The Oct. 1 start of the 2025-26 infectious diseases season is arriving with a stark dose of reality for many North Carolina residents wanting — if not needing — to boost their protection against the latest COVID strains.
With the goals of helping resolve, or at least address vaccine confusion, Gov. Josh Stein took action Friday by authorizing an executive standing order — effective immediately — in response to the Trump administration’s current federal health guidelines.
The standing order enables people ages 65 and older, as well as those ages 18 to 64 with at least one high-risk condition, to get the 2026-26 COVID vaccine booster dose without a prescription through the services of a pharmacy chain or local pharmacy.
Typical high-risk conditions involve asthma, cancer, heart disease, lung disease, obesity, diabetes, history of smoking, depression, severe physical inactivity and pregnancy.
Pharmacists will ask individuals to attest to their high-risk condition, but they will not be required to provide medical documentation.
DHHS said the standing order is based on the state’s Public Readiness and Emergency Preparedness Act.
Stein called the prescription requirement for the two groups “unnecessary red tape.”
“Health care providers and pharmacists recommend vaccination as a safe and effective tool to protect yourself and your community from COVID-19,” Stein said.
“This action ensures that North Carolinians most at risk who want protection from COVID-19 can get it as we enter the cold and flu season.”
Even though DHHS projects millions of North Carolinians will want a COVID vaccine booster, Stein acknowledged that there may be pushback against the standing order from anti-vaccine advocates.
“If you do not want a COVID vaccine, don’t get one,” Stein said. “But if you do, and the FDA recommends, you should be able to get it.
“This is about choice. It is not a mandate.”
How we got here
The booster dose was approved by the Food and Drug Administration in late August for distribution to pharmacies.
However, before Stein’s executive order, North Carolina was among 11 states whose state law requires presenting a prescription until the federal Advisory Committee on Immunization Practice determines which individuals are eligible for the 2025-26 COVID vaccine booster without a prescription.
Until federal health recommendations are set — possibly by Sept. 30 — health insurers may not pick up most or all of the $225 per dose cost, which could be making getting the vaccine cost-prohibitive for many individuals. You may be able to save on a COVID vaccine with a GoodRx coupon.
“The standing order will serve as a prescription for immunizing pharmacists to administer COVID-19 vaccines to adults for whom the FDA has already approved the vaccine,” according to a N.C. Department of Health and Human Services news release.
Before the standing order was issued, some CVS MinuteClinics had been marketing providing the vaccine booster for free with health insurance coverage.
Minute Clinics, like other urgent-care clinics, operate as separate providers, not pharmacies, within CVS locations, according to DHHS.
“They do not need authorization from NCDHHS or an external provider’s order.
“Individuals receiving services at these sites are typically charged for a medical evaluation and the vaccine. Typically, medical insurance will pay for both.”
DHHS cautioned that “since the seasonal vaccine formulations were recently approved by FDA, it may not yet be available at all locations.”
“People should call their pharmacy of choice to see if they have COVID-19 vaccines available and make an appointment if needed.
“You should bring your insurance card if you have one and be prepared to answer a few simple questions, like how old you are or whether you have a qualifying condition.”
‘Unnecessary barrier’
Stein said the standing order issued by state Health Director Dr. Larry Greenblatt is aimed at addressing “a lot of uncertainty right now about who can get the COVID-19 vaccine and who will be able to afford it.”
For adults not in those two categories, they can get the vaccine booster, but are required to present a prescription to a pharmacist.
Parents are required to talk to a health care professional before children ages 6 months to 17 can be vaccinated.
State Health Secretary Dr. Dev Sangvai said the prescription requirement “at this critical access point is an unnecessary barrier for patients, providers and pharmacies, and to the health and well-being of North Carolinians.”
DHHS said Friday that during 2024, there were more than 120,000 emergency department visits for COVID-like illness, resulting in more than 21,600 hospitalizations.
According to DHHS, more than 70% of COVID-19 doses in North Carolina were given at pharmacies last year, “showing those facilities are an important point of access for those who want the COVID-19 vaccine.”
Sangvai said the standing order was prompted in large part by confusion among potential booster recipients and among pharmacists.
“People are thinking they have the same ability to access the vaccine at a pharmacy like they did in previous years,” Sangvai said.
“Pharmacies have been saying they are seeing individuals coming to the counter requesting a COVID vaccine, only to be turned away because of the lack of a prescription.”
Sangvai said getting the COVID vaccine booster is important because booster doses tend to weaken over time.
“The current vaccine has been modified to best match the current COVID strains circulating.”
“The North Carolina Retail Merchants Association supports allowing North Carolinians 18 and older who choose to receive a COVID vaccine to get it at their local pharmacy without a prescription in accordance with recently issued FDA guidelines,” said Andy Ellen, the association’s president and general counsel.
“This order reduces confusion and brings North Carolina in line with the policies in place in the overwhelming majority of other states.”
“Most insurance plans are accepted,” Cone said. “If a patient does not meet the FDA eligibility criteria, it is unclear whether it will be covered by insurers. We recommend they reach out to their insurer.”
State law restrictions
Further complicating the current reality: a bipartisan state law passed in 2023 restricts how immunizing pharmacists administer all vaccines.
The key restriction is that vaccines must be recommended annually by the federal Advisory Committee on Immunization Practice.
The ACIP committee’s board has been filled with vaccine skeptics appointed by U.S. Health Secretary Robert Kennedy Jr.
“NCDHHS is closely monitoring for changes in federal recommendations for COVID vaccines,” the department said.
“At the same time, we are actively exploring options to improve vaccine availability and ensure that all North Carolinians have convenient access to vaccinations throughout the state.”
NCDHHS cited that “professional medical societies continue to recommend COVID vaccination for all young children and pregnant women.”
National perspective
Some pharmacists may be reluctant to give shots to customers who fall outside the FDA’s approval range, Brigid Groves, vice president with the American Pharmacists Association, told The Associated Press.
Earlier this year, the CDC changed its recommendation from all healthy pregnant women should be vaccinated for COVID to “no guidance.”
The American College of Obstetricians and Gynecologists recommends pregnant women continue to get the vaccine.
The American Academy of Family Physicians recommends the COVID-19 vaccine for children ages 6 to 23 months given the potential serious risk from a COVID infection.
“As we navigate fall respiratory virus season and shifting federal guidelines, the AAFP urges all adults, children and families to stay up to date on recommended vaccines to keep themselves and their loved ones healthy,” the group said.
In August, U.S. DHHS notified states participating in the federal Vaccines for Children program that they must respect state religious and conscience exemptions from vaccine mandates.
“States have the authority to balance public health goals with individual freedom, and honoring those decisions builds trust,” Kennedy said in a statement.
“Protecting both public health and personal liberty is how we restore faith in our institutions and Make America Healthy Again.”
Uncertain and confused
Joshua Swift, Forsyth County’s health director, said he understands the uncertainty and confusion circulating in the local community about accessibility to the COVID-19 booster.
Swift said the best advice he has at the moment is that “individuals should consult with their medical provider for detailed guidance regarding their specific medical needs.”
Kamilah Pleasants, assistant health director for Forsyth, told the county commissioners on Sept. 8 that the limited funds that the department has for COVID-19 vaccine for the 2025-26 season is being dedicated to children.
Forsyth County Commissioner Dan Besse said that “I am interested in looking to see where in our budget we might find some limited funds for additional purchases. That is, if we have the ability to use it, of course.”
“I am deeply concerned about the impact on our community’s health from the lack of availability” of the COVID-19 vaccine, Besse said.
“The need for public vaccination is higher, not lower, and I am outraged at the decisions coming from national DHHS over this.
“Quite frankly, (U.S. Health) Secretary (Robert) Kennedy Jr.’s (statements) have been widely condemned by the medical community as without factual basis, and putting many at-risk people at greater risk of serious illness,” Besse said.