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Pfizer says COVID-19 vaccine works in kids ages 5 to 11

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Pfizer said Monday its COVID-19 vaccine works for children ages 5 to 11 and that it will seek U.S. authorization for this age group soon — a key step toward beginning vaccinations for youngsters.

The vaccine made by Pfizer and its German partner BioNTech already is available for anyone 12 and older. But with kids now back in school and the extra-contagious delta variant causing a huge jump in pediatric infections, many parents are anxiously awaiting vaccinations for their younger children.

For elementary school-aged kids, Pfizer tested a much lower dose — a third of the amount that’s in each shot given now. Yet after their second dose, children ages 5 to 11 developed coronavirus-fighting antibody levels just as strong as teenagers and young adults getting the regular-strength shots, Dr. Bill Gruber, a Pfizer senior vice president, told The Associated Press.

The kid dosage also proved safe, with similar or fewer temporary side effects — such as sore arms, fever or achiness — that teens experience, he said.

“I think we really hit the sweet spot,” said Gruber, who’s also a pediatrician.

Gruber said the companies aim to apply to the Food and Drug Administration by the end of the month for emergency use in this age group, followed shortly afterward with applications to European and British regulators.

Earlier this month, FDA chief Dr. Peter Marks told the AP that once Pfizer turns over its study results, his agency would evaluate the data “hopefully in a matter of weeks” to decide if the shots are safe and effective enough for younger kids.

An outside expert said scientists want to see more details but called the report encouraging.

“These topline results are very good news,” said Dr. Jesse Goodman of Georgetown University, a former FDA vaccine chief. The level of immune response Pfizer reported “appears likely to be protective.”

Many Western countries so far have vaccinated no younger than age 12, awaiting evidence of what’s the right dose and that it works safely. Cuba last week began immunizing children as young as 2 with its homegrown vaccines and Chinese regulators have cleared two of its brands down to age 3.

While kids are at lower risk of severe illness or death than older people, more than 5 million children in the U.S. have tested positive for COVID-19 since the pandemic began and at least 460 have died, according to the American Academy of Pediatrics. Cases in children have risen as the delta variant swept through the country.

“I feel a great sense of urgency” in making the vaccine available to children under 12, Gruber said. “There’s pent-up demand for parents to be able to have their children returned to a normal life.”

In New Jersey, 10-year-old Maya Huber asked why she couldn’t get vaccinated like her parents and both teen brothers have. Her mother, Dr. Nisha Gandhi, a critical care physician at Englewood Hospital, enrolled Maya in the Pfizer study at Rutgers University. But the family hasn’t eased up on their masking and other virus precautions until they learn if Maya received the real vaccine or a dummy shot.

Once she knows she’s protected, Maya’s first goal: “a huge sleepover with all my friends.”

Maya said it was exciting to be part of the study even though she was “super scared” about getting jabbed. But “after you get it, at least you feel like happy that you did it and relieved that it didn’t hurt,” she told the AP.

Pfizer said it studied the lower dose in 2,268 kindergartners and elementary school-aged kids. The FDA required what is called an immune “bridging” study: evidence that the younger children developed antibody levels already proven to be protective in teens and adults. That’s what Pfizer reported Monday in a press release, not a scientific publication. The study still is ongoing, and there haven’t yet been enough COVID-19 cases to compare rates between the vaccinated and those given a placebo — something that might offer additional evidence.

The study isn’t large enough to detect any extremely rare side effects, such as the heart inflammation that sometimes occurs after the second dose, mostly in young men. The FDA’s Marks said the pediatric studies should be large enough to rule out any higher risk to young children. Pfizer’s Gruber said once the vaccine is authorized for younger children, they’ll be carefully monitored for rare risks just like everyone else.

A second U.S. vaccine maker, Moderna, also is studying its shots in elementary school-aged children. Pfizer and Moderna are studying even younger tots as well, down to 6-month-olds. Results are expected later in the year.

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AP journalist Emma Tobin contributed to this report.

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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.

Lauran Neergaard, The Associated Press

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CFL leaves door open for Argos' quarterback Bethel-Thompson playing in East final

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TORONTO — The CFL has left the door open to McLeod Bethel-Thompson playing in the East Division final Sunday.

The Toronto Argonauts starting quarterback was held out of practice and sent home Friday after attending the Toronto Raptors 97-93 home win over the Milwaukee Bucks on Thursday night.

That violated the CFL’s COVID-19 protocol, which would’ve normally meant Bethel-Thompson having to quarantine for four days and provide two negative tests before being able to resume team activities.

But Toronto hosts the Hamilton Tiger-Cats in the conference final Sunday afternoon at BMO Field.

The CFL announced Friday afternoon Bethel-Thompson will be allowed to play Sunday if he produces negative COVID testing following a 48-hour quarantine at his residence.

Argos Dexter McCoil, Charleston Hughes, Llevi Noel and Jeff Richards also attended the basketball game and will be subject to the same requirements as Bethel-Thompson.

Toronto (9-5) finished atop the East Division standings to secure home-field advantage for the conference final.

Bethel-Thompson was 7-2 as Toronto’s starter this season.

Both the Argos and Raptors are owned by Maple Leafs Sports & Entertainment.

If Bethel-Thompson can’t play, Antonio Pipkin will start for Toronto on Sunday.

The six-foot-three, 225-pound Pipkin started Toronto’s season-ending 13-7 home loss to Edmonton on Nov. 16, completing 10-of-22 passes for 111 yards and an interception while rushing for 78 yards and a TD on nine carries.

Video of Bethel-Thompson holding his infant daughter at the NBA game was carried on the Argos’ Twitter account Thursday night but was no longer available Friday.

But it was present long enough for Hamilton receiver Brandon Banks to notice.

“Wow when I tried to go to raptors game the @cfl told me I couldn’t go!” Banks tweeted. “I ain’t snitching but shit fishy ! #Protocol #tier1.”

Bethel-Thompson also appeared on TSN’s broadcast of the Raptors-Bucks game.

TSN is the CFL’s broadcast partner.

“So lemme get this straight,” TSN’s Kayla Grey, who interviewed Bethel-Thompson during the broadcast, tweeted Friday. ” … a starting quarterback goes on a national broadcast to promote an East Final that he is now forced to miss because the league is forcing him to quarantine for going to a game to promote said East Final?

“Baby what a mess.”

This report by The Canadian Press was first published Dec. 3, 2021.

The Canadian Press

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Canada buying up to 1.5 million courses of oral antiviral drugs to fight COVID-19

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OTTAWA — Procurement Minister Filomena Tassi says Canada has signed agreements to buy up 1.5 million courses of oral antiviral treatment for COVID-19.

The government has signed up for an initial one million courses of antiviral treatment, once Health Canada endorses their safety and efficacy. 

Pfizer submitted a request for Health Canada approval earlier this week. 

Canada has also purchased 500,000 courses of Merck’s oral antiviral treatment for COVID-19, with the option to purchase another 500,000 once Health Canada approves the drug. 

The drugs are designed to block the enzyme essential for viral replication.

Merck’s clinical trial showed a 50 per cent reduced risk of hospitalization or death compared to placebo patients with mild or moderate COVID-19. 

This report by The Canadian Press was first published Dec. 3, 2021.

The Canadian Press

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