New FDA coronavirus vaccine rules bring U.S. closer to other countries

The Food and Drug Administration decision this week to narrow the group of people for whom it would approve annual coronavirus vaccines brought U.S. policy closer to that of many other countries. But the change sparked confusion over who can get shots amid resignations by top public health officials who say the Trump administration and Health and Human Services Secretary Robert F. Kennedy Jr. have undermined vaccine science, a context with far fewer parallels.

On Wednesday, the FDA signed off on new coronavirus vaccines for people age 65 and older, as well as for those with underlying health conditions — narrowing the approval for the shots, which had been routinely available to nearly all Americans. People who do not fall into those categories will have to consult with a doctor to get a vaccine. Previously, anyone older than 6 months had been broadly advised by the Centers for Disease Control and Prevention to get a booster shot.

The World Health Organization, from which the United States has withdrawn under President Donald Trump, makes its own vaccine recommendations. It says coronavirus vaccines are a high priority for pregnant and immunocompromised people and the elderly, while revaccination is “not routinely recommended” for healthy adults or minors. Mexico’s vaccination policy largely echoes the WHO recommendations, and the country runs annual vaccination campaigns targeting high-risk individuals. Canada’s Health Department recommends coronavirus vaccines to groups including people older than 65, health care workers, pregnant people, and those belonging to Indigenous communities.

The picture looks largely similar in Europe, with most countries recommending coronavirus vaccines for those at high risk or over ages ranging from 60 to 80.

These recommendations follow a risk-based approach to vaccination, under which those likeliest to experience severe illness are prioritized for vaccine access. This approach does not bar people who want vaccines from obtaining one — though as far back as 2023, the European Centre for Disease Prevention and Control noted “diminishing population interest in getting vaccinated and a perception of ‘return to normality’” as a challenge in terms of boosting vaccine uptake.

In the United States, the FDA approves vaccines based on safety and effectiveness, while the CDC issues recommendations on who should receive them. Otherwise healthy people could still receive the coronavirus vaccine free if the CDC and its advisory committee that makes recommendations on immunization policy decides to follow its previous universal policy: that everyone ages 6 months and older receive annual coronavirus shots. Trump administration health officials, however, have expressed skepticism about that approach.

The point of universal guidelines earlier in the pandemic, some experts say, was to more easily reach high-risk people.

Public health officials in other countries largely chose the risk-based approach instead, aligning with WHO recommendations.

The CDC and that advisory committee have not yet weighed in on the FDA’s latest decision, and that committee is not scheduled to meet until mid-September. In June, Kennedy purged the members of the CDC advisory panel, opting to handpick replacements.

The CDC also recently ended its blanket recommendation that pregnant women get coronavirus shots. While many countries continue to offer coronavirus vaccines for pregnant women, Britain’s Joint Committee for Vaccination and Immunization no longer recommends it, saying there is little evidence that it is cost effective.

Most Americans rely on insurance companies to pay for vaccines and pharmacies to administer them, according to CDC data. But the move from the current policy of universal recommendation to more targeted guidance may result in a patchwork of rules, differing from state to state, and varying degrees of access. At CVS, for instance, pending guidance from the CDC, coronavirus vaccines are available without prescriptions in some states but only with prescriptions in others. Doctors and hospitals, unlike pharmacies, are generally allowed to administer vaccines as they deem necessary.

Canada, Mexico and many European countries offer public health care benefits. Eligible citizens of both countries — as well as noncitizens in Mexico and in certain Canadian provinces, such as Ontario — can receive a free coronavirus vaccine.

“This process will be evidence-based, evaluate multiple sources of data, including but not limited to ACIP, and will be informed by customer needs,” she said, referring to the CDC panel.

Adding to the confusion, some professional associations, such as the American Academy of Pediatrics, have issued their own guidance to counter recent changes at the leading health agencies under Kennedy. Critics say the confusion appears to be deliberate.

“I think the goal of Robert F. Kennedy Jr. is to be confusing — to make vaccines less available, less affordable, more feared,” said Offit. “And he’s only been doing this for what, six months? So this is just the beginning of what will be a continued war against vaccines.”

In a statement posted on social media Wednesday, Kennedy said that coronavirus vaccine shots remained “available for all patients who choose them after consulting with their doctors,” but that he had aimed to “end coronavirus vaccine mandates.”

The White House on Wednesday fired Susan Monarez as CDC director after she refused to resign amid pressure to change the agency’s vaccine policy. Three senior CDC officials — Demetre Daskalakis, the agency’s top respiratory illness and immunization official; Deb Houry, the chief medical officer; and Dan Jernigan, who helped oversee its infectious-disease response — resigned this week, saying they had been asked to participate in vaccine approval processes under Kennedy that went against science.

“The data analyses that supported this decision have never been shared with CDC despite my respectful requests to HHS and other leadership. … I have never experienced such radical non-transparency, nor have I seen such unskilled manipulation of data to achieve a political end rather than the good of the American people,” he wrote.