ACIP vaccine votes break with evidence-based policy

COVID-19

During the two-day meeting, ACIP unanimously voted to drop its recommendation that people 65 and older receive a COVID-19 vaccine and, instead, to endorse vaccination only after consultation with a health professional.

The newly constructed panel also voted to recommend that people between 6 months and 64 years, or their caregivers, discuss the risks and benefits of vaccination with a provider. This stance is broader than the FDA's, which last month limited approvals of updated vaccines to people above age 65 or those with risk factors.

If adopted by the CDC, the guidance change would keep COVID-19 vaccines covered by insurance. But by framing vaccination as a matter of personal choice, the panel risks further fueling vaccine hesitancy and contributing to declining vaccination rates.

Additionally, ACIP members voted to urge the CDC to adopt what the committee said was a more comprehensive informed consent process, detailing "at least six risks and uncertainties" they argue should be disclosed to patients.

Advisors were evenly divided 6-6 on whether to endorse a recommendation that cities and states require a prescription for updated COVID-19 vaccines, leading the committee's Chair, Martin Kulldorf, to cast the tiebreaking vote against the recommendation.

Requiring a prescription would have added extra barriers to getting a COVID-19 booster, considering roughly two-thirds of adults who were vaccinated last year got the shots at a pharmacy, according to CDC data presented during the meeting.

Other committee members argued that requiring prescriptions would make individuals more aware of potential vaccination risks. But decisions on whether a drug needs a prescription usually fall under the FDA's authority, not ACIP.

ACIP member Retsef Levi, an Israeli applied mathematician with no medical background, presented findings from the committee’s COVID-19 vaccine working group. Levi claimed that serious safety concerns associated with mRNA vaccines are not being properly addressed and that current evaluations rely on "low-quality" data.

In reality, Pfizer and Moderna's mRNA vaccines were approved by the FDA based on clinical studies with tens of thousands of volunteers. More than 70,000 participants were enrolled in initial trials, which demonstrated over 90% efficacy in preventing illness.

Hundreds of millions of doses have since been administered, and while protection against infection has waned with viral changes and rising natural immunity, data show protection against severe disease has remained strong.

Studies and real-world evidence continue to show that the vaccines are effective against serious COVID-19 illness and are safe, with rare side effects. However, members still cast doubt on the safety and efficacy of mRNA vaccines and questioned the reliability of hospitalization data.

Combined MMRV

On the first day, the committee decided 8-3 that children under the age of 4 should not receive the combined MMRV vaccine, citing the rare risk of febrile seizures in infants.

Febrile seizures are most common in children under 5 and are typically harmless in the long run, though the panel acknowledged they can be distressing for family members. The risk decreases when vaccines are given to older children.

For children aged 4-6, ACIP recommends separate doses of the MMR vaccine and varicella. However, parents concerned about side effects tend to already schedule separate appointments to split the vaccines.

The vote would have barred children in the federal Vaccines for Children program from receiving the MMRV shot until age 4. But in a follow-up motion, the committee voted against aligning the no-cost program with the recommendation, leaving current coverage unchanged for the time being.

Hepatitis B

After a lengthy debate, the committee voted 11-1 on Friday to table the vote on whether to delay hepatitis B vaccinations given to newborns. Public health experts oppose any such change to the decades-old recommendation, warning it would weaken protections against infection.

Since the hepatitis B vaccine mandate for newborns began in 1991, the number of U.S. childhood infections has dropped by 95%. Today, fewer than 1,000 children or adolescents in the United States contract the virus annually.

Although it is unclear how the committee will move forward, the hepatitis B vaccine guidelines are being revisited despite no new data.

The renewed scrutiny echoes long-running attacks on the vaccine by Children’s Health Defense, the anti-vaccine group Kennedy chaired for 8 years before taking office. The advocacy group suggests hepatitis B poses little risk to infants and argues the vaccine can be harmful, despite no scientific evidence to support those claims.

What's next?

All recommendations now head to Acting CDC Director Jim O'Neill for approval before becoming official government policy.

O'Neill, a biotech investor and close ally of RFK Jr., was appointed to lead the agency after Kennedy fired Senate-confirmed infectious disease expert Dr. Susan Monarez last month for refusing to support what she described as unscientific directives.

Monarez later told a Senate health committee that Kennedy planned to alter the childhood vaccine schedule without "data or science to point to."

At the meeting, Kulldorff said two new working groups are being formed, one to examine vaccines recommended during pregnancy and another to review the timing of childhood immunizations.

He added that both groups would re-examine the vaccines the CDC currently recommends for children and pregnant people, with further changes possible once their reviews are complete.