FDA to Limit Access to COVID Vaccines—What This Means For You

The majority of Americans may be ineligible for a COVID booster shot this year, according to new guidelines from the Food and Drug Administration (FDA).

In an article published Tuesday in The New England Journal of Medicine (NEJM), Vinay Prasad, the FDA’s vaccine division chief, and Martin Makery, the agency’s commissioner, said the FDA is changing its process for approving COVID boosters for healthy Americans under 65. The agency will now require clinical trial data before granting authorization—which means there’s a good chance the boosters never reach the market.

FDA officials said the new approval process makes sense for the current COVID situation, but some experts are concerned that the policy may be too limiting.

The COVID booster approval process is not changing for the following groups:

• Adults aged 65 and older
• People older than 6 months with at least one risk factor for severe COVID

The FDA expects that 100 to 200 million Americans will fall under the latter group, given the broad list of risk factors they provided, including:

• Obesity
• Type 1 and 2 diabetes
• Mood disorders, including depression
• Physical inactivity
• Smoking, current or former

The FDA will continue to approve booster shots for these populations based on immunogenicity, or proof that a vaccine can generate antibodies. Under this streamlined process, the FDA expects to authorize a new COVID booster for these groups.

As of now, “healthy” people—or those without risk factors for severe COVID—younger than age 65 won’t be able to get a booster this fall.

Booster shots for this group will be subject to a stricter approval process. Vaccine makers will now have to prove the booster’s effectiveness with randomized, controlled trial data before the FDA approves it for the public.

“The FDA’s new framework for vaccine approvals will prioritize high-risk populations while simultaneously requiring robust, gold-standard clinical data for low-risk individuals,” a spokesperson for the U.S. Department of Health and Human Services (HHS) told Health.

Under this framework, it will be difficult for manufacturers to get a booster shot approved for healthy people, Shira Doron, MD, chief infection control officer for Tufts Medicine and hospital epidemiologist at Tufts Medical Center, told Health.

She noted that clinical trials are more time-consuming and expensive for companies. Because participants in these trials will have varying levels of immunity to COVID from previous vaccinations and infections, “it’s going to be hard to show” that a shot can offer meaningful extra protection.

Pablo Penaloza-MacMaster, PhD, an associate professor of microbiology-immunology at Northwestern University Feinberg School of Medicine, agreed that booster approval for healthy people is unlikely.

“While the FDA has not necessarily prohibited boosters for healthy individuals, the new requirements may create a regulatory bottleneck that could render the vaccines inaccessible to people under 65 without comorbidities,” he told Health in an email.

The FDA’s main justification for shifting away from the “one-size-fits-all” approach to COVID vaccination is that the efficacy of multiple booster shots to protect healthy people from COVID—especially in those who’ve also had multiple infections—is “uncertain,” officials explained in the NEJM article.

They cited this uncertainty as the reason for low COVID booster rates, saying many Americans “remain unconvinced” of the shot’s effectiveness.

The officials also said the U.S. policy has been “aggressive” compared to other countries like Canada and the U.K.

“With the COVID pandemic behind us, it is time to adopt a common-sense approach to COVID policy, grounded in gold-standard science, that balances the needs of all populations,” the HHS spokesperson added.

Penaloza-MacMaster said the new requirement for clinical trials may be “overly rigid, expensive, and impractical,” given the rapidly evolving nature of the COVID virus.

“By the time the results of the clinical trial are available, the circulating variant may be different,” he said. “This approach would limit access to updated vaccines for millions of Americans who still wish to reduce their risk of disease, even if their risk is low.”

Still, Doron said it makes sense that the approval process and recommendations for COVID boosters would evolve as we exit an emergency situation and the FDA’s new framework aligns with policies in other countries.

“Having risk-based guidelines is the norm in every other country,” Doron said. “The U.S. has been an extreme outlier in its recommendations.”

Experts challenged the FDA’s assertion that COVID boosters may not protect healthy people from the virus, citing real-world data that boosters still improve the breadth and durability of immune responses, even in healthy individuals.

Yet, COVID booster rates remain low, and Doron agrees with FDA officials that the U.S. has a problem with public trust.

“We have a substantial proportion of Americans who lost trust in public health for a variety of reasons during COVID, including losing trust in vaccines,” she said. “This framework is, I believe, designed to help improve trust in vaccines.”

If a COVID booster is not approved for healthy people, it will be more difficult to get a shot, but likely not impossible, experts said.

The question is whether insurance will cover a vaccine approved only for high-risk groups, for a healthy person. Experts say it likely won’t be covered, but you may be able to get the booster by paying out-of-pocket.

Given the long list of risk factors, however, Doron said you could probably find one that applies to you. “You can really make it work for you if you really want it,” she added.

There are some reasons why healthy people may still want a booster shot. Penaloza-MacMaster pointed out that COVID can still lead to prolonged illness and missed work in healthy individuals, and boosters can make it harder for the virus to spread to high-risk groups.

However, even without the latest booster, experts say the risk of severe COVID in healthy people is low.

“It is a safe vaccine. I hate to think of people wanting it and not being able to get it,” Doron said. “But when people ask me directly, if they’re young and healthy, they say, ‘Do you think I need it?’ I don’t really have any evidence to say that you do.”