After at times contentious discussions over the science behind COVID vaccine and suspicions over its impacts, the vaccine advisory panel for the Centers for Disease Control and Prevention (CDC) today in a four-part vote fine-tuned its COVID vaccine recommendations and narrowly rejected its working group’s proposal to require a doctor’s prescription for the vaccine.
The main measure that would have added barriers to vaccination was a proposal that would have advised states and localities to require a doctor’s prescription for COVID vaccine for all groups, which in the initial vote was a 6-to-6 tie, with Martin Kulldorff, PhD, chair of the Advisory Committee on Immunization Practices (ACIP), breaking the tie with his no vote. Kulldorff is a statistician and epidemiologist formerly at Harvard University.
The unexpected result came after 2 days of choppy and sometimes chaotic proceedings that saw the group earlier today reverse one of its votes on the measles, mumps, rubella, and varicella (MMRV) vaccine and postpone another on the birth dose of hepatitis B vaccine. Liaison members, and even some ACIP members, at times voiced sharp concerns about the lack and quality of evidence backing the proposals, while raising questions about transparency and why ACIP was even weighing the topics.
Michael Osterholm, PhD, MPH, director at the Center for Infectious Disease Research and Policy (CIDRAP) at the University of Minnesota and leader of the Vaccine Integrity Project, said the proceedings shined a spotlight on the replacement of our nation’s evidence-based system that helped create access to lifesaving vaccines by an ideology-based system determined to limit access.
Committee members also often seemed to lack understanding of the laws and regulations that govern vaccine administration and healthcare delivery in the US.
Despite the pledge to not take away vaccines, Health and Human Services (HHS) Secretary Robert F. Kennedy Jr, did that through ACIP’s decision yesterday to limit access to the MMRV vaccine and continues to work to limit access to approved COVID vaccines, he said.
“Over and over, during the often-disorganized proceedings, CDC experts presented peer-reviewed vaccine data to members of the committee, only to have them dismiss, misunderstand, or mischaracterize the information or introduce their own unvetted and unpublished data,” Osterholm said. “Committee members also often seemed to lack understanding of the laws and regulations that govern vaccine administration and healthcare delivery in the US.”
Weighing potential barriers to vaccination
Most of the members who voted against the main measure worried that a prescription would be a barrier to immunization, especially for people who don’t have regular doctors and those in underserved areas, many of whom they said are in the groups at higher risk for severe COVID illness. They also aired concerns about adding an extra burden to already busy doctor’s offices. Those who voted for the measure, however, said the doctor’s prescription was needed to ensure that patients are adequately informed of the risks and benefits of vaccination.
The three other measures were less controversial. In one other vote, the group weighed in on adult and pediatric immunization schedules. They decided that adults age 65 and older should be vaccinated based on their own assessment and emphasized that, for people ages 6 months to 64 years old, the vaccination benefit is most favorable for those with underlying health conditions.
In two other separate votes, the group recommend that the CDC add more language about risks and uncertainties, including to vaccine information statements, and that healthcare providers talk to patients about risks and benefits of vaccination and known risk factors regarding COVID.
The latest meeting of ACIP, now hand-picked by Kennedy, comes amid the rollout of updated COVID vaccines ahead of the respiratory virus season and, for now, avoids adding more confusion on top of recent narrowed indications and recommendations from the CDC.
Vigorous debate among working group members
The discussion was steered by lines of questioning that came from a COVID vaccine working group led by Retsef Levi, PhD, professor of operations management at MIT Sloan School of Management and a known critic of COVID vaccines.
Ahead of the meeting, the working group drew on consultants who specialized in topics such as myocarditis and uncertainties about immune changes and the distribution of vaccine mRNA in the body. The working group also included scientists involved with vaccines and COVID, some of whom have served on federal vaccine advisory groups before.
The experts included Stanley Perlman, MD, PhD, a professor of microbiology and immunology, and pediatrics at the University of Iowa; Henry Bernstein, DO; Henry Bernstein, DO, professor of pediatrics at the Donald and Barbara Zucker School of Medicine at Hofstra/Northwell in New York; and Mitchell Miglis, MD, assistant professor of neurology at the Stanford Center for Autonomic Disorders at Stanford University.
In his presentation today, Levi focused on the safety concerns, the effectiveness of the vaccines, a purported lack of research, and several uncertainties, including whether the vaccine causes long-term health problems that are similar to long COVID. He also said the mRNA vaccines need more rigorous purity studies.
Behind the scenes in the lead-up to the meeting, the working group met with representatives from Pfizer, which detailed a small randomized-controlled trial that it conducted in pregnant women. During today’s meeting the Pfizer representative said the trial included 150 pregnant women in each arm of the study, one of which included women vaccinated from 24 to 36 weeks of pregnancy. Birth defects were seen in 5% of the vaccinated group and 3% of the unvaccinated group, which she said for both groups was in line with background rates of birth defects. She also noted that some of the birth defects were likely present before vaccination.
In one of the biggest flashpoints of the meeting, Kulldorff pressed that birth defects were fourfold higher in the vaccinated group, eight versus two. The Pfizer representative maintained the original percentages, based on the company’s interpretation of the data.
If you don’t want to say they are safe and effective, just say, ‘They work.’
Meanwhile, during the minority group presentation, Bernstein maintained that simple, stable vaccine recommendations can increase coverage. He also aired concerns about COVID risks for young children, who have hospitalization rates that are similar to seniors, and the importance of vaccination for pregnant women who can pass antibodies to their babies. “In summary, vaccination for pregnant women matters.”
Regarding the vaccine safety records and impact in bringing down pandemic numbers, Bernstein said, “If you don’t want to say they are safe and effective, just say, ‘They work’.”
