FDA advisory committee recommends authorizing Pfizer's COVID vaccine for kids

The U.S. Food and Drug Administration isn't bound by the committee's recommendation, but is expected to consider it and make a decision in the coming days on whether to approve the vaccine for kids five to 11 years old.

Health Canada is also reviewing the vaccine for kids five to 11 years old

A 19-year-old receives the Pfizer COVID-19 vaccine at a FEMA vaccination centre in Miami in this file photo. On Tuesday, an advisory committee to the FDA moved a kid-sized dose of the vaccine closer to authorization in the U.S. (Lynne Sladky/Associated Press)

A U.S. Food and Drug Administration (FDA) advisory committee has voted in favour of Pfizer-BioNTech's COVID-19 vaccine for children five to 11 years old. 

The vaccines and related biological products advisory committee voted unanimously with one abstention that the vaccine's benefits outweigh any potential risks, including a side effect of myocarditis (inflammation of the heart) that's been very rare in teens and young adults who get a much higher dose.

The dose for young children is just one-third of the Pfizer shot already recommended for everyone 12 and older.

The FDA isn't bound by the committee's recommendation, but is expected to take it into consideration and make its decision within days.   

If the FDA authorizes the kid-size doses, there's still another step before children in the U.S. can get the shot.  Next week, the Centers for Disease Control and Prevention will also have to decide whether to recommend the shots and whether all children should get them or targeted groups. 

Health Canada is currently reviewing Pfizer's vaccine to decide whether to authorize its use for five- to 11-year-olds in Canada. 

While children are at lower risk of severe COVID-19 than older people, 5- to 11-year-olds have faced substantial illness — including over 8,300 hospitalizations — about a third of them requiring intensive care — and nearly 100 deaths, FDA vaccine chief Dr. Peter Marks told the advisory panel.

Also, "infections have caused many school closures and disrupted the education and socialization of children," he said.

"I want to acknowledge the fact that there are strong feelings" among the public for and against child vaccinations, Marks added, noting that the discussion would be on scientific data "not about vaccine mandates, which are left to other entities outside of FDA."

Full-strength shots made by Pfizer and its partner BioNTech are already available for everyone 12 and older in the U.S., but pediatricians and many parents are clamouring for protection against COVID-19 for younger children. The extra-contagious delta variant has caused an alarming rise in pediatric infections — and families are frustrated with school quarantines and having to say no to sleepovers and other rites of childhood to keep the virus at bay.

States are getting ready to roll out shots for little arms — in special orange-capped vials to distinguish them from adult doses — as soon as the government gives the OK. More than 25,000 pediatricians and other primary care providers in the U.S. have signed up so far to offer vaccination.

Study results

Pfizer's study tracked 2,268 children ages five to 11 who got two shots three weeks apart of either a placebo or the kid dose. Vaccinated children developed levels of virus-fighting antibodies just as strong as teens and young adults who got the full-strength shots, the company said. 

And so far, 16 kids given dummy shots developed symptomatic COVID-19 compared to three vaccinated youngsters, meaning the vaccine was nearly 91 per cent effective. Most of the study data was collected in the U.S. during August and September as the delta variant surged.

The kid dosage also proved safe, with similar or fewer temporary side effects — such as sore arms, fever or achiness — that teens experience. At FDA's request, Pfizer more recently enrolled another 2,300 youngsters into the study, and preliminary safety data has shown no red flags.

The study isn't large enough to detect any extremely rare side effects, such as the heart inflammation that occasionally occurs after the second dose, mostly in young men and teen boys.

The FDA analysis calculated that in most scenarios of the continuing pandemic, the vaccine would prevent roughly 200 to 250 COVID-19 hospitalizations for every 1 million children vaccinated, with about 58 hospitalizations for the heart inflammation.

The side effect risk is based on levels in teens, and Pfizer expects it to be far lower in younger children getting the kid-size dose.

Moderna is also studying smaller doses of its COVID-19 vaccine for use in children under 12. 


With files from CBC News

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