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Here's what's up with the fall Covid shot *fail* [1]
['This Content Is Not Subject To Review Daily Kos Staff Prior To Publication.']
Date: 2025-05-22
I feel compelled to address the new Covid shot announcement impacting updated shots for this fall, and the New England Journal of Medicine article published at doctors this week. Many of my patients asked me about vaccines today. And many of them have been rolling up their sleeves for Covid shots this spring, as who knows what will be available this fall. Now we have a better idea.
And before I go any further, I believe that if people don’t want to stay up to date on Covid vaccines at this point, even though they are very safe, that should be up to them. But this is different.
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What’s “the new plan” for Covid shots this fall?
Yesterday we learned that the two guys newly put in charge of vaccine policy at FDA want to restrict Pfizer and Moderna shots going forward as follows:
Only for people over the age of 65
Only for people 6 months to 65 years old with high risk medical conditions
They have already restricted Novavax to:
People over age 65
People over age 12 with high risk medical problems
Expanding anything beyond this will require difficult, expensive, and possibly unethical randomized controlled trials. These trials will only look at the usual obvious stuff like acute symptoms, hospitalizations and deaths, with no mention of longer term surveillance or deeper dives into long Covid prevention, excess mortality reduction, rates of conditions like dementia, coronary artery disease, Parkinson’s, and stroke.
It is fairly pointed out that most other countries have narrowed their recommendations. So why not us, too? But the US should not restrict Covid vaccine eligibility simply because other countries do so, as America has unique healthcare system complexities, demographic characteristics, and equity challenges that made universal recommendations more practical and effective than risk-based restrictions. Limiting access will create unnecessary barriers while undermining individual choice and community protection benefits, particularly given that the majority of US adults already have qualifying risk factors, and restricting eligibility will just reduce overall vaccine uptake and public trust.
The two guys leading the charge, Drs. Prasad and Makary, preempted a scheduled FDA meeting for this Thursday to review the formula for the 2025-2026 Covid shots. Thanks to the many of you who left comments on the public docket. It matters. They also preempted any coordination with the June ACIP meeting, which is highly unusual and not cool.
STAT News summed up the new FDA stance quite well today:
It remained unclear if the framework encompasses only new Covid boosters, or also new primary vaccinations for children, and how long existing shots for children, sold by Pfizer and Moderna and approved under emergency use authorizations, would remain in force since Covid is no longer considered an emergency. The announcement by FDA Commissioner Marty Makary and the agency’s top vaccine regulator (Prasad) left physicians and infectious disease specialists with numerous questions, including how long healthy adults might continue to receive Covid vaccines, whether the FDA has the authority to decide who is eligible for vaccines, how people considered high risk would have their eligibility established for insurance coverage, and whether health care workers and others who get vaccinated to protect high risk individuals would continue to be eligible for vaccines.
And by the way, my guess is that the upcoming Covid shots will not be much different than what is available now. I think they will follow WHO guidance. Even though we backed out of the World Health Organization, we can still look at their answers on the test while the teacher is not watching. This was released by the WHO last week:
The WHO Technical Advisory Group on COVID-19 Vaccine Composition advises manufacturers that monovalent JN.1 or KP.2 vaccines remain appropriate vaccine antigens; monovalent LP.8.1 is a suitable alternative vaccine antigen.
What are the practical implications of restrictions for people?
I think we will see a further decline in vaccination rates, especially for those under age 65, but across the board.
Most of the updated Covid shots have shown about a 50-60% reduction in Covid illnesses for people who get the shots for at least a month or two, with protection waning after that. Most studies have shown a reduction in illness severity, chance of long Covid, and other problems like subacute heart attacks. I’ve documented this stuff in my Covidlandia series over the past 1.5 years. More Covid illnesses in kids, adults, and seniors from less vaccination will be expected to result in communities and individuals experiencing:
More clinic visits for illness
More hospitalizations (do you know how sick you have to be to get admitted to the hospital?)
More deaths
More long Covid, which can last for months, years, and permanently. These recommendations seem designed to single out for exposure the group most likely to develop long Covid — folks between 35-50 yo.
Higher than usual mortality rates which bake in accelerated coronary artery disease, higher rates of stroke, heart attacks, etc. after Covid infections
More community spread, affecting all of us, and especially those at higher risk
Less personal choice, something we are supposed to glorify here in the US. It’s supposed to work both ways.
Less protection for healthcare workers frequently exposed to Covid, who don’t even make the cut. What about teachers, etc?
More absenteeism at schools and lost productivity at work
Financial barriers for many people whose insurance companies will no longer cover Covid vaccines if not recommended
mRNA shots will probably cost over $200 at a pharmacy. This coupon from GoodRx might help cut that down significantly. Great. Cutting coupons for Covid shots.
What are the broader implications?
I think Katelyn Jetelina summed this up very well earlier today in her substack:
This isn’t about whether everyone needs a yearly Covid-19 vaccine—that’s a legitimate, ongoing scientific debate, and one ACIP was already tackling in June. This is about how decisions are made—and who gets to make them. FDA political appointees are sidelining expert panels, bypassing transparency, and turning public health into a performance. That might fly in other arenas, but shouldn’t when it comes to people’s health and daily lives. Vaccine decisions must be rooted in evidence, debate, and transparency. If this is the new model, we should all be alarmed.
I guess it could be worse
Many adults who really want a shot this fall will be able to find a way to get one. Most adults have a “high risk condition” such as obesity, physical inactivity, or even depression — all of which are on the list. Yet being overweight is a well-established risk factor for severe Covid and other complications, but it is not currently listed. But the ability to qualify for a shot may be porous. We don’t know the personal burden of proof yet. Would lying around on the couch for a day qualify someone to get a shot based on “physical inactivity?”
Baggage.
Let’s get into the NEJM piece.
Author Prasad once wrote on his blog: “I think the vaccines did save lives — when given to old, non immune people in early 2021— but I also think RFK Jr is mostly correct. The companies pushed it in kids and pushed repeated dosing to steal more money without proof that this was needed.”
Author Makary once said: “The greatest perpetrator of misinformation during the pandemic has been the United States government. Misinformation that COVID was spread through surface transmission. That vaccinated immunity was far greater than natural immunity. That masks were effective[...]That myocarditis was more common after the infection than the vaccine.” His statements have been analyzed as unfair and inaccurate.
Here are some shortcomings of their framework and framing:
The article states that "less than 25% of Americans received boosters each year," portraying this as evidence that Americans and healthcare providers "remain unconvinced" about boosters. This is problematic because low uptake doesn't exclusively indicate skepticism about vaccine efficacy - it also reflects access issues, pandemic fatigue, poor communication, and cumulative misinformation from all kinds of streams.
The article advocates for "randomized, controlled trial data evaluating clinical outcomes" for healthy persons aged 6 months to 64 years, while accepting immunogenicity data (antibody titers) as sufficient for those 65+ or with risk factors. This creates an artificial and illogical double standard in evidence requirements: If immunogenicity is a valid scientific basis for approval in high-risk groups, why wouldn't it be valid for others? The article proposes placebo-controlled RCTs for vaccines that are already known to be effective, which raises ethical concerns about denying protection to placebo recipients.
A really disturbing line from the NEJM article: “For all healthy persons — those with no risk factors for severe Covid-19 — between the ages of 6 months and 64 years, the FDA anticipates the need for randomized, controlled trial data evaluating clinical outcomes before Biologics License Applications can be granted.” Really? You don’t consider little ones worth vaccinating even with a primary series?? Over 2,000 kids in the US have died of Covid. Worldwide as of December 2023, over 17,500 kids had died of Covid. 90% were unvaccinated, and about 50% were older than age 10.
Already vaccinated kids are going to have a hard time if they or their parents want to stay up to date with Covid vaccines. I know this won’t trouble that many parents, as the group fiction is that all kids do fine with Covid. And yet many do not, especially in the realm of subtle long Covid, cumulative wear and tear on the lungs, brain, and immune system, etc. I compiled a reference a while back showing the ongoing benefits of keeping kids — yes, kids — up to date on Covid shots just like we recommend with flu shots.
Also, that problematic line starts out with “For all healthy persons — those with no risk factors for severe Covid-19…” Do you also find that subtle binary categorization of people as “healthy” and “unhealthy” to be gross? Offensive? Ableist? On that slippery slope to eugenics? None of us are either healthy or unhealthy, clean or dirty, pure or tainted, saint or sinner. To dismiss people on the CDC list, including pregnant women, people with asthma, and people with depression for example as “unhealthy” is pretty gross. You will note that the authors estimate only 18% of the adult population between ages 50 and 64 are by their definition “healthy” and therefore eligible for their exclusive RCT of Covid shots. What kind of conclusions can be drawn from such a narrow study population that justifies such carved up new recommendations?
Furthermore, by acknowledging that 100-200 million Americans would still qualify for vaccines under their proposal, the authors essentially admit their framework is more about creating barriers to access than truly tailoring recommendations to risk.
The article completely fails to address long Covid prevention at all, especially in younger adults and children. This is what I am drowning in right now practicing primary care. I see this all the time, and given the lack of a simple blood test to confirm long Covid we are all left guessing. But trust me, the fatigue, brain fog, exertional shortness of breath, muscle aches, and mental health burden after some Covid infections is real. Many people do not connect the dots until we’ve ruled out lots of other possibilities. That’s expensive and not fun for people either. And I just wrote a post containing multiple recent studies showing ongoing benefit to help prevent long Covid with updated shots. Here are 1, 2, 3 just for fun, and even a bonus one for kids. The old school CDC of last year before everything sucked agreed with updated shots to help prevent long Covid based on their review of the evidence.
The authors use the word equipoise not just once, but twice. The first time was interesting, the second time infuriating. Nota bene — equipoise means “a balance of forces or interests.”
The authors used the term gold standard not just once, but twice, in back-to-back sentences. They are trying to brand this term like a memecoin, and wield it to summarily dismiss any data from different types of studies other than RCTs. But this gold standard obsession dismisses 4+ years of observational studies on Covid vaccines, and doubles down on several critical biostatistical errors in judgement: Ethical constraints : Conducting placebo-controlled RCTs for established vaccines poses ethical challenges since it deliberately withholds potentially life-saving interventions from control groups. Temporal limitations : RCTs typically require lengthy timelines incompatible with the urgent need to address rapidly evolving viral variants. Observational studies can provide timely real-world effectiveness data when RCTs aren't feasible. Generalizability issues : RCTs often have strict inclusion/exclusion criteria, potentially limiting their applicability to diverse populations. See above. Efficacy estimates become potentially unreliable for broader populations. Statistical power concerns : Detecting rare outcomes (like severe COVID in younger populations) requires large sample sizes in RCTs, while observational studies can leverage large existing datasets. Complementary evidence : Modern epidemiology recognizes that robust causal inference comes from triangulating multiple evidence types. Observational studies, especially large cohort studies with appropriate methods for confounding control, provide crucial complementary evidence. Practical implementation insights : Observational studies reveal real-world effectiveness under typical use conditions, addressing questions RCTs can't answer about implementation effectiveness. Addressing waning immunity : Observational studies are better suited to study long-term effectiveness and waning immunity patterns over time. While RCTs absolutely remain important, and can be considered gold standard evidence in many situations, elevating them as the sole valid source of actionable intelligence demonstrates a fundamental misunderstanding of modern epidemiological methods and the complementary roles different study designs play in public health decision-making. It becomes an ideology. A purity test, like so many others lately. And finally, the tone of the NEJM article penned by Prasad and Makary should be addressed. Words matter, as they say. The article employs several rhetorical strategies that undermine its scientific credibility. For example:
Dismissive attitude : The article claims "the U.S. policy has sometimes been justified by arguing that the American people are not sophisticated enough to understand age- and risk-based recommendations." They fail to provide any citation for this claim, creating a straw man argument. In fact, US policymakers, ACIP, and CDC have gone to great lengths with thoughtful, inclusive, nuanced justifications for their previous recommendations about shots. You just have to take the time to read it. But straw men are easier.
Everyone else is doing it, so why aren’t we? Didn’t we learn something about everyone jumping off bridges, being popular doesn’t mean being right, and thinking for ourselves back in school?
False savior narrative: The authors position themselves as rescuing public health policy by "balancing competing values" and providing "information that is desperately craved by health care providers and the American people," implying current policymakers are ignoring these concerns. I’m also not desperately craving some randomized, controlled, narrow situational truth gleaned from 18% of a healthy middle aged population. I just want my personal choice to get a Covid vaccine each year, consistent with the evidence that comes from multiple study designs and top quality journals. I want my patients to have that, too.
Conclusion
Perhaps the entire article and policy framework dropped this week by Drs. Prasad and Makary could have recommended a very American way of handling this. You know, like a hybrid, cooperative approach?
Everyone can get it, but only high-risk groups are told they should.
This would mean insurance still covers it, and we can keep studying it.
The end.
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This post was first published yesterday on my Substack called Examined.
Please do sign up if you want to be included in future updates on this topic and others of interest to good primary care.
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