Federal vaccine panel remade by RFK Jr. votes to maintain insurance coverage for Covid shots

WASHINGTON — A government advisory committee voted unanimously Friday to recommend that individuals 6 months and older should discuss the risks and benefits of Covid-19 vaccines with their health care providers before deciding whether to get vaccinated.

The decision falls short of prior years’ recommendations that the vast majority of Americans get the shots but would preserve insurance coverage for people who decide to do so.

“This vote provides for immunization coverage through all payment mechanisms including entitlement programs such as Children’s Health Insurance Program, Medicaid, and Medicare, as well as insurance plans through the federal health insurance marketplace,” a Health and Human Services Department spokesperson said. 

The committee recommended the vaccines to a broader population than the Food and Drug Administration, which last month limited approvals of the updated vaccines to people above age 65 or those with risk factors. It’s not unheard of for ACIP and FDA to diverge, said Yale health policy researcher Jason Schwartz. But in this case, the discrepancy on Covid shots will affect millions of people. 

“There is an increasingly fragmented set of voices not just related to medical groups, but even within the federal government itself regarding how these vaccines should be used,” Schwartz said. “Confusion is an enormous challenge for vaccination. That’s where we find ourselves.”

The vote may have protected insurance coverage, but the FDA’s limited approvals may still make it difficult for healthy Americans to get Covid shots without a doctor’s prescription.

After a lengthy debate, the committee rejected a proposal to recommend states require prescriptions for Covid vaccines. The committee voted 6-6, with Chair Martin Kulldorff breaking the tie by voting no. ACIP does not typically weigh in on whether a medication should require a prescription, as this falls under the FDA’s jurisdiction.

The committee also voted to recommend the CDC push health care providers to include more language about “risks and uncertainties” in vaccine information statements given to patients, and to encourage them to discuss risks and benefits of vaccines with patients.

The fate of Covid-19 shots had been uncertain, as the voting questions ACIP would consider were not revealed until the very end of the meeting, leading to a disjointed discussion that repeatedly turned into a cross-examination by committee members of CDC staff or vaccine maker representatives. The committee — whose members were handpicked by health secretary Robert F. Kennedy, Jr. after he fired the original advisers earlier this year — cast doubt on the safety and efficacy of mRNA Covid-19 vaccines in particular, and questioned the reliability of data capturing hospitalization rates due to Covid. 

Most concerns were theoretical, for example the suggestion that vaccine materials might have a “nonspecific effect” on the body. Others were more grounded in data, such as a presentation on myocarditis rates, which is a noted safety signal among Covid vaccine recipients. 

Pfizer and Moderna’s initial randomized controlled trials for their Covid vaccines enrolled more than 43,000 and more than 30,000 participants respectively.  Those shots showed a 90% efficacy rate in preventing illness. Their effectiveness in preventing illness has waned as the virus has changed and natural immunity has grown, but protection against severe disease has held strong, according to data from the CDC. 

Hundreds of millions of people in the United States have received Covid-19 vaccines, and billions have received them worldwide. This has allowed researchers at the FDA and elsewhere to identify any dangerous side effects that may not have shown up in the initial clinical trials. Researchers have noted an elevated — but rare — risk of myocarditis, or inflamed heart muscle, in young men particularly. But there is no evidence that the vaccines in use now cause any other major safety risks.

Over the past few months, the FDA has approved updated Covid-19 vaccines from Pfizer, Moderna, and Novavax for people over 65 or with underlying risk factors. The move surprised vaccine policy experts, as typically the FDA decides whether a vaccine is broadly safe and effective and the CDC’s vaccine advisory committee decides who should receive it. 

Public health experts worried that the FDA’s restrictions would impede vaccine access, as doctors might be less willing to offer the shots off-label. Some people have struggled to get Covid vaccines since. The American Academy of Pediatrics countered the FDA by recommending Covid shots for all children between 6 months and 23 months, as well as children over 2 at risk for severe disease. 

But most private health insurers have already announced they would continue to cover updated Covid-19 vaccines this year regardless of regulatory limitations, assuaging some fears about access. ACIP’s vote to recommend the vaccine, despite the caveat of shared clinical decision-making, mandates that public health insurers cover Covid shots as well. 

Sanofi, the commercial distributor of Novavax’s Covid vaccine, was encouraged by the vote. 

“This supports continued access and coverage for eligible individuals, which is good news for the millions of Americans who continue to want vaccination as an option for prevention,” said Sanofi spokesperson Evan Berland.

The committee separately tabled a vote on whether to delay newborns’ first hepatitis B vaccine dose, a move public health experts have opposed. Members had spent most of Thursday pressing CDC scientists on whether it was necessary to recommend the first dose be given at birth to all babies. In a set of votes on Thursday and Friday, they restricted access to the combination measles, mumps, rubella and varicella shot for children under age 4, favoring separate doses of the MMR vaccine and one that prevents chickenpox, or varicella.