Missourians who have gotten a COVID-19 vaccine each fall will likely have a harder time finding shots this year.
Manufacturers update the vaccines annually to match circulating variants of the virus in a similar process to flu vaccines. Health officials have recommended updated shots each fall.
But in a change from previous federal recommendations, the U.S. Food and Drug Administration has approved this year’s shots only for older people and those with underlying health conditions.
“The American people demanded science, safety, and common sense. This framework delivers all three,” said U.S. Health Secretary Robert F. Kennedy Jr.
“It is increasingly becoming clear that a healthy person who is under the age of 65 likely will not be able to receive the vaccine in the same way, or with the same access, convenience, kind of ease of use that they did in the past,” said Dr. Laura Morris, a family medicine physician at University of Missouri Health who advises the CDC on immunization practices.
What’s changed since last year?
President Donald Trump’s administration has installed new federal officials – such as Kennedy – who have been skeptical of wide-reaching vaccine policies.
FDA Commissioner Marty Makary and Vinay Prasad, the head of the FDA’s office that regulates vaccines, laid out their immunization philosophy in the New England Journal of Medicine in May.
The two authors said that COVID immunity may not require annual updates and that “natural immunity from COVID-19 against severe disease appears robust.”
Additionally, Makary and Prasad said the country’s one-size-fits-all approach to vaccination may have caused mistrust and fatigue among U.S. residents, who have become less likely to get vaccinated against the coronavirus and are also more likely to eschew vaccines for their kids.
In line with this philosophy, the FDA approved three COVID-19 vaccines late last month for limited groups, including those over 65 and high-risk patients.
Does this mean patients in Missouri won’t be able to get the vaccine as easily?
In short: Yes, especially for patients who are under 65 and who are otherwise healthy.
In previous years, the vast majority of patients received their immunizations at CVS, Walgreens and other pharmacies, according to the CDC.
But pharmacists in Missouri can’t dispense vaccines without FDA approval, said Catherine Gilmore, an assistant professor of pharmacy practice at the University of Health Sciences and Pharmacy in St. Louis.
Those under 65 without an underlying condition will require a doctor’s prescription to get the vaccine, since physicians are able to prescribe “off-label.” Those over 65 and who otherwise meet the conditions for FDA approval will likely still be able to get their shots at these locations.
“It’s getting a lot stickier, especially from our perspective as pharmacists, with who can give them,” Gilmore said. “That due diligence we have to do as pharmacists to make sure that we're reviewing if a patient has that comorbidity … how do I document that? How do I assess it?”
She added, “You know, this is giving me deja vu to when the original COVID vaccine rollout happened, and we had those people in different categories.”
Question: How will patients be able to get it?
If patients are over 65 or in a high-risk group, they will be able to get the vaccine without a doctor’s approval.
People may be surprised that they are a member of a high-risk group. In their New England Journal of Medicine article, FDA leaders listed conditions such as obesity, mood disorders and physical inactivity alongside cancer, asthma and other health risks.
“They have a broader scope than I think some people do realize,” Morris said.
This CDC will clarify the list of qualifying conditions when the agency issues guidelines later this month, Morris said. While the guidelines cannot be broader than what the FDA has issued, there is significant wiggle room when it comes to what those conditions can include. It’s possible the CDC could list working in a hospital or proximity to high-risk people as factors.
Many insurers and state pharmacy boards make policy decisions based on those CDC guidelines. Missouri pharmacy statues say that “except as otherwise authorized by law, vaccines must also be administered in accordance with treatment guidelines established by the Centers for Disease Control and Prevention (CDC) or in accordance with manufacturer’s guidelines.”
If patient are otherwise healthy, they will need a physician’s prescription, said Patrick Aguilar, managing director of health at Washington University’s Olin Business School.
“This becomes an issue on several levels,” he said. “One is physicians being willing to recommend the vaccine for people who wouldn't fit the FDA criteria. Another is pharmacies being able to provide the vaccines without a physician present.”
What do chain pharmacies have to say?
People under 65 trying to book a COVID-19 vaccine appointment at Walgreens or CVS locations in Missouri and Illinois are directed to a prompt that asks if they have high-risk conditions.
If a patent clicks “yes,” Missouri and Illinois patients are able to get an appointment at CVS. The Walgreens prompt directed patients in Missouri to a page that informed them they still needed a prescription to get the vaccine, but appointments in Illinois are available for high-risk patients without a prescription.
“State pharmacy laws govern where we can currently vaccinate,” said CVS spokeswoman Amy Thibault. Based on the FDA approval, CVS can vaccinate in both Missouri and Illinois, granted patients meet the new requirements.
Walgreens has not responded to emailed questions.
What could this mean for public health?
Throughout the pandemic, health experts said that large-scale vaccination protects patients from illness and hospitalization and shields the most vulnerable. Public health officials have said removing barriers to vaccination is the best way to increase uptake.
Morris, who acts as a liaison to the CDC on behalf of the American Academy of Family Physicians, said she advocates for vaccinating people with a high risk of exposure, not just those with health risks.
“The severity of the virus has changed. The number of people transmitting the virus, luckily, has dropped,” she said. “But the fact remains that from a public health perspective, having healthy people immunized also helps to prevent transmission.”
It’s also possible the changes could affect insurance coverage.
“Whether this will be paid for by the insurance companies themselves … or whether patients will be asked to pay the fee themselves. … Those are all open questions,” Aguilar said.
While the vaccine is still available to everyone with a doctor’s consultation, he acknowledged it’s likely many people will not want to go through the trouble.
“I think the thing that's going to be interesting about this is what degree of motivation consumers have to receive the vaccine in the face of these barriers,” he said.
