Covid: US vaccine advisors approve Pfizer jab for five to 11-year-olds

A 13-year-old receives her Covid jab. Credit: AP

A US Food and Drug Administration advisory panel has voted to approve the use of BioNTech/Pfizer Covid-19 vaccine for five to 11-year-olds, paving the way for America to become the first country to introduce vaccinations for younger children.

The panel, who voted unanimously with 17 votes and one absentation, believe the vaccine's benefits in preventing coronavirus within that certain age group outweigh any potential risk.

One risk includes a heart-related side effect deemed very rare in teens and young adults, despite their use of a much higher shot dose.

While children are at lower risk of severe coronavirus than older people, ultimately many panelists decided it’s important to give parents the choice to protect their children, especially those at high risk of illness or who live in places where other precautions, like masks in schools, aren’t being used.

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FDA adviser Jeannette Lee, a Professor in the Department of Biostatistics at the University of Arksansas, said: "The virus is not going away. We have to find a way to live with it and I think the vaccines give us a way to do that."Adviser Dr. Eric Rubin of Harvard University said the decision is a "close call."

He said: “I do think it’s a relatively close call.

“It’s really going to be a question of what the prevailing conditions are but we’re never going to learn about how safe this vaccine is unless we start giving it.”

If the FDA authorises the kid-size doses, the Centers for Disease Control and Prevention will have to decide whether to recommend the shots and which youngsters should get them.

Full-strength shots made by Pfizer and its partner BioNTech already are recommended for everyone 12 and older.

While there is less coronavirus cases among five to 11-year-olds in the US, they still have faced substantial illness, including over 8,300 hospitalisations reported, about a third requiring intensive care, and nearly 100 deaths.

Is the Pfizer vaccine effective among younger children?

A study of elementary schoolchildren found the Pfizer shots are nearly 91% effective at preventing symptomatic infection, even though the youngsters received just a third of the dose given to teens and adults.

Pfizer’s study tracked 2,268 children ages 5 to 11 who got two shots three weeks apart of either a placebo or the kid dose.

Vaccinated youngsters developed levels of virus-fighting antibodies just as strong as teens and young adults who got the full-strength shots.

The child dosage also proved safe, with similar or fewer temporary side effects, such as sore arms, fever or achiness, that teenagers 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.

In the trial the child dosage proved safe, with similar or fewer temporary side effects, such as sore arms, fever or achiness. Credit: AP

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.

But with cases falling across the US, the FDA panel had to consider whether the pandemic might recede so much that more children could face side effects from the vaccine than would be protected from coronavirus.

“If the trends continue the way they are going then the emergency for children is not what we might think it might be,” said Dr. James Hildreth of Meharry Medical College.