Pfizer asked U.S. regulators Monday to expand use of its updated COVID-19 booster shot to children ages 5 to 11.

Elementary school-aged children already received kid-sized doses of Pfizer’s original vaccine, a third of the dose given to everyone 12 and older — two primary shots plus a booster.

If the Food and Drug Administration agrees, they would start getting a kid-sized dose of the new omicron-targeted formula when it is time for their booster.

FDA vaccine chief Dr. Peter Marks said last week he expected a decision on boosters for that age group soon.

Pfizer and its partner BioNTech also announced a new study of the omicron-focused booster in even younger children, those ages 6 months through 4 years, to test different doses.

Updated boosters made by both Pfizer and rival Moderna rolled out earlier this month for everyone 12 and older. They’re a tweak to vaccines that already have saved millions of lives — a combination or “bivalent” shot that contains half the original recipe and half protection against the BA.4 and BA.5 omicron relatives responsible for most of today’s COVID-19 cases.

The hope is that the modified boosters will help tamp down continuing COVID-19 cases and blunt another winter surge. As of last week, the Centers for Disease Control and Prevention said 4.4 million Americans had gotten an updated booster so far.

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Pfizer will spend about $5.4 billion to buy Global Blood Therapeutics as the pharmaceutical giant continues to invest some of the cash influx reaped during the COVID-19 pandemic.

Pfizer said Monday that the acquisition will boost its work in rare hematology. Global Therapeutics, which was founded in 2011, makes Oxybryta tablets for treating sickle cell disease.

Pfizer has been flush with cash since its COVID-19 vaccine, Comirnaty, and its treatment, Paxlovid, have hit the market, starting with the vaccine in late 2020. The drugmaker has now announced deals valued at a total of nearly $19 billion, counting debt, since late last year.

The latest deal follows Pfizer’s $11.6 billion acquisition of Biohaven, which the companies announced in May, and a $6.7 billion acquisition of Arena Pharmaceuticals announced last December.

Pfizer also detailed in April a smaller acquisition of the privately held ReViral Ltd., which is developing a treatment for respiratory syncytial virus.

Pfizer Inc.’s vaccine and treatment brought in more than $16 billion combined just in the recently completed second quarter.

Comirnaty rang up nearly $37 billion in sales last year alone, but those sales are expected to fade in a few years. Pfizer also faces over the next decade the loss of patent protection for key products like Eliquis for preventing blood clots and strokes.

The company plans to have about $25 billion in sales by 2030 come from new business developments.

Aamir Malik, the company’s chief business innovation officer, told analysts recently that Pfizer was “leaving very few stones unturned” in looking for expansion opportunities. Malik said Pifzer was looking for deals that will add substantial value either scientifically or commercially.

“I think we’re very excited about the opportunities that are ahead of us and the flexibility that our balance sheet gives us to pursue those,” he said during a call to discuss second-quarter results.

Malik told analysts that the Biohaven deal alone could add $6 billion in peak sales to Pfizer’s business.

The drugmaker said Monday that the sickle cell disease franchise of Global Blood Therapeutics, which includes treatments still in development, could eventually reach worldwide peak sales of more than $3 billion.

Oxbryta sales were about $195 million last year, but Pfizer said it plans to speed up distribution of the drug to parts of the world most impacted by the disease.

Sickle cell disease is an inherited blood disorder that can lead to bouts of acute pain and organ damage. It occurs particularly among people of African descent. The companies say there are 4.5 million people living with the disease globally.

Pfizer will pay $68.50 per share in cash for each share of Global Blood Therapeutics. That represents a premium of nearly 43% from the stock’s closing price of $47.99 on Aug. 4, the day before The Wall Street Journal reported that Pfizer was in advanced talks on a deal.

Both companies’ boards have approved the deal, which still needs regulatory approval and approval from GBT shareholders. The companies say the deal could close as soon as the fourth quarter.

Shares of Global Blood Therapeutics Inc., based just outside San Francisco, rose more than 4% to $66.58 in morning trading. Broader indexes and shares of New York-based Pfizer climbed slightly.

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WASHINGTON (AP) — Federal health officials said Sunday that kid-sized doses of Pfizer’s COVID-19 vaccines appear to be safe and effective for kids under 5, a key step toward a long-awaited decision to begin vaccinating the youngest American children.

The Food and Drug Administration posted its analysis of the Pfizer shot ahead of a Wednesday meeting where outside experts will vote on whether the shots are ready for the nation’s 18 million babies, toddlers and preschoolers. Kids under 5 are the only group not yet eligible for COVID-19 vaccination in the U.S.

Late last week the FDA posted a similar analysis of Moderna’s shots for children under 6.

If regulators clear the shots by one or both companies, vaccinations could begin as soon as next week with the drugmakers ready to rapidly ship doses ordered by the government. Parents have been pressing federal officials for months for the opportunity to protect their smallest children as more adults shed masks and abandon other public health precautions.

While only about 3% of U.S. COVID cases are in the age group 6 months to 4 years, hospitalization and death rates in that group are higher than those for older children, according to the FDA’s analysis — one reason experts have said protecting this group is important.

The FDA said children who received Pfizer’s shots during testing developed high levels of virus-fighting antibodies expected to protect them against coronavirus. That’s the basic threshold needed to win FDA authorization. But additional testing turned up key differences, with stronger results for Pfizer.

Pfizer’s vaccine, given as a three-shot series, appeared 80% effective in preventing symptomatic COVID-19, although that calculation was based on just 10 cases diagnosed among study participants. The figure could change as Pfizer’s study continues.

Moderna’s two-dose series was only about 40% to 50% effective at preventing milder infections, though the two companies’ shots were tested at different times during the pandemic, when different variants were circulating. Moderna has begun testing a booster for tots.

On Wednesday, the FDA will ask an independent panel of vaccine experts to debate both companies’ data before voting. The FDA is not required to follow the group’s recommendations, but the process is seen as a key step in publicly vetting the shots.

The FDA is expected to make its official decision shortly after Wednesday’s all-day meeting. The next step: the Centers for Disease Control and Prevention, which recommends how to use vaccines, will convene its own expert panel to debate which tots need vaccinations.

It’s not clear how much demand there will initially be for the shots. A recent survey suggests only 1 in 5 parents of young children would get their kids vaccinated right away. Vaccines have been available since November for older U.S. schoolchildren, yet less than a third of those ages 5 to 11 have gotten the two recommended doses, according to government figures.

For the youngest children, each company is offering different dose sizes and number of shots, beginning at 6 months through 4 years for Pfizer and through 5 years for Moderna.

Pfizer and its partner BioNTech plan to offer two shots three weeks apart followed by a third at least two months later — each one-tenth the dose given to adults. Pfizer is currently the only company with a COVID-19 vaccine for older U.S. children.

Moderna is seeking FDA clearance for two shots, each a quarter of its adult dose, given about four weeks apart.

The FDA currently allows Moderna’s vaccine to be used only in adults. But some countries allow full-size doses for teens and half-size shots for kids ages 6 to 11 — a step the FDA also is considering.

More than 30,000 U.S. children younger than 5 have been hospitalized with COVID-19 and nearly 500 coronavirus deaths have been reported in that age group, according to U.S. health officials.

The government allowed pharmacies and states to start placing orders for tot-sized doses last week, with 5 million initially available — half made by Pfizer and half by Moderna.

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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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Pfizer now hopes to tell U.S. regulators how well its COVID-19 vaccine works in the littlest kids by late May or early June.

Pfizer is testing three extra-small doses of its vaccine in children under 5 after two shots didn’t prove quite strong enough. Initial results had been expected last month but the company laid out the latest timeline Tuesday during its discussion of quarterly financial results.

Currently in the U.S., only children ages 5 or older can be vaccinated, using Pfizer’s vaccine — leaving 18 million younger tots unprotected.

Rival Moderna hopes to be the first to offer vaccinations for the youngest children. Last week, it filed with the Food and Drug Administration data it hopes will prove two of its low-dose shots work in children younger than 5. Moderna also has filed FDA applications for older kids, although the agency hasn’t ruled on them.

The FDA already has set tentative dates in June to publicly review data on COVID-19 vaccines for tots under 5, from either or both companies.

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WASHINGTON (AP) — Pfizer and its partner BioNTech asked U.S. regulators Tuesday to authorize an additional booster dose of their COVID-19 vaccine for seniors, saying data from Israel suggests older adults would benefit.

Currently the U.S. urges two primary shots followed months later by a booster dose for everyone age 12 and older. The new application seeks to add a fourth shot only for the over-65 population that has been hit hardest by the pandemic.

The Food and Drug Administration and the Centers for Disease Control would have to approve the request. If so, a key question would be how soon seniors would be advised to roll up their sleeves.

While authorities say the vaccinations continue to offer strong protection against severe illness, they haven’t held up as well against milder infections especially those due to the omicron mutant. With COVID-19 cases finally plummeting after the intense omicron surge, public health experts are starting to look ahead to what next steps might be needed — if a new variant crops up or, barring that, whether to try shoring up coronavirus protection in the fall at the same time people get flu vaccinations.

Speaking to CBS’ “Face the Nation” on Sunday, Pfizer CEO Albert Bourla signaled the company’s plans.

“The protection that you are getting from the third, it is good enough, actually quite good for hospitalizations and deaths. It’s not that good against infections,” he said. “But we are just submitting those data to the FDA and then we will see what the experts also will say outside Pfizer.”

The U.S. booster campaign was based on evidence that the shots’ effectiveness, particularly against milder infections, was waning about six months after the last dose. Calls for a third shot grew once it became clear the vaccines weren’t as strong against the omicron mutant as they were against earlier versions of the virus.

Many scientists say the ultimate goal of vaccination is to prevent severe illness, not mild infections, and early CDC data show the shots still are doing a good job at that. During the omicron wave, effectiveness against hospitalization was 91% in people who had gotten their booster two months earlier, and 78% by the fourth month after that booster.

Pfizer based its new application on data from Israel, which already was offering a second booster to people age 60 and older and health care workers.

While some early data left unclear just how much benefit another shot offered — or for how long — Pfizer said Tuesday that an analysis of health records of more than 1.1 million Israeli seniors showed confirmed infections were two times lower and rates of severe illness were four times lower among those who got two boosters instead of just one.

Pfizer also cited an ongoing study of healthcare workers that tracked a jump in virus-fighting antibodies after getting the additional booster.

In the U.S. so far, a fourth dose is recommended only for people with severely weakened immune systems, who need three doses to begin with for the best chance at any protection.

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WASHINGTON (AP) — Pfizer on Tuesday asked the U.S. to authorize extra-low doses of its COVID-19 vaccine for children under 5, potentially opening the way for the very youngest Americans to start receiving shots as early as March.

In an extraordinary move, the Food and Drug Administration had urged Pfizer and its partner BioNTech to apply earlier than the companies had planned — and before it’s settled if the youngsters will need two shots or three.

The nation’s 19 million children under 5 are the only group not yet eligible for vaccination against the coronavirus. Many parents have been pushing for an expansion of shots to toddlers and preschoolers, especially as the omicron variant sent record numbers of youngsters to the hospital.

“I would say the parents in my office are desperate” to get young kids vaccinated, said Dr. Dyan Hes, who runs a pediatrics practice in New York City, where vaccination rates are high. For many, “that’s the first thing they ask when they walk through the door: ‘When do you think the shot is going to come out?’”

Pfizer aims to give children as young as 6 months shots that contain one-tenth of the dose given to adults. The company said it had started submitting its data to the FDA and expects to complete the process in a few days.

An open question is how many shots those children will need. Two of the extra-low doses turned out to be strong enough for babies but not for preschoolers in early testing. Pfizer now is testing a third shot, data that’s expected in late March.

That means the FDA may consider whether to authorize two shots for now, with potentially a third shot being cleared later if the study supports it.

Pfizer CEO Albert Bourla said in a statement that company scientists believe this age group ultimately will need three of the extra low-dose shots but that FDA action now could let parents begin the vaccination process while awaiting a final decision.

The FDA said it will convene a panel of independent researchers and physicians in mid-February to help review the Pfizer data. The agency isn’t required to follow their advice, but the input is a key step in publicly vetting vaccine safety and effectiveness.

The question of how long to wait for new vaccine data — and how much to require — is a concern for FDA regulators, who face pressure to be more proactive against a virus that has repeatedly confounded health experts.

The FDA asked Pfizer to begin submitting its application now due to omicron’s “greater toll on children,” an agency spokeswoman said, citing a peak in cases among children under 5.

“In light of these new data and the rise in illnesses and hospitalization in this youngest age group, FDA believed that it was prudent to request that Pfizer submit the data it had available,” agency spokeswoman Stephanie Caccomo said in an emailed statement.

The FDA’s ultimate decision could come within the month, but that isn’t the only hurdle. The Centers for Disease Control and Prevention also has to sign off.

The Biden administration has been trying to speed the authorization of COVID-19 shots for children, contending vaccinations are critical for opening schools and day care centers and keeping them open, and for freeing up parents from child care duties so they can go back to work.

Yet vaccination rates have been lower among children than in other age groups. As of last week, just 20% of kids ages 5 to 11 and just over half of 12- to 17-year-olds were fully vaccinated, according to the American Academy of Pediatrics. Nearly three-quarters of adults are fully vaccinated.

Young children are far less likely than adults to get severely ill from the coronavirus, but it can happen, and pediatric COVID-19 infections are higher than at any other point in the pandemic.

“What we’re seeing right now is still a lot of hospitalizations and unfortunately some deaths in this age group,” said Dr. Sean O’Leary of the University of Colorado, who is on the AAP’s infectious disease committee. If the FDA clears vaccinations for these youngsters, “that’s going to be really important because all of those hospitalizations and deaths essentially are preventable.”

For kids under 5, Pfizer’s study is giving participants two shots three weeks apart, followed by a third dose at least two months later. The company is testing whether the youngsters produce antibody levels similar to those known to protect teens and young adults.

In December, Pfizer announced that children under 2 looked to be protected but that the antibody response was too low in 2- to 4-year-olds. It’s not clear why, but one possibility is that the extra-low dose was a little too low for the preschoolers.

Since the preliminary results showed the shots were safe, Pfizer added a third dose to the testing in hopes of improving protection.

A Kaiser Family Foundation poll found just 3 in 10 parents of children under 5 would get their youngster vaccinated as soon as shots were authorized, while about a quarter said they definitely would not. Results of the survey of 1,536 adults, conducted in mid-January, were released Tuesday.

Chicago health officials have been trying to prepare parents for months for the day the shots are available, said Dr. Nimmi Rajagopal, a family medicine physician for Cook County Health, which oversees the public hospital system. Some parents wonder how rigorously the shots will be evaluated or have other questions that she said are critical to address.

Rajagopal is excited about getting her own 2-year-old son vaccinated if FDA clears the way, so it will be safer for him to play with other children.

“I have been waiting and waiting and waiting,” she said.

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The long-awaited milestone comes as U.S. cases, hospitalizations and deaths are all rising and health officials warn of a tsunami of new infections from the omicron variant that could overwhelm hospitals.

The drug, Paxlovid, is a faster way to treat early COVID-19 infections, though initial supplies will be extremely limited. All of the previously authorized drugs against the disease require an IV or an injection.

An antiviral pill from Merck also is expected to soon win authorization. But Pfizer’s drug is all but certain to be the preferred option because of its mild side effects and superior effectiveness, including a nearly 90% reduction in hospitalizations and deaths among patients most likely to get severe disease.

“The efficacy is high, the side effects are low and it’s oral. It checks all the boxes,” said Dr. Gregory Poland of the Mayo Clinic. “You’re looking at a 90% decreased risk of hospitalization and death in a high-risk group — that’s stunning.”

The Food and Drug Administration authorized Pfizer’s drug for adults and children ages 12 and older with a positive COVID-19 test and early symptoms who face the highest risks of hospitalization. That includes older people and those with conditions like obesity and heart disease, though the drug is not recommended for patients with severe kidney or liver problems. Children eligible for the drug must weigh at least 88 pounds (40 kilograms).

The pills from both Pfizer and Merck are expected to be effective against omicron because they don’t target the spike protein where most of the variant’s worrisome mutations reside.

Pfizer currently has 180,000 treatment courses available worldwide, with roughly 60,000 to 70,000 allocated to the U.S. Federal health officials are expected to ration early shipments to the hardest hit parts of the country. Pfizer said the small supply is due to the manufacturing time — currently about nine months. The company says it can halve production time next year.

The U.S. government has agreed to purchase enough Paxlovid to treat 10 million people, and it will be provided free to patients. Pfizer says it’s on track to produce 80 million courses globally next year, under contracts with the U.K., Australia and other nations.

President Joe Biden said the pill marks a “significant step forward in our path out of the pandemic” and said his administration will work with states to ensure equitable distribution.

Health experts agree that vaccination remains the best way to protect against COVID-19. But with roughly 40 million American adults still unvaccinated, effective drugs will be critical to blunting the current and future waves of infection.

The U.S. is now reporting more than 140,000 new infections daily and federal officials warn that the omicron variant could send case counts soaring. Omicron has already whipped across the country to become the dominant strain, federal officials confirmed earlier this week.

Against that backdrop, experts warn that Paxlovid’s initial impact could be limited.

For more than a year, biotech-engineered antibody drugs have been the go-to treatments for COVID-19. But they are expensive, hard to produce and require an injection or infusion, typically given at a hospital or clinic. Also, laboratory testing suggests the two leading antibody drugs used in the U.S. aren’t effective against omicron.

Pfizer’s pill comes with its own challenges.

Patients will need a positive COVID-19 test to get a prescription. And Paxlovid has only proven effective if given within five days of symptoms appearing. With testing supplies stretched, experts worry it may be unrealistic for patients to self-diagnose, get tested, see a physician and pick up a prescription within that narrow window.

“If you go outside that window of time I fully expect the effectiveness of this drug is going to fall,” said Andrew Pekosz, a Johns Hopkins University virologist.

The FDA based its decision on company results from a 2,250-patient trial that showed the pill cut hospitalizations and deaths by 89% when given to people with mild-to-moderate COVID-19 within three days of symptoms. Less than 1% of patients taking the drug were hospitalized and none died at the end of the 30-day study period, compared with 6.5% of patients hospitalized in the group getting a dummy pill, which included nine deaths.

Pfizer’s drug is part of a decades-old family of antiviral drugs known as protease inhibitors, which revolutionized the treatment of HIV and hepatitis C. The drugs block a key enzyme which viruses need to multiply in the human body.

The U.S. will pay about $500 for each course of Pfizer’s treatment, which consists of three pills taken twice a day for five days. Two of the pills are Paxlovid and the third is a different antiviral that helps boost levels of the main drug in the body.

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Associated Press writer Tom Murphy contributed to this report.

MATTHEW PERRONE | AP News

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Most Americans should be given the Pfizer or Moderna vaccines instead of the Johnson & Johnson shot that can cause rare but serious blood clots, U.S. health officials said Thursday.

The strange clotting problem has caused nine confirmed deaths after J&J vaccinations — while the Pfizer and Moderna vaccines don’t come with that risk and also appear more effective, said advisers to the Centers for Disease Control and Prevention.

The panel recommended the unusual move of giving preference to the Pfizer and Moderna vaccines, and late Thursday the CDC’s director, Dr. Rochelle Walensky, accepted the panel’s advice.

Until now the U.S. has treated all three COVID-19 vaccines available to Americans as an equal choice, since large studies found they all offered strong protection and early supplies were limited. J&J’s vaccine initially was welcomed as a single-dose option that could be especially important for hard-to-reach groups like homeless people who might not get the needed second dose of the Pfizer or Moderna options.

But the CDC’s advisers said during a meeting Thursday that it was time to recognize a lot has changed since vaccines began rolling out a year ago. More than 200 million Americans are considered fully vaccinated, including about 16 million who got the J&J shot.

New data from unprecedented safety tracking of all those vaccinations persuaded the panel that while the blood clots linked to J&J’s vaccine remain very rare, they’re still occurring and not just in younger women as originally thought.

In a unanimous vote, the advisers decided the safer Pfizer and Moderna vaccines are preferred. But they said the shot made by J&J’s Janssen division still should be available if someone really wants it — or has a severe allergy to the other options.

“I would not recommend the Janssen vaccine to my family members” but some patients may — and should be able to — choose that shot, said CDC adviser Dr. Beth Bell of the University of Washington.

The clotting problems first came up last spring, with the J&J shot in the U.S. and with a similar vaccine made by AstraZeneca that is used in other countries. Eventually U.S. regulators decided the benefits of J&J’s one-and-done vaccine outweighed what was considered a very rare risk — as long as recipients were warned.

European regulators likewise continued to recommend AstraZeneca’s two-dose vaccine although, because early reports were mostly in younger women, some countries issued age restrictions.

COVID-19 causes deadly blood clots, too. But the vaccine-linked kind is different, believed to form because of a rogue immune reaction to the J&J and AstraZeneca vaccines because of how they’re made. It forms in unusual places, such as veins that drain blood from the brain, and in patients who also develop abnormally low levels of the platelets that form clots. Symptoms of the unusual clots, dubbed “thrombosis with thrombocytopenia syndrome,” include severe headaches a week or two after the J&J vaccination — not right away — as well as abdominal pain and nausea.

While it’s still very rare, the Food and Drug Administration told health care providers this week that more cases have occurred after J&J vaccinations since the spring. They occur most in women ages 30 to 49 — about once for every 100,000 doses administered, the FDA said.

Overall, the government has confirmed 54 clot cases— 37 in women and 17 in men, and nine deaths that included two men, the CDC’s Dr. Isaac See said Thursday. He said two additional deaths are suspected.

The CDC decides how vaccines should be used in the U.S., and its advisers called the continuing deaths troubling. In comparing the pros and cons of all the vaccines, the panelists agreed that side effects from the Pfizer and Moderna vaccines weren’t as serious — and that supplies now are plentiful.

Nor is J&J still considered a one-and-done vaccine, several advisers noted. The single-dose option didn’t prove quite as protective as two doses of the Pfizer and Moderna vaccines. Plus, with extra-contagious virus mutants now spreading, booster doses now are recommended.

For J&J recipients, a booster is recommended at least two months after vaccination. U.S. health officials had previously OK’d mixing vaccines for booster shots.

Several countries, including Canada, already have policies that give preference to the Pfizer and Moderna vaccines. But J&J told the committee its vaccine still offers strong protection and is a critical option especially in parts of the world without plentiful vaccine supplies or for people who don’t want a two-dose shot.

While blood clots are rare, “unfortunately cases of COVID-19 are not,” J&J’s Dr. Penny Heaton said.

The U.S. is fortunate in its vaccine availability and Thursday’s action shouldn’t discourage use of J&J’s vaccine in places around the world where it’s needed, said CDC adviser Dr. Matthew Daley of Kaiser Permanente Colorado.

The FDA also warned this week that another dose of the J&J vaccine shouldn’t be given to anyone who developed a clot following either a J&J or AstraZeneca shot.

The committee also heard some of the first data on reported side effects of Pfizer vaccinations in younger children. Early last month, the CDC recommended a two-dose series for that age group, and more than 7 million doses have been given so far. But few problems have been reported. Of the 80 reported cases of serious side effects, about 10 involved a form of inflammation that has been seen in male teens and young adults.

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WASHINGTON (AP) — Pfizer said Tuesday that its experimental pill to treat COVID-19 appears effective against the omicron variant.

The company also said full results of its 2,250-person study confirmed the pill’s promising early results against the virus: The drug reduced combined hospitalizations and deaths by about 89% among high-risk adults when taken shortly after initial COVID-19 symptoms.

Separate laboratory testing shows the drug retains its potency against the omicron variant, the company announced, as many experts had predicted. Pfizer tested the antiviral drug against a man-made version of a key protein that omicron uses to reproduce itself.

The updates come as COVID-19 cases, deaths and hospitalization are all rising again and the U.S. hovers around 800,000 pandemic deaths. The latest surge, driven by the delta variant, is accelerating due to colder weather and more indoor gatherings, even as health officials brace for the impact of the emerging omicron mutant.

The Food and Drug Administration is expected to soon rule on whether to authorize Pfizer’s pill and a competing pill from Merck, which was submitted to regulators several weeks earlier. If granted, the pills would be the first COVID-19 treatments that Americans could pickup at a pharmacy and take at home.

President Joe Biden called Pfizer’s drug “another potentially powerful tool in our fight against the virus,” in a statement Tuesday.

The U.S. government has agreed to purchase enough of Pfizer’s drug to treat 10 million people. But Pfizer executives have indicated that initial supplies will be limited, with only have enough to treat tens of thousands of people before the end of the year. By March the company hopes to ramp up production to provide millions of courses of treatment.

Pfizer’s data could help reassure regulators of its drug’s benefit after Merck disclosed smaller-than-expected benefits for its drug in final testing. Late last month, Merck said that its pill reduced hospitalizations and deaths by 30% in high-risk adults.

Both companies initially studied their drugs in unvaccinated adults who face the gravest risks from COVID-19, due to older age or health problems, such as asthma or obesity.

Pfizer is also studying its pill in lower-risk adults — including a subset who are vaccinated — but reported mixed data for that group on Tuesday.

In interim results, Pfizer said its drug failed to meet its main study goal: sustained relief from COVID-19 for four days during or after treatment, as reported by patients. But the drug did achieve a second goal by reducing hospitalizations by about 70% among that group, which included otherwise healthy unvaccinated adults and vaccinated adults with one or more health issues. Less than 1% of patients who got the drug were hospitalized, compared with 2.4% of patients who got a dummy pill.

An independent board of medical experts reviewed the data and recommended Pfizer continue the study to get the full results before proceeding further with regulators.

Across both of Pfizer’s studies, adults taking the company’s drug had a 10-fold decrease in virus levels compared with those on placebo.

The prospect of new pills to fight COVID-19 can’t come soon enough for communities in the Northeast and Midwest, where many hospitals are once again being overloaded by incoming virus cases.

Both the Merck and Pfizer pills are expected to perform well against omicron because they don’t target the coronavirus’ spike protein, which contains most of the new variant’s mutations.

Centers for Disease Control and Prevention Director Rochelle Walensky, appearing on NBC’s “Today” on Tuesday, said the best way for people to protect themselves against COVID-19 is to get vaccinated and get a booster shot. She said the Pfizer pill, if authorized by the FDA, “will be another great tool, but we need to diagnose people early.”

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