Vaccine Safety 9: The FDA Memo That Betrayed Public Trust — What You Need to Know

Summary

In this urgent Vaccine Safety episode, Heather breaks down the truth behind the now-infamous leaked FDA memo claiming that COVID vaccines caused pediatric deaths. With public trust shaken and misinformation spreading fast, this episode separates evidence from assertion, explains how vaccine safety is actually evaluated, and lays out what parents deserve to know. From the real risks of COVID in kids to the collapse of clear public health communication, this is a sober, science-grounded look at a moment when the truth matters more than ever.

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Full Episode

You’re listening to Infectious Dose. Today…we need to talk about something serious.

Let me be honest: I’m angry. Not performatively angry, not internet-angry — but deeply, professionally angry in a way I don’t think I’ve ever been on this show. Because what’s happening right now at the FDA, HHS, and CDC is not just bureaucratic chaos. It’s a failure of responsibility that directly affects parents trying to make safe decisions for their kids.

And I feel this anger on a personal level. I was once a young parent, just like so many of you, trying to make sense of vaccines and risks and benefits. I had an unusual privilege: direct access to mentors like Dr. C.J. Peters — one of the world’s iconic infectious disease experts — who could answer my hard questions in plain English. Most parents don’t get that. They get headlines, they get fear, and now they get memos that appear to be politically motivated and lack scientific transparency being lobbed across agencies without evidence.

Americans deserve so much better than this. They deserve public health agencies that communicate clearly, honestly, and scientifically — not this bizarre, irresponsible spectacle that is putting lives at risk. And parents deserve a system they can trust, not one they have to fact-check in the middle of the night because a leaked email says something terrifying with zero data attached to it.

So today, we’re going to set the record straight. Because the truth still matters, the evidence still matters, and your ability to make an informed decision for your child absolutely matters. If our public institutions won’t communicate that clearly right now…then I will.

Let's unpack the story that exploded online: claims that the FDA has “admitted” the COVID vaccine caused ten deaths in children. You may have seen people celebrating it as proof they were right all along, or politicians declaring that the FDA finally “confessed.” But the truth behind the memo is far more complicated, far more political, and importantly, not supported by evidence.

Here’s what actually happened.

Recently, Dr. Vinay Prasad — now serving as both Director of the FDA’s Center for Biologics Evaluation and Research (the office that oversees vaccine safety) and Chief Medical and Scientific Officer — issued an internal memo that made headlines across the vaccine and public health communities.

His dual appointment, confirmed by HHS in September 2025, marked a surprising return to the agency and came with significant internal controversy. That context matters.

In the memo, sent to the entire center, Prasad asserted that the COVID vaccine had caused at least ten pediatric deaths, and that the FDA would be changing its regulatory requirements for vaccines as a result. No data were included. No case details. No timeline. No methodology. Just the claim.

And that’s where things already start to break down. Because experts across the field — including former FDA officials, long-time vaccine researchers, and even internal CBER staff — read that memo and immediately said: “Where is the evidence?” Paul Offit, a professor at Children’s Hospital of Philadelphia, the co-developer of a vaccine for rotavirus, said in an interview for STAT News that extraordinary claims require extraordinary evidence, and Prasad provided none.

According to the memo, he and senior adviser Tracy Beth Høeg reviewed 96 deaths reported to VAERS between 2021 and 2024. Prasad wrote that “no fewer than 10 are related” to the vaccine and added that the “real number is higher.” But again, he didn’t share how those conclusions were reached. VAERS reports can be anything from coincidence to misclassification to events completely unrelated to vaccination. Determining causation requires thorough medical review, autopsy data, mechanistic plausibility, background rates, and independent expert analysis. None of that was done here. If they had that evidence, they would share it — not withhold it.

Multiple former FDA and CDC leaders, quoted in STAT, said they could not evaluate the claim at all because the memo lacks the scientific analysis that would normally accompany something this serious. They pointed out that without details, there's no way to know which vaccines were involved, which ages, what timeframes, whether autopsies showed myocarditis, or whether viral infections like adenovirus or parvovirus — common causes of myocarditis — had been ruled out.

Put simply: Prasad said the cases exist, but he didn’t show the data.

Internal FDA staff told reporters they were shocked at the memo’s tone and conclusions, calling it “misleading,” “politically charged,” and “irresponsible.” One noted that jumping from raw VAERS case reports to sweeping vaccine policy changes aligned suspiciously well with Prasad’s preexisting views. Several said they feared the memo was written with the intention of being leaked.

And that matters, because the context here is not subtle. The FDA, CDC, and ACIP have undergone unprecedented political interference. Experts have been removed, advisory committees dismantled, and top officials replaced with people appointed specifically to push certain narratives. Against that backdrop, a memo like this doesn’t read like a scientific assessment. It reads like the political messaging that it is.

And all of this happened just days before ACIP — the CDC’s Advisory Committee on Immunization Practices — held its December 2025 meeting, the first major meeting since every independent vaccine expert was removed and replaced with political appointees aligned with the new antivaccine leadership. This matters, because ACIP isn’t symbolic. ACIP decides which vaccines are recommended for every child in the United States. Their decisions determine insurance coverage and access.

More than twelve thousand medical societies, health organizations, and patient advocacy groups submitted comments before the meeting — and their message was unified and urgent: ACIP is moving toward weakening or dismantling long-standing vaccine recommendations that protect infants, children, cancer patients, pregnant people, and immunocompromised families. Organizations like the American Academy of Pediatrics, the Infectious Diseases Society of America, the American Cancer Society, the National Foundation for Infectious Diseases, and many others warned that abandoning evidence-based recommendations will cost lives.

Viewed through that lens, Prasad’s memo looks less like a scientific document and more like a political signal — something designed to build support for weakening vaccine policies and to justify antivaccine positions inside ACIP. The timing, the lack of data, the appeals to fear about vaccines in pregnancy and giving multiple shots at once — these are not evidence-based conclusions. They are ideological talking points.

And as a virologist — and as a parent who once had to navigate these decisions myself — watching the country’s most important vaccine advisory body be reshaped into an antivaccine echo chamber is horrifying. This isn’t academic. These decisions determine whether children stay healthy, whether schools remain safe, and whether preventable diseases regain ground in this country.

And if you want proof of how dangerous this new ACIP really is, look at what they just did: they voted to delay the newborn hepatitis B vaccine until two months of age. This is not a small tweak. This is not a harmless change. Hepatitis B is a virus that can be silently transmitted at birth, and when newborns get it, ninety percent of them develop lifelong chronic infection. That means decades of liver inflammation, cirrhosis, liver cancer, and in many cases, death. The birth dose is one of the most effective tools we have ever had in public health, and removing it will cause preventable infections. Every major medical organization — the American Academy of Pediatrics, the American College of Obstetricians and Gynecologists, the Infectious Diseases Society of America, the American Cancer Society — all warned ACIP not to do this. They did it anyway.

So I need to say this clearly: if you are expecting a baby, ignore this new ACIP recommendation, please. It is not evidence-based. It does not reflect the consensus of pediatricians, OB/GYNs, infectious disease specialists, or liver disease experts. Talk to your doctor. Follow the standard medical guidance that has protected millions of children for decades. Do not let a politically reshaped committee put your baby at risk.

But let’s step back and talk about what VAERS is and isn’t, because Prasad’s claim hinges entirely on those reports.

VAERS is an early warning system. It accepts any report from anyone — parents, clinicians, the public — whether or not the vaccine is suspected to be the cause. It captures coincidence, noise, incomplete information, and even incorrect reports. It is not designed to establish causation. It’s a starting point meant to detect patterns, not a conclusion.

When legitimate safety signals appear in VAERS, they don’t stand alone. They’re validated through multiple independent systems that are far more rigorous and controlled. One of those is the Vaccine Safety Datalink, or VSD — a long-standing collaboration between major healthcare organizations and academic researchers that uses real medical records, not self-reports, to monitor millions of patients in near real time. VSD looks for patterns: Are vaccinated kids having an outcome more often than unvaccinated kids? Is it happening at a rate higher than we’d expect by chance? It’s one of the most powerful tools we have for distinguishing coincidence from causation. (NOTE: VSD is operated by the CDC so there's no telling how long it will remain a useful tool for accurate vaccine safety data).

Another system is BEST — the Biologics Effectiveness and Safety initiative — which pulls from massive electronic health record databases and insurance claims across the country. Instead of anecdotes, BEST analyzes actual clinical encounters: diagnoses, procedures, labs, outcomes. If a real safety issue exists, it shows up across these datasets, consistently and measurably.

These systems work alongside international surveillance networks from Europe, Canada, Israel, and the UK. And here’s the key point: if a vaccine truly caused pediatric deaths, it wouldn’t just appear in a handful of VAERS reports. It would surface across VSD, across BEST, across insurance databases, and across other countries’ monitoring systems as well. But that’s not what the data show — anywhere. Myocarditis after mRNA vaccination was detected precisely because those systems worked. But when it comes to pediatric deaths, no independent system has corroborated Prasad’s claim. As of this recording, no international surveillance systems — including those in Europe, Canada, Israel, or Australia — have reported validated cases of vaccine-caused pediatric deaths. Nowhere.

Meanwhile, we have extensive, peer-reviewed evidence that COVID vaccines reduce severe disease in children. And to appreciate what that really means, we need to talk about two conditions that parents need a better understanding of: MIS-C and long COVID.

MIS-C — multisystem inflammatory syndrome in children — is a rare but serious inflammatory condition that appears several weeks after a SARS-CoV-2 infection. It was first recognized during the pandemic and is considered a complication unique to SARS-CoV-2 infection. It can occur even after very mild or unnoticed infections, which is part of what made it so frightening early on. Although MIS-C shares some features with Kawasaki disease and toxic shock syndrome, its timing, severity pattern, and strong association with prior SARS-CoV-2 infection distinguish it as a unique post-infectious syndrome. A child who seemed to “bounce back” can suddenly develop high fevers, abdominal pain, vomiting, rash, red eyes, low blood pressure, and inflammation affecting the heart, lungs, kidneys, brain, or gastrointestinal tract. Many kids with MIS-C require intensive care, and some develop lasting cardiac problems. It’s rare, but before vaccines were available, MIS-C was one of the most frightening pediatric outcomes of COVID because it often appeared out of nowhere and hit previously healthy children hardest. Once vaccination rolled out, rates of MIS-C plummeted in vaccinated kids. Multiple peer-reviewed studies show vaccination reduces the risk of MIS-C by around 90% in teenagers, and a large U.S. state analysis found vaccinated kids had dramatically lower incidence of MIS-C across age groups. That is what real risk reduction looks like.

And then there’s long COVID in children. We tend to hear more about adults, but kids can experience lingering symptoms too: fatigue that interferes with school or sports, headaches, difficulty concentrating, disrupted sleep, abdominal pain, shortness of breath, and exercise intolerance. For some children, these symptoms persist for months. A smaller subset experience relapsing patterns that take them out of normal routines again and again. Estimates vary, but multiple studies suggest vaccination reduces the risk of long COVID by around 40 to 60 percent in children and adolescents — especially for kids who have never been infected before.

Add that protection to the fact that hospitalization rates drop dramatically in vaccinated children, and the picture becomes even clearer. Kids are at lower absolute risk than older adults, yes, but lower risk is not no risk. COVID has killed children — more than 800 in a single year early in the pandemic — making it a top ten cause of death in Americans under 19. And death is only the most extreme outcome. The complications along the way — MIS-C, long COVID, cardiac involvement, severe pneumonia — are all part of the real landscape of pediatric COVID.

Calling that a “tremendously low risk” ignores the data and ignores the families who lived through it. COVID is a vaccine-preventable disease. And vaccines don’t just prevent infection-to-hospitalization trajectories; they prevent the ripple effects that follow infection, the complications that alter a school year, a sports season, or a child’s long-term health. That’s not “tremendously low risk.” That’s a vaccine-preventable disease.

So why did this memo matter so much?

Because it wasn’t just about those ten VAERS reports. Prasad used them as a springboard to question vaccines in pregnancy, propose changes to influenza vaccine regulation, and suggest the FDA might reevaluate giving multiple childhood vaccines at the same visit — something that is safe, effective, and critical to maintaining coverage. Experts worry these proposals are based not on evidence, but ideology.

And when internal FDA memos become political talking points before scientific reviews are completed, trust in the entire system erodes.

So let’s get to the heart of it: do we have evidence that the COVID vaccine has caused pediatric deaths?

No. We have a memo. We have no peer-reviewed data, no reproducible analysis, no case descriptions, no autopsy reports, no independent reviews, and no corroboration from any other monitoring system in the world. And that's because, to date, there is no peer-reviewed, scientifically valid evidence supporting a causal link between COVID vaccines and pediatric deaths. None. And without that, this memo is not a scientific finding. It’s an assertion.

And if you want to understand how mRNA vaccines work, listen to my episode on what they are and how they work.

As a virologist, I can tell you: real vaccine injuries are taken incredibly seriously. They are investigated rigorously and transparently. If there were solid evidence that the vaccine caused even a single pediatric death, scientists, regulators, and clinicians would be the first to say so. Because truth, not politics, is what keeps people safe.

So where does this leave parents?

Confused. And that’s exactly the danger. When internal documents are used without evidence to undermine vaccines, families lose access to clear, actionable information.

We’re living through a moment where public health communication is being reshaped, and not always for the better. But the data still matter. The science still matters. And your ability to make informed decisions still matters.

Before we go, I want to say something directly to you as parents, caregivers, and anyone who wants to stay healthy. You deserve honesty. You deserve clarity. And you deserve a public health system that earns your trust instead of breaking it.

If you’re feeling overwhelmed or unsure where to turn, you’re not alone. I’m here to help you navigate this, and the science is still on your side. And I'm not the only by any means. There are other incredible science communicators working every day to explain the evidence clearly and compassionately — people like Katelyn Jetelina, Angela Rasmussen, Tara Smith, Paul Offit, and many others who remain committed to truth. Seek them out. Support them. Let them be part of your circle of clarity. There's a list at the end of the blog post for this episoide, before the citations.

Take care of yourselves and of each other. And when things feel confusing, come back to the evidence, come back to curiosity, and come back to the people who are still committed to telling you the truth.

I’ll be here, holding fast to the science.

OTHER SCIENCE COMMUNICATORS TO FOLLOW

Public Health & Epidemiology

• Dr. Katelyn Jetelina (“Your Local Epidemiologist”) Clear, calm, data-driven updates; widely trusted.

• Dr. Tara C. Smith Epidemiologist and longtime debunker of vaccine misinformation.

• Dr. Angela Rasmussen Virologist with clear, rigorous communication; excellent at correcting media misinterpretations.

• Dr. Peter Hotez Well-known vaccine scientist; careful and evidence-based

• Dr. Jason Salemi Exceptional data communicator who explains epidemiologic trends clearly.

• Conor Browne Biorisk analyst who posts accurate, vetted information on pandemic potential pathogens, protective measures and fights disinformation.

Vaccine Safety & Pediatric Health

• Dr. Paul Offit World expert in vaccinology; his public commentary is measured and authoritative.

• Dr. Daniel Summers Pediatrician and excellent communicator on childhood vaccines and misinformation.

• Science communicators at Shots Heard Round the World A vetted group dedicated to countering coordinated antivaccine misinformation.

General Science Communication (Trustworthy & Accessible)

• Dr. Raven Baxter (“Raven the Science Maven”) Engaging, evidence-focused communicator with strong credibility.

• Dr. Becky Cunningham (“Dr. Becky Physics” on YouTube) Brings clarity and approachability to complex topics; beloved for accuracy.

• Dr. Simon Maechling PhD Chemist working hard to debunk disinformation

REFERENCES

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Flaxman, S., et al. (2023). Assessment of COVID-19 as the underlying cause of death among children and young people aged 0 to 19 years in the US. JAMA Network Open, 6(3), e230324. https://jamanetwork.com/journals/jamanetworkopen/fullarticle/2800816

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