Host: Dr. Ryan Cole | Guests: Dr. Kat Lindley, Dr. Lynn Fynn, and Dr. David Wiseman
mRNA flu shots are making headlines, and a new executive order has put vaccine policy back in the spotlight. For patients and parents, that leaves a lot to sort through.
This week, host Dr. Ryan Cole, IMA Head of Medical & Scientific Affairs, is joined by Dr. Lynn Fynn and Dr. Kat Lindley, IMA Senior Fellow in Family Medicine, for a candid conversation on the questions, controversies, and policy decisions shaping the future of public health.
Sometimes when it rains, it pours. And this week the vaccine news was torrential enough that IMA called an urgent webinar to sort it all out.
In the span of a few days: the FDA approved Moderna’s mRNA influenza vaccine for adults 50 and older, a new executive order narrowed the universal childhood vaccine schedule, and newly released messages from Anthony Fauci’s government phone showed senior health officials privately weighing the risks of COVID vaccination during pregnancy.
Dr. Ryan Cole, Dr. Kat Lindley, and Dr. Lynn Fynn take up each in turn, joined later by research bioscientist Dr. David Wiseman on the pregnancy record. Across all three, the panel keeps returning to the same question.
“Ask them the question. Based on what? Based on what are you making your conclusions?”
Dr. Ryan Cole
Meet the Experts
Kat Lindley, DO, FACOFP
Director of the IMA Fellowship Program; Senior Fellow, Family Medicine. Dr. Lindley is a board-certified family physician, owner of Lindley Medical, and co-founder of the Global Health Project. She brings the exam-room perspective of a physician helping families make these decisions.
Dr. Lynn Fynn
Retired infectious disease specialist focused on clinical research. Dr. Fynn holds patents in novel therapeutic formulations and has developed supplement formulations used by professional athletes worldwide. She brings experience in clinical research, regulation, and adverse-event surveillance.
David Wiseman, PhD, MRPharmS
Research bioscientist. Dr. Wiseman’s career spans pharmacy, pharmacology, immunology, experimental pathology, pharmacovigilance, and regulatory science. He has made more than 36 governmental submissions on vaccine issues and has testified before the Texas Senate and the U.S. Senate.
Ryan Cole, MD
IMA Head of Medical & Scientific Affairs; Senior Fellow, Pathology; Dr. Cole is a board-certified anatomic and clinical pathologist whose work has focused on tissue pathology, immune function, and vaccine safety.
1. What the mRNA Flu Shot Approval Rests On
On August 5, the FDA approved Moderna’s mFLUSIVA, the first mRNA influenza shot cleared in the United States. Adults 50 to 64 received traditional approval; those 65 and older received accelerated approval, which means the head-to-head evidence against their current standard of care is not complete. The headline result was a 26.6% efficacy figure. That is a relative number, and Dr. Fynn converted it.
“Well, basically their efficacy claim is that 26.6% relative efficacy with the Moderna shot, but to frame it honestly, it means going from 2.8% to 2% of participants getting confirmed flu.”
Dr. Lynn Fynn
Both figures are accurate. The 26.6% is how much lower one group’s flu rate was than the other’s; the 2.8% and 2.0% are those rates themselves. Out of every 1,000 participants, roughly 28 caught confirmed flu on the older shot and 20 on mFLUSIVA. Dr. Fynn’s argument is that this eight tenths of a percentage point, not the 26.6%, is the number a patient can use.
Two features of the trial limit what any of it can tell you. The comparison ran against another flu shot rather than saline, so it cannot speak to placebo-controlled safety. And adverse events were collected through participant diaries for 14 days, so problems appearing weeks or months later fall outside the window.
Two further points from Dr. Fynn shape what happens next:
- She has spoken with three former FDA officials who examined Moderna’s February submission and declined to advance it, judging it neither robust enough nor properly designed. No new studies followed.
- She does not expect the shot to be widely available this fall. As she explained it, a court ruling has left ACIP unable to issue a recommendation, and without one, insurers have no obligation to cover it.
2. “Seasonal” Is the Part That Changes the Math
A COVID shot was framed as a one-time event, then a booster, then an annual. A flu shot starts as an annual, so every risk question about this platform carries a multiplier no trial has examined.
Dr. Cole comes at this from the perspective of a pathologist. Hemagglutinin is a protein from the surface of the influenza virus, and the shot instructs the recipient’s own cells to manufacture it, across three strains.
“Human cells are meant to make human proteins.”
Dr. Ryan Cole
He added that the product does not stay in the arm, and that nothing published shows the manufacturing process changed after the COVID rollout, which leaves the DNA template question open. Five years on, Dr. Fynn noted, there are still no carcinogenicity studies and no teratogenicity studies.
Dr. Lindley raised the question a clinician actually faces. A patient can now be offered mRNA shots for COVID, RSV, and influenza, and nobody has studied that combination in anyone.
3. A Narrower Childhood Vaccine Schedule
On August 10, the President signed an executive order establishing what it calls the Gold Standard Childhood Vaccine Recommendations. It cuts the number of diseases covered by universal recommendations from 18 to 11, moving the rest into risk-based recommendations or shared clinical decision-making. The HHS Task Force on Safer Childhood Vaccines has 90 days to deliver an implementation plan covering the timing and sequencing of doses, separate vaccine options beginning with MMR, and alternatives to aluminum-containing adjuvants.
What that amounts to is parental authority: more room for a family and a physician to decide what is given, when, and in what combination. The panel’s reservations were about durability and implementation rather than the order itself.
“I’m not saying anything bad about the EO. It’s all good, believe me, but again, it’s an EO that can be reversed with the next administration, whoever that is, until we get Congress involved in repealing that indemnity act.”
Dr. Lynn Fynn
Lasting reform, Dr. Fynn argued, would require Congress to revisit the liability protections established in 1986. Implementation will also vary by state: Dr. Lindley contrasted Texas, where parents can obtain an exemption through the state website, with California, where exemptions are far harder to secure. Many pediatricians, the panel expects, will keep following American Academy of Pediatrics guidance.
Dr. Lindley’s point was that parents still hold the final say:
“At the end of the day, patient is in charge, and if they start leaving pediatricians’ offices more and more and more, they’re going to have to change their practices.”
Dr. Kat Lindley
Dr. Elizabeth Mumper’s updated Parents Guide to Childhood Immunizations can help families review the individual vaccines and prepare questions for their physicians.
4. What Officials Discussed Privately About Pregnancy
On August 10, Senators Ron Johnson and Rand Paul released the first text chain pulled from Anthony Fauci’s government phone, one of more than 34,000 messages on it. Dated January 25, 2021, the chain has Fauci, CDC Director Rochelle Walensky, and Surgeon General Vivek Murthy discussing possible risks of COVID vaccination during pregnancy: concern that fever after the second dose could theoretically increase the risk of first-trimester miscarriage, and questions about whether mRNA vaccine material could reach the fetus. None of it proves the vaccines caused harm. It does show unresolved questions in hand while public guidance offered broad reassurance. Dr. Fynn noted that pregnancy is already an inflammatory state, which makes any added inflammation or fever a legitimate safety question.
Dr. David Wiseman added another part of the record. Drew Weissman, a Nobel Prize recipient whose work contributed to the mRNA platform, conducted mouse experiments suggesting vaccine material could reach the placenta. Dr. Wiseman stressed that the evidence was theoretical at that stage.
He also identified two CDC-sponsored pregnancy studies initiated in 2021:
- Both stated an urgent need for outcome data on COVID vaccination during pregnancy.
- At least one received an exemption from informed consent, on the grounds that it was observational rather than interventional.
“They were conducting a medical experiment on people without their consent.”
Dr. David Wiseman
IMA has published a fuller account of what the texts contain and a call for accountability.
Smart Moms Ask is where IMA collected these questions for parents: short videos from pediatricians and specialists, a Q&A library, and resources on COVID vaccination in pregnancy and childhood.
What Patients Can Do Now
All three developments are unfinished. The executive order’s implementation plan is due within 90 days, and a later administration can reverse it. The flu shot’s real safety picture depends on adverse event reporting, which Dr. Fynn described as built to make problems look smaller than they are: clinicians are legally required to report to VAERS, and during the COVID rollout, she said, they were discouraged from doing it and some hospitals impeded it. Dr. Wiseman examined those reporting failures in detail during Inside the VAERS Data. On the texts, a Senate committee has voted to hold Fauci in contempt, and Dr. Lindley argued that scrutiny should extend to Walensky and the other officials who shaped the guidance of that period.
None of that resolves on a timeline that helps a patient this fall. What a patient does control is the appointment.
“Stand up for yourself. Ask the questions. Why do I need this? What are the safety issues involved?”
Dr. Lynn Fynn
If they are not answered, Dr. Fynn recommends asking for the package insert and deciding only when you are ready.
Related Reading
More on: Childhood Vaccination Schedule | Dr. Katarina Lindley | Dr. Lynn Fynn | Dr. Ryan Cole | FDA | mRNA | NIH
