On May 20, U.S. Food and Drug Administration (FDA) officials announced that Covid-19 vaccines will no longer be available to everyone. Instead, annual boosters will be limited to people ages 65 and older, and those with certain medical conditions that put them at high risk for severe infection.
In a virtual town hall and an article published in The New England Journal of Medicine, FDA Commissioner Marty Makary, MD, and Vinay Prasad, MD, the agency’s director of the Center for Biologics Evaluation and Research, argued that the benefits of additional doses of the vaccine for healthy people aged 64 and under were “uncertain,” and the administration of boosters shouldn’t continue until the results of placebo-controlled trials are available.
“With the COVID pandemic behind us, it is time to adopt a common-sense approach to COVID policy,” a spokesperson for the FDA tells Rolling Stone. “Healthy individuals aged six months to 64 will require randomized, controlled trials for future vaccine approvals.” The Centers for Disease Control and Prevention (CDC) estimates that 30,000-50,000 people have died from Covid since Oct. 1, 2024, and that during that period, there have been 9.3 million to 15.6 new cases.
This policy marks a shift away from individuals and their doctors deciding whether someone should continue to get Covid-19 vaccine boosters, and gives that power to the federal government.
Since the FDA’s new guidance was announced, medical professionals and public-health officials have expressed concerns about the logistics and ethics of Makary and Prasad’s plan, as well as the many questions it leaves unanswered. Rolling Stone spoke with three vaccine experts to try to make sense of the agency’s updated policy. Here’s what we learned.
Why the change in policy?
Starting with its title — “An Evidence-Based Approach to Covid-19 Vaccination” — Makary and Prasad’s article in the New England Journal of Medicine attempts to plant seeds of doubt about the safety and efficacy of the current Covid-19 boosters, claiming that the “United States has adopted a one-size-fits-all regulatory framework” as far as determining who has access to the vaccine. Similarly, an FDA spokesperson tells Rolling Stone that “a rubber-stamping approach to approving Covid boosters in perpetuity without updated clinical trial data under the Biden Administration is now over.”
In the article, Makary and Prasad also suggest that the existing Covid-19 vaccine doesn’t represent “a commitment to gold-standard science.” Peter Hotez, MD, dean of the National School of Tropical Medicine at Baylor College of Medicine and co-director of the Texas Children’s Hospital Center for Vaccine Development, disagrees, calling this claim “disingenuous,” because the FDA has always based its decisions on rigorous research. “Even the title is a bit puzzling, because there is an evidence-based approach to Covid vaccination,” he tells Rolling Stone. “It implies that the FDA hasn’t been evidence-based in the past. That’s simply not true.”
Wilbur Chen, MD, chief of the adult clinical studies section within the Center for Vaccine Development and Global Health at the University of Maryland School of Medicine, is also worried about the message this sends. “For the people who are conspiracy theorists and already had hesitancy, it gives them a reason to think that there is something wrong with these vaccines, or that there is a safety problem that we have to explore, or an erosion of the trust in or the value of the vaccines,” he tells Rolling Stone. “I am very concerned about the erosion of public trust overall.”
Makary and Prasad go on to contend that Covid-19 vaccination policies in the U.S. should more closely resemble those in parts of Europe, which restrict boosters to older adults and high-risk individuals. Paul Offit, MD, director of the Vaccine Education Center at the Children’s Hospital of Philadelphia, is in favor of a targeted recommendation for high-risk groups, as they’re the ones most likely to be hospitalized with a Covid-19 infection. However, he says that Makary and Prasad “make a somewhat disingenuous analogy to countries in Europe that do this, because even though they do target high-risk groups, they still have the vaccine licensed for everyone — and that’s not true here.”
Notably, at the virtual town hall Makary and Prasad “were falling all over themselves, talking about how they were pro-vaccine,” says Offit, who is also a member of the FDA’s Vaccines and Related Biological Products Advisory Committee. At one point Prasad called himself “an extreme pro-vaccine person,” then went on to seemingly distance himself from his boss, HHS Secretary Robert F. Kennedy Jr. — a known vaccine skeptic — saying “I actually have never spoken to RFK and I’ve never met the man.”
On top of everything else, Makary and Prasad ignored the usual process for approving vaccines. Typically, the CDC’s Advisory Committee on Immunization Practices (ACIP) makes recommendations regarding who should be eligible to receive a vaccine, while, as a regulatory agency, the “FDA is mostly supposed to just license vaccines and not really make decisions on which populations to authorize it in,” Chen explains. “It’s getting to the point where they’re blending recommendations for use, rather than just licensing [vaccines]. They’re pushing that boundary, and, in a sense, trying to supersede the ACIP.”
Does this mean I can’t get a Covid-19 vaccine?
Although Covid-19 boosters are no longer licensed for healthy people aged 64 and under, the new policy leaves the door open for those who still want to get additional doses of the vaccine. The list of acceptable underlying conditions that qualify someone for a booster includes many of the usuals — like asthma, diabetes, heart conditions, and immunodeficiencies — as well as others like “physical inactivity,” depression, and obesity. One estimate suggests that between 100 million and 200 million Americans will meet these criteria.
These broad categories will make the policy confusing to implement, Chen says. Offit agrees.
“I don’t quite see how that plays out in the real world,” he says. “A lot of people get their vaccine from the pharmacist. Is the pharmacist supposed to serve as a gatekeeper and determine whether or not you’re obese or have type 2 diabetes? That’s just not going to happen. I’m a little put off by the hubris of [Makary and Prasad] deciding how this is all supposed to work in public health.”
Meanwhile, Chen predicts “that people will probably understand that if they want to get vaccinated, they can game the system.” Or, as Hotez points out, “basically, there’s no change; anyone who wants to get vaccinated can get vaccinated with these criteria.” In other words, more than anything, the FDA’s new rules are largely symbolic.
In addition to telling your pharmacist that you’re physically inactive, another option would be for physicians to prescribe the off-label use of Covid-19 vaccines for healthy people under 64 who want to continue to get boosters, Chen says. But because they’d be off-label — or prescribed to a person who isn’t approved to receive the vaccine — those without health insurance would have to pay full price for Covid boosters, which cost between $150 and $300. “What the FDA did was make it so that you really can’t make that decision and get it paid for,” Offit explains. “The insurance companies won’t pay for something that’s off-label.”
Interestingly, the FDA’s updated regulations mark a striking departure from the administration’s usual position calling for less government oversight in healthcare. Previously, when it came to healthy people 64 and under, the decision whether to get a Covid booster was between a person and their doctor. “Now you’ve taken that away from them,” Hotez explains. “It’s somewhat ironic: this whole administration and HHS is all about health freedom, medical freedom. It seems to me, you’ve taken that away from people, and put the state in charge, instead of the individual and their doctors.”
Why had the medical establishment supported boosters up until now?
In their article, Makary and Prasad contend that the benefits of repeat dosing for low-risk individuals are “uncertain.” During the virtual town hall, Makary said that he “love[s] the idea of vaccinations,” and doubled down on this claim of uncertainty, saying that for a healthy 52 year-old, the value of getting annual Covid boosters is “a scientific unknown.” But Chen, Hotez, and Offit say that’s not the case: some notable protections that the vaccine provides are conspicuously absent from their guidelines and messaging.
“One of the aspects that they don’t address at all is Long Covid,” Hotez says. “We now have good evidence that vaccinations stop not only severe illness, hospitalizations, and death, but also Long Covid.” For example, a study published in April in the journal Lancet eClinicalMedicine found that unvaccinated children and adolescents were up to 20 times more likely to develop Long Covid than their vaccinated peers by preventing infection in the first place.
This is another example of how the FDA’s new guidance restricts personal choice. “If you’re a healthy, 45 year-old person who is concerned about Long Covid and wants to keep up with their annual boosters, now you’ve taken that decision away from them,” Hotez explains. “You’re going to deny them the ability to protect themselves against Long Covid.”
Makary and Prasad also fail to mention that Covid-19 is a thromboembolic virus and causes heart attacks and strokes, Hotez notes. “They don’t really consider the potential long-term cardiovascular consequences,” he says.
Isn’t more research a good thing?
In many cases, yes: more research means more data to use to inform vaccine policy. “The FDA’s new guidelines require clinical trials for the approval of new Covid-19 boosters for healthy Americans under age 65,” the FDA spokesperson told Rolling Stone.
But in this case, the studies Makary and Prasad are proposing may be ethically questionable and may prevent the authorization of the Covid-19 vaccine for low-risk populations, the experts we spoke to say. In their New England Journal of Medicine article, they proposed conducting randomized, saline placebo-controlled trials on healthy individuals between the ages of 50 and 64 and using the findings to inform whether the vaccine should be licensed for low-risk people. “Ultimately, these studies alone can provide reassurance that the American repeat-boosters-in-perpetuity strategy is evidence-based,” Makary and Prasad write.
Generally speaking, it is considered unethical to conduct placebo-controlled trials when an effective intervention is available — in this case, the Covid-19 vaccine. “I don’t see how ethically you can do that study,” Offit says. “The virus is still circulating and is still going to cause hundreds of thousands of hospitalizations and tens of thousands of deaths every year.”
While the 50 to 64 year-olds who are otherwise healthy are at low risk, “they’re not at no risk,” Offit says.”Anybody can be felled by this virus,” he explains. “Do you really want to give a placebo when you know that the virus is circulating and you know that you have a vaccine that works? I just don’t see how you conscience that ethically.”
The other problem is that Makary and Prasad never reveal their study design, so it’s unclear what their research timeline would look like. “Sponsor-driven, randomized, placebo-controlled trials are very large and very expensive,” Hotez says. “They will take a considerable amount of time. It could take six months to a year to enroll enough people in those studies in order to conduct them, and by then you’ve got a new variant.”
Ultimately, Chen fears that the messaging about Covid-19 vaccines from Makary and Prasad will make matters worse. “For public health reasons, we want to have clear messages to the public that are reassuring that public health works, and that the vaccines that we license work, and I fear that we’re eroding that public trust,” Chen says.
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