What actually just happened with COVID vaccine recommendations?
RFK Jr's surprise announcement blindsided his own CDC and upended policy on COVID vaccination for pregnant women and children in under 60 seconds. What happened and why it matters.
Disclaimer: I am not a physician, an immunologist or an HHS insider, and it’s all still roiling around. It showed up almost overnight as an issue, so I may not have everything 100% accurate, but I’m going to be offline for a few days and wanted to cover what appears to be the current status before then. See also the administration’s cancellation this week of almost $800K in Moderna funding of an mRNA vaccine under development for bird flu, likely adding to the angst. Bottom line: while I’m out, keep listening to those who make sense, in particular watch Dr. Jetelina’s Substack page: she is wired in at the CDC and internationally.
Flanked by the heads of the FDA and (vaccine-uninvolved) NIH, in a 58-second announcement on X on Tuesday, HHS Sec. Robert Kennedy blindsided his own CDC and threw the vaccine world and health providers into turmoil, more chaos no one needs these days from DC.
The Hill notes that “absent from the group was anyone representing the CDC, which may or may not have an acting director with the authority to sign off on vaccine recommendations.” The announcement “blew through” the CDC approval process for vaccines that involves two agencies and outside experts.
Background
COVID has been with us now for more than five years in ever-evolving mutations. Between vaccination and natural immunity, it’s now endemic—regularly occurring within an area or community—but no longer the threat to most of us that it originally was. That “most” is key to how other countries now approach re-vaccination.
While the US has remained at “vaccinate everyone,” peer countries have gone to a risk-based approach, providing free vaccination and boosters to those most at risk rather than to the entire population. At least within public health, it was widely understood the CDC was likely moving in that direction, with a committee meeting scheduled for today, May 29, to examine the issue, and another committee meeting in June to likely finalize new recommendations—our scientific review process. Both the FDA and CDC are involved in those processes, which were fully supported in the past by the now-head of the FDA, Dr. Martin Makary.
Epidemiologist Dr. Katelyn Jetelina has a good summary of the process in her post.
What happened?
On May 20, the FDA Commissioner, Marty Makary, MD and his advisor, Vinay Prasad, MD, unveiled a major shift in U.S. Covid-19 vaccine policy published in a New England Journal of Medicine (NEJM)1 perspective piece; read it here. There were two key points:
Going forward, Covid-19 vaccines would only be recommended for people over 65 or with at least one qualifying condition. Over 20 qualifying conditions were listed that increase risk of severe COVID, including “pregnancy and recent pregnancy.”
Offering boosters to young adults will require manufacturers to run a new placebo-controlled trial after a variant arrives.
As Jetelina notes, this all sounds reasonable. “After all, severe COVID-19 is far less common in healthy young people. Given growing immunity, real scientific questions exist about whether annual boosters are still warranted for everyone. And, yes, other countries do things differently.”
But she also points out why new placebo-controlled trials are unrealistic for mutations. As we saw repeatedly during COVID, mutations occur rapidly; running trials as if those were a brand new disease (versus a mutation of a known entity) can demand time we emergencies often don’t allow. There are also ethical questions about giving trials administering a placebo when a known-safe vaccine is available.
All that was already causing concern when Kennedy added fuel to the fire this week. Keeping in mind Makary (FDA) reports to Kennedy (HHS), on May 27 RFK announced on X that he unilaterally decided to strike the recommendation that pregnant women and some children should have COVID vaccination, which appeared to be assumed in Makary’s NEJM article.
Makary and Prasad of the FDA are both physicians. They have their own agendas on vaccination, or Kennedy wouldn’t have selected them to lead the FDA, but they fully understand scientific and medical research processes. Kennedy is an attorney, and—as attorneys are trained to do—is laser-focused on research that supports his case and only his case,2 and no one would ever accuse him of being pro-vaccination. There’s no ethical requirement for attorneys to give opponents information that could help the opponents. Suppressing cases supporting the opposition is fair play for attorneys unless they’re caught—the absolutely opposite of scientific processes and medical research. And that’s without the inherent hackle-raising among physicians about a lawyer telling them how to practice medicine.
Why it matters
As Dr. Jetelina points out, the committees that were supposed to come up with recommendations on vaccination were already scheduled to review changes today, actually, and at a scheduled June meeting. To me, it looks like the NEJM piece was likely preparatory to announcing expected changes from those committees—to prepare people for the change.
From what I can gather two days into this there are three key, related issues:
The conflict between RFK’s announcement and the Prasad-Makary piece on vaccination policy for pregnant women and children.3 The key issue here may be RFK’s use of the word “healthy.” Remember—he’s not a physician; medical-speak isn’t his default.
Any change in policy will affect health insurance coverage of vaccination.
Whatever is happening, it’s a big, sudden4 change from current public health policy—although it’s also where our peer countries are.5 And big changes always invite reaction.
For most in public health, the biggest issue of all is not changing recommendations; those were expected. What worries public health is the clear appearance of politics overriding science and scientific processes put in place to safeguard care. That leads to further erosion of trust and more damage to at-risk populations, including the potential withdrawal of funding for vaccination for at-risk populations.
Dr. Jetelina’s piece on this was written before the RFK announcement; that’s her analysis as well. Zachary Rubin, MD is nationally known and double board certified in pediatrics and allergy/immunology. He wrote this piece after the RFK announcement. His summary is on point: “The CDC's decision to halt recommendations for COVID-19 vaccinations in healthy children and pregnant women is a significant shift in public health policy. While aimed at aligning with a more targeted approach, it raises concerns about increased health risks, the integrity of public health processes, and the potential for reduced vaccine accessibility. Ongoing dialogue and rigorous scientific evaluation are essential to ensure that public health decisions serve the best interests of all populations.”
What’s next?
We could see RFK back off, as he did over measles vaccination, clarifying that he and the FDA are on the same page—that he didn’t mean no vaccine for pregnant women and that he meant “healthy kids,” and the FDA and CDC define who is “healthy” or not as in the NEJM article. Blindsiding his own CDC doesn’t help him or anyone else govern effectively.
I’ll be without computer access for a few days with no ability to update. This will likely continue to shake out. Stay tuned.
NEJM, one of the most respected medical journals in the world, is on RFK’s brand new (May 27) list of “corrupt” medical journals, to which he says he may bar government scientists from submitting publications. You have to wonder about the timing a week after the Prasad-Makary piece was published in NEJM; push-back from the NEJM editorial board or related others perhaps?
In market research, we call that “happy ending research”—research that supports my position.
Pandemic data indicated a significant benefit from COVID vaccination during pregnancy for both mother and baby, as did data on at-risk kids in particular. There were unresolved issues around teens and young men about myocarditis.
It might have been a lot less “sudden” if Makary had been allowed to proceed along the lines he appeared to be with the NEJM article: preparing us for what was coming from the CDC committees this month and in June. The “sudden” was likely greatly exacerbated by RFK’s announcement.
A table in the Prasad-Makary NEJM piece lists peer country policies on COVID vaccination. Keep in mind these peer countries have lower healthcare costs and better access and outcomes, something we continue to resist dealing with openly, but that we eventually will have to face; our costs—particularly in the face of limited access and poor outcomes—are unsustainable.