FDA’s New COVID Vaccine Rules Complicate Access for Young and Healthy North Carolinians
RALEIGH, N.C. – Getting a COVID-19 vaccine in North Carolina just became more complicated. The FDA has narrowed approval of the updated 2025–26 shots to people 65 and older or younger individuals with underlying health conditions, creating new barriers for millions of residents.
What the FDA’s Decision Means
The updated vaccines, made by Pfizer, Moderna, and Novavax, are now only authorized for those most at risk. For healthy young adults and children, the shots are no longer approved — unless a doctor prescribes them “off-label.”
FDA Commissioner Marty Makary defended the move, writing on X:
“100% of adults in this country can still get the vaccine if they choose. We are not limiting availability to anyone.”
White House press secretary Karoline Leavitt echoed the message:
“The FDA’s decision does not affect the availability of COVID vaccines for Americans who want them. We believe in individual choice.”
But experts say that in practice, the change is confusing and could discourage uptake.
Confusion at Pharmacies
Pharmacies have been the primary location for vaccine distribution, but now access is limited by both state law and corporate policy.
- In 19 states, including North Carolina, pharmacists can only administer vaccines to people who meet FDA and CDC guidelines.
- In 13 states, including NC and Virginia, CVS says customers will now need a doctor’s prescription — even if they qualify.
- In three states, CVS will not provide the new vaccine at all until regulations are clarified.
Dorit Reiss, a law professor at UC San Francisco who studies vaccine policy, warned:
“It’s a mess. And by the way, that’s going to probably decrease uptake all by itself, because people aren’t going to know.”
Insurance Coverage Still Unclear
Private insurers say they are prepared to cover the cost of vaccines for all patients, but many are waiting for official recommendations from the CDC’s Advisory Committee on Immunization Practices (ACIP), which meets September 18–19.
Tina Stow, a spokesperson for America’s Health Insurance Plans, explained:
“Individual health plans and plan sponsors will be prepared to make coverage decisions informed by science, the latest medical evidence and data.”
The situation is especially uncertain for people on Medicare and Medicaid, which are directly tied to CDC recommendations.
Uptake Already Low
Last year, only 23% of adults and 13% of children nationwide received the updated COVID shot, according to the CDC. Public health officials worry that the new restrictions, combined with lingering confusion, will drive those numbers even lower heading into the winter respiratory virus season.
Do you think the FDA made the right call by restricting COVID vaccines to high-risk groups, or will it make protecting the public harder this winter? Share your thoughts in the comments and join the discussion at SaludaStandard-Sentinel.com.
