The Food and Drug Administration recently announced that it has removed the emergency use authorizations for Covid-19 vaccines. Now, only certain populations in the US will have access to the new shot starting this fall.
This summer, the Food and Drug Administration (FDA) announced that they have removed emergency use authorizations for Covid-19 vaccines. These authorizations allow the FDA to expedite the availability of certain medications. This comes right after the FDA worked to approve an updated version of the vaccine, which is now only available for certain groups.
The new restrictions limit the access to the shots for adults 65 and older and individuals with at least one underlying condition that puts them at a higher risk for severe infection from Covid-19. Previous guidelines gave all Americans aged six months and older access to the vaccine.
This change also comes at a time when a new Covid variant, known as XFG or “Stratus,” is spreading throughout the US. The US health secretary Robert F Kennedy Jr praised the FDA in a post to X, stating that “the framework ended Biden-era vaccine mandates while still keeping vaccines available to those who want them.”
FDA commissioner, Dr Marty Makary, said in his own post: “100% of the adults in this country can still get the vaccine if they choose.”
However, experts like Dr. Adam Ratner, a member of the American Academy of Pediatrics, are stating that access will not be as easy as before, which is alarming considering the way Covid is still present in the US.
“We have plenty of Covid circulating in the US. The more people who choose not to vaccinate their kids and not to vaccinate themselves, the more it will spread, [which could lead to] larger and more severe outbreaks.”
The FDA has approved Moderna vaccines for those six months and older, Pfizer for those five years and older, and Novavax for those 12 year and older. While health officials are stating that any adult who wants a vaccine can get one, other experts are saying that’s unlikely.
“This is misleading,” wrote Dr Jake Scott, a clinical associate professor of infectious diseases at Stanford Medicine.
“Insurance won’t cover off-label use ($150+ costs), pharmacies can’t administer [vaccines] without CDC recommendations you haven’t issued, and you eliminated Pfizer for under-5s entirely.”
“‘Available’ with barriers isn’t accessible,” he stated.
Scott also told the Guardian that the FDA’s announcement “causes so much chaos and confusion.” Under the new FDA rules, people under 65 must be considered “high risk” to qualify.
It’s currently unclear whether or not official CDC immunization guidelines will match the FDA’s, as the CDC’s advisory committee on immunization practices (ACIP) need to meet this month to discuss Covid vaccination policy.
In June, Kennedy fired all 17 sitting members of the ACIP panel and announced eight new members who, like Kennedy, have been vocal vaccine skeptics.
“There’s a lot of concern about this ACIP and our ability to get science-based recommendations from them,” says Ratner. The FDA’s rules now state adults under 65 qualify for a Covid vaccine if they “have at least one underlying condition that puts them at high risk for severe outcomes from Covid-19.”
Dr. Richard Ricciardi, a practicing nurse practitioner and associate dean for clinical practice and community engagement at the George Washington University School of Nursing, stated that it’s currently unclear what an underlying condition will be. “The definitive answer to that has not been put out by the FDA or the CDC yet, so who qualifies for a vaccine is still a little nebulous.”
A previous list from the CDC in February this year lists 22 qualifying conditions including things like asthma, cancer, HIV, and more. The previous list included pregnancy as an underlying condition, and it’s unclear whether the new list from the CDC will be the same, as Kennedy announced in May that Covid vaccines are no longer recommended for healthy pregnant women and children.
“Since the CDC no longer recommends Covid-19 vaccines for healthy children, there is confusion among parents and healthcare providers about whether children will be able to get Covid vaccines or other routine vaccines,” Ratner said to the Guardian. In fact, the new guidelines oppose the AAP’s recommended vaccine schedule which states “infants and children 6 months through 23 months of age are at high risk for severe Covid-19.”
“I wish I had a good answer to how people are going to access vaccines in the coming weeks and months. I guess we will find out more, but it’s a frustrating and confusing time for all of us.”
Scott stated that he suspects there’s going to be a large amount of hesitation among doctors to “prescribe something off-label that they may be liable for.”
“Can you go to Canada and get it? Yeah, you probably could, but why would we have to go to another country to get vaccinated?” says Ricciardi.
CDC data shows that during the 2024-2025 cold and flu season, nearly 90% of people who received a Covid vaccination got it in a pharmacy. Now, pharmacists are unsure what the 2025-2026 season will look like.
“Pharmacists are a little bit anxious because if the ACIP takes on and recommends the same guidelines the FDA has approved, a lot of patients will be unable to get a Covid-19 vaccine,” says Allison Hill, the director of professional affairs at the American Pharmacists Association.
Pharmacy regulations vary from state to state, with some having their own statutes and others following ACIP recommendations. Some states also allow pharmacists to administer vaccines that are off-label.
CVS and Walgreens, two of the nation’s biggest pharmacy chains, are already limiting how and where they provide vaccines.
A spokesperson for CVS said on Friday that “the chain would continue to offer vaccines in 34 states, require prescriptions to administer them in 13 states and the District of Columbia, and stop offering Covid vaccines altogether in Massachusetts, Nevada and New Mexico,” according to the Guardian.
“This is a result of the current regulatory environment, and the lists may change at any time.”
“In the US, a lot of people don’t have insurance, and a lot of people who have insurance don’t have primary care doctors, and they don’t get much medical attention,” says Scott.
“Requiring people to jump through hoops will only further deter people from getting vaccines,” says Hill.
“We know that patients, when they come into the pharmacy and you talk to them about a vaccine, they really need to get that vaccine then and there,” she says.
“If you have to wait on a prescription, you lose the patient.”
Eric Mastrota is a Contributing Editor at The National Digest based in New York. A graduate of SUNY New Paltz, he reports on world news, culture, and lifestyle. You can reach him at eric.mastrota@thenationaldigest.com.
