U.S. health advisers on Thursday endorsed new COVID-19 boosters that target today’s most common omicron strains, saying if enough people roll up their sleeves, the updated shots could blunt a winter surge.

The tweaked shots made by Pfizer and rival Moderna promise Americans a chance at their most up-to-date protection at yet another critical period in the pandemic. They’re combination or “bivalent” shots, half the original vaccine and half protection against the BA.4 and BA.5 omicron versions now causing nearly all COVID-19 infections.

Advisers to the Centers for Disease Control and Prevention struggled with who should get the new booster and when — because only a similarly tweaked vaccine, not the exact recipe, has been studied in people so far.

But ultimately the panel deemed it the best option considering the U.S. still is experiencing tens of thousands of COVID-19 cases and about 500 deaths every day — even before an expected new winter wave.

“I think they’re going to be an effective tool for disease prevention this fall and into the winter,” said CDC adviser Dr. Matthew Daley of Kaiser Permanente Colorado.

Comparing the tweak that has been studied in people and the one the U.S. actually will use, “it is the same scaffolding, part of the same roof, we’re just putting in some dormers and windows,” said Dr. Sarah Long of Drexel University.

The CDC is expected to adopt that recommendation soon, the last step before shots can begin. Millions of doses are expected to reach vaccination sites nationwide by Labor Day, CDC officials said.

The original COVID-19 vaccines still offer strong protection against severe illness and death, especially among younger and healthier people who’ve gotten at least one booster.

But those vaccines were designed to target the virus strain that circulated in early 2020. Effectiveness drops as new mutants emerge and the longer it’s been since someone’s last shot. Since April, hospitalization rates in people over age 65 have jumped, the CDC said.

The new updated shots are only for use as a booster, not for someone’s first-ever vaccinations. The Food and Drug Administration cleared Pfizer’s bivalent option for people 12 and older while Moderna’s is for adults only.

A big unknown: Exactly how much benefit people will get from one of those extra shots.

The CDC said more than 1,400 people have been included in studies of a prior tweak to the vaccine recipe — targeting an earlier omicron strain named BA.1. That omicron-targeting combo shot proved safe and able to rev up virus-fighting antibodies — and European regulators on Thursday recommended using that type of booster.

In the U.S., the Food and Drug Administration wanted fall boosters to target the currently circulating omicron strains — and rather than waiting until possibly November for more human studies to be finished, the agency accepted mouse testing that showed the newer tweak sparked a similarly good immune response.

That’s how flu vaccines are updated every year, the CDC noted.

Still, several CDC advisers said that to get the maximum benefit, people will need to wait longer between their last vaccination and getting the new booster than the two months that the FDA set as the minimum. Waiting at least three months would be better, from the last shot or if someone had recently recovered from COVID-19, they said.

Before this new COVID-19 booster update, people 50 and older already were urged to get a second booster of the original vaccine — and those who did saw some extra protection especially the longer it had been since their last shot, said CDC’s Dr. Ruth Link-Gelles.

The new combination booster “should provide at least similar or better protection against omicron since it’ll be a better match” to today’s virus strains, she told the panel.

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American adults who haven’t yet gotten vaccinated against COVID-19 may soon get another choice, as advisers to the Food and Drug Administration on Tuesday backed a more traditional type of shot.

Next, the FDA must decide whether to authorize the protein vaccine made by latecomer Novavax as the nation’s fourth coronavirus shot for adults. It’s made with more conventional technology than today’s dominant Pfizer and Moderna shots and the lesser-used Johnson & Johnson option.

N ovavax shots are already available in Australia, Canada, parts of Europe and multiple other countries, either for initial vaccinations or as mix-and-match boosters. But U.S. clearance is a key hurdle for the Maryland-based company.

FDA’s vaccine chief Dr. Peter Marks said another choice in the U.S. may entice at least some vaccine holdouts — whatever their reason — to consider rolling up their sleeves.

“We do have a problem with vaccine uptake that is very serious in the United States,” Marks said. “Anything we can do to get people more comfortable to accept these potentially life-saving products is something that we feel we are compelled to do.”

A final FDA decision isn’t expected immediately, as the agency finishes combing through the data.

Nor is it clear how widely a Novavax vaccine would be used, at least right away. Only about 27 million U.S. adults remain unvaccinated, according to the Centers for Disease Control and Prevention. Eventually, Novavax hopes also to become a choice for the millions more who haven’t yet had a booster dose of today’s vaccines, regardless of which shot people got originally.

The FDA advisory panel voted that the benefits of two primary Novavax doses outweigh its risks — but they had a lot of questions about the shots’ role at this point in the pandemic.

“This vaccine does indeed fill some unmet needs,” such as an option for people with allergies to competing shots, said Dr. Michael Nelson of the University of Virginia.

But the FDA is considering two adult doses for now, when other COVID-19 vaccines have needed a third dose, he said.

And while “this vaccine has incredible potential,” there’s no clear evidence yet of how well it works against the more contagious omicron variant and its siblings, added fellow adviser Dr. Bruce Gellin of the Rockefeller Foundation.

Large studies in the U.S., Mexico and Britain found two doses of the Novavax vaccine were safe and about 90% effective at preventing symptomatic COVID-19. One complication: Those studies were done far earlier in the pandemic.

Novavax chief medical officer Dr. Filip Dubovsky said tests of a booster dose revved up virus-fighting antibodies that could tackle the omicron mutant, data that FDA will have to consider later.

This type of vaccine “we think generates a broad immune response against a broad array of variants,” he told the FDA advisory panel.

Trial participants generally experienced only mild reactions such as injection-site pain or fatigue, but the FDA did highlight a possible concern: six cases of heart inflammation, known as myocarditis, found among the 40,000 people who received the vaccine in studies.

COVID-19 vaccines are coming under close scrutiny for the possibility of heart inflammation after the Pfizer and Moderna shots were linked to that rare risk.

Novavax argued there were other potential causes for the reports. Other infections including COVID-19 also can cause heart inflammation. The company said more than 744,000 vaccinations in other countries so far support the shots’ safety.

Several of FDA’s advisers said the Novavax vaccine should come with a warning until more is known but cautioned against comparisons with the Pfizer and Moderna shots’ estimated rate of the rare side effect.

“I don’t want to stigmatize this vaccine inappropriately,” said Dr. Cody Meissner of Tufts University.

The Novavax vaccine is made of copies of the spike protein that coats the coronavirus, packaged into nanoparticles that to the immune system resemble a virus. Then an immune-boosting ingredient, or adjuvant, that’s made from the bark of a South American tree is added that acts as a red flag to ensure those particles look suspicious enough to spark a strong immune response.

Protein vaccines have been used for years to prevent hepatitis B, shingles and other diseases.

That’s very different than the vaccines currently used in the U.S. The most widely used Pfizer and Moderna vaccines deliver genetic instructions for the body to produce its own copies of the spike protein. J&J uses a cold virus to deliver those instructions.

Manufacturing problems held up Novavax’s vaccine but the company said those problems have been resolved. Novavax, a small biotech company, created the vaccine in its research lab. But the Serum Institute of India, the world’s largest vaccine maker, produces most of its shots including those slated for the U.S.

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Three doses of Pfizer’s COVID-19 vaccine offer strong protection for children younger than 5, the company announced Monday, another step toward shots for the littlest kids possibly beginning in early summer.

Pfizer plans to submit the findings to U.S. regulators later this week. The Food and Drug Administration already is evaluating an application by rival Moderna to offer two-dose vaccinations to tots — and set June 15 as a tentative date for its independent scientific advisers to publicly debate the data from one or both companies.

The news comes after months of anxious waiting by parents desperate to vaccinate their babies, toddlers and preschoolers, especially as COVID-19 cases once again are rising. The 18 million youngsters under 5 are the only group in the U.S. not yet eligible for COVID-19 vaccination.

Pfizer has had a bumpy time figuring out its approach. It aims to give tots an extra low dose — just one-tenth of the amount adults receive — but discovered during its trial that two shots didn’t seem quite strong enough for preschoolers. So researchers gave a third shot to more than 1,600 youngsters — from age 6 months to 4 years — during the winter surge of the omicron variant.

In a press release, Pfizer and its partner BioNTech said the extra shot did the trick, revving up the children’s levels of virus-fighting antibodies enough to meet FDA criteria for emergency use of the vaccine with no safety problems.

Preliminary data suggested the three-dose series is 80% effective in preventing symptomatic COVID-19, the companies said, but they cautioned the calculation is based on just 10 cases diagnosed among study participants by the end of April. The study rules state that at least 21 cases are needed to formally determine effectiveness, and Pfizer promised an update as soon as more data is available.

While the vaccine effectiveness likely could change somewhat, “all of this is very positive for those parents who are looking forward to having a vaccine for their younger children in the coming months,” said Dr. William Moss of the Johns Hopkins Bloomberg School of Public Health, who was not part of the study.

If FDA confirms the data, the vaccine could “be an important tool to help parents protect their children,” agreed Dr. Jesse Goodman of Georgetown University, a former FDA vaccine chief. But he cautioned that it’s essential to track how long protection lasts, especially against serious disease.

What’s next? FDA vaccine chief Dr. Peter Marks has pledged the agency will “move quickly without sacrificing our standards” in evaluating tot-sized doses from both Pfizer and Moderna.

Comparing the two companies’ approaches to vaccinating the littlest kids promises to be challenging.

Moderna asked FDA to authorize two shots, each containing a quarter of the dose given to adults. While that spurred good levels of virus-fighting antibodies, Moderna’s study found effectiveness against symptomatic COVID-19 was just 40% to 50% during the omicron surge, much like for adults who’ve only had two vaccine doses.

“We’ve learned in older children and adults that … we really need three doses to get protection” against newer variants like omicron, Moss said.

That’s something Moderna plans to study, and Moss said he didn’t expect the question would hold up FDA authorization of the first two doses.

Complicating Moderna’s progress, the FDA so far has allowed its vaccine to be used only in adults. Other countries allow it to be given as young as age 6, and the company also is seeking FDA authorization for teens and elementary-age kids.

The FDA has tentatively planned for its expert panel to consider Moderna’s vaccine for older kids a day before taking up the question of shots for the littlest.

If FDA clears either vaccine or both, the Centers for Disease Control and Prevention would have to recommend whether all kids under 5 should receive the shots or only those at high risk.

While COVID-19 generally isn’t as dangerous to youngsters as to adults, some children do become severely ill or even die. And the omicron variant hit children especially hard, with those under 5 hospitalized at higher rates than at the peak of the previous delta surge.

It’s not clear how much demand there will be to vaccinate the youngest kids. Pfizer shots for 5- to 11-year-olds opened in November, but only about 30% of that age group have gotten the recommended initial two doses. Last week, U.S. health authorities said elementary-age children should get a booster shot just like everyone 12 and older is supposed to get, for the best protection against the latest coronavirus variants.

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Moderna hopes to offer updated COVID-19 boosters in the fall that combine its original vaccine with protection against the omicron variant. On Tuesday, it reported a preliminary hint that such an approach might work.

Today’s COVID-19 vaccines all are based on the original version of the coronavirus. But the virus continues to mutate, with the super-contagious omicron variant — and its siblings — the latest threat.

Before omicron came along, Moderna was studying a combination shot that added protection against an earlier variant named beta. Tuesday, the company said people given that beta-original vaccine combination produced more antibodies capable of fighting several variants — including omicron — than today’s regular booster triggers.

While the antibody increase was modest, Moderna’s goal is to produce a combination shot that specifically targets omicron. “These results really give us hope” that next step will work even better, said Dr. Jacqueline Miller, a Moderna vice president.

Tuesday’s data was reported online and hasn’t been vetted by independent experts.

COVID-19 vaccines still are providing strong protection against severe disease, hospitalization and death, even against omicron. That variant is so different from the original coronavirus that it more easily slips past the immune system’s defenses, although studies in the U.S. and elsewhere show an original booster dose strengthens protection. Some countries offer particularly vulnerable people a second booster; in the U.S., that’s anyone 50 or older or those with a severely weakened immune system.

Health officials have made clear that giving boosters every few months isn’t the answer to the mutating virus. They’ve begun deliberating how to decide if and when to change the vaccine recipe.

Just switching to a vaccine that targets the latest variant is risky, because the virus could mutate again. So Moderna and its rival Pfizer both are testing what scientists call “bivalent” shots — a mix of each company’s original vaccine and an omicron-targeted version.

Why would Moderna’s earlier, beta-targeted combo shot have any effect on omicron? It includes four mutations that both the beta variant and the newer omicron have in common, Miller said.

Now Moderna is testing a bivalent shot that better targets omicron — it includes 32 of that variant’s mutations. Studies of two booster doses are underway in the U.S. and Britain; results are expected by late June.

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LOUISVILLE, Ky. (AP) — Cadell Walker rushed to get her 9-year-old daughter Solome vaccinated against COVID-19 — not just to protect her but to help stop the coronavirus from spreading and spawning even more dangerous variants.

“Love thy neighbor is something that we really do believe, and we want to be good community members and want to model that thinking for our daughter,” said the 40-year-old Louisville mom, who recently took Solome to a local middle school for her shot. “The only way to really beat COVID is for all of us collectively to work together for the greater good.”

Scientists agree. Each infection — whether in an adult in Yemen or a kid in Kentucky — gives the virus another opportunity to mutate. Protecting a new, large chunk of the population anywhere in the world limits those opportunities.

That effort got a lift with 28 million U.S. kids 5 to 11 years old now eligible for child-sized doses of the Pfizer-BioNTech vaccine. Moves elsewhere, like Austria’s recent decision to require all adults to be vaccinated and even the U.S. authorizing booster shots for all adults on Friday, help by further reducing the chances of new infection.

Vaccinating kids also means reducing silent spread, since most have no or mild symptoms when they contract the virus. When the virus spreads unseen, scientists say, it also goes unabated. And as more people contract it, the odds of new variants rise.

David O’Connor, a virology expert at the University of Wisconsin-Madison, likens infections to “lottery tickets that we’re giving the virus.” The jackpot? A variant even more dangerous than the contagious delta currently circulating.

“The fewer people who are infected, the less lottery tickets it has and the better off we’re all going to be in terms of generating the variants,” he said, adding that variants are even more likely to emerge in people with weakened immune systems who harbor the virus for a long time.

Researchers disagree on how much kids have influenced the course of the pandemic. Early research suggested they didn’t contribute much to viral spread. But some experts say children played a significant role this year spreading contagious variants such as alpha and delta.

Getting kids vaccinated could make a real difference going forward, according to estimates by the COVID-19 Scenario Modeling Hub, a collection of university and medical research organizations that consolidates models of how the pandemic may unfold. The hub’s latest estimates show that for this November through March 12, 2022, vaccinating 5- to 11-year-olds would avert about 430,000 COVID cases in the overall U.S. population if no new variant arose. If a variant 50% more transmissible than delta showed up in late fall, 860,000 cases would be averted, “a big impact,” said project co-leader Katriona Shea, of Pennsylvania State University.

Delta remains dominant for now, accounting for more than 99% of analyzed coronavirus specimens in the United States. Scientists aren’t sure exactly why. Dr. Stuart Campbell Ray, an infectious disease expert at Johns Hopkins University, said it may be intrinsically more infectious, or it may be evading at least in part the protection people get from vaccines or having been infected before.

“It’s probably a combination of those things,” he said. “But there’s also very good and growing evidence that delta is simply more fit, meaning that it’s able to grow to higher levels faster than other variants that are studied. So when people get delta, they become infectious sooner.”

Ray said delta is “a big family” of viruses, and the world is now swimming in a sort of “delta soup.”

“We have many lineages of delta that are circulating in many places with no clear winners,” Ray said, adding that it’s hard to know from genetic features which might have an edge, or which non-delta variants might dethrone delta.

“I often say it’s like seeing a car parked on the side of the road with racing slicks and racing stripes and an airfoil on the back and a big engine,” Ray said. “You know it looks like it could be a real contender, but until you see it on the track with other cars, you don’t know if it’s going to win.”

Another big unknown: Dangerous variants may still arise in largely-unvaccinated parts of the world and make their way to America even as U.S. children join the ranks of the vaccinated.

Walker, the Louisville mom, said she and her husband can’t do anything about distant threats, but could sign their daughter up for vaccination at Jefferson County Public Schools sites on a recent weekend. Solome is adopted from Ethiopia and is prone to pneumonia following respiratory ailments after being exposed to tuberculosis as a baby.

She said she wants to keep other kids safe because “it’s not good to get sick.”

As a nurse leaned in to give Solome her shot, Walker held her daughter’s hand, then praised her for picking out a post-jab sticker appropriate for a brave kid who just did her part to help curb a pandemic.

“Wonder Woman,” Walker said. “Perfect.”

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An influential advisory panel on Tuesday recommended kid-size doses of Pfizer’s COVID-19 vaccine for children ages 5 to 11, putting the U.S. on the brink of a major expansion of vaccinations. A final decision was expected within hours.

The Food and Drug Administration already has OK’d the kid-size doses — just a third of the amount given to teens and adults — as safe and effective for the younger age group. But the Centers for Disease Control and Prevention formally recommends who should receive FDA-cleared vaccines — and its advisers unanimously decided Pfizer’s shots should be opened to 28 million youngsters.

If the CDC’s director, Dr. Rochelle Walensky, signs off as expected, it will mark the first opportunity for Americans under 12 to get the powerful protection of any COVID-19 vaccine.

“Today is a monumental day in the course of this pandemic,” Walensky told the advisory panel as it began its deliberations earlier Tuesday.

She said while the risk of severe disease and death is lower in young children than adults, it is real — and that COVID-19 has had a profound social, mental health and educational impact on youngsters, including widening disparities in learning.

“There are children in the second grade who have never experienced a normal school year,” Walensky said. “Pediatric vaccination has the power to help us change all of that.”

Pediatricians in parts of the country are ready to start getting shots into little arms as soon as they get the final OK, as Pfizer already has begun shipping millions of doses to states, doctors’ offices and pharmacies.

Many pediatricians and parents have clamored for protection for youngsters so they can resume normal childhood activities without risking their own health — or fear bringing the virus home to a more vulnerable family member.

And several panelists who’ve cared for hospitalized youngsters said they want parents with questions to know the shots are safe and far better than gambling their child will escape a coronavirus infection.

“I have vaccinated my kids,” said CDC adviser Dr. Helen Keipp Talbot of Vanderbilt University, saying she wouldn’t recommend something for other families unless she was comfortable with it for her own. “We have seen the devastation of this disease.”

In the U.S., there have been more than 8,300 hospitalizations of kids ages 5 to 11, about a third requiring intensive care, according to government data. The CDC has recorded at least 94 deaths in that age group, with additional reports under investigation.

And while the U.S. has seen a recent downturn in COVID-19 cases, experts are worried about another uptick with holiday travel and as winter sends more activity indoors where it’s easier for the coronavirus to spread.

Pfizer’s kid shots contain a third of the vaccine dose that’s already been used to vaccinate millions of people 12 and older. The 5- to 11-year-olds will receive two shots, three weeks apart, the same schedule as everyone else — but a smaller amount in each shot, using a smaller needle.

A study of 2,268 youngsters found the kid-size vaccine is nearly 91% effective at preventing symptomatic COVID-19 — based on 16 diagnoses among kids given dummy shots compared to just three who got the real vaccination.

CDC officials calculated that for every 500,000 kids this age vaccinated, between 18,000 and 58,000 COVID-19 cases would be prevented, and prevent anywhere from 80 to 226 hospitalizations.

The FDA examined more children, a total of 3,100 who were vaccinated, in concluding the shots are safe. The younger children experienced similar or fewer reactions — such as sore arms, fever or achiness — than teens or young adults get after larger doses.

That study wasn’t large enough to detect any extremely rare side effects, such as the heart inflammation that occasionally occurs after the second full-strength dose, mostly in young men and teen boys. Regulators ultimately decided the benefits from vaccination outweigh the potential that younger kids getting a smaller dose also might experience that rare risk.

Some of CDC’s advisers said for some parents, deciding to get their children vaccinated may hinge on that small but scary risk.

“The risk of some sort of bad heart involvement is much higher if you get COVID than if you get this vaccine,” Dr. Matthew Oster, a pediatric cardiologist at Emory University, told the panel. “COVID is much riskier to the heart.”

Last week, FDA’s advisers struggled with whether every young child needed a vaccine. Youngsters hospitalized with COVID-19 are more likely to have high-risk conditions such as obesity or diabetes — but otherwise healthy children can get seriously ill, too, and the CDC’s advisers ultimately recommended the shots for all of them.

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