'He's in our hearts': Family and friends still seek answers one year after Nathan Wise’s disappearance
It’s been a year since Nathan Wise went missing and his family is no closer to finding out what happened to him.
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.
It’s been a year since Nathan Wise went missing and his family is no closer to finding out what happened to him.
Dozens of Ontarians are expressing frustration in the province’s health-care system after their family doctors either dropped them as patients or threatened to after they sought urgent care elsewhere.
An Ottawa pizzeria is being recognized as one of the top 20 deep-dish pizzas in the world.
Amazon's paid subscription service provides free delivery for online shopping across Canada except for remote locations, the company said in an email. While customers in Iqaluit qualify for the offer, all other communities in Nunavut are excluded.
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Russia’s President Vladimir Putin began a Cabinet shakeup on Sunday, proposing the replacement of Sergei Shoigu as defence minister as he begins his fifth term in office.
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English, history, entertainment, math and geography: high school trivia teams could be quizzed on any of it when they compete at the Reach for the Top Nationals in Ottawa in June.
An Ottawa pizzeria is being recognized as one of the top 20 deep-dish pizzas in the world.
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The Canada Science and Technology Museum is inviting visitors to explore their poop. A new exhibition opens at the Ottawa museum on Friday called, 'Oh Crap! Rethinking human waste.'
The Regina Police Service says it is the first in Saskatchewan and possibly Canada to implement new technology in its detention facility that will offer real-time monitoring of detainees’ vital health metrics.
Just as she had feared, a restaurant owner from eastern Quebec who visited Montreal had her SUV stolen, but says it was all thanks to the kindness of strangers on the internet — not the police — that she got it back.