The Journal. — "The FDA Commissioner on Vaccines and Public Trust"

Date: September 9, 2025
Hosts: Ryan Knutson, Jessica Mendoza
Guest: Dr. Marty Makary, FDA Commissioner

Overview

In this episode, Ryan Knutson speaks with Dr. Marty Makary, the Commissioner of the Food and Drug Administration (FDA), to discuss sweeping changes in U.S. vaccine policy under the Trump administration and HHS Secretary Robert F. Kennedy Jr., the FDA’s approach to COVID booster approval, ongoing investigations into vaccine safety, and the broader issue of public trust in health institutions. The conversation delves into the rationale behind recent FDA decisions, reactions from the medical community, and efforts to bolster scientific transparency and accountability in the wake of declining public confidence.

Key Discussion Points & Insights

The FDA's Role in Vaccine Policy

[02:44 – 03:33]

• Makary clarifies the FDA acts as a regulator, not a recommender: their charge is to ensure vaccine manufacturers’ claims align with submitted data.
• Emphasizes importance of vaccine-preventable diseases: "Any death from a vaccine-preventable illness is a tragedy." [03:04, Makary]

COVID Booster Policy Shift to “Risk Stratified Approach”

[03:52 – 04:42]

• The FDA has limited approval of new COVID boosters to those over 65 or with health risks, departing from previous broader recommendations.
• Makary: "Does a young 6 year old boy in America need another 70 Covid shots in his avg lifespan?" [04:14]
• Agency returns to 'gold standard science'—requiring clinical trials, especially for approval in younger, healthy individuals: "We're getting back to our gold standard system at the FDA and that is we're gonna approve based on data." [05:40, Makary]

Controversy Over Internal FDA Recommendations

[06:27 – 07:25]

• Some FDA staff advocated for broader COVID booster approval, but Makary cites a divided consensus.
• The FDA sought to avoid both extreme stances (total bans or universal boosters), sticking to data-driven risk stratification.
• Clinical trials are now required for broader approvals; companies have agreed to this step.

Investigating Vaccine Injury Reports

[07:32 – 09:06]

• Makary discusses active FDA investigations into self-reported deaths from the COVID vaccine among children: "We're calling the families, talking to the doctors, reviewing the autopsies. And I think Americans have a right to that information." [08:37, Makary]
• Results are expected "in the coming weeks." [08:49]

CDC Vaccine Advisory Panel Overhaul

[09:06 – 10:40]

• Makary critiques the prior CDC advisory committee (ACIP) as monolithic in thinking, supporting the recent firing for more diversity of opinion. "I don't think they did a very good job because they were monolithic in their thinking." [09:31, Makary]
• Pushes back against American Academy of Pediatrics’ criticism, citing their past mistakes: "The American Academy of Pediatrics has made some massive mistakes over the years..." [10:13, Makary]

Shifting State Public Health Coalitions & Vaccine Schedules

[11:44 – 12:59]

• States like Oregon, Washington, and California are forming their own coalitions due to distrust of the CDC.
  • Makary highlights JAMA data: public trust in health policy dropped from 71% to 40% since before the pandemic. [12:12]
• Makary opposes the sweeping end to school vaccine mandates, as in Florida, but acknowledges growing distrust.

The Dangers of Public Health Absolutism

[13:18 – 14:23]

• Scientific process requires debate, not censorship: "If we don't have a healthy debate, we may not get at the truth." [13:53, Makary]
• Cites historic failures due to lack of discourse (e.g., saturated fat, peanut allergy recommendations, opioid safety).

Politicization of Vaccines and Building Trust

[14:23 – 15:23]

• Agrees vaccines have become too politicized.
• Calls for honesty about data quality for each vaccine and timing—urges pediatricians to acknowledge nuanced concerns. "You win more bees with honey than fire. I think we need to listen more to parents." [15:21, Makary]

Transparent Communication About Vaccine Risks

[16:33 – 19:48]

• Makary stands by discussing vaccine risks openly, including reports of rare deaths and myocarditis: "Ask a person who is insisting that the COVID vaccine is 100% safe in young males, ask them what the risk of myocarditis is. ... It's one in 2,600." [18:07, Makary]
• Emphasizes: "This should not be a political opinion. We should have good data to drive the decision making." [19:44, Makary]

FDA Review of Tylenol and Autism Links

[20:12 – 21:49]

• Discusses the ongoing review of claims linking Tylenol use in pregnancy and autism; no conclusions yet.
• The autism report aims to be comprehensive, examining "every single thing out there." [21:24]
• FDA continues to review new data and updates recommendations as warranted.

Cracking Down on Pharmaceutical Advertising

[22:13 – 24:09]

• Makary announces a major enforcement push: over 100 letters to pharmaceutical companies about misleading advertisements—up from only one in 2023. "We are finally taking action on our regulation that says ads cannot create a misleading impression." [22:41, Makary]
• Plans to close regulatory loopholes and make U.S. advertising standards less lenient.

Notable Quotes & Memorable Moments

• "We're getting back to our gold standard system at the FDA and that is we're gonna approve based on data."
  — Dr. Marty Makary [05:40]

• "We have to have a healthy scientific discourse. ... If we don't, we may not get at the truth."
  — Dr. Marty Makary [13:52]

• "Trust in public health is down in a general JAMA study from 71% before the pandemic to 40% last year."
  — Dr. Marty Makary [12:12]

• "You win more bees with honey than fire. I think we need to listen more to parents."
  — Dr. Marty Makary [15:21]

• "This should not be a political opinion. We should have good data to drive the decision making."
  — Dr. Marty Makary [19:44]

Important Timestamps

• 02:44 – Start of Dr. Makary interview, the FDA’s regulatory role
• 03:52 – Decision to restrict COVID booster approvals
• 05:40 – "Gold standard" and demand for new clinical trials
• 07:32 – Launch of investigation into child vaccine death reports
• 09:06 – CDC advisory committee overhaul and Makary’s critique
• 12:12 – 31-point drop in public health trust (JAMA study)
• 14:23 – Vaccines and politicization
• 18:07 – Myocarditis risk in young males; open discussion of vaccine safety
• 20:53 – Discussion of Tylenol, autism, and pending data review
• 22:13 – FDA enforcement against misleading pharmaceutical ads

Takeaways for Listeners

• The FDA is shifting to more rigorous and targeted vaccine approvals, especially for COVID boosters, and is requiring stronger data for broader recommendations.
• The agency is actively investigating claims of vaccine injury, emphasizing transparency and data-driven policy.
• Public trust challenges stem from both past public health mistakes and a lack of open debate; Makary is adamant about restoring discourse and scientific scrutiny.
• Pharmaceutical advertising oversight will tighten significantly.
• The agency is also reviewing recent studies on medicines like Tylenol for potential health risks, promising a comprehensive approach to public safety.

For those concerned about how vaccine policy is being shaped in the U.S. amid political, scientific, and public trust turmoil, Dr. Makary's commentary provides insight into how the FDA is navigating these tensions in pursuit of restoring credibility and safeguarding public health.