Who is eligible for a COVID shot? What to know about the FDA’s latest changes

The FDA will no longer recommend annual COVID vaccinations for healthy people younger than age 65, officials said this week.

Adults over age 65 and anyone over 6 months with one or more chronic or underlying health conditions, such as asthma, cancer, diabetes or pregnancy, are still recommended to get an updated shot.

To gain approval for COVID vaccines for other groups in the future, pharmaceutical companies would need to conduct new randomized clinical trials for younger healthy populations, according to FDA Commissioner Dr. Martin Makary and Dr. Vinayak Prasad, who directs the FDA’s Center for Biologics Evaluation and Research.

“The FDA will approve vaccines for high-risk persons and, at the same time, demand robust, gold-standard data on persons at low risk,” Makary and Prasad wrote Tuesday in the New England Journal of Medicine.

The shift was a marked departure from previous guidance, which recommended an annual COVID vaccine for everyone 6 months and older. The FDA’s new blueprint, outlined in the journal article, estimated 100 to 200 million people would be eligible under the new guidelines.

Requiring trials “will provide information that is desperately craved by health care providers and the American people,” Makary and Prasad wrote.

But other experts are worried about hindering the nation’s ability to develop timely vaccines against future pathogens while withholding vaccine doses from healthy people who want further protection now. These new FDA recommendations appear to have been “rushed toward to an agenda” without scientific review of experts in vaccine science, said Dr. Gregory Poland, president of Atria Research Institute. They also raise questions about how the FDA will regulate both future and existing medicine, and the degree to which expert input will be included.

The move by FDA also appears to preempt a scheduled meeting of a CDC advisory panel in June, where experts would typically meet to discuss the vaccine recommendations.

Here’s what the recent changes could mean for you.

Under the new recommendations, who should get a COVID vaccine?

Healthy adults under the age of 65 and children aged 6 months or older are not recommended to receive the updated COVID vaccines going forward, according to the FDA.

FDA officials under the current Trump administration said Tuesday the virus has infected many Americans “multiple times” and claimed that there has been “a reduction in the evidence standard for dose after dose,” Prasad said.

There are some exceptions for people with underlying conditions, including:

• Asthma
• Cancer
• Diabetes
• Pregnancy
• Depression
• Chronic lung diseases
• HIV

Flexing its regulatory clout, the FDA would require pharmaceutical companies to conduct randomized clinical trials on vaccines used within younger and healthy populations before granting licenses.

What do these COVID shot changes mean for families and care workers?

While vaccine coverage would remain the same for people over age 65 or anyone 6 six months or older with underlying risk factors, the people who share their lives or close quarters may not get the same protection. Healthy people who live in the same household or health care and child care providers who have no chronic conditions would not qualify to receive updated doses under these recommendations.

These restrictions may result in continued declines in COVID vaccine uptake.
Historically, the U.S. has “not been great at a targeted and tailored approach” to vaccine access, said Abram Wagner, an assistant professor of epidemiology and global public health at the University of Michigan. “The more you put restrictions into place, it just filters down that it’s more and more difficult to get the vaccine.”

Why did the FDA say COVID vaccine changes were necessary?

FDA officials pointed to similar recommendations in other nations, including Canada, Denmark and Australia, as validation for this policy change.

“It would almost seem as if the current U.S. strategy, which is urging every single baby and teenager and child and healthy American and high-risk American, encouraging every single one to get a booster every year, that is the outlier, contrary approach,” said Makary during a livestreamed question-and-answer session. Prasad agreed, adding, “Now, we are back in line with the rest of the world.”

Overall, Bill Hanage, professor of epidemiology at T.H. Chan School of Public Health at Harvard University, said it is “quite reasonable” to say that not everyone will benefit equally from receiving the COVID vaccine. However, he said the countries FDA officials pointed to “typically have health systems that in this country would be considered socialized.”

Where does the Trump administration stand on vaccines?

Health Secretary Robert F. Kennedy Jr. was the founder and chairman of an anti-vaccine advocacy organization for years. Though Kennedy affirmed support for the measles-mumps-rubella vaccine in a Senate hearing on Tuesday, when asked last week whether he supported vaccinating his own child, Kennedy said he does not think people should take medical advice from him. At his confirmation hearings, senators on both sides of the aisle expressed concern about Kennedy’s stance and the importance of live-saving vaccines.

Public trust in vaccines and vaccination uptake have declined in the U.S. in recent years. Prasad called this trend in attitudes “a backlash” that has led to “reduced rates of important, vital vaccine programs.” That includes the MMR vaccine, “which has been clearly established as safe and highly effective,” Makary and Prasad wrote in NEJM.

On Thursday, days before the COVID recommendations were released, Makary announced he was planning to “unleash a massive framework” on the FDA’s expectations for vaccine makers.

The new change to COVID vaccine recommendations was unexpected in part because the Centers for Disease Control and Prevention usually offers the public guidelines for who should get what and when. The FDA regulates the use of vaccines, medicines and medical devices based on whether they are safe and effective. The CDC’s Advisory Committee on Immunization Practices is scheduled to meet in late June and is expected to discuss who should receive COVID vaccines then.

Will insurance cover updated vaccines? Will people who want a shot be able to get it?

On Tuesday, Makary said the FDA would stick to its “general promise that we are not going to be removing vaccines from the market that are already approved.”

That’s where the CDC could come in. That agency can add a provision that allows healthy people under age 65 to get vaccinated against COVID if that is their choice, said Dr. William Schaffner, professor of infectious disease at Vanderbilt University.

However, people may have to pay for those doses out of pocket as insurance companies are unlikely to cover COVID vaccines for healthy populations unless they are “standardized on the vaccine schedule,” Poland said. “Given the current politics, I don’t see CDC endorsing something counter to what DHHS and FDA are doing.”

How will these changes affect the next COVID booster?

The changes announced by the FDA could cause major delays when a more nimble response to fast-moving viruses like SARS-COV-2 is needed. Requiring clinical trials of vaccines targeting pathogens that change rapidly “is just not feasible,” Wagner said.

“This is really shackling the development and utilization of vaccines,” Poland said.

It is also unclear how these changes will result in getting more people vaccinated, Hanage said.

What it is likely to do is “to make it more difficult for people who would like to get a vaccine to get one,” he said. “This is effectively a no-vaccine mandate for a large number of Americans.”