A newly comprised federal panel tasked with providing vaccine guidance would add new safety warnings for COVID inoculations and almost required prescriptions to get the vaccine .
The move came after two days of deliberation over proposed changes to the administration and schedule of several vaccines. It remains unclear if the proposed changes could impact Washington state, which has joined a partnership of states on the West Coast to provide rival vaccine recommendations.
Traditionally nonpartisan, the Advisory Committee on Immunization Practices had been made of independent experts who create the Centers for Disease Control and Prevention's vaccine recommendations for physicians across the country to follow. In June, U.S. Health Secretary Robert Kennedy Jr. replaced all 17 members of the committee with new members, many of whom agree with his critical view of vaccine recommendations or usage.
The Food and Drug Administration in May limited the vaccine to those 65 or older and those who may be at increased risk for severe COVID-19 illness. On Friday, the ACIP committee voted that healthy adults could still access the COVID vaccine as long as they discussed with their doctor or pharmacist the risks and potential benefits of the vaccine.
They also recommended the CDC require medical providers to describe risks to vaccination, including that evidence of the protection provided by the COVID vaccine are of "low quality at best."
Other risks providers would describe to patients include that seasonal mRNA boosters may be associated with increased vulnerability to COVID and other respiratory viruses, that the vaccine may cause "prolonged and debilitating post vaccine syndrome," that deaths related to the vaccine have been documented and that the safety of COVID vaccination during pregnancy has never been tested appropriately.
ACIP member Retsef Levi, who chaired the coronavirus vaccine work group, said these warnings would return trust to the CDC's recommendations.
"This has nothing to do whether we need to take the vaccine or not. This has to do with acknowledging what the risks are and being truthful to parents and patients about what are the risks," Levi said.
University of Washington professor and immunologist Helen Chu, who served on the ACIP committee before being fired earlier this year, said these decisions were made without a scientific basis.
"They do not have subject matter expertise, nor an understanding of the basic structure of how the ACIP works. Importantly, over the course of the last two days, they have not followed standard protocols for careful review of the data, including a review of how we might implement new vaccines, considering the cost effectiveness of vaccines, or the process by which we distribute vaccines to clinics where they are going to be administered," Chu said.
The West Coast Health Alliance recommends all those more than six months of age should be vaccinated for COVID-19, including those who are pregnant and healthy adults. A Washington Department of Health standing order authorizes pharmacies and other providers in the state to administer the updated COVID vaccine.
In a statement, the Washington DOH said they would "review their guidance and assess how it aligns with current evidence and national recommendations" in light of the new ACIP recommendations.
ACIP chair Martin Kulldorff pushed back on claims the new committee members were anti-vaccine.
"The members of this ACIP committee are committed to reassuring the public and restoring public confidence by removing unnecessary risk and harms whenever possible. That is a pro-vaccine agenda," he said. "False accusations that we and other respectable vaccine scientists are unscientific and dangerous antivaxxers just adds legitimacy to antivax positions."
Kulldorff claimed any insinuation of this kind was "political in purpose" and challenged his critics to a public debate.
"You should only trust scientists that are willing to debate fellow scientists with different views. I hereby invite each of the nine former CDC directors to have a live public debate with me concerning vaccines," he said. "If they are not willing to engage in an open and honest debate with this committee that they are so severely criticizing, then I advise that you should not trust them."
Members of the newly reconstituted body narrowly rejected their most controversial proposal: that patients receive a prescription before COVID-19 vaccination.
Levi said such a requirement was needed to ensure patients fully understood the risks of vaccination.
"If we believe that this is really a nuanced decision and that there should be a conversation that is deep, I think it is very strange not to prescribe," he said.
Vaccines typically do not require individual prescriptions. Opponents of the proposal argued such a requirement for a single vaccine would limit its access.
"I'm really concerned about the requirement of a prescription, because I believe the segment of the population that is underinsured, has lack of access to health care, they're going to be unable to get a prescription, and those are the people that are at highest risk for a lot of these comorbid conditions," said ACIP member Catherine Stein.
The prescription requirement failed in a tied 6-6 vote. Because of the close vote, Chu is concerned the proposal will return.
"I don't think it's settled. I think it will probably come up again," Chu said. "If you require a prescription from a doctor to be able to get your vaccine, that just puts an extra level of an extra barrier to care, an extra hurdle that you have to jump over to be able to access your COVID vaccine."
The panel also considered changes to the combination measles, mumps and rubella vaccine and the hepatitis B vaccine. The panel removed a recommendation for the combined MMR and varicella - or chickenpox - vaccine for infants, instead endorsing separate MMR and chickenpox vaccines.
According to Chu, this change is unlikely to impact many children because providers typically do not use the combined vaccine.
ACIP indefinitely tabled a vote to recommend against administering hepatitis B vaccines at birth, which has been the standard of care since 1991. It is unclear if the committee will return to the issues.
"Birth dose hepatitis B vaccine is a highly safe and effective vaccine and has been routinely given since birth," Chu said.
Any recommendations of the ACIP committee will not go into effect until ratified by the CDC director.