Three doses of Pfizer's COVID-19 vaccine offer strong protection for children younger than 5, the company announced Monday. Pfizer plans to give the data to U.S. regulators later this week in a step toward letting the littlest kids get the shots.
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 tots under 5 are the only group in the U.S. not yet eligible for COVID-19 vaccination.
The U.S. Food and Drug Administration has begun evaluating data from rival Moderna, which hopes to begin offering two kid-sized shots by summer.
Pfizer has had a bumpier time figuring out its approach. It aims to give tots an even lower 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 tots' 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.
The companies already had submitted data on the first two doses to the FDA, and BioNTech's CEO, Dr. Ugur Sahin, said the final third-shot data would be submitted this week.
"The study suggests that a low, 3-microgram dose of our vaccine, carefully selected based on tolerability data, provides young children with a high level of protection against the recent COVID-19 strains," he said in a statement.
Pfizer's conclusion that the tots produce antibodies similar to levels that protect young adults was encouraging, said Dr. Jesse Goodman of Georgetown University, a former FDA vaccine chief.
If FDA confirms the data, the vaccine could "be an important tool to help parents protect their children," Goodman said. 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.
Moderna is seeking to be the first to vaccinate the littlest kids. It submitted data to the FDA saying tots develop high levels of virus-fighting antibodies after two shots that contain a quarter of the dose given to adults. The Moderna study found effectiveness against symptomatic COVID-19 was 40% to 50% during the omicon surge, much like for adults who've only had two vaccine 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 had set tentative dates in June for its scientific advisers to publicly debate Moderna's and Pfizer's data. The latest target: June 14 to consider whether to allow Moderna vaccine for older kids and June 15 to debate vaccinations for tots under 5, from either or both companies depending on the status of the applications.
If either vaccine is cleared for the littlest kids, the Centers for Disease Control and Prevention would have to recommend whether all kids under 5 should receive them 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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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.
Ceremonies, events and protests are being held across Canada today to mark the anniversary of a Hamas attack on Israel that triggered the ongoing war in Gaza.
The Oct. 7 attack by Hamas fighters on Israel last year, and the immediate Israeli retaliation that followed, sent shockwaves throughout the world that have shaken Canada culturally and politically.
Israelis were holding vigils and sombre ceremonies on Monday to mark a year since the Oct. 7, 2023, Hamas attack, the deadliest in the country's history, which sparked the war in Gaza and scarred Israelis indelibly.
Christopher Ciccone, a multihyphenate artist, dancer, designer and younger brother of Madonna, has died. He was 63.
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Ceremonies, events and protests are being held across Canada today to mark the anniversary of a Hamas attack on Israel that triggered the ongoing war in Gaza.
A 54-year-old inmate at the Toronto South Detention Centre has been charged in connection with a deadly jail beating late last week that claimed the life of a 69-year-old prisoner.
The Archbishop of Toronto is among 21 new cardinals Pope Francis named Sunday and the lone new cardinal from North America.
A unique form of clouds made an appearance over the skies of Ottawa on Sunday evening.
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Some Manitobans are cleaning up Sunday morning, after intense winds barreled through southern parts of the province Saturday.
Advocacy groups behind a so-called suicide capsule said Sunday they have suspended the process of taking applications to use it as a criminal investigation into its first use in Switzerland is completed.
Israelis were holding vigils and sombre ceremonies on Monday to mark a year since the Oct. 7, 2023, Hamas attack, the deadliest in the country's history, which sparked the war in Gaza and scarred Israelis indelibly.
Donald Trump's fourth scheduled stop in eight days in Wisconsin is a sign of his increased attention as Republicans fret about the former president's ability to match the Democrats' enthusiasm and turnout machine.
British Prime Minister Keir Starmer's chief of staff quit on Sunday, citing concerns that growing news reports about her role 'risked becoming a distraction to the government.'
As a junior at George Washington University, Ty Lindia meets new students every day. But with the shadow of the Israel-Hamas war hanging over the Washington, D.C., campus, where everyone has a political opinion, each new encounter is fraught.
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The Oct. 7 attack by Hamas fighters on Israel last year, and the immediate Israeli retaliation that followed, sent shockwaves throughout the world that have shaken Canada culturally and politically.
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In an interview with CTV’s Question Period host Vassy Kapelos, airing Sunday, Cohen said that despite the failed attempt at a pause, he still believes a ceasefire is possible.
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Bruzzese came down with COVID-19 in February 2023, and received her injection at the end of March. “Being able to recognize smells is something we take for granted, until you can’t.â€
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Scientists announced on Thursday a milestone in neurobiological research with the mapping of the entire brain of an adult fruit fly, a feat that may provide insight into brains across the animal kingdom, including people.
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Dubai's Emirates airline has banned pagers and walkie-talkies from its planes, following last month's attacks on such devices carried by the Lebanese militant group Hezbollah.
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Vanderbilt takes down AP poll No. 1 Alabama 40-35 in historic college football victory.
New data from the Insurance Bureau of Canada (IBC) shows that even though claims for auto theft dropped in the first half of 2024 compared to their 2023 peak, the rates of reported theft remain well above those of years prior.
Tesla is recalling more than 27,000 Cybertrucks because the rearview camera image may not activate immediately after shifting into reverse, the fifth recall for the vehicle since it went on sale late last year.
A Pickering, Ont., student going to college to be a mechanic is shocked the engine in his two-year-old car will not be repaired under warranty after the dealership claimed he had been 'over-revving' the engine.
Bernie Hicks, known as the ‘Batman of Amherst,’ always wanted to sit in a Batmobile until a kind stranger made it happen.
Bubi’s Awesome Eats, located on University Ave West took to social media to announce the closure on Friday.
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Avry Wortman, 13, scored two touchdowns on Sunday during her team's win in the under 14 Greater Moncton Football Association.
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A husband and wife have been on the road trip of a lifetime and have decided to stop in Saskatchewan for the winter.
A man parked a minivan in front of Vancouver City Hall Sunday evening and set it ablaze, according to police.
A man stole a police car and drove it onto the field of an East Vancouver park Sunday morning, placing “dozens of bystanders in harm’s way,†according to police.
All that was left of a downtown Langley restaurant Sunday was a pile of rubble behind a blue fence, after a massive fire tore through it the morning before.
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A unique form of clouds made an appearance over the skies of Ottawa on Sunday evening.
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Ontario Provincial Police say a man has died after striking obstacles on the St. Lawrence River while driving a personal watercraft.
Alexandre Look, a 33-year-old Montreal native, was among the concertgoers who were murdered a year ago Monday at the Supernova music festival during a brutal assault on Israel carried out by Hamas militants. He is among at least eight people, either Canadian citizens or with ties to Canada, who died during the Oct. 7 attacks.
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Monday marks one year since the Hamas attack that killed 1,200 Israelis and triggered the ongoing war in Gaza.
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Monday is the first anniversary of the Hamas attack in Israel that killed 1,200 people and sparked a war that has since spread beyond the borders of the Gaza Strip.
The eight sons of Richard and Sarah Harvie from Gormanville, N.S., are believed to be the most siblings from one family, from either North America or the British Commonwealth, to serve in the Second World War.
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An annual vintage sale known as “Art from the Attic†returned to St. Vital Centre Sunday, with thousands of collectibles and art pieces on display.
For the 52nd week, pro-Palestinian protesters rallied in Winnipeg, calling for peace in the Middle East amid the ongoing Israel-Hamas war.
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According to police, officers responded to reports of a stabbing in the area of Victoria Street North and St. Ledger Street around 5:30 a.m. Sunday.
In a display of strength and perseverance, a Cambridge, Ont. resident has completed a unique aquatic challenge.
Emergency services were called to the area of Stone Road West and Chancellors Way around 1:20 a.m. Sunday for a report of a single motor vehicle collision.
As Saskatchewan's population grows, a number of new constituencies have been created to account for larger numbers in certain areas, including within Regina and Saskatoon.
A permanent memorial at the site of the 2018 Humboldt Broncos bus crash is about to be a step closer.
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Weeneebayko Area Health Authority and the Government of Ontario have awarded a $1.8 billion fixed-price contract to design, build and finance a new Far North hospital.
According to a survey on recent alcohol consumption, younger Canadians are more likely to have not had a drink in the past week. For those interested in slowing or stopping their alcohol consumption, there's a phrase: 'sober curious.'
Hundreds of people are gathering today in cities across Canada to remember the victims of Hamas's Oct. 7 attack on Israel and the hostages that have still not yet made it home.
Tears were shed and emotions ran high at the 33rd annual CIBC Run for the Cure in downtown London, Ont. on Sunday.
The London Knights continue to get players back from NHL training camps but while the roster takes shape, wins have been tough to come by in the early season.
People across Florida were given notice Sunday that Hurricane Milton is intensifying rapidly and will likely be a major hurricane before slamming midweek into the storm-ravaged Gulf Coast.
Fire crews are investigating a Saturday evening fire at a barn in Oro-Medonte.
Hundreds wore pink and attended the two CIBC 'Run for the Cure' events in the region.
Lakehead University's Orillia Campus hosted the 2024 NASA Space Apps challenge this weekend, which allowed teams of students, mentors and scientists to brainstorm solutions for global issues using real-world NASA data.
OPP responded to a collision in which a vehicle struck a pedestrian on the roadway.
The event serves as a pivotal platform for open-class boxers from across Ontario to compete for provincial titles and the opportunity to advance to the Canadian National Championships.
October is library month, and at Essex county council on Wednesday, Deputy Warden Joe Bachetti encouraged residents to support their local library.
NDP Leader David Eby promised Sunday to support police in British Columbia to keep illegal guns off the streets and protect communities, but accused B.C. Conservative Leader John Rustad of planning to make the province less safe.
The calculus of predicting an election and identifying its key battlegrounds is complex enough in any race, but observers of the British Columbia poll this month are facing a pair of unknown quantities that make the math even more confounding.
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Nearly two years after a man was stabbed to death in downtown Kelowna, RCMP have made an arrest in the case.
NDP Leader David Eby is promising to offer a $75-million loan forgiveness program to entice doctors, nurses and heath professionals to expand health-care services in rural British Columbia.
Three young suspects have been arrested in connection with a swarming attack on a teenager in B.C.'s Okanagan last week – and authorities have asked the public to stop circulating disturbing videos of the incident.
While the summer may be over, construction season in Lethbridge is not.
Lethbridge police executed dozens of warrants and laid numerous charges in another targeted enforcement project in the downtown area.
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As part of an ongoing investigation, provincial police are seeking the public’s assistance in locating a Kubota tractor stolen in North Shore Township, Ont., last month.
A 33-year-old man was arrested Saturday for allegedly spraying bear mace at three individuals in northwestern Ontario.
A drug raid on a home on the Far North Attawapiskat First Nation last week resulted in two local residents being charged and more than $50,000 in suspected narcotics, including methamphetamine, being seized.
He may not have logged the fastest time or even gone the full distance, but residents of a Newfoundland town agree the goat who unexpectedly joined the local weekend half marathon was the event's undisputed champion.
A mother in a community where the cost of living is one of the highest in the country says grocery prices are 'inhumane' and retailers are putting profits ahead of people’s basic human right to food.
A soccer game in England on Tuesday night drove a spike in online traffic across the Atlantic to a website launched by the Newfoundland and Labrador government.
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