FDA’s New COVID-19 Vaccine Policy: What It Means for You

In a dramatic change of course, the U.S. Food and Drug Administration (FDA) revealed on May 21, 2025, that it will no longer advise healthy adults and children to receive annual COVID-19 shots. This is a dramatic change from the previous advice from the agency, which suggested everyone above six months get an annual vaccination. The shift, which is being implemented by the FDA's new leadership under Commissioner Dr. Martin Makary and Dr. Vinay Prasad, director of the Center for Biologics Evaluation and Research, has raised support and alarm among public health professionals and the general public. Here's a breakdown of what this entails, why it is occurring, and how it can impact you and your loved ones.

What's Changing?
Over the past several years, the FDA has handled COVID-19 vaccines like traditional flu shots, greenlighting booster shots based on lab tests that demonstrate they will induce immune responses against emerging versions of the virus. That process enabled vaccine companies such as Pfizer, Moderna, and Novavax to produce updated shots annually in the fall without performing large-scale clinical trials for each modification. The new policy reverses that strategy significantly.

The FDA will now only approve seasonal COVID-19 vaccines for two groups only: people aged 65 and older, and those who are more than six months old with health conditions that put them at risk of severe COVID-19, including asthma, diabetes, obesity, or pregnancy. For the rest of us—healthy individuals below 65 and kids—the FDA is mandating vaccine makers to use randomized, placebo-controlled clinical trials to establish that the shots are safe and effective before they become available for wider use. What this means is that if you're a healthy 40-year-old or have a healthy 10-year-old child, you may not be able to get an updated COVID-19 vaccine this fall unless these trials are finished.

The Novavax vaccine, which employs the old protein-based technology as opposed to mRNA vaccines produced by Pfizer and Moderna, has already been affected by these new limits. On May 19, 2025, the FDA did give it full approval—albeit just for seniors and individuals 12 and older with one or more high-risk conditions. This is a more limited approval than Novavax had in its earlier emergency use status, and it reflects the FDA's general move to tighten its control over vaccine approvals.

Why the Change?
The FDA announcement comes under the pressure of the Trump administration's new health leadership, such as Health and Human Services Secretary Robert F. Kennedy Jr., a long-time vaccine critic. In an article posted in The New England Journal of Medicine, Makary and Prasad contend that the U.S. has been the exception to advising yearly COVID-19 vaccines for all. They note that other high-income nations, such as Denmark and Switzerland, only advise those vaccines for older populations and those at highest risk. They also reference falling vaccine take-up—only some 23% of U.S. adults received the most recent COVID-19 vaccination through April of 2025—as proof that the public is not convinced about the jabs' worth for healthy individuals.

Makary and Prasad stress the requirement for "gold-standard data" to support vaccinating low-risk groups. They contend that since a majority of Americans have now had multiple doses of COVID-19 vaccination or infections, the risk profile of the virus has altered, and repeated boosters among healthy individuals have uncertain benefits. "We have embarked upon this multiyear booster after booster after booster campaign and distrust of the American public," Prasad stated during a livestreamed FDA talk. We don't have gold-standard science to back this up for average-risk, low-risk Americans."

The new policy also indicates doubt from the administration. Kennedy has previously expressed doubt about the safety of vaccines, once inaccurately labeling the COVID-19 vaccine "the deadliest ever created." Though Makary and Prasad say their approach is separate from Kennedy's, skeptics are concerned that this change falls in line with a larger anti-vaccine attitude from the administration.

What Are the Concerns
The public health community is split on the FDA's new strategy. On the one hand, some embrace the emphasis on strict data. A former federal vaccine official, Rick Bright, described the guidelines as "refreshing," and stated that not everyone is at an equal risk of contracting COVID-19, and that this reality should be represented in public policy. The FDA estimates that 100 to 200 million Americans, or about one-third of the population, will continue to be eligible for vaccines under the new regulations, either because of age or medical condition.

Others view grave drawbacks. Dr. Paul Offit, director of the Vaccine Education Center at the University of Pennsylvania, contends that performing placebo-controlled trials in well populations is unethical. "We know SARS-CoV-2 is still circulating, causing hospitalizations and death, and there's no population that has no risk," he said to NPR. Offit and others note that COVID-19 vaccines have already been demonstrated to decrease hospitalizations and deaths in all age groups, even if severe disease is less common in younger, healthier individuals. 

Another issue is access. If vaccines aren't licensed for healthy adults and children, insurers may not pay for them, making it more difficult for those who wish to be vaccinated to access them. Vaccines can be prescribed "off-label" by physicians, but they will be reluctant without explicit FDA approval, and out-of-pocket expenses would be a deterrent. Michael Osterholm, director of the University of Minnesota's Center for Infectious Disease Research and Policy, deemed the policy a betrayal of Kennedy's vow not to remove vaccines from anyone and insisted that it "neuters" the typical process of vaccine recommendations by the CDC's Advisory Committee on Immunization Practices (ACIP).

There's also the matter of timing. Randomized trials are costly and time-consuming, taking months or years. Anna Durbin of Johns Hopkins Bloomberg School of Public Health cautioned that such studies may not be available in time for yearly vaccine updates, depriving healthy Americans of access to the newest shots during subsequent surges. That could be especially dangerous if a more lethal variant surfaces.

Lastly, certain experts are concerned about the overall message this conveys. Critics such as Dr. Eric Rubin, an immunologist at Harvard, say that observational data already indicate vaccines have worked in younger populations, and insisting on placebo trials could instill public mistrust by suggesting the shots have not been properly tested. X posts bear out this tension—some users celebrate the FDA's action as "finally following the science," others bemoan it as a step toward curtailing access to an already proven tool.

What About Novavax?
The Novavax vaccine, marketed as Nuvaxovid, has been at the center of this policy pivot. Unlike mRNA vaccines, Novavax employs a more conventional protein-based strategy, one that some prefer out of worry over mRNA technology. It was first approved for emergency use in 2022 but had its full approval delayed beyond the FDA's April 1, 2025, deadline. When it was ultimately approved on May 19, it was not without strings attached: the vaccine is now only for the elderly and those over age 12 with high-risk conditions.

The FDA also asked Novavax to agree to further trials, such as a Phase 4 placebo-controlled trial in healthy adults ages 50-64 to see if the vaccine is beneficial for this age group. The agency also desires studies on possible heart conditions such as myocarditis, an unusual side effect observed with other COVID-19 vaccines. Novavax CEO John Jacobs embraced the approval, saying that their target customer—older and at-risk patients—are exactly those most likely to get vaccinated in the first place. But others, such as former FDA Chief Scientist Jesse Goodman, say that the agency overreacted by placing those restrictions, which are generally the CDC's province.

What Does This Mean for You?
If you’re over 65 or have a high-risk condition like asthma or diabetes, not much changes—you’ll still have access to updated COVID-19 vaccines this fall, assuming the FDA approves them based on immune response data. The “high-risk” category is broad, covering conditions like depression, pregnancy, and even physical inactivity, which applies to many Americans. But it's uncertain how much evidence you'll have to provide to meet eligibility, and some physicians may apply the criteria more rigidly than others.

In the case of healthy adults below the age of 65 and children, there is more uncertainty. If there aren't new trials, newer vaccines won't be licensed for you, potentially restricting your choices if you wish to guard against infection or shield your family. This could be particularly relevant for parents of small children or those in households with vulnerable relatives, since vaccinating the healthy can decrease spread to the vulnerable groups. And then there's the possibility of "long COVID," which even healthy folks can get, and immunizations have been found to decrease the likelihood of that.

Vaccine manufacturers are responding cautiously. Pfizer and Moderna have acknowledged the FDA’s guidance and say they’re in ongoing talks with the agency, but it’s uncertain whether they’ll conduct the required trials. These studies are costly and could take years, potentially leaving a gap in vaccine access for healthy Americans.

Looking Ahead
The FDA’s new policy reflects a broader shift in how we’re approaching COVID-19 as the pandemic evolves. With so many Americans now immunized against infection or previously vaccinated, the risk profile of the virus has altered since 2020. But the controversy over this policy reveals a deeper conflict: how do we weigh the imperative of strict data against the facts on the ground of public health? And how do we keep faith in vaccines when the government's own messaging appears to flip so spectacularly?

As we enter the fall, be sure to monitor FDA and CDC updates. The FDA's vaccine advisory committee met on May 22 to decide which strains to aim at for the 2025-2026 season, but the new policy has already begun to confuse, with some members asking how strain updates will be handled under the new policy. The CDC's ACIP is also meeting in June to reconsider its own recommendations, which may help further delineate who should receive vaccination.

For the moment, if you're in a high-risk category, just schedule your shot as before. If not, you may have to take a careful gamble—consult with your physician on your individual risk and whether off-label vaccination is an option. This policy change is a reminder that COVID-19 remains a complicated and evolving challenge, and navigating it involves both prudence and careful thinking.

What do you make of the FDA's new strategy? Are you worried about access to vaccines, or do you embrace the push for additional data? Let me know your thoughts in the comments—I'd love to hear from you.