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With no new data or clear reasoning, a panel of advisors hand-selected by anti-vaccine Health Secretary Robert F. Kennedy Jr. voted last September to strip federal recommendations for a combination shot against measles, mumps, rubella, and varicella (chickenpox). An analysis published today by independent researchers does the work the advisors neglected to do before the vote and, in turn, shows how harmful the decision is to vulnerable US toddlers.
The decision last fall followed clumsy discussion by Kennedy's dubiously qualified advisors, who make up the Advisory Committee on Immunization Practices (ACIP) for the Centers for Disease Control and Prevention. Most noticeably, their unprompted review of the MMRV vaccine did not include a standard decision-making framework ACIP has historically used to comprehensively evaluate what the change would mean for US children in practice—including basic questions, such as which children would be affected.
Still, the decision meant that private health insurance providers would no longer be required to cover the vaccine, called MMRV. It also meant the shot would no longer be available through a federal program that provides vaccines to about half of American children, mostly from low-income families.
Independent advisors for the Food and Drug Administration on Friday voted 9–0 in support of approving Moderna's seasonal mRNA flu vaccine, which a Trump appointee at the agency initially tried to block from even being reviewed.
In an all-day meeting, members of the FDA's advisory committee—known as VRBPAC for Vaccines and Related Biological Products Advisory Committee—pored over data and presentations on the vaccine, which is dubbed mRNA-1010 and branded as mFlusiva. The presentations included a review from FDA scientists, which was supportive of the vaccine.
Data from a Phase 3 trial including over 40,000 adults age 50 and older found the mRNA vaccine was around 27 percent more effective against seasonal flu than a standard flu shot. A smaller Phase 3 trial, involving data from nearly 3,000 people age 65 years and older, showed the shot produces stronger immune responses than a high-dose flu vaccine, which is recommended for this age group. The safety profile of the vaccine was also generally good.
After some uncertainty—and a little drama—the Trump administration is appealing a ruling by a judge last month that temporarily halted anti-vaccine changes Health Secretary Robert F. Kennedy had implemented at the Centers for Disease Control and Prevention. Those changes include filling a key vaccine advisory panel with dubious anti-vaccine allies and unilaterally slashing childhood vaccine recommendations.
On March 16, US District Judge Brian Murphy issued a temporary injunction on those changes, essentially blocking the appointment of Kennedy's advisors, nullifying all votes they made on federal vaccine policy, and undoing the changes to the CDC childhood vaccination schedule. Murphy ruled that Kennedy's advisors were unqualified, and their appointment and the changes to vaccine recommendations violated federal procedures. The ruling stems from a case brought against Kennedy and the Department of Health and Human Services (HHS) by the American Academy of Pediatrics (AAP).
Prior to the ruling, lawyers for the government argued that Kennedy's actions were "unreviewable" and his authority was such that he could advise Americans to actively inject themselves with measles virus rather than the vaccine if he wanted. Murphy rejected that argument in his ruling and found the AAP would likely succeed with their claim that Kennedy's changes were illegal.
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