Kennedy’s vaccine committee raises new hurdles to COVID shots

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ATLANTA — The federal vaccine committee appointed by Health Secretary Robert F. Kennedy Jr. voted unanimously Friday to further limit access to COVID-19 vaccines, recommending that adults 65 and older receive the shots only after discussing the potential benefits and risks with a health care provider.

The panel also said that everyone from 6 months to 64 years old could get the vaccine after consulting with a provider. But it was unclear whether that contradicted the Food and Drug Administration’s authorization of the shots only for adults over 65 and younger people with certain health conditions.

Together, the decisions raise questions about whether Americans can continue to walk into their neighborhood pharmacies for routine vaccinations or whether in some states they will first need a doctor’s permission.

The votes came on the second meeting day of a committee that was hurriedly assembled by Kennedy. Most of the panelists are first-time members, and their inexperience seemed to contribute to the confusion that marred both days of the meeting. About half of the committee members were appointed to the panel this week.

The recommendations approved by the panel, called the Advisory Committee on Immunization Practices, were less restrictive than many had expected. But they will still make it more difficult for pharmacists in some states to administer the shots to older adults. About two-thirds of Americans who received last year’s COVID vaccine got it at a pharmacy or a drugstore.

“We think that it’s appropriate to bring it to something that is being discussed between a physician or medical provider and a patient,” said Retsef Levi, the committee member who led the COVID work group and presented the proposed votes.

The nation is no longer in an “emergency situation,” he said.

Kennedy had already restricted access to the vaccine for healthy pregnant women and healthy children. The FDA authorized this year’s COVID shot only for adults 65 and older or for other adults with certain medical conditions.

The panel also unanimously voted to recommend that the Centers for Disease Control and Prevention describe the risks of COVID vaccines to patients and health care providers. Providers are already legally required to provide patients with a sheet explaining the risks and benefits.

But the committee stopped short of approving a recommendation that would also have required Americans to have a prescription for the vaccines. That proposal elicited the strongest disagreement among the panelists, with some members noting that a significant percentage of Americans, particularly those living in rural areas, do not have access to a health care provider. It did not pass.

Most committee members have publicly opposed COVID vaccines or vaccine mandates, so their decision to limit access to the shots was not entirely surprising.

But the language and the specifics of the restrictions alarmed some public health experts.

“There will be preventable deaths that result from these decisions,” said Dr. Lakshmi Panagiotakopoulos, who oversaw the CDC’s work group on the COVID vaccine before she resigned in June.

“Having people without vaccine and clinical expertise having the power to harm so much of the public is unbearable,” she said, referring to the panelists.

The chaos from the first day of the meeting bled into the second day, as the panel first voted in the morning session not to allow a federal vaccine program to cover the cost of a combination vaccine that protects against measles, mumps, rubella and varicella, or chickenpox.

This reversed a vote it had cast Thursday to allow the coverage, apparently because some members had misunderstood the way it was worded.

Then the panel voted to postpone indefinitely a vote on a vaccine for hepatitis B that is typically given to all newborns. Panelists said they felt unready to decide whether to limit the use of the shot.

Some said they still had questions about the vaccine’s safety, while others seemed relieved that the panel did not make what they saw as a rash decision that might harm children.

“We are more prudent when we are cautious,” Dr. Joseph Hibbeln, a neuroscientist formerly at the National Institutes of Health, said as he voted to table the question.

Thursday’s session ended with the panel members at odds.

A hot microphone caught one panelist calling another committee member “an idiot,” although it was unclear who was speaking.

Friday’s session, too, at times devolved into raised voices and sharp remarks. Dr. Jason Goldman, a liaison to the committee from the American College of Physicians, accused the committee’s chair, Martin Kulldorff, of muzzling him.

“You want debate and discussion, but you’re muting people and silencing them,” Goldman said. “If you could respectfully tell the public how you are going to be analyzing all of these vaccine decisions, we can have confidence in this committee.”

Kulldorff retorted: “You made that comment before, and I responded to that comment in a very nice and polite manner.”

The COVID vote followed a contentious and sharply polarized debate, with many committee members questioning the safety and effectiveness of the shots.

During a discussion about whether the vaccine provided protection from the virus, Dr. Natalie Thornburg, who leads a respiratory division at the CDC, said the antibodies produced in response to the vaccines were believed to be protective.

But one of the panelists, Robert Malone, said there was no clear evidence to indicate the level of antibodies needed for protection.

“You really have no right to assert what your feelings or opinions are about whether or not there’s a correlation between any of these outcomes,” Malone said. “There is no established correlative protection for COVID period, full stop, and stop saying otherwise.”

Dr. Fiona Havers, who resigned from the CDC in June, after Kennedy fired all 17 of the previous ACIP members, said she was dismayed by the exchange. Havers has often presented at ACIP meetings.

“I was shocked at how Robert Malone spoke to Dr. Thornburg, a well-respected leading scientist at CDC,” Havers said. “That level of disdain for her expertise and lack of professionalism would not have been tolerated during ACIP meetings in the past.”

Some outside experts also were taken aback.

“It was disheartening to witness continued personal attacks on scientists during the ACIP meeting rather than sticking to the data, the end goal, the health and well-being of the American people,” said Dr. Anne Zink, a public health expert at Yale University and the former chief medical officer of Alaska.

In his presentation, Levi, who led the COVID work group, said that assessments of the effectiveness of the vaccines were “based on very low-quality data and analyses” and that vaccine injuries were “demonstrably not recognized.”

(His slides were not available on the agency’s website, as is the norm, but a health department spokesperson made them available to reporters during Levi’s talk.)

CDC staff members and representatives of major medical organizations, including the American Medical Association, and other experts were united in their agreement that the vaccines are safe and effective.

“Or, if we don’t want to say effective, they work,” said Dr. Henry Bernstein, a member of the COVID work group.

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