The Food and Drug Administration’s contentious approval of a questionable Alzheimer’s drug took another hit Thursday as congressional investigators called the process “rife with irregularities.” The 18-month investigation by two House committees detailed “atypical collaboration” between FDA regulators and a company it’s supposed to oversee -- Aduhelm manufacturer Biogen. The probe also cited Biogen documents saying the company intended to “make history” when it set what investigators called an “unjustifiably high” initial price of $56,000 a year for the drug. The criticism comes as the FDA is expected to decide whether to approve another new Alzheimer’s drug in January. Thursday’s report urged the agency to “take swift action” to ensure that any future Alzheimer’s approvals aren’t met with “the same doubts about the integrity of FDA’s review.” Read more: Drug slows Alzheimer's but can it make a real difference? The FDA and Biogen issued statements Thursday defending the Aduhelm approval process. In 2021, the FDA overruled its own independent scientific advisers when it approved Aduhelm even though research studies failed to prove it really helped patients. Biogen had halted two studies after disappointing results suggested the drug wasn’t slowing Alzheimer’s inevitable worsening -- only to later contend that a new analysis of one study showed higher doses offered an incremental benefit. The FDA argued the drug’s ability to reduce a hallmark of Alzheimer’s, a buildup of plaque in the brain, suggested it was likely to slow the disease. Backlash was immediate as three FDA advisers resigned in protest and the agency’s then-acting chief called for an internal investigation. Eventually Medicare refused to pay for the drug -- even after the yearly price was dropped to $28,000 -- unless patients enrolled in clinical trials to prove if it indeed slowed cognitive decline. Thursday’s report said FDA and Biogen engaged in an unusually high volume of phone calls, meetings and emails, some of them not properly documented. In addition, the regulators and company spent months working together to prepare a briefing document for FDA’s advisers that didn’t adequately represent substantial disagreement within the FDA about how to handle Aduhelm, the report said. Read more: Alzheimer's Disease: Symptoms, Causes, Preventions The investigators recommended that FDA take steps to restore trust in the approval process that include properly documenting interactions with drugmakers. They also urged manufacturers to take into account advice from patient groups and other outside experts on fair drug pricing. In a statement Thursday, FDA said the Aduhelm decision “was based on our scientific evaluation of the data” and that the agency’s own internal review found its interactions with Biogen were appropriate. But it said it plans to update guidance on Alzheimer’s drug development and will review the investigation’s findings. In its own statement, Biogen said: “Alzheimer’s is a highly complex disease and we have learned from the development and launch of Aduhelm” but that it “stands by the integrity of the actions we have taken.”

U.S. regulators on Friday authorized the first COVID-19 shots for infants and preschoolers, paving the way for vaccinations to begin next week. The Food and Drug Administration’s action follows its advisory panel’s unanimous recommendation for the shots from Moderna and Pfizer. That means U.S. kids under 5 — roughly 18 million youngsters — are eligible for the shots. The nation’s vaccination campaign began about 1 1/2 years ago with older adults, the hardest hit during the coronavirus pandemic. There’s one step left: The Centers for Disease Control and Prevention recommends how to use vaccines. Its independent advisers began debating the two-dose Moderna and the three-dose Pfizer vaccines on Friday and will make its recommendation Saturday. A final signoff is expected soon after from CDC Director Dr. Rochelle Walensky. At a Senate hearing Thursday, Walensky said her staff was working over the Juneteenth federal holiday weekend “because we understand the urgency of this for American parents.” She said pediatric deaths from COVID-19 have been higher than what is generally seen from the flu each year. “So I actually think we need to protect young children, as well as protect everyone with the vaccine and especially protect elders,” she said. The FDA also authorized Moderna’s vaccines for school-aged children and teens; CDC’s review is next week. Pfizer’s shots had been the only option for those age groups. For weeks, the Biden administration has been preparing to roll out the vaccines for little kids, with states, tribes, community health centers and pharmacies preordering millions of doses. With FDA’s emergency use authorization, manufacturers can begin shipping vaccine across the country. The shots are expected to start early next week but it’s not clear how popular they will be. Without protection for their tots, some families had put off birthday parties, vacations and visits with grandparents. “Today is a day of huge relief for parents and families across America,” President Joe Biden said in a statement. While young children generally don’t get as sick from COVID-19 as older kids and adults, their hospitalizations surged during the omicron wave and FDA’s advisers determined that benefits from vaccination outweighed the minimal risks. Studies from Moderna and Pfizer showed side effects, including fever and fatigue, were mostly minor. White House COVID-19 coordinator Dr. Ashish Jha predicted the pace of vaccinations for kids under 5 to be far slower than it was for older populations and said the administration doesn’t have any internal targets for the pace of vaccinations. “At the end of the day, our goal is very clear: We want to get as many kids vaccinated as possible,” Jha told The Associated Press. In testing, the littlest children developed high levels of virus-fighting antibodies, comparable to what is seen in young adults, the FDA said. Moderna’s vaccine was about 40% to 50% effective at preventing infections but there were too few cases during Pfizer’s study to give a reliable, exact estimate of effectiveness, the agency said. “Both of these vaccines have been authorized with science and safety at the forefront of our minds,” Dr. Peter Marks, FDA’s vaccine chief, said at a news briefing. Marks said parents should feel comfortable with either vaccine, and should get their kids vaccinated as soon as possible, rather than waiting until fall, when a different virus variant might be circulating. He said adjustments in the vaccines would be made to account for that. “Whatever vaccine your health care provider, pediatrician has, that’s what I would give my child,” Marks said. The two brands use the same technology but there are differences. Pfizer’s vaccine for kids younger than 5 is one-tenth of the adult dose. Three shots are needed: the first two given three weeks apart and the last at least two months later. Moderna’s is two shots, each a quarter of its adult dose, given about four weeks apart for kids under 6. The FDA also authorized a third dose, at least a month after the second shot, for children who have immune conditions that make them more vulnerable to serious illness. Both vaccines are for children as young as 6 months. Moderna next plans to study its shots for babies as young as 3 months. Pfizer has not finalized plans for shots in younger infants. A dozen countries, including China, already vaccinate kids under 5, with other brands. Immediately upon hearing of the FDA’s decision, Dr. Toma Omofoye, a Houston radiologist, made appointments for her 4-year-old daughter and 3-year-old son. Without the shots, her family has missed out on family gatherings, indoor concerts, even trips to the grocery store, she said. During a recent pharmacy stop, Omofoye said her daughter stared and walked around like it was Disneyland, and thanked her. “My heart broke in that moment, which is why my heart is so elated now,” Omofoye said. But will other parents be as eager to get their youngest vaccinated? By some estimates, three-quarters of all U.S. children have already been infected. And only about 30% of children aged 5 to 11 have gotten vaccinated since Pfizer’s shots opened to them last November. The FDA officials acknowledged those low rates and said the government is committed to getting more older kids vaccinated and having better success with younger kids. “It’s a real tragedy, when you have something free with so few side effects that prevents deaths and hospitalization,” said FDA Commissioner Robert Califf. Roughly 440 children under age 5 have died from COVID-19, federal data show. Read: UNICEF finds Bangladesh as Covid-19 vaccine success story Dr. Beth Ebel of the University of Washington School of Medicine in Seattle, said the tot-sized vaccines would be especially welcomed by parents with children in day care where outbreaks can sideline parents from jobs, adding to financial strain. “A lot of people are going to be happy and a lot of grandparents are going to be happy, too, because we’ve missed those babies who grew up when you weren’t able to see them,” Ebel said.

The first COVID-19 shots for U.S. infants, toddlers and preschoolers moved a step closer Wednesday. The Food and Drug Administration’s vaccine advisers gave a thumbs-up to vaccines from Moderna and Pfizer for the littlest kids. The outside experts voted unanimously that the benefits of the shots outweigh any risks for children under 5 — that’s roughly 18 million youngsters. They are the last age group in the U.S. without access to COVID-19 vaccines and many parents have been anxious to protect their little children. If all the regulatory steps are cleared, shots should be available next week. Also read: Bangladesh number 1 recipient of COVID-19 vaccines under COVAX: UNICEF “This is a long-awaited vaccine,” said one panel member, Dr. Jay Portnoy of Children’s Hospital in Kansas City, Missouri. “There are so many parents who are absolutely desperate to get this vaccine and I think we owe it to them to give them a choice to have the vaccine if they want to.” Dr. Peter Marks, FDA’s vaccine chief, opened the meeting with data showing a “quite troubling surge” in young children’s hospitalizations during the omicron wave, and noted 442 children under 4 have died during the pandemic. That’s far fewer than adult deaths, but should not be dismissed in considering the need for vaccinating the youngest kids, he said. “Each child that’s lost essentially fractures a family,” Marks said. While endorsing the vaccines, some panel members said they believe chances are minimal for severe illness and death in young children. “Risks from vaccination are very low, but so are risks from COVID-19 for the youngest kids,” said Dr. Cody Meissner of Tufts University. Also read: Declare vaccines as global goods, Hasina urges World Health Assembly FDA reviewers said both brands appear to be safe and effective for children as young as 6 months old in analyses posted ahead of the all-day meeting. Side effects, including fever and fatigue, were generally minor in both, and less common than seen in adults. The two vaccines use the same technology but there are differences. In a call with reporters earlier this week, vaccine experts noted that the shots haven’t been tested against each other, so there’s no way to tell parents if one is superior. “You can’t compare the vaccines directly,” said Dr. Jesse Goodman of Georgetown University, a former FDA vaccine chief. If the FDA agrees with its advisers and authorizes the shots, there’s one more step. The Centers for Disease Control and Prevention will decide on a formal recommendation after its own advisers vote on Saturday. If the CDC signs off, shots could be available as soon as Monday or Tuesday at doctor’s offices, hospitals and pharmacies. Pfizer’s vaccine is for children 6 months through 4 years; Moderna’s vaccine is for 6 months through 5 years. Moderna’s shots are one-quarter the dose of the company’s adult shots. Two doses appeared strong enough to prevent severe illness but only about 40% to 50% effective at preventing milder infections. Moderna added a booster to its tests and expects to eventually offer one. Pfizer’s shots are just one-tenth its adult dose. Pfizer and partner BioNTech found that two shots didn’t provide enough protection in testing, so a third was added during the omicron wave. Pfizer’s submitted data found no safety concerns and suggested that three shots were 80% effective in preventing symptomatic coronavirus infections. But that was based on just 10 COVID-19 cases; the calculation could change as more cases occur in the company’s ongoing studies. Several advisers, noting that protection is low after two Pfizer doses, worried that some parents might end up skipping the third shot, or mistakenly thinking their kids are better protected between shots, leaving them vulnerable. Educating parents must be done “very very carefully so that they are not misled about what the vaccines actually provide,” said Dr. Archana Chatterjee of Rosalind Franklin University. The same FDA panel on Tuesday backed Moderna’s half-sized shots for ages 6 to 11 and full-sized doses for teens. If authorized by the FDA, it would be the second option for those age groups. Currently Pfizer vaccine is their only choice. The nation’s vaccination campaign started in December 2020 with the rollout of adult vaccines from Pfizer and Moderna, with health care workers and nursing home residents first in line. Teens and school-age children were added last year. Moderna said in April that it is also seeking regulatory approval outside the U.S. for its little kid shots. According to the World Health Organization, 12 countries already vaccinate kids under 5, with other brands. In the U.S., it remains uncertain how many parents want their youngest vaccinated. By some estimates, three-quarters of all children have already been infected. And only about 29% of children aged 5 to 11 have been vaccinated since Pfizer’s shots opened to them last November, a rate far lower than public health authorities consider ideal. Dr. Nimmi Rajagopal, a family medicine physician at Cook County Health in Chicago, said she’s been preparing parents for months. “We have some that are hesitant, and some that are just raring to go,” she said.  

Drugmaker Moderna asked the Food and Drug Administration on Thursday to authorize a fourth shot of its COVID-19 vaccine as a booster dose for all adults. The request is broader than rival pharmaceutical company Pfizer's request earlier this week for the regulator to approve a booster shot for all seniors. In a press release, the company said its request for approval for all adults was made “to provide flexibility” to the Centers for Disease Control and Prevention and medical providers to determine the “appropriate use” of a second booster dose of the mRNA vaccine, “including for those at higher risk of COVID-19 due to age or comorbidities." Also read: Moderna jab will be given as booster doses: DGHS U.S. officials have been laying the groundwork to deliver additional booster doses to shore up the vaccines' protection against serious disease and death from COVID-19. The White House has been sounding the alarm that it needs Congress to “urgently” approve more funding for the federal government to secure more doses of the COVID-19 vaccines, either for additional booster shots or variant-specific immunizations. U.S. health officials currently recommend a primary series of two doses of the Moderna vaccine and a booster dose months later. Moderna said its request for an additional dose was based on “recently published data generated in the United States and Israel following the emergence of Omicron.” Also read: Moderna: Initial booster data shows good results on omicron On Tuesday, Pfizer and its partner BioNTech asked U.S. regulators to authorize an additional booster dose of their COVID-19 vaccine for seniors, saying data from Israel suggests older adults would benefit.

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. Read: Danes halt virus restrictions; rest of Europe a patchwork 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. Full Coverage: Coronavirus pandemic 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.” Read: Myanmar takeover anniversary marked by strike, int’l concern 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.

The U.S. is expanding COVID-19 boosters as it confronts the omicron surge, with the Food and Drug Administration allowing extra Pfizer shots for children as young as 12. Boosters already are recommended for everyone 16 and older, and federal regulators on Monday decided they’re also warranted for 12- to 15-year-olds once enough time has passed since their last dose. But the move, coming as classes restart after the holidays, isn’t the final step. A panel to the Centers for Disease Control and Prevention is expected to decide later this week whether to recommend boosters for the younger teens with a final decision by Dr. Rochelle Walensky, the CDC’s director. The FDA also said everyone 12 and older who's eligible for a Pfizer booster can get one as early as five months after their last dose rather than six months. FDA vaccine chief Dr. Peter Marks said even though serious illness is uncommon in younger teens, a booster will help them avoid that risk — while also helping reduce the spread of omicron or any other coronavirus mutant. “Hopefully this will be not just a call for people to go get their booster shot,” but for the tens of millions of unvaccinated Americans to rethink that choice, Marks said. “It's not too late to start to get vaccinated.” Also read: FDA paves way for Pfizer COVID-19 vaccinations in young kids The FDA based its latest booster decision largely on real-world data from Israel that found no new safety concerns when 6,300 12- to 15-year-olds got a Pfizer booster five months after their second dose. Likewise, the FDA said even more data from Israel showed no problems with giving anyone eligible for a Pfizer booster that extra dose a month sooner than the six months that until now has been U.S. policy. The chief safety question for younger teens is a rare side effect called myocarditis, a type of heart inflammation seen mostly in younger men and teen boys who get either the Pfizer or Moderna vaccines. The vast majority of cases are mild — far milder than the heart inflammation caused by COVID-19 — and they seem to peak in older teens, the 16- and 17-year-olds. Marks said the side effect occurs in about 1 in 10,000 men and boys ages 16 to 30 after their second shot — but that a third dose appears less risky, by about a third. That's probably because more time has passed before the booster than between the first two shots, he said. While the FDA didn’t consult its independent scientific advisers before making that decision, the CDC's own advisory panel is sure to closely weigh how much benefit this age group is likely to get before backing the extra shot. Vaccines still offer strong protection against serious illness from any type of COVID-19. But health authorities are urging everyone who’s eligible to get a booster dose for their best chance at avoiding milder breakthrough infections from the highly contagious omicron mutant. Children tend to suffer less serious illness from COVID-19 than adults. But child hospitalizations are rising during the omicron wave -- most of them unvaccinated. Pediatrician and global health expert Dr. Philip Landrigan of Boston College welcomed the FDA's decisions, but stressed that the main need is to get the unvaccinated their first shots. “It is among unvaccinated people that most of the severe illness and death from COVID will occur in coming weeks,” he said in an email. "Many thousands of lives could be saved if people could persuade themselves to get vaccinated.” Also read: Pfizer asks FDA to OK COVID-19 booster shots for all adults The vaccine made by Pfizer and its partner BioNTech is the only U.S. option for children of any age. About 13.5 million 12- to 17-year-olds — just over half that age group — have received two Pfizer shots, according to the CDC. For families hoping to keep their children as protected as possible, the booster age limit raised questions. The older teens, 16- and 17-year-olds, became eligible for boosters in early December. But original vaccinations opened for the younger teens, those 12 to 15, back in May. That means those first in line in the spring, potentially millions, are about as many months past their last dose as the slightly older teens. As for even younger children, kid-size doses for 5- to 11-year-olds rolled out more recently, in November -- and experts say healthy youngsters should be protected after their second dose for a while. But the FDA also said Monday that if children that young have severely weakened immune systems, they will be allowed a third dose 28 days after their second. That’s the same third-dose timing already recommended for immune-compromised teens and adults. Pfizer is studying its vaccine, in even smaller doses, for children younger than 5. What about timing of boosters for adults who got the Moderna or Johnson & Johnson vaccines? The FDA said it didn’t have any new data from Moderna to back a timing change and people who’d already had two Moderna shots should continue to wait six months for a booster. As for people who originally got the single-dose J&J shot, the U.S. already recommends another dose of any vaccine two months later.

Pfizer asked U.S. regulators Tuesday to allow boosters of its COVID-19 vaccine for anyone 18 or older, a step that comes amid concern about increased spread of the coronavirus with holiday travel and gatherings. Older Americans and other groups particularly vulnerable to the virus have had access to a third dose of the Pfizer and BioNTech vaccine since September. But the Food and Drug Administration has said it would move quickly to expand boosters to younger ages if warranted. Pfizer is submitting early results of a booster study in 10,000 people to make its case that it’s time to further expand the booster campaign. Also Read: Pfizer says COVID-19 pill cut hospital, death risk by 90% While all three vaccines used in the U.S. continue to offer strong protection against severe COVID-19 illness and death, the shots’ effectiveness against milder infection can wane over time. Pfizer’s new study concluded a booster could restore protection against symptomatic infection to about 95%, even as the extra-contagious delta variant was surging. Side effects were similar to those seen with the company’s first two shots. A median of 11 months after their last Pfizer vaccination, trial participants were given either a third dose or a dummy shot. Researchers tracked any infections that occurred at least a week later, and so far have counted five cases of symptomatic COVID-19 among booster recipients compared to 109 cases among people who got dummy shots. The Biden administration had originally envisioned boosters for all adults, but faced a stinging setback in September when the FDA’s scientific advisers rejected extra Pfizer doses for everyone. The panel wasn’t convinced that young healthy people needed another dose, particularly when most of the world’s population remains unvaccinated, and instead recommended boosters just for certain groups — one of a series of decisions about extra doses for all of the three vaccines used in the U.S. Also Read: FDA paves way for Pfizer COVID-19 vaccinations in young kids The current rules: People who initially received Pfizer or Moderna vaccinations are eligible for a booster six months later if they’re 65 or older, or are at high risk of COVID-19 because of health problems or their job or living conditions. Because the single-dose Johnson & Johnson vaccine hasn’t proven as effective as its two-dose competitors, any J&J recipient can get a booster at least two months later. Also, anyone eligible for a booster doesn’t have to stick with their initial vaccination type and can get a different company’s vaccine, what’s called mixing and matching. About 194 million Americans are fully vaccinated. Under today’s policies, authorities already estimated about 2 of every 3 vaccinated adults could qualify for a booster within the next few months. Many who don’t meet the criteria often score an extra shot because many vaccine providers don’t check qualifications. FDA spokeswoman Alison Hunt said the agency would review Pfizer’s application “as expeditiously as possible,” but would not set a timeline for a decision. She also said the FDA hasn’t yet decided whether to convene its panel of outside experts to vet the data. If the FDA authorizes Pfizer’s request for expanded boosters, the Centers for Disease Control and Prevention then will make recommendations for how to use them. Globally, boosters also are a hodge-podge. Some countries restrict them to older or medically fragile people while others have few restrictions. Israel, for example, has allowed Pfizer boosters for anyone 12 and older. Canada’s health regulator on Tuesday authorized Pfizer boosters for people 18 and older. Also Read: World could return to normal within a year: Pfizer CEO

The Food and Drug Administration on Friday paved the way for children ages 5 to 11 to get Pfizer's COVID-19 vaccine. The FDA cleared kid-size doses — just a third of the amount given to teens and adults — for emergency use, and up to 28 million more American children could be eligible for vaccinations as early as next week. One more regulatory hurdle remains: On Tuesday, advisers to the Centers for Disease Control and Prevention will make more detailed recommendations on which youngsters should get vaccinated, with a final decision by the agency’s director expected shortly afterwards. “The rationale here is protect your children so that they can get back towards normal life,” said FDA vaccine chief Dr. Peter Marks. “The tremendous cost of this pandemic has not just been in physical illness, it’s been in the psychological, the social development of children” too. Also read: Merck agrees to let other drug makers make its COVID pill A few countries have begun using other COVID-19 vaccines in children under 12, including China, which just began vaccinations for 3-year-olds. But many that use the vaccine made by Pfizer and its partner BioNTech are watching the U.S. decision, and European regulators just began considering the companies' kid-size doses. With FDA's action, Pfizer plans to begin shipping millions of vials of the pediatric vaccine — in orange caps to avoid mix-ups with the purple-capped doses for everyone else — to doctors' offices, pharmacies and other vaccination sites. Once the CDC issues its ruling, eligible kids will get two shots, three weeks apart. While children are at lower risk of severe illness or death from COVID-19 than older people, 5- to 11-year-olds still have been seriously affected -- including over 8,300 hospitalizations, about a third requiring intensive care. The FDA said 146 deaths have been reported in that age group. And with the extra-contagious delta variant circulating, the government has counted more than 2,000 coronavirus-related school closings just since the start of the school year, affecting more than a million children. “With this vaccine kids can go back to something that’s better than being locked at home on remote schooling, not being able to see their friends,” said Dr. Kawsar Talaat of Johns Hopkins University. “The vaccine will protect them and also protect our communities.” The American Academy of Pediatrics also applauded FDA’s decision, and said pediatricians were “standing by” to talk with parents. Also read: US financing body, Biological E finalise agreement to expand COVID manufacturing capabilities in India Vaccinating this age group is “an important step in keeping them healthy and providing their families with peace of mind,’’ said Dr. Lee Savio Beers, the academy’s president. Earlier this week, FDA's independent scientific advisers voted that the pediatric vaccine's promised benefits outweigh any risks. But several panelists said not all youngsters will need to be vaccinated, and that they preferred the shots be targeted to those at higher risk from the virus. Nearly 70% of 5- to 11-year-olds hospitalized for COVID-19 in the U.S. have other serious medical conditions, including asthma and obesity, according to federal tracking. Additionally, more than two-thirds of youngsters hospitalized are Black or Hispanic, mirroring long-standing disparities in the disease's impact. The question of how broadly Pfizer's vaccine should be used will be a key consideration for the CDC and its advisers, who set formal recommendations for pediatricians and other medical professionals. A Pfizer study of 2,268 schoolchildren found the vaccine was nearly 91% effective at preventing symptomatic COVID-19 infections, based on 16 cases of COVID-19 among kids given dummy shots compared to just three who got vaccinated. The FDA ultimately assessed more children — 3,100 — who received the kid dosage to conclude it was safe. Youngsters experienced similar or fewer temporary reactions — such as sore arms, fever or achiness — that teens experience. But the 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. It's unclear if younger children getting a smaller dose also will face that rare risk. FDA pledged Friday to keep a close watch. Some parents are expected to vaccinate their children ahead of family holiday gatherings and the winter cold season. Laura Cushman of Salt Lake City plans to get her three children — ages 7, 9 and 11 — vaccinated as soon as possible. “We just want them to get to resume their pre-COVID life a little bit more. And feel safe about it,” she said. But a recent Kaiser Family Foundation survey suggests most parents won't rush to get the shots. About 25% of parents polled earlier this month said they would get their children vaccinated “right away.” But the remaining majority of parents were roughly split between those who said they will wait to see how the vaccine performs and those who said they “definitely” won't have their children vaccinated. The similarly made Moderna vaccine also is being studied in young children, and both Pfizer and Moderna also are testing shots for babies and preschoolers.

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. Also read: J&J seeks US clearance for COVID-19 vaccine booster doses 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. Also read: Am I fully vaccinated without a COVID-19 vaccine 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.

U.S. health advisers said Thursday that some Americans who received Moderna’s COVID-19 vaccine at least six months ago should get a half-dose booster to rev up protection against the coronavirus. The panel of outside advisers to the Food and Drug Administration voted unanimously to recommend a booster shot for seniors, as well as younger adults with other health problems, jobs or living situations that put them at increased risk from COVID-19. The recommendation is non-binding but it’s a key step toward expanding the U.S. booster campaign to millions more Americans. Many people who got their initial Pfizer shots at least six months ago are already getting a booster after the FDA authorized their use last month — and those are the same high-risk groups that FDA's advisers said should get a Moderna booster. Also read: J&J seeks US clearance for COVID-19 vaccine booster doses But there's no evidence that it's time to open booster doses of either the Moderna or Pfizer vaccine to everybody, the panel stressed — despite initial Biden administration plans to eventually do that. The coronavirus still is mostly a threat to unvaccinated people — while the vaccinated have strong protection against severe illness or death from COVID-19. “I don’t really see a need for a ‘let it rip’ campaign for everyone," said Dr. Michael Kurilla of the National Institutes of Health. As for the dose, initial Moderna vaccination consists of two 100-microgram shots. But Moderna says a single 50-microgram shot should be enough for a booster. The agency convened its experts to weigh in on who should get boosters and when for those who received the Moderna and Johnson & Johnson shots earlier this year. The panel will discuss J&J on Friday. Also read: Am I fully vaccinated without a COVID-19 vaccine booster? The FDA will use its advisers’ recommendations in making final decisions for boosters from both companies. Assuming a positive decision, there’s still another hurdle: Next week, a panel convened by the Centers for Disease Control and Prevention will offer more specifics on who should get one. Many U.S. scientists remain divided about exactly who needs boosters and their purpose — whether they’re needed mostly for people at risk of severe disease or whether they should be used to try to reduce milder infections, too. The FDA panel wrestled with whether Moderna presented enough evidence backing its low-dose booster. As the delta variant surged in July and August, a Moderna study found people who were more recently vaccinated had a 36% lower rate of “breakthrough” infections compared with those vaccinated longer ago. Another study of 344 people found a six-month booster shot restored virus-fighting antibodies to levels thought to be protective — and that included large jumps in antibodies able to target the delta variant. But that was a small study, and only about half of those people got the exact series of doses that would be offered under a Moderna booster campaign. “The data itself is not strong but it is certainly going in the direction that is supportive of this vote,” said Dr. Patrick Moore of the University of Pittsburgh. And several advisers worried that boosting with a lower dose might cost people some of the potential benefit of a full-strength third shot. Also read: COVID-19 vaccine boosters could mean billions for drugmakers “That may actually have a tremendous impact on the durability,” Kurilla said. Moderna said it chose the lower-dose booster because it triggered fewer uncomfortable shot reactions such as fever and achiness but also leaves more vaccine available for the global supply. One very rare side effect of both the Moderna and Pfizer vaccines is heart inflammation, particularly among young men soon after the second dose — and one lingering question is whether another dose could spark more cases. Moderna's booster study wasn't large enough to spot such a rare risk. But Israel began offering Pfizer boosters sooner than the U.S. and to more of its population. Thursday, Dr. Sharon Alroy-Preis of Israel's health ministry told the FDA panel that after 3.7 million booster doses administered, there's no sign the extra shot is any riskier. Because the Moderna vaccine is similar, the FDA's advisers found that data reassuring. While Pfizer's boosters are only for certain high-risk groups of Americans, Israeli officials credit wider booster use in their country to stemming the delta surge. “There is no question in my mind that the break of the curve was due to the booster dose,” Alroy-Preis said in response to FDA advisers who noted that other countries have seen a lowering of delta cases without widespread booster use. But FDA's advisers also highlighted one confusing issue: People with severely weakened immune systems already can get a third full dose of the Moderna vaccine soon after the initial vaccinations — so a lingering question is whether they should be eligible for a booster, too, which would be their fourth dose.