A powerful committee that advises the US Centers for Disease Control and Prevention (CDC) on vaccine policy voted on Friday against recommending that people obtain a prescription for a Covid-19 vaccine. However, the panel also voted to recommend that people speak with a clinician before obtaining the shot and that coronavirus vaccinations should be based on “individual-based decision making”.
The votes on the recommendations came after hours of impassioned debate that, at times, devolved into confusion and apparent animosity over the committee’s procedures and the safety of vaccines. Healthcare professionals and experts following the committee’s meeting were also left deeply confused about the significance of the committee’s votes and recommendations, and whether they would make it more difficult for people to obtain Covid vaccines.
The recommendation over Covid vaccine prescriptions left the panel, the Advisory Committee on Immunization Practices (ACIP), sharply divided, as six members voted to adopt it while six voted to reject it. The chair, Martin Kulldorff, broke the tie by voting against the recommendation.
However, the committee did vote to recommend that the CDC “engages in an effort to promote more consistent and comprehensive informed consent processes”, including potentially highlighting six “risks and uncertainties” around Covid vaccines.
The committee’s recommendations can determine which vaccines are provided free of charge through the US government, shape state and local laws around vaccine requirements, and influence which vaccines health insurers tend to cover.
Although the prescription recommendation did not pass, the committee’s moves are sure to further complicate the already fragmented landscape of vaccine availability.
The vaccine landscape has changed rapidly since Robert F Kennedy, who has long questioned the safety of vaccines, took control of the US Department of Health and Human Services.
In late August, the Food and Drug Administration approved updated versions of the Covid-19 vaccine only for people who are 65 or older or for people who have a medical condition that makes them high risk. That move unleashed widespread bewilderment over whether young, healthy people can still get vaccinated against Covid.
Some pharmacy chains, like CVS and Walgreens, said they would require prescriptions for the vaccine or cease offering them entirely in some states. Other states, including New York, moved to protect access to the vaccine for people who don’t have prescriptions.
Kennedy fired the previous iteration of the advisory committee and instead appointed several advisers who have little to no documented expertise with vaccines, or have criticized them heavily. That lack of experience came into focus repeatedly during the committee’s two-day meeting.
On Thursday, during the first day of the meeting, the committee voted to recommend that children receive multiple shots to protect against mumps, measles, rubella and varicella – or chicken pox – rather than a single vaccine. But afterward, when asked to vote on whether they would recommend that Vaccines for Children, a US government program that provides free vaccines to low-income children, continue covering the combined MMRV vaccine, many of the members seemed unsure of what Vaccines for Children was.
However, they initially voted to maintain Vaccines for Children’s coverage of the combined MMRV vaccine. Then, on Friday morning, the committee voted to reverse that vote and instead eliminate coverage for the combined vaccine.
The Friday meeting was punctuated by highly tense outbursts. A microphone caught one member calling another “an idiot”, although it wasn’t clear who was speaking. During one barbed exchange, one member demanded of another: “Show me that study!”
At one point, a member took the floor to announce that the discussions at the meeting had demonstrated that “we are not, as a committee, anti-vaxxers”.
A planned vote on the hepatitis B vaccine was also tabled after members pointed out inconsistencies in the wording of the vote and suggested that they would prefer to recommend delaying the hepatitis B vaccine until even later in a child’s life. Although voting had begun, the members ultimately decided to postpone the vote until at least their next meeting.
Experts who spoke to the committee at the meeting highlighted the members’ tendency to raise hypothetical situations, opinions and anecdotal experiences, rather than focusing on data that demonstrates the safety of Covid vaccines.
“Relying on case reports, anecdotes and selected basic science data – is that enough to justify a change in policy or a recommendation that limits an effective vaccine?” said Grant Paulsen, who spoke on behalf of the Pediatric Infectious Diseases Society.
“I would encourage the committee to make decisions based on the data rather than theoretical concerns that are raised. Those are certainly valid concerns – I’m not here to dismiss them. Continued monitoring, continuing research is vital, but really should not be a barrier to families looking to access this tool to protect their children.”
