"Customers expect they can just walk in and then get the vaccine like it used to be. But that's changed now," said Senthil Radhakrishnan, Pharmacy Manager at Raleigh Pharmacy.
The vaccines are approved for use in people 65 and older, as well as those younger with at least one health condition that makes them high-risk, with age limitations based on each respective vaccine (six months and older for Moderna, five years and older for Pfizer-BioNTech, 12 years and older for Novavax).
"These vaccines are available for all patients who choose them after consulting with their doctors," Health and Human Services Secretary Robert F. Kennedy Jr. wrote in a post on X. "The American people demanded science, safety, and common sense. This framework delivers all three."
According to the CDC, those conditions include asthma, cancer, chronic lung disease, diabetes, Down syndrome, heart conditions, obesity, and pregnancy, among others.
"The most important thing for parents to do right now is to talk to a health care professional, talk to your pediatrician about whether or not your child is high risk, especially if you're a young child under the age of two months, or if you're around anyone who is at high risk," said ABC News Medical Contributor Dr. Alok Patel.
The FDA plays just one role in this process. Next month, the CDC's Advisory Committee on Immunization Practices (ACIP) is scheduled to meet and review the FDA approval, where they'd make their recommendations on its usage to the CDC.
"Normally, we would have guidance from the Advisory Committee on Immunization Practices at this point, and that's what pharmacists go by for their vaccine administrations. Doctors also use that as a reference, and that's not happened yet, which is one way in which this season is unusual. That's what's creating some of this confusion," said Dr. Zack Moore, who serves as NCDHHS State Epidemiologist.
Private insurers and the federally funded Vaccines for Children Program rely on guidance from ACIP in determining whether to provide coverage for vaccines.
"The question remains is will insurance cover them and will they be available to everyone as easily as they have been in the past? So, if you are 65 and older or have a high-risk medical condition, you should be covered. But if not, you're going to want to go through a doctor and many places are suggesting you may need a prescription," said Patel.
While COVID cases are rising nationally and in North Carolina, they still remain markedly lower than this same time period in prior years. Still, health officials are warning against downplaying its seriousness.
"Vaccines are still the most important way to protect yourself and your family against severe illness or complications from COVID," said Moore.
"Even though children tend to do pretty well compared to other populations, I'll tell you from firsthand experience, not as a medical journalist but as a pediatrician who works in the hospital, we still see children hospitalized regularly with complications from COVID-19," Patel explained.
Citing the "current regulatory environment," CVS listed North Carolina among 13 states and Washington, D.C. in which it's currently requiring customers to provide a prescription from a provider to receive a shot. Back at Raleigh Pharmacy, Radhakrishnan is working to inform customers about the changes.
"A lot of them don't know the new guidelines. They just call in and say, 'I need a vaccine'. Then I ask them, 'What's your age?' If they are below 65, then do they have any underlying diseases," said Radhakrishnan.