Chaos at CDC's vaccine meeting. One member resigns. Some scientific materials not vetted by agency experts. American Academy of Pediatrics boycotts.
It's going great.
The Trump Administration, via HHS Secretary Robert F. Kennedy Jr., is attacking access to vaccines by weaponizing the CDC’s Advisory Committee on Immunization Practices. As RFK’s newly-installed iteration of ACIP met for the first time today, I received a flurry of insights from CDC insiders that I want to share with you. Please help me amplify their voices. We need the public to know what is going on. Thank you for supporting and sharing this work as widely as you can.
The CDC’s Advisory Committee on Immunization Practices, such that it is, opened its June 25-26 meeting today.
The stakes: The committee’s votes are binding legal policy—meaning that private insurers must cover vaccines for populations recommended by ACIP. That said, these companies could choose to cover vaccines not recommended by Secretary Kennedy’s ACIP. In contrast, federal insurance programs like Medicaid and Medicare are tied to these votes, so they would not be permitted to cover vaccines that are not endorsed by ACIP votes.
In the early hours of the meeting, chaos had already ensued. Here’s some of what I’ve learned, including some breaking news…
Member resigns. Conflicts of interest ignored.
(Note: I made some post-publication edits below to reflect updates on what constitutes quorum.)
One of ACIP’s voting members newly installed by Secretary Kennedy, Dr. Michael Ross, resigned. The reason given: Dr. Ross was not willing to sell some of his stock. (Dr. Ross had no publications on vaccinations, I’m told, but that’s not relevant, apparently.)
This left the committee without the required* eight-person quorum needed for votes that have legally binding implications. *Update: Previously ACIP quorum was eight voting members, but I just learned that this was specific to when there were seventeen members. It turns out that quorum is half of the current voting members. (I’m attaching the PDF with the prior rules at the bottom of this article just to provide receipts on why I thought that it was eight.) Had there been no quorum, the fate of the votes for this meeting would have been unclear—though it’s likely that someone would have received a field promotion without the usual vetting process. In the past, voting members of ACIP went through vetting that typically took many months, even years. If someone is elevated to voting-member status today, it would represent an unusual, if not unprecedented, lack of transparency.
Here’s the latest on what constitutes quorum, according to Richard Hughes, a lawyer and vaccine advocate:
“They have a quorum because at least 4 voting members are present.
See below:
• Under Section 222 of the Public Health Service Act, the Secretary determines the number of committee members. This determination is subject to the requirements of the Federal Advisory Committee Act which does not require any specific number of committee members in total or to constitute a quorum.
• Under federal rules, no meeting of ACIP shall be held in the absence of a quorum. A quorum shall consist of a majority of the committee's authorized membership. 51 FR 30055 16.7(h).
• Given that there are currently 7 ACIP members (Dr. Michael Ross, one of RFK’s picks for the ACIP committee, recently withdrew from ACIP during the financial holdings review required of members before they can start work on the committee), a quorum would require 4 members.
• The ACIP policies and procedures also reiterates the requirement that a majority of voting members must be present for a vote to occur.
• These policies and procedures further require that “[w]henever eight or more members are not eligible to vote, the Executive Secretary or his or her designee shall have the authority to temporarily designate the ex officio members as voting members.”
• However, this was written presumably when there were 16 members and 8 people constituted a quorum.
• Now that there are 7 ACIP members, as stated above, 4 members constitute a quorum so the policy should read “[w]henever four or more members are not eligible to vote, the Executive Secretary or his or her designee shall have the authority to temporarily designate the ex officio members as voting members.”
• Given the above, it appears that the Executive Secretary will only have to temporarily designate at least ex officio member as a voting member should four ACIP members not be eligible to vote.” —Richard Hughes.
In addition, several of ACIP’s new members claimed no conflicts of interest, despite for example, having been compensated as expert witnesses in lawsuits against the makers of Gardasil—the life-saving vaccine that protects against cervical cancer by decreasing human papilloma virus rates.
Breaking News: Some publicly presented scientific materials were not vetted by CDC scientists.
Not all of the scientific materials posted on the CDC’s ACIP website were vetted by CDC experts. This is breaking news that has not been reported elsewhere, to the best of my knowledge.
In the past, when ACIP met, the CDC posted materials online ahead of time—including slide decks created by CDC scientists or vetted for scientific accuracy by internal subject matter experts. When external experts were scheduled to give presentations at ACIP meetings, CDC scientists would receive the materials in advance to vet them for accuracy before posting them online. Specifically, such materials required approvals by the agency’s Designated Federal Officer. In the past, the DFOs were well-known CDC experts, including Dr. Melinda Wharton, who was recently pulled from her role overseeing ACIP. It’s unclear whether the agency’s current DFO saw any of the materials.
Specifically, I learned that at least two presentations planned for this meeting were not seen, vetted, edited, or approved by CDC subject matter experts. This has not been previously reported in the media, but was confirmed by CDC insiders with adequate knowledge of the process.
One of the presentations was on thimerosal, a preservative in a few vaccines that the anti-vaxxer community has blamed for autism, given by registered nurse Lyn Redwood. (Redwood is an RFK ally who is not a voting member of ACIP.) The PDF included references to studies that do not exist, Reuters reported yesterday. Scientists whose names were cited in the non-existent papers confirmed that. They also disagreed with Redwood’s characterization of findings from their other related work.
The second presentation on measles, mumps, rubella, and varicella (MMRV) vaccine safety is set to be given Thursday by Dr Martin Kulldorff, a newly-installed voting member of ACIP. That presentation has still not been posted online as of Wednesday afternoon. As of Wednesday morning, CDC scientists had not even seen the presentation, nor been briefed on its contents, I was told.
Some scientific materials were created and vetted by CDC scientists.
When ACIP materials for this week’s meetings were posted, some of them were not slide decks, but rather, wordy briefing documents. Those included two PDFs reviewing the scientific literature regarding the safety of thimerosal in a few vaccines as well as the overall safety of MMRV vaccines. Neither document indicated worrisome risks that warrant reassessments of vaccine safety, it seemed to me.
Importantly, those documents were created by CDC officials, I learned, and were posted to ACIP’s website yesterday by CDC staff. That said, the thimerosal document was no longer online as of today. It’s unclear who removed it or why. The MMRV document remains live.
Staffers I spoke to were worried that the two briefing documents, generated by subject matter experts at the CDC would not be discussed or even acknowledged during the meeting, because they were not attached to any formal presentations on the meeting agenda.
That said, many observers (including me) were heartened by signs that the CDC scientists assigned to ACIP work groups remain committed to generating and disseminating rigorous scientific appraisals. The unsigned PDFs I reviewed appeared to be in line with typically rigorous CDC standards.
In short, the CDC remains a science-based agency on the inside. But the work of these committed career-scientists is now being undermined by RFK’s ACIP—including committee members whose votes will determine what vaccines are accessible to the American public.
Language of votes not published in advance. Is that legal?
When ACIP votes on national vaccine policy, the language of those votes is posted in advance. HHS Secretary Robert F. Kennedy’s newly-installed iteration of the committee seems uninterested in adhering to those norms. While ACIP votes on influenza and thimerosal in influenza vaccines were scheduled for Wednesday afternoon, as of Wednesday afternoon, specific language had not been shared with either the public or the usual CDC officials. That’s shocking—if not overtly illegal, given the stakes.
Had anyone seen the voting language yet? It’s possible that only one or small number of Trump appointees babysitting the CDC on behalf of Secretary Kennedy (likely without scientific expertise) had seen the voting language ahead of time. In particular, Trump appointee Stuart Burns reportedly provided the only substantive update on ACIP proceedings at last week’s CDC’s All-Hands meeting. So, it’s possible that Burns saw the language, but that's unknown. This, to CDC insiders, reflects the ongoing attempted coup of ACIP by Secretary Kennedy’s HHS. It also aligns with Stuart Burns’s history as having served as chief of staff to Dr. Dave Weldon, the failed CDC Director nominee who has long ties to discredited views on thimerosal-containing vaccines. (Burns arrived at the CDC in February when Weldon was nominated to lead the agency. For some reason, Burns remained at CDC even after Weldon’s nomination was pulled.)
Science aside, there are legal implications around the failure to release the language of ACIP votes in advance. “I think there’s a good claim they violated the Federal Advisory Committee Act by not giving notice of it,” Professor Dorit Reiss of UC San Francisco Law told me.
American Academy of Pediatrics boycotts proceedings.
The American Academy of Pediatrics announced today that it would take the unusual step of boycotting the ACIP meeting. AAP President Dr. Sue Kressly also said that the AAP would continue to generate its own vaccine recommendations. Other groups followed suit. Other expert bodies showed up to the meeting, though, in an attempt to represent science.
Odds and ends.
Three other brief items to highlight:
Thimerosal doesn’t actually fall into ACIP territory. Whether the preservative should be included in vaccines is a decision that resides with the FDA.
The ACIP meeting on Wednesday featured some typical scientific briefings by CDC scientists, including on Covid-19 epidemiology and vaccine effectiveness. However, no votes regarding Covid-19 recommendations were scheduled (normally the June meeting would be when this would be done). The reason? Easy. Why bother to have a vote when HHS Secretary Kennedy has already unilaterally decided what our national policy on that is? Again, science aside, the lack of transparency and audacious disrespect for the scientific and regulatory process is astounding.
At the time of this writing, none of the votes had occurred. I’ll have more analysis on that as news breaks. In fact…
Join Dr. Katelyn Jetelina and me live, Thursday afternoon, 1 p.m., ET.
Dr. Katelyn Jetelina and I will be on Substack Live to discuss all of this immediately following the ACIP meeting’s scheduled conclusion at 1 p.m. ET tomorrow. Here’s the link. We hope to see you there. Please add your questions to the Comments section.
That’s all for now. Thanks for reading and supporting science, facts, and the actual American way!
If you have information about any of the unfolding stories we are following, please email me or find me on Signal at InsideMedicine.88.
Previous ACIP quorum information:
Just so glad that our Pediatricians are taking a stand and I am writing my senators a lot! Thank you for keeping us updated. I hope it will get a movement going of getting the Secretary out.
I can't think of any questions right now...in fact, it's hard to think at all with what's going on every single day with this regime. As an environmental and public health professional I am drawn in particular to these issues. It's just so, so bad what's happening it takes my breath away.