Inside Baseball on FDA rejecting Moderna Vaccine
Super-sized Throwback Thursday on Public Health
The Food and Drug Administration (FDA) has rejected Moderna’s new mRNA flu vaccine with a “Refusal to File.” This is a big deal. It is the FDA saying that they won’t even look at the application, they are rejecting it without a review. According to our in-house expert—my wife, who spent 25 years as a biostatistician at the FDA—this decision stinks. This New York Times article aligns with her suspicions.
So, we’ll take a little break from Veepology1 to share her expertise along with our Throwback Thursday below on an unscientific advisory committee meeting on the Covid vaccine. That analysis also benefited from my wife’s expertise. Combined these incidents show how the administration is elevating cranks and using bureaucratic mechanisms to undermine science and public health.
In her career my wife reviewed well over 100 drug applications. She did exactly one “Refusal to File.” In that case, the company had not prepared their data properly, so it was impossible for her to evaluate their findings. My wife reports that she had to fight for this. The FDA as an agency prefers NOT to do this. A study found that about 4% of total applications received this unceremonious rejection.
The letter informing Moderna of the “Refuse to File” comes from the director of the Center for Biologics Evaluation and Research (CBER) Dr. Vinay Prasad—a political appointee. My expert source tells me that usually a letter like that comes from the office or division director (that’s a level or two below.) It is very unusual for the Center Director to get involved with a decision like this. Reporting has confirmed that Prasad over-ruled career staff on this (and other) issues.
Sidenote, the letter itself, which is an official government document, has numerous typos and other errors.
Moderna states that it met twice with the FDA, first in April 2024 to have the protocols for the drug trials reviewed. Moderna carried out the trials and met with FDA in August 2025 for a pre-submission review to doublechecks that everything is in the proper order for the FDA to conduct its review. At this point the FDA agreed that the drug application was ready for review. Then Dr. Prasad got involved and, in the words of The Washington Post editorial board: “Regulators move[d] the goalposts…”
The government letter, signed by Prasad, states that “control arm does not reflect the best-available standard of care.” The mRNA vaccine was tested against Flaurix, a traditional vaccine in common use, so it isn’t clear what the problem is. But HHS spokesperson Andrew Nixon stated that Moderna failed to use a high dose vaccine as a control product which could have led to increased risk of illness. Prasad’s boss, FDA Commissioner Dr. Marty Makary, echoed Nixon’s criticism claiming on Fox News, “Some say that the trial that they conducted was unethical.”2
Moderna hotly contests this, stating that everything done was done with the knowledge and approval of the FDA. According to my wife, they’ll have receipts. Companies keep extensive notes of their discussions with the FDA and Moderna is undoubtedly preparing to take this to court.
Makary also appears to recognize that his agency may have gone too far, stating on Fox News that this was just part of the normal back and forth between a company and the FDA. But “Refusal to File” is most certainly not business as usual—see above.
Normal would be the FDA reviewing the vaccine and not approving it or requiring more studies and analysis.
This instance and the post below both highlight how the administration has elevated fringe voices in our nation’s public health system. These cranks will often insist that they are merely responding to the lack of trust in medicine and public health. They are arsonists, setting fires while shouting that the fire department doesn’t know what it’s doing.
RFK’s anti-vax clown car committee
Originally posted September 19, 2025.
The new Advisory Committee on Immunization Practices (ACIP), established by HHS Secretary RFK Jr. to undermine well-established science, is the bizarro world version of an advisory board on public health and medical issues.
These advisory boards consist of serious professionals, while the public comments are often emotional appeals that fly in the face of science and good practice. ACIP is the opposite, the committee members made an array of poorly substantiated claims, while the public comments represented medical and public health organizations begging the committee to take science seriously.
The consequences for public health are ominous. But this official sanctioned anti-vax circus is also a microcosm of the loss of trust in our society. It also just might provide hints as to how to get it back.
“An Embarrassment to Biostatistics”
That’s what my wife, a retired FDA biostatistician, who supported and observed numerous advisory boards over her career, shouted at the ACIP chair Martin Kulldorff as we watched the meeting.3
Kulldorff has a long academic record and some real achievements. He was a professor of medicine at Harvard and a biostatistician at Brigham and Women’s Hospital. He was dismissed from Harvard for failing to comply with the vaccine mandate.
Kulldorff was questioning a representative of Pfizer about a study they had done on the effects of their Covid-19 vaccine on pregnant women. The study gave 150 pregnant women the vaccine and another 150 pregnant women a placebo. The study found that among the first group there were 8 congenital abnormalities of the fetus while in the second group there were 2 congenital abnormalities.
Sounds bad and Kulldorff harped on this point.
The Pfizer representative noted that there is typically a 3-5% occurrence of congenital abnormalities in any group of fetuses so these findings were not out of bounds. Further these abnormalities usually occur in the first trimester, before the vaccines were administered. Having taken a few stat classes in grad school,4 even I knew that this was all well within the realm of probability and not determinative of anything. Run more trials.
My wife had more technical and um, vivid, criticism.
But Kulldorff gave a simple and easy to understand story. Which one will stick?
The Plural of Data isn’t Anecdote
One member of the committee stated that in her small town there had been four cases of lung cancer after vaccinations. She didn’t claim a direct link, but felt further research was needed.
Again, it is hard to say without a lot more information whether there is anything to this. There are lots of reasons people get lung cancer and there hasn’t been a major increase in lung cancer rates since vaccinations began.
But the seed has been planted.
A bunch of stories may not be scientifically valid data, but it can add up in public perception.
Lies, Damn Lies, and Statistics…
Levi Restef, a member of the committee, a professor at MIT’s Sloan School of Management, and head of the Covid vaccine working group, gave a lengthy presentation based on his working groups findings. He argued that the Covid-19 vaccine was not effective and has significant effects that have been dubbed the post-vaccination syndrome (PVS). Further he argues that our current safety surveillance capabilities (pharmacovigilance) would miss this syndrome.
Restef, is an expert on operations research—how to do things faster and more efficiently. Supply chain optimization is a common example of the problems that the field addresses. He’s a smart guy and knows a lot of math. In his career he’s worked on healthcare issues, such as optimizing hospital operations. Like many such people, he may lack humility in addressing fields in which he is not well-versed: such as medicine and public health.
One of his major claims about the effects of the vaccine was based on a paper using data from South Korea where about 44 million people were vaccinated. He cited a couple hundred bad outcomes (including cases where young people died suddenly.) First, we cannot say for certain that these adverse outcomes were related to the vaccine. More research is needed. Secondly, a few hundred adverse outcomes from 44 million is a tiny number. Restef argued since the vaccine may not be any good anyway, so why take the risk?
Restef also highlighted the Pfizer study mentioned above. He spoke about the loss of trust in public health and cited a study by Rasmussen polling that indicated that 56% of Americans “suspect COVID-19 vaccines caused death.” I don’t know the details of the poll, but Rasmussen is not a well-regarded polling firm. Surely a math whiz like Restef would know something about this (or maybe not—operations research probably doesn’t include a lot of work on public opinion research.)
The Weak Rebuttal
Professor Henry Bernstein offered the minority opinion, representing himself and two other members of Restef’s working group. At this point I turned to my wife and observed, “He is about to say that Restef is total bullshit.”5
Bernstein offered a very sober factual account of how epidemics are managed, how pharmacovigilance works, and how the COVID vaccines are essential and have saved lives.
Bernstein made a valuable specific point contrary to Restef. Restef said that in the South Korean data there were numerous cases of young people suffering and dying from myocarditis. Bernstein explained that the CDC pharmacovigilance process accepted huge numbers of clinical reports of adverse events. These reports are raw data—not a formalized, specific, collection of data. These reports are valuable, they can provide indications of major problems or issues requiring research.6 Bernstein stated that in all of these clinical reports about post-vaccine events in the United States there were no instances of reports of myocarditis.
Bernstein’s statement was absolutely sound and would have been effective for an academic audience. It was not compelling. There was no story—and therein lies the problem—but perhaps the solution.
Distrust of Authority
It is in an American’s political DNA to distrust concentrations of power and authority because they threaten liberty and equality—our most prized values. We are in an age of Creedal Passion, when this distrust becomes its own kind of contagion. (I can’t say often enough that our experts have in many cases earned this distrust.)
As an early example, Andrew Jackson’s “spoils system” wasn’t only political patronage. It was rooted in the belief that any decent American could take on any public position. If these government positions became sinecures, the holders would become an elite holding authority and power of their fellow citizens. This would be an anathema to the American ideal.
It’s a worthy sentiment, but an advanced society requires complex institutions that become concentrations of power and authority.
We need to reconcile that worthy aspect of the American people with the demands of modernity.
Telling Stories
Many of the public comments told stories. Pediatricians spoke of the declines in infants in their care suffering from horrible diseases thanks to vaccines. A woman who suffered from hepatitis-B described how it has limited every part of her life and stated that parents should spare their children this suffering and get them vaccinated.
Statistics are not well understood by the general public. Besides large-scale innumeracy, statistics can be manipulated, and understanding the basis behind findings is difficult—even for the statisticians!
Most people don’t understand the world in general and risk in particular through statistics and probability. They understand it through stories, anecdotes, and specifics.
This is a fundamental problem because the experts, the technocrats, tend to understand risk in terms of probabilities. The experts often don’t take public perceptions of risk seriously, but experts in the field of risk perception and communication have observed that the public’s understanding of risk may be richer and bring new insights that are important.7
When experts ignore this, they lose public trust.
It is essential that the experts meet the general public where they are, hear and understand their concerns, and tell stories to explain things. This applies to vaccines, environmental issues, disaster preparations, and really decision-making in every domain.
Done well, it results in a better-informed public.
It is time consuming, and not just for the individual practitioner. A serious risk communication campaign requires difficult research, testing, and training.
But at this point, what choice do we have?
There is actually some really interesting stuff going on in the world of Veepology right now. Coming soon…
That whole “some people are saying” rhetorical device is very Trumpy. But it’s sad to see an MD use it on a serious technical issue.
This newsletter is supposed to be about vice presidents, but it’s also about helping to peer behind the curtain of our institutions and understand what they are doing and why. I happen to have an in-house expert on public health and medical issues, so I thought this would be a good item to share. Thanks for your indulgence.
Full disclosure, I passed these graduate school stat classes because my wife held my hand and walked me through how it all worked.
This in itself is unusual. At one point when Bernstein’s slides stopped showing, Bernstein joked that they had cut him off to squelch the minority opinion. This was collegial. But there were a lot of irregularities in the meetings. There was poor preparation, many committee members did not understand their role. The schedule was accelerated and the CDC experts did not have adequate time to gather background materials for the committee—although they strenuously tried. Having supported these meetings, my wife knows how much preparatory work goes into them.
In my world. these reports are the equivalent of raw intelligence. To derive useful and actionable information from it requires experienced analysts.
This is from a paper I presented at a conference at Stanford—a phrase I will never tire of saying or writing as long as I live!