President Biden is yet again facing backlash over the FDA’s booster approval process, which recommended boosters for children this week without convening a panel of advisors to weigh in on the matter.
"Dear President Biden, FDA is bypassing it's scientific advisors to authorize boosters for all kids 12-15 next week. This is unconscionable – undermines the integrity of the FDA's standard process! Please require FDA to put this authoriz [sic] before the VRBPAC advisory comm for a vote!" Dr. Marty Makary, chief of the Johns Hopkins Islet Transplant Center and Fox News contributor, tweeted Saturday.
The Vaccine and Related Biological Products Advisory Committee voted against giving the Pfizer-BioNTech's COVID-19 booster shots to most people back in September. It instead voted to limit boosters to those aged 65 and older, as well as to people at risk of severe illness, citing the lack of evidence showing the boosters are safe for younger people.
"We’re being asked to approve this as a three-dose vaccine for people 16 years of age and older, without any clear evidence if the third dose for a younger person when compared to an elderly person is of value," committee member Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, said at the time.
The controversy over boosters in the early fall was compounded when two FDA officials - the director of the FDA’s Office of Vaccines Research & Review, Marion Gruber, and its deputy director Phil Krause - resigned from the agency.
The pair issued a scathing criticism of the widespread use of boosters in a piece published in the Lancet on Sept. 13, which was co-authored by a handful of experts warning that "current evidence does not appear to show a need for boosting in the general population, in which efficacy against severe disease remains high."
By November, however, the FDA approved the Pfizer-BioNTech and Moderna vaccine boosters for everyone 18 and older without input from the advisory committee.
The agency said at the time that it did not convene its advisory panel because the committee had already discussed the use of boosters and "the requests do not raise questions that would benefit from additional discussion," the New York Times reported on Nov. 19.
The FDA approved the Pfizer-BioNTech COVID-19 vaccine booster for 16 and 17-year-olds last month, and broadened eligibility Monday to 12-15 year olds.
Former FDA commissioner during the Trump administration, Scott Gottlieb, said during an appearance on "Face the Nation" Sunday that schools should not mandate boosters for children, noting that the durability of vaccines in 12 to 16-year-olds "has been more robust than what we've seen in adults." He added that kids overall are "at less risk overall from the infection."
Dr. Makary agrees.
"It is a slap in the face to science for @US_FDA to circumvent the standard convening of the expert advisory board... FDA is quietly doing this because their experts previously voted it down, voicing concerns about medical harms," Makary tweeted Saturday.
Makary added in comment to Fox News on Monday that it's within Biden's "jurisdiction to demand that his FDA put the decision to a vote by the experts as was done with other major FDA [Emergency Use Authorizations]."
Dr. Marc Siegel, professor of Medicine at the NYU Langone Medical Center and Fox News contributor, said he supports the advisory board taking up the issue because they need to "figure out the utility of it."
"I don't want anybody to be suggesting this vaccine, or its boosters, are unsafe for that group. That's wrong. And the purpose of convening the advisory committee is not to question safety. It's to question who should get it," Siegel told Fox Digital on Monday.
"If we start suggesting that this, this vaccine is unsafe, then we're playing into the hands of the anti-vaxers, who are filling hospitals."
The New York Times reported on Dec. 30 that some experts said that the Biden administration’s focus on getting younger people boosters is misguided and officials should instead work on vaccinating those who have not yet gotten the shots. Offit told the outlet that getting such shots to young Americans was "focusing on the people who are already protected."
Republican Sen. Rand Paul, who is also a physician, criticized the Biden administration on Twitter Sunday for the government "ignoring its own rules to push booster vaccines on kids for a disease is that is less deadly in children than the seasonal flu."
Makary argued in a Wall Street Journal op-ed published last month that booster mandates for young people "will cause medical harm for the sake of transient reductions in mild and asymptomatic infections." He cited a December study by Oxford researchers that found "young people suffered myocarditis, pericarditis and arrhythmias more frequently from Moderna’s vaccine than from Covid itself."
While the long-term cardiac effects of boosters in younger people is "unknown."
"Forcing immune, young, healthy, low-risk students to get a third vaccine shot is excessive and wasteful. These precious vaccine doses should be going to poor countries that still don’t have enough," Makary concluded in his op-ed.
The White House referred Fox News to the FDA when approached for comment on the concerns from health officials.
The FDA directed Fox News later Monday to a press call where the director of the Center for Biologics Evaluation and Research within the FDA said the advisory board is called upon at the discretion of FDA officials.
"The reason for not taking it to our advisory group: We use our discretion when we bring things to advisory group. When we feel like there is some question that is likely to actually need public discussion," Dr. Peter Marks said on the call. "We sometimes consult our advisory committee chairs to decide what questions to bring to committee."
He explained that the increase in cases in the last 48 hours prompted officials "to try to move as quickly as we possibly could."