The Food and Drug Administration authorized COVID-19 booster shots for children as young as five without approval from its vaccine advisory committee, raising alarms that the Biden administration is prioritizing pandemic politics over physicians' recommendations.
The Vaccines and Related Biological Products Advisory Committee did not convene ahead of this week's FDA decision on boosters for children ages 5 to 11. By forgoing a committee meeting on the decision, the FDA is precluding public comments from committee members who are skeptical of the necessity of booster shots for young children, who experience low rates of serious COVID-19 illness.
It is standard practice for the FDA to consult the advisory committee before major vaccine decisions. This committee was convened, for example, when the FDA debated the authorization of the first two doses of the vaccine for children last year. One member of the committee, Dr. Paul Offit of the Children's Hospital of Philadelphia, told the Washington Free Beacon that the FDA has "completely circumvented" the process for raising concerns about the authorization.
"You should be circumspect about whether or not your recommendation could cause a problem," said Offit, who runs his hospital's Vaccine Education Center.
Phil Kerpen, president of American Commitment, said the FDA’s decision to act without convening its committee of experts shows that getting the decision right isn't the primary goal.
"I think it really shows that they're not really concerned about getting it right, or the science," Kerpen said. "If they were concerned about getting it right they would at least want the input from their own advisers, but they didn't want to be embarrassed."
The FDA's decision comes as the Biden administration pushes for additional COVID-19 vaccine booster shots across all age groups. The CDC in March recommended a fourth shot for Americans ages 50 years and older, and on Thursday recommended a booster for children 5 to 11. The rate of hospitalization for children ages 5 to 11 is less than 1 in 100,000, according to the CDC. As of November, the agency recorded 94 deaths in the age group out of 1.9 million reported cases.
The Vaccines and Related Biological Products Advisory Committee consists of a variety of doctors across the country who work for hospitals, universities, and the federal government.
The FDA defended its decision not to convene the advisory committee in a press release this week, saying it was not in need of additional guidance.
"The FDA concluded that the request did not raise questions that would benefit from additional discussion by committee members," the release said.
While the committee voted in favor of authorizing the first two doses of the vaccine to children last year, several committee members noted that it was a difficult decision and would likely be hesitant to advise a booster. One member, Dr. Michael Kurilla, said one dose would likely be sufficient.
"I think that the possibility that they likely only need one dose at best is going to be very optimal, is probably going to be more than sufficient for them," Kurilla said.
Another member said the vaccine models were likely overestimating its benefits for young children. "We're all concerned about the myocarditis issue and I do think the model has overestimated the hospitalizations prevented," Dr. Mark Sawyer said. "I do think we need it as a tool for high-risk children."
The FDA declined to provide additional comment beyond its press release.