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The FDA Has Limited Approvals For COVID Vaccines This Year. With Pharmacy Appointments Already Available, Who Can Even Get a Shot?

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The FDA has announced who is approved to get their COVID-19 vaccine in 2025. (Luis Alvarez/Getty Images)

If you’ve been wondering, “When will the 2025 COVID vaccine be widely available?” you’re not alone.

By this time last year, the 2024-25 COVID-19 vaccines had already been approved by the Food and Drug Administration, recommended by the Centers for Disease Control and Prevention for everyone age 6 months and older and rolled out across the country for several weeks.

The FDA approved updated COVID-19 shots on Aug. 27, but for the first time has limited their use for many Americans, recommending them only for people 65 and older or those younger with a health condition that puts them at higher risk.

The FDA also removed one of the two vaccines available for young children.

Pharmacies including CVS, Walgreens and Safeway have already begun offering appointments online for eligible people, despite the fact that the CDC’s vaccine advisory panel recommendation — which is usually what health insurers base their decisions on around which vaccines they’ll cover for patients — still isn’t here.

Something else to know: On Sept. 3, Governor Gavin Newsom announced he was joining the governors of Oregon and Washington in launching a new “West Coast Health Alliance” that would form its own recommendations in the coming weeks around who should get the updated COVID-19 vaccine in California this year — in the light of what the officials called “the Trump Administration’s destruction of the U.S. CDC’s credibility and scientific integrity.”

So as COVID-19 cases keep rising in the Bay Area, who can even get a vaccine right now? How can you make an appointment, and how could California’s upcoming decisions on vaccines change eligibility?

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Keep reading for what we know about the FDA’s decision to limit COVID-19 vaccines this year, how it affects children, whether people who aren’t considered “high risk” might still be able to get a COVID-19 shot and how it could change health insurance covering these vaccines.

Jump straight to:

Who can get an updated COVID shot this year, according to the FDA?

Previously, the federal government recommended that everyone age 6 months and older should get a COVID-19 shot.

But on Aug. 27, the FDA said that the updated COVID-19 shots from Pfizer, Moderna and Novavax are approved for people at higher risk from the disease, which is:

  • Everyone age 65 and older
  • Younger adults and children with at least one high-risk health condition (also called “comorbidities”), such as asthma or obesity.

Novavax’s shot is only open to people 12 or older, under the same risk-based restrictions now in place for the Moderna and Pfizer options. It’s the nation’s only protein-based COVID-19 vaccine.

Dr. Peter Chin-Hong, an infectious disease expert at UCSF, said the FDA’s decision was “regrettable in the way that it sidelines some others who also have a disproportionate risk for getting serious disease, such as pregnant people, even if they have no comorbidities, and children under two in particular.”

Dr. Abraar Karan, an infectious disease physician and researcher at Stanford University, also stressed the benefits of COVID-19 vaccination for otherwise healthy people that he sees every day when working urgent care shifts.

“I will say that being able to basically be protected enough [to reduce] the chance that you have to miss work, where you have come in and be seen here to be evaluated? It is a big benefit,” he said.

Karan also flagged the ongoing risks of longer-term impacts from a COVID-19 infection. Even if a person doesn’t develop long COVID, he said, many still experience “several days or weeks of weakness, fatigue, mental fog,” he said — for days or even weeks after their infection.

So what counts as ‘high risk’ from COVID?

While we still don’t know if this criteria will be changed, the CDC’s current list of health conditions that make a person at higher risk of severe illness, hospitalization or death from COVID-19 includes:

  • Cancer
  • Chronic lung, kidney and liver disease
  • Heart conditions
  • Certain disabilities
  • HIV infection
  • Mental health conditions, including depression
  • Obesity
  • Being a current or former smoker.

See the full list of who the CDC currently deems high risk.

What has the FDA said about COVID vaccines for kids?

The FDA’s approval said that anyone under 65 — including children — must have an underlying health condition that puts them at higher risk from COVID-19.

Previously, all children aged 6 months and over were recommended to get vaccinated against COVID-19.

What do we know about who can get a COVID-19 vaccine in 2025? (Matt Hunt/Getty Images)

Additionally, Pfizer’s vaccine will no longer be available for any child under 5, even if they have an underlying health condition, because the FDA has revoked the shot’s emergency authorization for that age group.

Parents and caregivers will still be able to seek out shots from rival Moderna, the other drugmaker of mRNA vaccines, which has full FDA approval for children as young as 6 months. But the company’s Spikevax vaccine is only approved for children with at least one serious health problem.

Novavax’s shot is only open to people 12 or older, under the same risk-based restrictions as are now in place for the Moderna and Pfizer options.

That said, in May, the CDC removed the COVID-19 vaccine for healthy children from their recommended immunization schedule, but then updated the guidelines to allow for parents and caregivers to obtain the vaccine for their children only after consulting with their doctor, known as “shared clinical decision-making.”

Last week, the American Academy of Pediatrics offered its own recommendations for kids, saying annual shots are strongly recommended for children ages 6 months to 2 years and advised for older children. The AAP acknowledged that their recommendation “differs from recent recommendations of the Advisory Committee on Immunization Practices of the CDC, which was overhauled this year and replaced with individuals who have a history of spreading vaccine misinformation.”

So what happens next with COVID vaccines?

In June, Health Secretary Robert F. Kennedy Jr. dissolved the CDC’s Advisory Committee on Immunization Practices and replaced its members with a number of doctors and researchers who have repeatedly questioned the safety of commonly used vaccines and ingredients.

That’s the panel that in previous years has met to offer annual recommendations for who should get that year’s updated COVID-19 shot, following the FDA approval — recommendations that health insurers then use to determine whose vaccines they’ll cover. After the CDC recommendations, in previous years, COVID-19 vaccines have typically been rolled out widely within days.

This year, the new ACIP panel is expected to meet on Sept. 18 and 19.

How will California’s new vaccine alliance impact who can get the new COVID shot this year?

On Sept. 3, Governor Gavin Newsom announced he was joining Oregon Governor Tina Kotek and Washington Governor Bob Ferguson in launching a new “West Coast Health Alliance” that would form its own recommendations “in the coming weeks” around who should get the updated COVID-19 vaccine in California this year.

The joint governors’ statement said that these states were forming the alliance in the light of “the Trump Administration’s destruction of the U.S. CDC’s credibility and scientific integrity,” pointing particularly to Kennedy’s purge of the CDC’s vaccine panel in May.

It’s not yet clear when exactly these localized recommendations will roll out, how they’ll expand on the FDA’s eligibility criteria and how any such expansion would impact how insurers might cover the updated COVID vaccines.

Why are online appointments already available at pharmacies for the new COVID-19 shots?

CVS, Walgreens and Safeway are already offering appointments online in California for eligible people to get the updated COVID-19 shot starting this week, despite the lack of the CDC recommendation.

You can only make an appointment to get vaccinated at these pharmacies if you’re age 65 or older, or check the box saying you have a health condition that puts you at higher risk from COVID-19 (i.e., that you meet the requirements of the latest FDA approval.)

In previous years, vaccine appointments at pharmacies have only rolled out once the CDC has weighed in. California is one of the 34 states in which pharmacies like CVS are permitted to offer the COVID-19 vaccine without a prescription from a provider.

Read our full guide to finding a COVID-19 vaccine at a pharmacy near you.

Will your vaccine at a pharmacy even be covered by health insurance if the CDC recommendation hasn’t been issued by Sept. 4? In a statement last week, CVS said that “Our understanding is that the COVID-19 vaccine is covered by most insurance plans at no cost for eligible patients,” but that patients should still “check with their insurer to determine whether the updated COVID-19 vaccine is covered by their individual health plan.”

Blue Shield and United Healthcare did not respond to KQED’s request for confirmation that they will indeed cover the shots for eligible patients before the CDC’s recommendation is released.

Remember, if you get your health care through a health system like Kaiser Permanente or Sutter Health, even if you’re eligible for the new COVID-19 shot according to the FDA you almost certainly won’t be able to get the vaccine covered by insurance at a pharmacy (the way you can’t get your flu shot covered by Kaiser at a pharmacy either.) Instead, you’ll have to wait until the vaccine is offered by Kaiser itself.

Jump to more about what we know about health insurance covering the new COVID-19 vaccines this year. 

Will I need to provide the pharmacy proof of any health conditions?

CVS confirmed Friday that if someone has self-attested in the CVS appointment scheduling process that they have a health condition that puts them at higher risk from COVID-19, they won’t be asked for documentation or proof of that condition by the pharmacist at their appointment in order to get their vaccine.

So if I don’t fall under the FDA’s new limits, can I still get an updated COVID vaccine this year?

We just don’t know yet.

On social media platform X, Kennedy claimed that COVID-19 vaccines “are available for all patients who choose them after consulting with their doctors.” While the updated COVID-19 vaccines — which target a newer version of the continuously evolving virus — were set to ship immediately after the FDA approval, access will still depend on decisions by federal health advisers, private health insurers, pharmacies and state authorities.

This all means it could be days or weeks before many Americans know for sure if they’ll be able to get a COVID-19 shot this year.

“I just worry that having targeted recommendations will make it harder for the people who even are part of the recommendations to get the vaccine,” said UCSF’s Chin-Hong. “Because of confusion and uncertainty amongst insurance companies and pharmacists, and professional bodies that represent clinicians.

“At the end of the day, what’s going to happen is that the people who need it the most are going to suffer the most,” he said.

What about getting the shot “off label”?

The FDA’s decision on Wednesday affects what’s called the vaccine’s “label.” It’s possible that someone who isn’t on the FDA’s list of groups approved for the COVID-19 shot could find a doctor or other health professional willing to give the shot “off label,” i.e., outside the use listed on the FDA label.

Doctors can write these off-label prescriptions “as long as you go over the risks and benefits with the patients,” said Chin-Hong — but there are still issues inherent in this approach, he said. Not only would a patient need to have access to a doctor they feel comfortable talking to about this, but it also relies on the provider themselves feeling comfortable to actually write the prescription.

There’s also the big question of whether your insurance will cover your vaccination if it’s off-label — i.e., if you’re not included in the FDA’s list of who can get the updated COVID-19 shot this year. For an insurer, it could be “low-hanging fruit for someone not to get covered, if it’s not officially authorized,” Chin-Hong said.

What about getting the shot at a pharmacy?

Depending on the CDC panel’s advice, Americans under 65 could be required to provide documentation of a serious medical condition before they can get the shot.

But pharmacists, who administer most COVID-19 vaccines in the U.S., typically aren’t expected to collect that kind of documentation. Case in point: If you make an appointment to get the new COVID-19 vaccine at CVS right now, you’ll only be asked to self-attest that you have a health condition that puts you at high risk from COVID-19, and CVS has confirmed the pharmacist won’t ask you for proof at your appointment.

Laws governing pharmacists’ ability to administer routine vaccinations vary by state, where pharmacists are licensed. And most relevantly here, not only may pharmacists be reluctant to give vaccines off-label, but many states actually limit vaccinations by pharmacists to those recommended by the CDC panel.

A woman with long blond hair, wearing a white face mask, fills a syringe from a small, clear vile that contains a Pfizer booster.
Previously, the federal government recommended COVID-19 vaccines for everyone age 6 months and older. That’s just changed. (Justin Sullivan/Getty Images)

If I can get an updated COVID shot, will it be covered by health insurance if I don’t fall under the FDA’s approval list?

COVID-19 shots can cost $150 or more out of pocket if not covered by insurance. Right now at CVS, the cost of a COVID-19 vaccine is $198.99.

Insurers typically base their vaccine coverage decisions on the recommendations of the CDC’s panel of advisers. But some say they will also look to medical professional groups, including the American Medical Association — potentially leaving the door open for insurers to cover vaccinations for more groups than are included in the FDA’s narrow approvals list.

In a statement Friday, a spokesperson for Kaiser Permanente told KQED that their clinical experts were “reviewing the details of the FDA’s approval of the 2025-26 COVID vaccine, and while they’d also be reviewing the CDC’s recommendations when they’re released, Kaiser would also be “evaluat[ing] other sources of clinical recommendations, including relevant medical societies, to ensure safe and effective administration of the COVID vaccine.”

“Kaiser Permanente is committed to making the 2025-26 COVID vaccine available at no cost to children and adults for protection from severe illness from COVID,” said the spokesperson — who did not give a timeframe on when Kaiser members could expect the shot to roll out within the health system. (Remember, if you get your health care through a health system like Kaiser Permanente or Sutter Health, you almost certainly won’t be able to get the new COVID-19 vaccine for free — i.e., covered by insurance — at a pharmacy like CVS or Walgreens, the way you can’t get your flu shot covered by Kaiser at a pharmacy either.)

KQED has reached out to other major California insurers about their plans to cover COVID-19 vaccination this year, but has not yet received a response.

Epidemiologist Dr. Michael Osterholm, leader of the Vaccine Integrity Project and director of the Center for Infectious Disease Research and Policy at the University of Minnesota, told KQED Forum on Aug. 21 that his group had also been in discussions with health insurers about the issue of who will get their COVID-19 vaccinations covered in 2025.

Insurers, Osterholm said, “are looking at ways that they can cover more than what has been recommended by the CDC — think of that as kind of the basement to their recommendations.”

“When they look at the ceiling, it may be that they will be able to justify paying for all of these vaccines as they did before,” he said.

Why is access to COVID vaccines changing?

The approach reflects the vaccine skepticism of President Donald Trump’s second administration. Kennedy and FDA Commissioner Marty Makary have both been outspoken critics of wide-scale vaccinations.

Earlier this month, when his Department of Health and Human Services canceled nearly half a billion dollars in contracts for mRNA vaccine development, Kennedy falsely claimed that the vaccines “don’t perform well against viruses that affect the upper respiratory tract,” like COVID-19.

Back in May, Kennedy said he “couldn’t be more pleased” to announce that the CDC had removed the COVID-19 vaccine for healthy children and healthy pregnant women from their recommended immunization schedule. This decision makes it much harder for these groups to get the COVID-19 shot because insurance companies would not be required to pay for them.

“It’s hard not to look at this [FDA] announcement within the framing of RFK Jnr.’s hesitancy, or pushback, against vaccines,” said Stanford’s Karan. “A lot of claims being made against mRNA vaccines that are sort of framing them in a light that is overly-critical or unjustified.”

“And so it’s hard not to think that this is also part of why these restrictions have been put in place,” said Karan.

Karan also flagged the point that despite his claims that mRNA COVID-19 “don’t perform well” against  the virus, Kennedy has nonetheless overseen the FDA approving them, in his own words, “for those at higher risk” from COVID-19.

You’re saying they’re not effective? But you’re actually saying ‘They are effective, we are approving them —  we’re just going to nitpick on who gets them and who doesn’t get them,'” said Karan.

“They’re all over the place.

Why is there a new version of the COVID vaccine?

COVID-19 vaccines do a good job preventing severe disease, hospitalization and death, which remain a bigger risk for seniors and people with underlying health factors, including heart disease, lung disease and cancer.

Preliminary data from the CDC estimates 47,500 Americans died from COVID-related causes last year. In at least two-thirds of those cases, COVID-19 was listed as the underlying cause of death. For the rest, COVID-19 was a contributing factor.

The updated shots from Pfizer, Moderna and Novavax target a coronavirus subtype named LP. 8.1, a recently dominant version of the virus that is closely related to some newly emerging cousins.

All three shots were initially made available under the FDA’s emergency use authorization, an expedited process to quickly review vaccines and other countermeasures during the pandemic. Pfizer had not yet sought full approval for its doses designed for children under 5, which is the reason that Moderna will be the only provider of shots for the youngest children this year.

In addition to revoking emergency use of Pfizer’s vaccine in young children, Kennedy said Wednesday the government also pulled remaining authorizations for all other COVID-19 vaccines and convalescent plasma, a therapy used during the pandemic to treat hospitalized patients before the first antiviral drugs became available.

This story contains reporting from The Associated Press.

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