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The upcoming fall and winter months are about to bring the usual crop of respiratory illnesses—influenza, respiratory syncytial virus (RSV), and, of course, COVID. But this will be the first time since COVID vaccines were developed that many people in the U.S. will not have easy access to immunization against SARS-CoV-2, the virus that causes the disease, which has contributed to the deaths of more than 1.2 million Americans to date.

Public health experts had nervously tracked U.S. health agencies’ actions on vaccines in general and COVID vaccines in particular since February, when longtime antivaccine activist Robert F. Kennedy, Jr., took the reins of the Department of Health and Human Services. Conflicting messaging and ambiguous guidance from the Centers for Disease Control and Prevention and the Food and Drug Administration shook up the usual launch of annual vaccines.

“We typically have this very clear set of dominoes for a vaccine rollout: it’s smooth; it’s synchronized; it’s sequenced,” says Katelyn Jetelina, an epidemiologist and founder of the newsletter Your Local Epidemiologist. “But we have these missing or wobbling dominoes right now, and so the rest of the chain is backed up.”

On August 27, one of those dominoes fell when Kennedy announced in a post on X that the FDA had approved the updated COVID vaccines only for adults aged 65 or older and those with underlying health conditions that increase risk of severe infection. The decision leaves healthy children and adults without easy access; they may be limited to receiving vaccines at physicians’ offices instead of pharmacies, and health insurance might not cover the full cost for everyone.

Scientific American spoke with experts about what the public can expect in terms of COVID-19 vaccines this fall.

COVID Cases Are Rising Again

All signs suggest that COVID cases in the U.S. are ticking up. Wastewater surveillance showed moderate, high, and very high levels of SARS-CoV-2 in much of the nation, as of the week ending on August 9. Rates of positive COVID tests and emergency department visits were also up as of the week ending August 16. All three measurements are early indicators of increased viral prevalence.

Although COVID death rates are currently low, they will likely rise on a delay from those early indicators. Regardless, SARS-CoV-2 continues to take lives: More than 100 people in the U.S. have died of COVID every single week of this year, according to the CDC. Similarly, rates of new long COVID diagnoses have slowed since the early days of the pandemic, but new infections continue to trigger the lingering and disabling syndrome.

Assessing COVID’s current risks is a tricky balance, says David Higgins, a pediatrician and vaccine delivery specialist at the University of Colorado School of Medicine. “We are clearly in a different place than we were in 2020 and 2021, and that is a good thing,” he says. “At the same time, I think the fact that we are in such a different place can maybe lead some people to underappreciate that COVID is still causing harm for many people.”

What COVID Vaccines Are Available This Year?

Three manufacturers have produced COVID vaccines this year: Moderna and Pfizer have made mRNA vaccines, and Novavax has made a protein-based shot. The two mRNA manufacturers, at least, tailored their vaccines to the LP.8.1 variant, the version of the COVID-causing virus that was increasing in prevalence when vaccine scientists decided which version to target this year.

As of the week ending on August 9, a newer variant called XFG represented 65 percent of infections. XFG and LP.8.1 are both members of the JN.1 family, which arose at the end of 2023. Experts expect this year’s formula to shield against XFG, although the exact degree of protection is always difficult to predict at the beginning of the season.

Why Is COVID Vaccine Access Changing?

COVID vaccines go through two separate federal government procedures that determine who can access them and how they can do so. This year, neither process has gone particularly smoothly.

One system is the CDC’s Advisory Committee on Immunization Practices (ACIP), which makes recommendations for who should receive which vaccines. This procedure governs access because insurance companies must fully cover the costs of recommended vaccines, according to the Affordable Care Act.

Earlier this year, Kennedy removed all existing members from the panel and appointed new ones—a highly unusual and criticized move—shortly before the scheduled June meeting. At that gathering, the committee was supposed to decide on this year’s COVID vaccine recommendations, but the replacement members declined to vote. It’s unclear when ACIP will meet next. The CDC’s website references a meeting that will occur in August or September but notes “dates TBD”; the next formally scheduled meeting is slated for October 22.

The other system is the FDA’s labeling process, which recently decided on access for healthy children and adults. This influences how vaccines are given. Agency personnel inspect the vaccines, ensure they are safe, and outline prescribing guidelines for health care providers. This process matters because pharmacists are generally not allowed to administer vaccines outside of what the label permits—typically, only doctors can provide vaccines “off-label.”

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