemiology at the Yale School of Public Health, told The Epoch Times in an email.
FDA officials said that authorization was based on data from testing on an earlier investigational booster that did not target BA.5 and was never released in the United States. That testing was only for adults (Moderna) and people older than 55 (Pfizer). They also pointed to safety and efficacy data from the old booster.
The new boosters contain spike protein components of the Wuhan virus strain and the BA.4/BA.5 subvariants. The virus causes COVID-19. BA.5 is currently the dominant strain in the United States.
The FDA originally authorized the new boosters in August. As part of the action, the regulatory agency revoked authorization for the old boosters, which contain only the Wuhan strain. The primary series of all COVID-19 vaccines in the United States still only target that strain.
Moderna, Pfizer, and Pfizer’s partner BioNTech praised the new authorizations.
Stéphane Bancel, Moderna’s CEO, said that the company was “proud to have received authorization for our updated, bivalent COVID-19 booster for children and adolescents 6 to 17 years of age.”
“This milestone is important to be able to provide access to variant-adapted vaccines to a broader population,” added Dr. Ugur Sahin, CEO of BioNTech.
The FDA did not convene its expert advisory panel before granting the authorization. The agency has increasingly bypassed the panel on vaccines during the COVID-19 pandemic since the committee pushed back when the FDA commissioner supported boosters before data analyses were performed. An agency spokesperson did not immediately respond to a request for comment.
The U.S. Centers for Disease Control and Prevention (CDC) has not yet weighed in on the new authorizations. The CDC previously recommended the shots for virtually all eligible Americans 12 and older, who were advised to get one just two months after their most recent shot.
People cannot get the new boosters unless they’ve received a primary series. Approximately 9 million children aged 5 to 11 have received a primary series as of Oct. 7, according to CDC data. That’s about a third of the age group’s population.
Between 13 million and 15 million people in total have received one of the new boosters through Oct. 9, White House COVID-19 response coordinator Dr. Ashish Jha told reporters in Washington this week.
As the weather turns cooler, “we tend to see a big uptick in flu vaccines, [and] we’re expecting more people to get the COVID vaccine,” Jha said.