Today, two FDA officials, Dr. Marty Makary and Dr. Vinay Prasad published an essay in The New England Journal of Medicine entitled “An Evidence-Based Approach to Covid-19 Vaccination.” It outlines the agency’s new posture on Covid boosters.
My friend and colleague Dr. Céline Gounder and were both reading it in tandem and texting our thoughts in real time. So, we decided to just go live with that conversation and just air it all out. Some of Makary and Prasad’s arguments make sense and some do not. So, we went through the essay point-by-point in The Doctor’s Lounge.
Closed captions (㏄) and a transcript option (📄) can be found beneath the video playback control bar above.
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Highlights from The Doctor’s Lounge with guest Dr. Céline Gounder.
Aided by ChatGPT.
FDA Paper Drops; We Go Live (00:00:00)
Dr. Faust welcomes listeners and introduces Dr. Céline Gounder. They discuss the surprise release of a New England Journal of Medicine paper authored by FDA leaders Dr. Vinay Prasad and Dr. Marty Makary proposing a new approach to COVID-19 vaccination. The hosts quickly set the stakes: this paper is going to spark controversy, and they intend to break it down live.
Vaccines Worked—But Policy Drifted (00:01:14)
The conversation opens with a retrospective: the initial COVID vaccines were a historic success, especially against severe disease and death. But short-term protection against infection was misunderstood, and booster strategies evolved inconsistently. Both hosts underscore the importance of continuing boosters for high-risk groups while noting the evidence is weaker for low-risk populations.
Who Decides? CDC vs. FDA Turf Concerns (00:02:30)
Dr. Gounder expresses concern that the FDA's proposal oversteps the CDC’s Advisory Committee on Immunization Practices (ACIP), which traditionally sets vaccine recommendations. Faust and Gounder break down the regulatory roles: FDA approves products for safety and efficacy; CDC and CMS decide who should get them and what’s covered by insurance. The paper’s recommendations may blur those lines.
Global Policy Comparison & Household Logic (00:06:00)
They examine Figure 1 in the paper, comparing international vaccine guidelines. While many countries target older or high-risk adults, Belgium and Germany stand out by including healthcare workers and high-risk household contacts. Both hosts applaud that nuance, highlighting how protecting others—like immunocompromised loved ones or patients—is a critical but overlooked use case.
Pregnancy and Young Infants Omitted Again (00:10:00)
Faust raises a major omission: pregnancy. Pregnant people are high risk and their infants are at even higher risk for hospitalization. Data supports maternal vaccination for protecting newborns, yet the FDA paper doesn’t mention this. Gounder adds that emergency room visits and healthcare utilization should be considered legitimate outcomes—not just hospitalizations and deaths.
The Uptake Problem Isn’t What They Say It Is (00:13:00)
They push back on the paper’s implication that low booster uptake reflects public confusion. Instead, Faust notes that vaccine hesitancy grew largely along political lines starting in 2016, not as a response to booster messaging. Gounder reframes the real problem: not enough outreach for the people who would benefit most, like older adults.
New FDA Framework: Who Gets Vaccines? (00:18:00)
The hosts reach the paper’s main proposal: vaccines will be authorized based on immunogenicity data for those 65+ or with high-risk conditions. For healthy people under 65, the FDA wants randomized controlled trials (RCTs) showing clinical benefit before approval. Both hosts note the irony: authors who’ve long demanded RCTs now rely on antibody data.
The Risk List Is a Mess (00:20:00)
Figure 2 lists medical conditions the CDC considers high-risk for severe COVID. It’s long—ranging from obesity to asthma to mental health—and both hosts call it confusing. Faust points out some conditions on the list don’t have strong supporting data, while others—like caregiving status—are missing. Gounder says the list needs a thorough reevaluation.
RCTs and a Questionable Primary Outcome (00:23:45)
The FDA's suggested trial design for healthy people 6 months to 64 years old uses symptomatic COVID-19 as the primary endpoint. Faust and Gounder both strongly disagree. They argue hospitalizations and deaths should be the main outcomes, as vaccines no longer prevent infection well. They worry this design sets the vaccine up to fail.
Booster Timing, Imprinting, and Real-World Impact (00:28:00)
They question the focus on six-month efficacy windows, pointing out that COVID waves don’t follow a regular schedule. Gounder argues high-risk people might benefit from more frequent boosting. Faust raises the issue of immune imprinting—repeated exposure to similar antigens might reduce future protection. The data on long-term benefit versus potential risks remains incomplete.
Long COVID: Data Still Murky (00:31:00)
They discuss long COVID and whether boosters reduce the risk. The evidence is strongest for primary vaccination, but benefits beyond the third or fourth dose are unclear. Faust references a Yale study suggesting high antibody levels might correlate with long COVID, underscoring the need for further research before promising protection from newer doses.
What About Variant Updates? (00:34:30)
Gounder says we shouldn’t require RCTs for every variant update—there wouldn’t be time to roll out updated vaccines before each wave. Faust suggests variant studies could be done after fall doses, during other seasonal surges, to refine formulations while preserving speed.
Infants Need Primary Series Access (00:39:00)
They shift focus to pediatric vaccines. Faust strongly argues infants deserve access to the primary vaccine series. With many newborns still immune-naive, the stakes are high. Maternal vaccination helps, but six-month-olds should get vaccinated directly. The idea of taking this option away based on cost-effectiveness models disturbs both speakers.
Imprinting: Explanation and Implications (00:43:00)
Faust stays on to explain immune imprinting for listeners. Repeated exposure to similar spike proteins—whether by infection or vaccination—can bias the immune response toward old variants, making future protection less effective. This can lead to counterintuitive findings, where boosted people appear to have more infections months later than those unboosted.
Imprinting Seen in Moderna vs Pfizer Patterns (00:46:00)
Faust describes a study he co-authored using Qatar’s data. It showed imprinting effects and differences between Moderna and Pfizer recipients—suggesting vaccine strength matters. The takeaway: high-risk people benefit from regular boosting, but the strategy for low-risk groups remains unsettled and should be studied further.
Novavax and the FDA’s Sudden Reversal (00:50:00)
Faust discusses Novavax’s delayed full FDA approval. The paper’s authors overruled staff to limit approval to high-risk groups only. He questions the data supporting this decision, noting that the original clinical trial wasn’t stratified by risk. The decision raises concern about top-down policymaking without transparency.
Primary Series for Kids: Science vs. Economics (00:54:00)
Faust outlines the case for keeping COVID primary vaccines available to infants and children. While many kids have already been infected, those who haven’t remain vulnerable. He introduces the “willingness to pay” framework: society routinely pays more per life-year saved for infants than for the elderly, and COVID vaccines for infants may still be cost-effective.
What Should the Fall Booster Include? (00:57:00)
He previews the upcoming VRBPAC meeting (the FDA’s vaccine advisory committee), which will focus on strain selection for fall boosters. There’s no indication they’ll decide on access or eligibility issues—that’s up to FDA, CDC, and CMS. Whether the primary series could be completely removed for kids under 12 remains a key unknown.
The Next Big Question: Will CDC Narrow Access? (01:00:00)
Faust anticipates that the CDC’s ACIP will adopt a more limited annual COVID booster policy, likely recommending shots only for high-risk individuals. The open question is whether they’ll still allow low-risk people to receive it. Faust urges the CDC to maintain flexibility and avoid making access decisions without clear supporting data.
We Must Agree on What Actually Happened (01:08:00)
As the session closes, Faust reflects on pandemic memory. He criticizes pundits for exaggerating “lockdowns” and school closures, arguing for an evidence-based historical record. To improve next time, we need to agree on facts—not just interpretations. COVID was awful, but it’s also the most important learning opportunity of his medical career.
Final Thoughts: Invite Debate, Preserve Access (01:10:00)
Faust wraps by reiterating the need for open debate, inclusive decision-making, and rigorous data—not top-down mandates. He’s skeptical of a trial design that could falsely suggest vaccines no longer help. What’s needed is nuance: boosters for those who need them, optional access for those who want them, and transparency all the way through.
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