The Vaccinated Dead Make Their ACIP Debut
What happens at FDA CBER doesn't stay at FDA CBER
I’m candid about being decidedly unimpressed by Food and Drug Administration (FDA) Center for Biologics Evaluation and Research (CBER) Director Vinay Prasad’s regulatory and scientific contributions to date, particularly his recent claim that there are at least ten children whose deaths were caused by COVID vaccination. Without providing evidence that this is true, he nonetheless plans to overhaul FDA CBER to change evaluation practices for the annual flu vaccine, COVID vaccines, vaccines given in combination, and vaccines for pregnant women. This will likely result in reduced access to essential vaccines.
My primary issue is that, despite writing a long, partisan, and marginally coherent essay about his management philosophy (faux collegial academic but also authoritarian) and his vision for a future in which no vaccines are able to meet standards for licensure, Prasad has failed to support the claim that justifies crippling CBER’s regulatory capacity. He presents no evidence whatsoever that COVID vaccines killed these kids besides his assurances that myocarditis-sniffing anti-vax attack dog and Senior Advisor for Clinical Sciences Tracy Beth Høeg unearthed proof in the Vaccine Adverse Event Reporting System (VAERS). VAERS is a passive surveillance system for collecting voluntarily reported vaccine injuries or deaths, so it can detect signals indicating a significant adverse event, but it also can contain a lot of reports that are unverifiable, inaccurate, or don’t have anything to do with vaccination. VAERS is useful for finding leads about vaccine safety, but it is not reliable on its own. Most people aren’t aware of that, so anti-vaxxers have misrepresented VAERS data for years as evidence of an unchecked or even intentionally suppressed epidemic of vaccine safety issues.
VAERS is monitored by both FDA and the Centers for Disease Control and Prevention (CDC). Vaccine safety monitoring is critical to the core functions of both the FDA (food and drug regulation) and CDC (public health and immunization), so both agencies conduct surveillance and investigate safety signals. When a safety signal is detected, both FDA and CDC scientists and clinicians will perform a detailed follow-up investigation, with extensive review of medical histories, clinical case reports, and data from other sources like the Vaccine Safety Datalink (VSD), which uses electronic health records data that are more verifiable and standardized than VAERS for adverse event reporting. VAERS is the beginning of a long and rigorous process to collect and analyze reliable data, which then allows the government to make informed decisions about its immunization program and public health guidance (CDC) and product licensure and labeling (FDA).
The CDC provides guidance in part through recommendations decided by majority vote at meetings of the Advisory Committee on Immunization Practices (ACIP). ACIP recommendations are also major determinants of vaccine access, since they determine which vaccines clinicians should give to their patients and how insurance companies reimburse them. The ACIP is a panel of what are theoretically independent experts, but who are now mostly either unqualified yes-men or anti-vaxxers. Two members from the latter camp, supply chain operations expert Retsef Levi and self-proclaimed mRNA vaccine inventor Robert Malone, immediately weighed in on Prasad’s claims that COVID vaccines killed kids.
Predictably, they didn’t like that actual experts all commented that Prasad needs to produce evidence that vaccines caused these deaths before making such broad structural changes to vaccine regulation at CBER that it blocks access to some vaccines altogether. If vaccines are killing kids according to Prasad, the fact that he is the nation’s top vaccine regulator and is famously a proponent of “evidence-based medicine” excuses him from actually providing any evidence to prove it.
These arguments are scientifically worthless. There is no science loophole I’m aware of that says you are exempt from needing to back up your claims with data because you’re the off-brand Muppet who podcasted his way into the CBER Director’s office. However, seeing these two chime in reminded me of the joint responsibility for vaccine safety. It also reminded me of the fact that ACIP is meeting this Thursday and Friday. And then I got a bad feeling about what might go down.
Send in the clowns
The ACIP meeting beginning Thursday has a vague agenda in place for day 1. The plan is to cover the entire vaccination schedule and (I suspect) workshop all the ways they can blow it up. In my opinion, this will be a two-pronged attack on the measles-mumps-rubella (MMR) vaccine and the birth dose of the hepatitis B virus (HBV) vaccine, probably with a hefty dose of fearmongering about aluminum salt adjuvants thrown in to lay the groundwork for future attacks on inactivated vaccines.
I have been an editor at Vaccine since 2021 and, as a result, I’ve watched a lot of ACIP meetings. Since becoming co-Editor-in-Chief on January 1 of this year, I’ve watched all of the ACIP meetings, both before and after Health and Human Services Secretary Robert F. Kennedy, Jr. fired the entire ACIP in June and replaced them with Levi, Malone, and their bumbling cohort of opportunistic anti-vaxxers. At every ACIP meeting this year, Høeg has represented the FDA and participated in the meetings as a non-voting agency liaison. It’s a perfect opportunity to share the treasures she unearthed while dumpster diving in VAERS with other like-minded anti-vaxxers who are empowered to create policy that restricts vaccine access for millions of people.
And who better to meet Høeg joyfully to assist in the mission to get COVID vaccines taken off the market than Levi and Malone? Levi chairs the COVID Vaccines ACIP workgroup. At the last meeting, he presided over a day of COVID vaccine disinformation during which he relentlessly fearmongered about vaccine safety and grossly overstated risks presented by mRNA vaccines. It culminated in votes on several nonsensical and unenforceable provisions that effectively didn’t really do much to alter COVID vaccine access, because the current ACIP is demonstrably inept. Levi believes that mRNA COVID vaccines are deadly and they should be banned immediately, so I can see why he’s got his ponytail in a bunch.
Malone is a perennially bitter man who feels slighted that he is not properly recognized as the real inventor of mRNA vaccines (he is properly recognized as not the inventor, because he didn’t invent them). You would think the wealth he has amassed from his Substack empire, his book (called PsyWar, it’s about how the New World Order is seizing control of our minds through coercive public health campaigns, which he calls “psychological bioterrorism”), his witness testimony against vaccine manufacturers, and his A-list status on the anti-vax conference and event tour circuit would be some consolation for not being credited for someone else’s achievement. However, it is not comfort enough, and Malone is constantly aggrieved. At the last ACIP meeting, he was like a poisonous mushroom with a beard, emitting a bilious cloud of toxic negativity every time he made an unnecessarily furious remark about correlates of protection.
But things are looking up for Team MAHA. Because Malone is the big boy vice-chair of ACIP, he has seen the evidence! Because it is “politically explosive” it remains under top secret ACIP/FDA embargo, but, rest assured, it is revolutionary. And it sure sounds like he is announcing that the big reveal will be at the ACIP meeting.
I am stunned, gobsmacked by his letter below. The significance and importance of this letter in the context of US and global vaccine policy cannot be overestimated. This is a revolution, the likes of which I never expected to see in my lifetime.
-ACIP Vice-Chair Robert Malone
Malone and Levi both certainly sound like they are chomping at the bit to take the “stunning” evidence from FDA and run with it all the way to voting recommendations that will finish off COVID vaccines for good. Finally, no more censorship! No more vaccines for many people who want or need them, either. But all revolutions require sacrifice, so be prepared to die from a preventable disease to serve this haughty science-coded Mall Santa’s anti-public health sovereign citizen political agenda.
Malone even thinks this is ushering in a revolution that will transform public health by making no anti-vax talking point too taboo to manufacture evidence for. No more of the “DOUBLE STANDARDS,” “group think,” and “epistemic capture” Malone and Levi are so concerned about. From now on, evidence-free policymaking can proceed unhindered in the federal government.
If and when this comes up at the ACIP meeting, the panel will use this to justify developing recommendations that could be much more effective at removing access from COVID vaccines. While we haven’t yet seen the evidence, I am suspicious that its ad hoc presentation and the lack of transparency surrounding its collection and analysis will be sufficient to persuade many experts that it is definitive evidence of causation. However, this has already set a precedent. It certainly seems as though CBER, Høeg, and ACIP have collaborated on this finding and intend to use it for policymaking, regardless of what an external or independent review might find.
This approach can be extended. If policy can be made with evidence that may exist but is analyzed in secret, then why bother ensuring that the evidence is high quality? Why validate it? Why have transparency in making vaccine policy at all? It’s a lot more convenient for loyalist appointees to make policy based on political objectives and just handwave about the evidence it is supposedly based on. Both FDA and ACIP will try to mine VAERS for optional “evidence” that other vaccines are suddenly unsafe and/or ineffective as well. Because this occurs within existing regulatory and policymaking frameworks—or at least the pretext of these frameworks, since ACIP no longer follows theirs—there is a veneer of credibility to it. To the casual observer, it appears like boring government public health science policy in action. But it is not. This is ideological capture and corruption of democratic, evidence-based best practices. It will get worse before it gets better.
That’s only if we don’t raise hell about this approach to developing immunization policy or regulating vaccines. Since they plan to use ACIP to credibility-wash a justification for stripping access to COVID vaccines (and probably attack the mRNA platform in general), it is critically important for the public to not accept anything less than a full review of the evidence by qualified experts. Both the FDA and ACIP must be held accountable for their actions, whatever the evidence may show.
As a public health professional, I'm stunned that this is reality. As a mom to an infant, I'm scared. She only just got her primary covid series, a bit late but thankfully before this next ACIP meeting. But now I have to worry about MMR (+V!)??? When she was 2 weeks old, I went through the ER entrance to get to my pulmonolgist, not knowing that the day before they saw a measles case. It is absolutely surreal to be worrying about this in 2025. Thank you for your reporting. I especially appreciate your appropriate level of anger toward these human wastes.
it was only a matter of time before any possible contraindication would be dredged and touted as an incendiary reason to discontinue vaccinations