Updated COVID shots are approved. Getting one may not be simple

The U.S. Food and Drug Administration has given a thumbs-up to updated mRNA COVID-19 vaccines from Pfizer-BioNTech, Moderna and a non-mRNA vaccine from Novavax-Sanofi, which means they’ll be coming to pharmacies and healthcare settings very soon.

All four approved vaccines target the JN.1-lineage XFG subvariant of COVID-19 for the 2026-27 season. Experts predict it will be a good match to what is circulating.

But changed recommendations from federal health officials led by Health and Human Services Secretary Robert F. Kennedy Jr. have created questions about who will be able to get the shots and whether insurance companies will cover them. And a federal court decision has created a greater muddle, which could make accessing the shots more difficult.

Those 65 and older have blanket approval to get the shots, which are recommended for them. The same applies to younger people with at least one underlying medical condition that could make them vulnerable to severe effects from COVID-19. But for others seeking a COVID vaccine, there are also questions now about whether insurance companies will pay for them, which they have routinely done in the past.

Moderna’s Spikevax is approved for ages 6 months to 64 in people with at least one underlying health condition, plus everyone who is 65 or older. Moderna’s lower-dose vaccine, mNEXSPIKE is approved for ages 12-64 at high risk of severe illness and for everyone 65 or older. The Pfizer-BioNTech Comirnaty shot is for ages 5 and older, with the same potential access challenge. Those 12 and older could also choose the Novavax-Sanofi shot, which is called Nuvaxovid.

Meanwhile, while the number of COVID infections is quite low, according to the Centers for Disease Control and Prevention, they are spreading, with some cases in nearly all states at the CDC’s last count.

Chaos and questions

Every year, a CDC advisory panel — the Advisory Committee on Immunization Practices — meets to recommend who should receive the vaccines. But Kennedy fired the 17-member existing panel, as Deseret News reported at the time, and picked his own eight new members, adding several others later. Then a federal court judge said Kennedy’s action was improper and temporarily suspended 13 of Kennedy’s appointees and voided their earlier votes. He also put a hold on the recommendation that others who want the shot have to consult a healthcare provider. So the panel and its recommendations are in a strange place at the moment.

As The New York Times reported, “About 30% to 60% of Americans have a qualifying condition, FDA officials estimated last year. Aside from age, a long list of factors can increase the risk of severe illness. They include asthma, diabetes, obesity, physical inactivity and pregnancy, as well as cancer, immune deficiency, some mental illnesses and various heart and lung diseases.”

Per The Washington Post reporting, “Two changes made under Kennedy’s leadership are still in effect: revisions regarding healthy children and pregnant women. There is currently no recommendation for pregnant women to receive the shots, and the vaccine is recommended for healthy children through shared decision-making, meaning parents and children should talk with health providers and decide what makes sense for them.”

Doctors can administer the shots off-label as part of that shared decision-making. But most people head to local pharmacies for their COVID shots. And not all doctors have the vaccines on hand. Whether pharmacies will choose to administer shots off-label — or even whether their states allow it — could vary widely nationwide.

Last year, some people seeking shots learned their state doesn’t allow the pharmacist to administer vaccines that the CDC has not recommended, based on the panel’s suggestions. So a panel without clear legal authority could really complicate access. The panel is being described by multiple sources as “in limbo.”

A spokeswoman for the CVS pharmacy chain told the Times that they would start administering doses very soon “to eligible patients in all states as permitted by law.” What that looks like in different states is not clear.

Some states are expected to require a prescription for young people who don’t have specific health conditions.

What about insurance?

Insurers cover shots the advisory committee green lights. But the panel’s questionable status makes it impossible to say what private insurers will do. Medicare has to cover the shots, which are approved and recommended for the people it covers.

AHIP, a trade organization with a lot of insurance companies as members, said those groups will continue to cover the COVID vaccines. Others are starting to say they will.

The Times notes the greatest uncertainty is within the Vaccines for Children program, which provides free vaccines to about half of American kids. The doses come from the CDC, and if there’s no CDC recommendation, it’s another area where uncertainty is the only certainty at the moment.

Medical societies expected to chime in

Several medical groups have said they’ll release their recommendations soon, perhaps as early as next week. The Post has collected their most recent positions on the topic:

• The American Academy of Pediatrics has recommended a COVID-19 vaccine for all children ages 6 through 23 months, and for any children at risk of severe disease. As for healthy children 2 and older, the academy leaves it to parents or guardians to decide.
• The American Academy of Family Physicians recommended that all adults 19 and older get the vaccine, calling it “especially important” for those 65 and older, those at greater risk of severe disease including those with compromised immune systems and those who have not previously received a COVID-19 shot.
• The American College of Obstetricians and Gynecologists said a few months ago that pregnant women should get routine updated shots, as should those considering becoming pregnant and those who are breastfeeding.