Wellness That Matters: Black Health News & Community Care
- The FDA will limit routine COVID vaccine approvals to seniors and people with underlying risks unless trials show benefit for healthy individuals.
- The decision may restrict access for healthy adults and caregivers, with unclear criteria like physical inactivity determining eligibility.
- The CDC advisory panel could recommend broader access, but insurers may stop covering vaccines for lower-risk people.
- Experts like Michael Osterholm warn narrower approval will reduce access and insurance coverage despite COVID's continued hospital burden.
(NEXSTAR) – A new policy announced by the Trump administration may limit which Americans can get a COVID booster when respiratory virus season rolls around this fall and winter.
The Trump administration said last week it will limit approval for seasonal COVID-19 shots to seniors and others at high risk pending more data on everyone else. The move raises questions about whether some people who want a vaccine, but may not be considered “high risk,” will still be able to get one.
What is the change in COVID vaccine guidance?
Over the past several years, the vaccine recommendations have encouraged all Americans 6 months and older to get an annual booster shot against the COVID-19 vaccine. The vaccine has been reformulated each year to specifically target newer, more common variants.
Now, the Food and Drug Administration says routine vaccine approvals will be limited to seniors and younger people with underlying medical risks, unless there is new research that shows the vaccine prevents severe disease, hospitalization, and death for healthy adults and children. The new framework urges manufacturers to do new clinical trials to prove the vaccines’ value in those healthier groups.
Will I have a harder time getting a COVID booster shot?
The FDA’s decision could make it more difficult for anyone who wants one to get an updated version of the booster shot, explained Libby Richards, a professor of nursing at Purdue University, in an article for The Conversation.
The FDA said it would still routinely approve new vaccine versions for those 65 and older or anyone with risk factors for severe illness from COVID-19. Those underlying conditions include asthma, cancer, chronic kidney or heart disease, diabetes, and pregnancy, among others.
There are other risk factors, like “physical inactivity,” that are also listed in the FDA article published in the New England Journal of Medicine, said Richards. That one is difficult to define, and it’s not clear how it will be judged if someone qualifies as active or inactive.
It’s also unclear how people who live with high-risk, vulnerable people will be treated. Caregivers or those who live with immunocompromised people may want to seek the vaccine to prevent making their loved ones sick, but don’t technically qualify under the updated FDA guidance unless they’re at risk of severe illness themselves.
Normally, Richards added, the FDA decides whether a vaccine is safe and effective, and it’s the the Centers for Disease Control and Prevention who makes recommendations on who is eligible to receive it.
The CDC’s advisory panel typically meets in June to make its own recommendations about the fall shots. The CDC panel could choose to grant access to everyone, or recommend the shots more strongly to high-risk groups (but still give lower-risk people their own choice to get a booster).
Another concern, even if the shot remains available to anyone who wants it, is whether insurers will continue to cover it for healthy adults and children given the updated FDA guidance.
“I’m certain that this will in fact mean that payers will not pay for the vaccines for many, many people who want to receive the vaccine and I think that’s a mistake,” said Michael Osterholm, director at the University of Minnesota’s Center for Infectious Disease Research and Policy, in an interview with NPR.
“The new, narrower FDA approval will likely reduce both access to COVID-19 vaccines for the general public and insurance coverage for COVID-19 vaccines,” Richards agreed.
While demand for vaccinations has dropped, the CDC estimates 30,000 to 50,000 adults have died from COVID-19 since October. The virus continues to cause “enormous burden” on the health care system, CDC’s Dr. Fiona Havers told an FDA panel last week.
Older adults count for most hospitalizations and deaths but COVID-19 also is “a major cause of pediatric hospitalization,” especially in children under 2 — many of whom had no underlying medical problems before their infections.
The Associated Press contributed to this report.
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