Tiebreaking vote prevents RFK Jr. panel from requiring prescriptions for Covid vaccines

ATLANTA (CN) — A panel of vaccine advisers for the U.S. Centers for Disease Control and Prevention continued discussions with health experts Friday and voted on recommendations for the administration of Covid-19 vaccines.

The Advisory Committee on Immunization Practices, whose recommendations must still be approved by the CDC director, grappled with how to implement Covid-19 vaccines as the virus dwindles in the post-pandemic world.

In a tied 6-6 vote, a proposal that state and local jurisdictions should require a prescription for the administration of the Covid-19 vaccination ultimately failed. A no vote from Dr. Martin Kulldorff, a Swedish epidemiologist who serves as chairman of the committee, was the tiebreaker.

Members who opposed the proposal expressed concerns that requiring a prescription would create a high barrier to vaccine access, especially in rural areas.

Some pharmacies around the country have already begun requiring prescriptions for the vaccine, after the FDA decided last month to recommend the shots only for adults over 65 and adults with underlying health conditions.

While data presented noted the efficiency of the vaccines in protecting individuals against the virus since 2020, some members also pushed for more disclosure and research from the CDC about potential risks.

“The risks and uncertainties related to the Covid-19 vaccine should be appropriately communicated by CDC to patients and medical providers to enable appropriate informed consent,” said Retsef Levi, an MIT professor of operations management.

All of the committee members, except for Kulldorff, voted in approval of the CDC engaging in an effort to promote more consistent and comprehensive informed consent processes and consider adding language that is accessible to patients and medical providers to describe documented risks.

Levi said that repeated vaccination can sometimes lead to increased vulnerability to other respiratory viruses. He also noted an extremely rare, but established link between Covid-19 mRNA vaccines — such as those developed by Pfizer and Moderna — and myocarditis.

While the vast majority of these vaccine-related myocarditis cases are mild, Levi pointed to a 2022 autopsy study of two teenage boys who died from cardiac complications within a week of receiving their second Pfizer dose. The medical examiner who performed the autopsy maintained that a vaccine-related myocarditis was the cause, but the CDC has disputed that bacterial infections were the main culprit.

Much of the discussion centered around efficacy concerns and hesitancy from the public toward vaccination as trust in the CDC erodes. Many experts also expressed concerns with the limited available data and using the number of hospitalizations as an efficacy factor when that rate could be impacted by other factors.

“How do we get better about individualizing care?” said Kirk Milhoan, a pediatric cardiologist and former U.S. Air Force flight surgeon.

In a unanimous decision, the committee voted for health care providers to discuss these risks and the benefits of the vaccination for each individual patient and consider the known risk factors for severe outcomes of Covid-19 such as age, prior infections and immunosuppression.

All 12 members also voted in favor of recommending that immunization for adults over 65 years old should be based on individual decisionmaking. They agreed the same should apply to ages between six months and 64, but with an emphasis that the risk-benefit is most favorable for those at an increased risk of severe Covid-19.

“We are not talking about an emergency situation anymore,” Levi said.

Following a lengthy debate Thursday, the committee backed off from a proposed change that would have scrapped the current recommendation that children receive the hepatitis B shot at birth.

“I move to postpone the question indefinitely,” Dr. Robert Malone, a vaccinologist and biochemist known for his early contributions to mRNA vaccine technology, said.

“I believe that there’s enough ambiguity here and enough remaining discussion about safety, effectiveness and timing that I believe that a vote today is premature.”

Members voted 11-1 to table taking any action on the birth dose of hepatitis B vaccine, with Kulldorff again as the lone dissenter.

Many medical experts expressed concerns with overhauling current recommendations, pointing to data showing they have safely and effectively helped dramatically reduce cases of hepatitis B. They noted that about half of people with hepatitis B are unaware of their infection, so they could unknowingly expose infants in their care.

The only potential benefit to rescinding the current recommendation was a possible reduction in extremely rare cases of adverse effects from the birth dose vaccine, which tend to be mild.

It also reversed a vote it took Thursday on coverage for a shot known as the MMRV: the measles, mumps, rubella and varicella, or chickenpox vaccine. On Friday, the panel said the Vaccines for Children program should not cover the combined shot if parents want it.

Eight of the panel’s members voted Thursday to change the current recommended vaccination age for the MMRV shot from 12 months to 4 through 12 years old.

The vaccine combines the MMR vaccine with the varicella vaccine into one shot that was designed to reduce the number of shots a child receives. But the change encourages children under the age of 4 to receive the two separate vaccinations.

The discussions marked the first among the committee’s new members appointed this year by Department of Health and Human Services Secretary Robert F. Kennedy Jr., who has been criticized for spreading anti-vaccine rhetoric. They also come amid chaos surrounding the leadership of the CDC, as the former head, Susan Monarez, told the Senate she was fired by the Trump administration for “holding the line” on the scientific consensus supporting childhood vaccine recommendations.

Monarez claimed that Kennedy demanded she agree in advance to approve every recommendation change proposed by the committee.

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