By Josh Nathan-Kazis

It's late August, there's a hurricane coming up the East Coast, schools are starting to open, and no one has any idea who can get an updated Covid-19 shot.

The Covid-19 pandemic is over, but the virus persists. It has killed up to 56,000 people in the U.S. since last October, according to the Centers for Disease Control and Prevention, and sickened up to 18 million. Pfizer, Moderna, and Novavax all plan to launch new versions of their Covid-19 vaccines this fall, updated to target a family of Covid-19 viruses called JN.1.

Who will be eligible to receive those shots remains a huge question mark.

Changing guidance from the federal government and scientific experts comes as the pandemic slides farther into the rearview, and doctors' thinking on how the vaccines should be used continues to evolve.

But the ascension of Robert F. Kennedy Jr. as U.S. health secretary has scrambled the federal government's approach to vaccines. Kennedy's skepticism of vaccines in general -- and of the messenger RNA-based shots in particular -- has already had a dramatic effect on how Covid-19 shots are being used in the U.S.

The Food and Drug Administration is likely to approve the updated shots in the coming days. All indications suggest that the approvals will be far narrower this year than in years past. The Centers for Disease Control and Prevention will convene outside vaccine experts sometime in August or September to issue recommendations that will guide how insurers cover the shots.

Meanwhile, though Covid-19 cases are currently low, the CDC now estimates that infections are growing or likely to grow in 34 states, and are stable in 14.

Here's what we know so far about this year's updated Covid-19 shots.

Who can get an updated Covid-19 shot this year?

There's no clear answer, and there won't be for weeks.

"Patients ought to understand what their options are going to be, come the fall," says Jennifer Nuzzo, professor of epidemiology at Brown University and director of the school's Pandemic Center. "I think this chaos is going to make it harder even for high risk people to be able to get vaccines."

The first major question is what the FDA will say about the updated shots.

In May, the FDA laid out a new framework for how Covid-19 vaccine approvals would work going forward. The framework said the agency will continue to approve updates of the Covid-19 shots for adults over 65, and for people over the age of six months with at least one risk factor for severe Covid-19 outcomes.

That implies the FDA will only approve the new shots this fall for people ages 65 and up, and for high-risk individuals from six months to 64 years old. That would be a far narrower set of approvals than last year, when the FDA authorized or approved the new shots for all age groups above 6 months old.

There's one important wrinkle here: The Pfizer shot is still only available under an emergency use authorization, or EUA, for children under the age of 5, and there have been media reports in recent weeks that the FDA is planning to revoke Pfizer's EUA. That would mean that the Moderna shot may be the only Covid-19 shot approved for young children.

Does that mean most adults under 65 won't be eligible to get an updated shot this fall?

The new FDA framework might not be as restrictive as it looks. The list of underlying medical conditions that FDA leadership said in May would qualify as a risk factor for severe Covid-19 was extensive, and included common conditions such as obesity. Other conditions on the list include physical inactivity, depression, asthma, and pregnancy and recent pregnancy. That all means that a large proportion of adults will likely be eligible to get the updated shots, though insurance coverage is a separate question.

We'll get to insurance in a moment. But first: What about healthy adults? Will they be cut off from Covid-19 shots?

Patients may be able to get the shots off-label, but there are lots of uncertainties.

If the FDA does issue narrower recommendations this year, says Josh Michaud, an associate director at the Global Health Policy program at the nonpartisan health policy organization KFF, people who aren't included within the FDA label "are in an uncertain situation about having access."

Drugs are routinely prescribed off-label in the U.S., and there is no rule or law against off-label prescribing. Michaud says the same holds true for vaccines.

"There are examples of vaccines that have been provided off-label," Michaud says. "It's not uncommon, in fact."

So interested patients will likely be able to get their doctors to prescribe the shots off-label. What isn't clear is whether insurers will pay for off-label vaccinations.

There are also questions about distribution. In recent years, patients have gotten used to getting their Covid-19 and flu shots at retail pharmacies, but whether retail pharmacies will be able to administer Covid-19 shots off-label is far from clear, and could vary by state.

That's all very confusing.

The complexities don't stop there! After the FDA issues its approvals of the updated shots, the CDC will convene its outside advisors to set its own recommendations. Kennedy fired and replaced all the members of that committee this past spring. That committee's recommendation will determine how the insurers are required to pay for the vaccines.

The CDC and Kennedy himself have put out their own new Covid-19 vaccination guidelines in recent months. Those guidelines contradict each other, and the framework from the FDA.

Kennedy said in late May the CDC would no longer recommend Covid-19 shots for healthy children or for healthy pregnant women. The CDC, shortly thereafter, put out a subtly different statement: It said that the parents of healthy children "should discuss the benefits of vaccination with a healthcare provider," though it dropped the recommendation that pregnant women get vaccinated.

What the CDC will ultimately say about the updated shots matters: If the CDC's advisors don't recommend the shot for a particular group of people, insurers don't need to cover it.

How much would it cost to pay out of pocket for a Covid-19 shot?

According to the CDC, adult doses of the Covid-19 shots from Pfizer and Moderna cost around $140. Pediatric doses cost less.

Who do doctors say should get an updated Covid-19 shot this fall?

This week, the American Academy of Pediatrics put out its own recommended vaccine schedule. The group said it recommends a Covid-19 vaccine for all children aged 6 months through 23 months, and for children and adolescents ages 2 through 18 who are at high risk for Covid-19, or have never been vaccinated against Covid-19.

Write to Josh Nathan-Kazis at josh.nathan-kazis@barrons.com

This content was created by Barron's, which is operated by Dow Jones & Co. Barron's is published independently from Dow Jones Newswires and The Wall Street Journal.

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August 20, 2025 16:23 ET (20:23 GMT)

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