The new FDA framework, published Tuesday in the New England Journal of Medicine by Dr. Vinay Prasad and Martin A. Makary, lays out new standards for updated COVID shots. The doctors say the agency will continue to use a streamlined approach to make them available to adults 65 and older as well as children and younger adults with at least one high-risk health problem.

However, the new framework urges companies to conduct large, lengthy studies before tweaked vaccines can be approved for healthier people. Previous federal policy recommended an annual COVID shot for all Americans six months and older.

In California, the COVID-19 vaccine rate among adults through March 2025 is 65,918. That number has increased from the previous year.

Prasad described the new approach as a “reasonable compromise” that will allow vaccinations in high-risk groups to continue while generating new data about whether they still benefit healthier people.

“For many Americans we simply do not know the answer as to whether or not they should be getting the seventh or eighth or ninth or tenth COVID-19 booster,” said Prasad, who joined the FDA earlier this month. He previously spent more than a decade in academia, frequently criticizing the FDA’s handling of drug and vaccine approvals.

It’s unclear what the upcoming changes mean for people who may still want a fall COVID-19 shot but don’t clearly fit into one of the categories.

Provisional data from the Centers for Disease Control and Prevention shows more than 47,000 Americans died from COVID-related causes last year. In California, 325 deaths attributed to COVID-19 were reported in the last three months.

The new FDA approach is the culmination of a series of recent steps under Health Secretary Robert F. Kennedy Jr., scrutinizing the use of COVID shots and raising questions about the broader availability of vaccines. It was released two days ahead of the first meeting of FDA’s outside vaccine experts under Trump.

Last week, the FDA granted full approval of Novavax’s COVID-19 vaccine but with major restrictions on who can get it — and Tuesday’s guidance mirrors those restrictions. The approval came after Trump appointees overruled FDA scientists’ earlier plans to approve the shot without restrictions.

Pfizer and Moderna, makers of the most commonly used COVID shots, each said they would continue to work with the agency.

The nation’s leading pediatrics group said FDA’s approach will limit options for parents and their children.

“Is the pharmacist going to determine if you’re in a high-risk group?” asked Dr. Paul Offit, a vaccine expert at Children’s Hospital of Philadelphia. “The only thing that can come of this will make vaccines less insurable and less available.”

“If the vaccine were no longer available or covered by insurance, it will take the choice away from families who wish to protect their children from COVID-19, especially among families already facing barriers to care,” said Dr. Sean O’Leary of the American Academy of Pediatrics.

The Associated Press contributed reporting.

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Most Americans should get an updated COVID-19 vaccine, health officials said Tuesday.

Advisers to the Centers for Disease Control and Prevention endorsed the new shots for everyone 6 months and older and the agency’s director quickly signed off Tuesday on the panel’s recommendation. That means doses should be available this week, some as early as Wednesday.

The severity of the COVID-19 pandemic has faded, but there are still thousands of hospitalizations and hundreds of deaths in the U.S. each week. Hospitalizations have been increasing since late summer, though the latest data indicate infections may be starting to level off, particularly in the South.

Still, experts worry that immunity from previous vaccinations and infections is fading in many people, and a new shot would save many lives.

According to a survey last month that CDC cited, about 42% said they would definitely or probably get the new vaccine. Yet only about 20% of adults got an updated booster when it was offered a year ago.

Doctors hope enough people get vaccinated to help avert another “tripledemic” like last year when hospitals were overwhelmed with an early flu season, an onslaught of RSV, or respiratory syncytial virus, and yet another winter coronavirus surge.

Here is what you need to know about the new COVID-19 shots:

WHO SHOULD GET THE UPDA

TED VACCINE?

The Food and Drug Administration approved the updated shot s from Pfizer and Moderna for adults and children as young as age 6 months. FDA said starting at age 5, most people can get a single dose even if they’ve never had a prior COVID-19 shot. Younger children might need additional doses depending on their history of COVID-19 infections and vaccinations.

The CDC decides how best to use vaccines and makes recommendations for U.S. doctors and the general public. The agency’s panel of outside exerts recommended the updated COVID-19 shots by a vote of 13-1. The no vote came from a panel member who had argued that the new shots should initially be recommended only for older people and others at greatest risk of severe illness. But other panel members said all ages could — and should — benefit.

“We need to make vaccination recommendations as clear as possible,” said one panel member, Dr. Camille Kotton, an infectious diseases doctor at Massachusetts General Hospital.

WHERE CAN I GET A SHOT?

The new vaccine will be available at pharmacies, health centers and some doctor offices. Locations will be listed on the government’s vaccines.gov website. The list price of a dose of each shot is $120 to $130, according to the manufacturers. But federal officials said the new COVID-19 shots still will be free to most Americans through private insurance, Medicare or Medicaid. For the uninsured or underinsured, the CDC is working with health departments, clinics and certain pharmacies to temporarily provide free shots.

On Tuesday, a Pfizer official said his company expected to have doses available at some U.S. locations as early as Wednesday.

WHY MORE COVID-19 SHOTS?

Similar to how flu shots are updated each year, the FDA gave COVID-19 vaccine makers a new recipe for this fall. The updated shots have a single target, an omicron descendant named XBB.1.5. It’s a big change. The COVID-19 vaccines offered since last year are combination shots targeting the original coronavirus strain and a much earlier omicron version, making them very outdated.

Pfizer, Moderna and Novavax all have brewed new supplies, and the FDA on Monday approved shots from Pfizer and Moderna. Novavax’s updated vaccine is still under review.

WILL THEY BE EFFECTIVE ENOUGH?

Health officials are optimistic, barring a new mutant. As expected, XBB.1.5 has faded away in the months it took to tweak the vaccine. Today, there is a soup of different coronavirus variants causing illness and the most common ones are fairly close relatives. Recent lab testing from vaccine makers and other research groups suggest the updated shots will offer crossover protection.

Earlier vaccinations or infections have continued to help prevent severe disease and death but protection wanes over time, especially against milder infections as the virus continually evolves. The FDA did allow seniors and others at high risk to get an extra booster dose last spring. But most Americans haven’t had a vaccination in about a year.

CAN I GET A FLU SHOT AND COVID-19 SHOT AT THE SAME TIME?

Yes. The CDC says there is no difference in effectiveness or side effects if people get those vaccines simultaneously, although one in each arm might be more comfortable. The CDC urges a yearly flu shot for pretty much everyone ages 6 months and up. The best time is by the end of October.

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The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Science and Educational Media Group. The AP is solely responsible for all content.

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COVID-19 vaccines are saving an untold number of lives, but they can’t stop the chaos when a hugely contagious new mutant bursts on the scene, leading people to wonder: Will we need boosters every few months? A new vaccine recipe? A new type of shot altogether?

That’s far from settled, but with the shots still doing their main job many experts are cautioning against setting too high a bar.

“We need collectively to be rethinking what is the goal of vaccination,” said Dr. Daniel Kuritzkes, infectious disease chief at Brigham & Women’s Hospital. “It’s unrealistic … to believe that any kind of vaccination is going to protect people from infection, from mild symptomatic disease, forever.”

If the goal is preventing serious illness, “we may not need to be doing as much fine-tuning of the vaccines every time a new variant comes.”

The virus is essentially shape-shifting as it mutates, with no way to know how bad the next variant will be. Already a sub-strain of omicron bearing its own unique mutations is circulating. Research is underway to create next-generation vaccines that might offer broader protection against future mutants — but they won’t be ready anytime soon.

The immediate solution: Getting today’s shots into more arms will “reduce the opportunities for the virus to mutate and spawn new Greek letters that we then have to worry about,” said Jennifer Nuzzo of the Johns Hopkins Center for Health Security.

WHY IMMUNITY ISN’T PERFECT

The job of blocking infection falls to antibodies, which form after either vaccination or a prior bout with COVID-19, ready to fight back the next time someone’s exposed.

One problem: Mutations change the appearance of the spike protein that covers the coronavirus much like a crook switches disguises to evade capture. That’s why omicron was more able to slip past that first defense than earlier variants — its spike coating was harder for existing antibodies to recognize.

Also, the immune system isn’t designed to be in a constant state of high alert, so the antibodies that fend off infection do wane over time. Several months after two doses of the Pfizer or Moderna vaccines, people had little protection against an omicron infection — a result of both waning antibodies and the variant’s mutation.

Thankfully, different immune system soldiers called T cells are key to prevent an infection from turning into severe illness — and that protection is lasting longer because T cells are recognizing other parts of the virus that don’t mutate as easily.

A THIRD DOSE MATTERS

After a booster, protection against symptomatic disease from omicron is about 70% — not as good as the 94% protection seen with earlier variants that more closely matched the vaccine yet highly effective. Importantly, the booster also further strengthened protection against serious illness.

Researchers are closely tracking if infection-fighting antibodies stick around longer after a third dose — but at some point, those levels are guaranteed to wane again. So-called memory cells can make more the next time the body senses they’re needed.

Still, Israel is offering a fourth dose to some people, including those 60 and older, and mulling giving the additional booster to all adults.

The debate is whether repeated boosting really is the best approach — especially since scary new variants are less likely to form once more of the world’s population gets initial vaccinations.

Endless boosting just to keep antibody levels constantly high is “not a public health strategy that works,” said Dr. Paul Offit, a vaccine expert at the Children’s Hospital of Philadelphia.

Pfizer and Moderna are testing omicron-specific boosters in some American adults, although it’s far from clear if authorities would abandon a vaccine recipe proven to save lives for a tweaked version in hopes of fewer breakthrough infections. Brewing a single shot with two kinds of vaccine is technically possible but, again, they’d have to prove the mixture doesn’t weaken the original protection against severe illness.

NEW APPROACHES IN THE PIPELINE

Whatever happens with omicron, it’s clear the coronavirus is here to stay and the U.S. National Institutes of Health is funding about $43 million in projects to develop so-called “pan-coronavirus” vaccines that promise to protect against more than one type. One possibility: Nanoparticles that carry pieces of spike proteins from four to eight different versions of the virus rather than the single type in today’s vaccines.

It’s a tantalizing idea, but NIH infectious diseases chief Dr. Anthony Fauci called it a years-long endeavor. “I don’t want anyone to think that pan-coronavirus vaccines are literally around the corner,” he said.

A possibly more direct approach: Creating COVID-19 vaccines that can be squirted into the nose to form antibodies ready to fight the virus right where we first encounter it. Nasal vaccines are harder to develop than injected versions but attempts are underway, including a large study just announced by India’s Bharat Biotech.

PROTECTION VARIES GLOBALLY

Complicating any possible change to vaccine strategy is the grim reality that only 10% of people in low-income countries have received at least one vaccine dose. Also, recent studies show that some types of vaccines used around the world appear easier than others for omicron to evade, meaning booster strategies may need to be tailored.

Yale University researchers found no omicron-targeted antibodies in the blood of people given two doses of vaccine made by China’s Sinovac. Following those initial shots with a Pfizer booster — a very different kind of vaccine — helped but not enough, only increasing antibody levels to the amount seen by Pfizer recipients who didn’t get a booster.

Overshadowing all of these questions is that “we don’t know how to predict the next strain,” said Dr. Jesse Goodman of Georgetown University, a former Food and Drug Administration vaccine chief. He wants to see a global strategy that defines the trigger for any vaccine change. “Otherwise we are going to have a confused public, again.”

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“By supporting conversations between families and health care providers and answering parents’ questions, we can connect more children to effective vaccines,” said CMS Administrator Chiquita Brooks-LaSure. “The Biden-Harris Administration is requiring states to cover vaccine counseling through Medicaid to create the space for children and parents to ask questions, get answers, and receive the information they need from trusted partners.”

CMS will now consider certain COVID-19 vaccine counseling visits for children and youth to be COVID-19 vaccine administration, for which state expenditures can be federally matched at 100% through the last day of the first quarter that begins one year after the end of the COVID-19 public health emergency, under the American Rescue Plan (ARP).  CMS will match COVID-19 vaccine counseling-only visits at the ARP 100% federal match rate only when they are provided to children and youth under age 21 as part of the Medicaid Early and Periodic Screening, Diagnostic and Treatment (EPSDT) benefit.  

Additionally, moving forward, CMS will require that states cover stand-alone vaccine counseling visits related to all pediatric vaccines under the EPSDT benefit. These state expenditures will be matched at the state’s regular federal medical assistance percentage.

This action not only underscores the importance of vaccination education, but is also a critical step towards protecting families by increasing their access to information from providers as they make informed decisions concerning vaccinations for their children.

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