By LAURAN NEERGAARD and MATTHEW PERRONE

AP – Kid-size doses of Pfizer’s COVID-19 vaccine appear safe and nearly 91% effective at preventing symptomatic infections in 5- to 11-year-olds, according to study details released Friday as the U.S. considers opening vaccinations to that age group.

The shots could begin in early November, with the first children in line fully protected by Christmas, if regulators give the go-ahead. That would represent a major expansion of the nation’s vaccine drive, encompassing roughly 28 million elementary school-age youngsters.

Details of Pfizer’s study were posted online. The Food and Drug Administration was expected to post its own review of the company’s safety and effectiveness data later in the day.

Advisers to the FDA will publicly debate the evidence next week. If the agency itself authorizes the shots, the Centers for Disease Control and Prevention will make the final decision on who should receive them.

Full-strength Pfizer shots already are authorized for anyone 12 or older, but pediatricians and many parents are anxiously awaiting protection for younger children to stem rising infections and record hospitalizations among them from the extra-contagious delta variant and to help keep kids in school.

The Biden administration has purchased enough kid-size doses — in special orange-capped vials to distinguish them from adult vaccine — for the nation’s 5- to 11-year-olds. If the vaccine is cleared, millions of doses will be promptly shipped around the country, along with kid-size needles.

More than 25,000 pediatricians and primary care providers already have signed up to get the shots into little arms.

The Pfizer study tracked 2,268 children in the 5-to-11 group who got two shots three weeks apart of either a placebo or the low-dose vaccine. Each dose was one-third the amount given to teens and adults.

Researchers calculated the low-dose vaccine was nearly 91% effective, based on 16 COVID-19 cases in youngsters given dummy shots versus three cases among vaccinated children. There were no severe illnesses reported among any of the youngsters, but the vaccinated ones had much milder symptoms than their unvaccinated counterparts.

Most of the study data was collected in the U.S. during August and September, when the delta variant had become the dominant COVID-19 strain.

In addition, young children given the low-dose shots developed coronavirus-fighting antibody levels just as strong as teens and young adults who got regular-strength vaccinations.

In another piece of encouraging news, the CDC reported earlier this week that even as the delta variant surged over the summer, Pfizer vaccinations were 93% effective at preventing hospitalizations among 12- to 18-year-olds.

Pfizer’s study of younger children found the low-dose shots proved safe, with similar or fewer temporary side effects such as sore arms, fever or achiness that teens experience.

The study isn’t large enough to detect any extremely rare side effects, such as the heart inflammation that occasionally occurs after the second dose, mostly in young men.

While children run a lower risk of severe illness or death than older people, COVID-19 has killed more than 630 Americans 18 and under, according to the CDC. Nearly 6.2 million children have been infected with the coronavirus, more than 1.1 million in the last six weeks as the delta variant surged, the American Academy of Pediatrics says.

Moderna also is studying its COVID-19 shots in elementary school-age youngsters. Pfizer and Moderna are studying even younger children as well, down to 6-month-olds. Results are expected later in the year.

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

WASHINGTON (AP) — U.S. regulators on Wednesday signed off on extending COVID-19 boosters to Americans who got the Moderna or Johnson & Johnson vaccine and said anyone eligible for an extra dose can get a brand different from the one they received initially.

The Food and Drug Administration’s decisions mark a big step toward expanding the U.S. booster campaign, which began with extra doses of the Pfizer vaccine last month. But before more people roll up their sleeves, the Centers for Disease Control and Prevention will consult an expert panel Thursday before finalizing official recommendations for who should get boosters and when.

The latest moves would expand by tens of millions the number of Americans eligible for boosters and formally allow “mixing and matching” of shots — making it simpler to get another dose, especially for people who had a side effect from one brand but still want the proven protection of vaccination.

Specifically, the FDA authorized a third Moderna shot for seniors and others at high risk from COVID-19 because of their health problems, jobs or living conditions — six months after their last shot. One big change: Moderna’s booster will be half the dose that’s used for the first two shots, based on company data showing that was plenty to rev up immunity again.

For J&J’s single-shot vaccine, the FDA said all U.S. recipients, no matter their age, could get a second dose at least two months following their initial vaccination.

The FDA rulings differ because the vaccines are made differently, with different dosing schedules — and the J&J vaccine has consistently shown a lower level of effectiveness than either of the two-shot Moderna and Pfizer vaccines.

As for mixing and matching, the FDA said it’s OK to use any brand for the booster regardless of which vaccination people got first. The interchangeability of the shots is expected to speed the booster campaign, particularly in nursing homes and other institutional settings where residents have received different shots over time.

FDA officials said they wanted to make the booster guidance as flexible as possible, given that many people don’t remember which brand of vaccine they received.

“Being able to interchange these vaccines is a good thing — it’s like what we do with flu vaccines,” FDA’s Dr. Peter Marks told reporters Wednesday evening. “Most people don’t know what brand of flu vaccine they received.”

Still, he added that many people will decide to get a booster from the same company as their initial vaccination.

The agency’s mix-and-match decision was based on preliminary results from a government study of different booster combinations that showed an extra dose of any type revs up levels of virus-fighting antibodies. That study also showed recipients of the single-dose J&J vaccination had a far bigger response if they got a full-strength Moderna booster or a Pfizer booster rather than a second J&J shot. The study didn’t test the half-dose Moderna booster.

Health authorities stress that the priority still is getting first shots to about 65 million eligible Americans who remain unvaccinated. But the booster campaign is meant to shore up protection against the virus amid signs that vaccine effectiveness is waning against mild infections, even though all three brands continue to protect against hospitalization and death.

“Today the currently available data suggest waning immunity in some populations of fully vaccinated people,” said FDA’s acting commissioner Dr. Janet Woodcock. “The availability of these authorized boosters is important for continued protection against COVID-19 disease.”

The Moderna booster decision essentially matches FDA’s ruling that high-risk groups are eligible for the Pfizer vaccine, which is made with the same technology.

FDA recommended that everyone who’d gotten the single-shot J&J vaccine get a booster since it has consistently shown lower protection than its two-shot rivals. And several independent FDA advisers who backed the booster decision suggested J&J’s vaccine should have originally been designed to require two doses.

Experts continue to debate the rationale of the booster campaign. Some warn that the U.S. government hasn’t clearly articulated the goals of boosters given that the shots continue to head off the worst effects of COVID-19, and wonder if the aim is to tamp down on virus spread by curbing, at least temporarily, milder infections.

FDA regulators said they would move quickly to expand boosters to lower age groups, such as people in their 40s and 50s, if warranted.

“We are watching this very closely and will take action as appropriate to make sure that the maximum protection is provided to the population,” said Marks, the FDA’s top vaccine official.

In August, the Biden administration announced plans for an across-the-board booster campaign aimed at all U.S. adults, but outside experts have repeatedly argued against such a sweeping effort.

On Thursday an influential panel convened by the CDC is expected to offer more specifics on who should get boosters and when. Their recommendations are subject to approval by the CDC director.

The vast majority of the nearly 190 million Americans who are fully vaccinated against COVID-19 have received the Pfizer or Moderna options, while about 15 million have received the J&J vaccine.

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Associated Press writer Mike Stobbe contributed to this story from New York.

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

By ZEKE MILLER and LINDSEY TANNER

WASHINGTON (AP) — Children ages 5 to 11 will soon be able to get a COVID-19 shot at their pediatrician’s office, local pharmacy and potentially even their school, the White House said Wednesday as it detailed plans for the expected authorization of the Pfizer shot for elementary school youngsters in a matter of weeks.

Federal regulators will meet over the next two weeks to weigh the safety and effectiveness of giving low-dose shots to the roughly 28 million children in that age group.

Within hours of formal approval, which is expected after the Food and Drug Administration signs off and a Centers for Disease Control and Prevention advisory panel meets on Nov. 2-3, millions of doses will begin going out to providers across the country, along with the smaller needles needed for injecting young children.

Within days of that, the vaccine will be ready to go into arms on a wide scale.

“We’re completing the operational planning to ensure vaccinations for kids ages 5 to 11 are available, easy and convenient,” White House COVID-19 coordinator Jeff Zients said. “We’re going to be ready, pending the FDA and CDC decision.”

The Pfizer vaccine requires two doses three weeks apart and a two-week wait for full protection to kick in, meaning the first youngsters in line will be fully covered by Christmas.

Some parents can hardly wait.

Dr. Sterling Ransone said his rural Deltaville, Virginia, office is already getting calls from people asking for appointments for their children and saying, “I want my shot now.”

“Judging by the number of calls, I think we’re going to be slammed for the first several weeks,” said Ransone, president of the American Academy of Family Physicians.

Justin Shady, a film and TV writer in Chicago, said his 6-year-old daughter, Grey, got nervous when he told her she would be getting the shots soon. But he is bribing her with a trip to Disney World, and “she’s all in.”

The family likes to travel, “we really just want to get back in the swing of seeing the world,” Shady said.

As for youngsters under 5, Pfizer and Moderna are studying their vaccines in children down to 6 months old, with results expected later in the year.

The Biden administration noted that the expansion of shots to children under 12 will not look like the start of the country’s vaccine rollout 10 months ago, when limited doses and inadequate capacity meant a painstaking wait for many Americans.

The country now has ample supplies of the Pfizer shot to vaccinate the children who will soon be eligible, officials said, and they have been working for months to ensure widespread availability of shots. About 15 million doses will be shipped to providers across the U.S. in the first week after approval, the White House said.

More than 25,000 pediatricians and primary care providers have already signed on to dispense the vaccine to elementary school children, the White House said, in addition to the tens of thousands of drugstores that are already administering shots to adults.

Hundreds of school- and community-based clinics will also be funded and supported by the Federal Emergency Management Agency to help speed the process.

The White House is also preparing a stepped-up campaign to educate parents and children about the safety of the shots and the ease of getting them. As has been the case for adult vaccinations, the administration believes trusted messengers — educators, doctors and community leaders — will be vital to encouraging vaccinations.

Dr. Lisa Reed, medical director for family medicine at MAHEC, a western North Carolina safety net provider that serves patients from rural Appalachia and more urban communities such as the tourist town of Asheville, said it is going to take effort to get some families on board.

Reed said she lives “in a community that has a lot of vaccine hesitancy, unfortunately.”

“Some have lower health literacy or belong to ethnic groups that are more hesitant in general” because of a history of mistrust, she said. And Asheville, she said, has a sizeable population of well-educated adults who are longtime vaccine skeptics.

While children run a lower risk than older people of getting seriously ill from COVID-19, at least 637 people age 18 or under have died from the virus in the U.S., according to the CDC. Six million U.S. children been infected, 1 million of them since early September amid the spread of the more contagious delta variant, the American Academy of Pediatrics says.

Health officials believe that expanding the vaccine drive will not only curb the alarming number of infections in children but also reduce the spread of the virus to vulnerable adults. It could also help schools stay open and youngsters get back on track academically, and contribute to the nation’s broader recovery from the pandemic.

“COVID has also disrupted our kids’ lives. It’s made school harder, it’s disrupted their ability to see friends and family, it’s made youth sports more challenging,” U.S. Surgeon General Dr. Vivek Murthy told NBC. “Getting our kids vaccinated, we have the prospect of protecting them, but also getting all of those activities back that are so important to our children.”

Murthy said the administration, which is imposing vaccine mandates for millions of adults, is leaving it up to state and local officials to decide whether to require schoolchildren to get vaccinated. But he said such measures would be “a reasonable thing to consider.”

“It’s also consistent with what we’ve done for other childhood vaccines, like measles, mumps, polio,” he said.

The U.S. has purchased 65 million doses of the Pfizer pediatric shot, which is expected to be one-third the dose given to adults and adolescents, according to officials. They will be shipped in smaller packages of about 100 doses each, so that more providers can deliver them, and they won’t require the super-cold storage that the adult version did at first.

About 219 million Americans age 12 and up, or 66% of the total population, have received a COVID-19 shot, and nearly 190 million are fully vaccinated.

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Tanner reported from Three Oaks, Michigan.