It will likely be harder for healthy Michiganders under the age of 65 to get the COVID-19 shot this fall.
That’s because the FDA has approved this year’s vaccine with more limitations, potentially setting off a chain reaction of changes to insurance coverage, uncertainty among pharmacists, and general public and provider confusion.
And all that confusion will likely have a chilling effect, said Michigan’s chief medical executive Dr. Natasha Bagdasarian.
“It doesn’t mean it will be impossible, but it may be a little bit harder to get your COVID vaccine,” she said Thursday.
Who is authorized to get the new COVID shots?
People 65 and older, and those over 6 months with medical conditions that put them at “high risk of severe outcomes from COVID-19.”
On Wednesday, U.S. Health and Human Services Secretary Robert F. Kennedy Jr. announced on X that the FDA has authorized the 2025-2026 shots “for those at higher risk,” and ended the Emergency Use Authorization (EUA) for COVID vaccines. Those EUAs made the vaccine available to everyone ages 6 months and older.
The FDA hasn’t released details about what it considers “higher risk,” but the CDC has a list of risk factors.
“If you are otherwise healthy, you would be receiving that vaccine ‘off-label,’” said Dr. Molly O’Shea, a pediatrician in Oakland County and a spokesperson for the American Academy of Pediatrics. (Off-label means a medication is prescribed for a purpose that hasn’t been approved by the FDA.)
And not every shot is approved for the same age groups. Pfizer said its new shot was approved for those 5 and up; Moderna’s Spikevax for those older than 6 months; and Novavax’s shot was approved for those over 12, all with the caveat that those individuals have “at least one underlying condition that puts them at high risk for severe outcomes from COVID-19.”
So how do I get the shot?
The fall supply should start arriving in the next few days. Pfizer announced that shipping of its new shots “will begin immediately to ensure robust supply and rapid access of this season’s vaccine in pharmacies, hospitals and clinics across the country.”
Novavax said its shots will be available “this fall.” And Moderna said its updated vaccines should be available “in the coming days.”
But if you’re not in one of the authorized groups, actually getting the shot may require jumping a few hurdles.
Pharmacies may be able to use your medical records to see if you’ve got underlying health conditions that qualify you. But for those who aren’t authorized, you may need your doctor to write you that off-label prescription.
And some pharmacists or doctors may be hesitant, O’Shea said.
“So anyone who opted to provide that vaccine in an off-label way, now has a liability risk that their med[ical] mal[practice insurance] may or may not cover.”
Will my insurance cover it?
So far, insurance coverage for the vaccine hasn’t changed, meaning they should all still be covering it at no cost.
But some types of coverage will probably change, assuming the Advisory Committee on Immunization Practices (ACIP) changes its guidance next month to reflect the new FDA limitations. ACIP is the group that advises the CDC, and insurers cover costs based on CDC guidance.
“We're hearing from private insurers that they will likely continue to offer all vaccines in the way that they always have, because it's for the benefit of their population,” Bagdasarian said. “But it will no longer be mandated, if ACIP changes their guidance.”
And some types of insurance almost always follow ACIP guidance, including the Vaccines for Children Program (VCP), a federally-funded program that provides free vaccines for kids who couldn’t otherwise afford them. It provides about 50% of all immunizations for kids in the U.S.
“It is my understanding that our member health plans will likely follow the FDA's guidance regarding the COVID-19 vaccination,” said Brian Mills, a spokesperson for the Michigan Association of Health Plans (MAHP) via email Thursday. “Customers are encouraged to contact their respective insurance provider with any specific questions about their policy coverage.”
Without insurance, the cost of a COVID shot can be about $200, though it ranges.
What about pregnant women and healthy kids?
Pregnant women and healthy kids (especially infants) are still at higher risk of getting severely ill from COVID, according to the American Academy of Pediatrics (AAP) and the American College of Obstetricians and Gynecologists (ACOG).
Those groups have recently gone so far as to issue their own guidance, opposing Kennedy’s decision in May to remove the COVID shot from the CDC’s recommended immunization schedules for pregnant women and healthy kids. (Although pregnancy is still included in the CDC’s list of medical conditions that put people at higher risk.) Kennedy has sharply criticized the AAP for releasing separate guidance, accusing it of participating in a “pay-to-play” scheme to promote corporate interests.
Pregnant women “have historically been at an increased risk of severe disease, adverse pregnancy outcomes, and maternal death from COVID-19 infections,” ACOG said in its updated guidance last week.
Getting the shot in pregnancy also offers important protection to newborns, who are at higher risk of hospitalization from COVID, but aren’t able to get the vaccine themselves until they’re six months old.
“Infants continue to be hospitalized for COVID-19 at higher rates than all age groups except adults 75 years and older,” the guidance said.
And while most older kids who get COVID will only have mild symptoms, some kids can get really sick. Plus, getting the COVID vaccine reduces the risk of severe disease, especially with constantly evolving variants.
All kids ages 6-23 months should also get vaccinated, along with “older children in certain risk groups,” according to the recent guidance from the American Academy of Pediatrics.
Healthy kids over the age of two should also get a single dose of the booster shot if their “parent or guardian desires their protection from COVID-19,” according to the AAP guidance.
The impact of all this confusion
The safety and efficacy of the COVID shot hasn’t changed, O’Shea said, even though the FDA’s guidance has.
“The guidelines and the recommendations around who can receive the vaccine were not based on any new information at all,” she said. “And instead, [they] were based on other more political ideas around vaccination, rather than on public health decisions.”
The state health department issued guidance recently encouraging everyone, including pregnant women and healthy kids, to continue getting the shot.
But interest in the shot has been waning in recent years, and the changes in federal guidance just add to the challenges, Bagdasarian said.
“We've already been hearing stories from folks around the state who try to get vaccines, and who have been turned away,” she said. “The people that I think have been most impacted thus far are pregnant women. I have heard at least two stories of pregnant women who have gone to pharmacies and [there has] been confusion, and so they have not received the COVID vaccine at those places.”
The conflicting guidance and potential insurance changes make that access even harder, she said. “All of these factors together could make it so challenging that certain segments of the population just decide to go without a COVID vaccine.”
