US clears Pfizer's Covid vaccine for 5-11 year olds

In October 2021, the photo provided by Pfizer shows children's doses of its COVID-19 vaccine in Puurs, Belgium.

AP

Text by: RFI Follow

2 min

Pfizer-BioNTech's Covid vaccine approved for children aged 5 to 11 in the United States;

they are thus the first country to authorize this vaccine in all children of this age group.

The FDA, the drug gendarme across the Atlantic, has just given the green light, paving the way for the vaccination of some 28 million American children.

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For 5-11 year olds, Pfizer and BioNTech have developed a less concentrated vaccine than that intended for those over 12 years old.

The quantity of active principle, the famous messenger RNA, is 10 micrograms, instead of 30. 

So what about its effectiveness? According to clinical trials conducted by Pfizer in children of this age group, it is 90% for symptomatic forms of Covid. Analyzes of the immune reaction also point in the direction of good protection: the dosage of neutralizing antibodies in 5-11 year-olds was found to be similar to that of 16-25 year-olds vaccinated with the initial product.

As for the risks associated with the vaccine, there were no serious adverse effects among the 3,000 children vaccinated during the trials. In particular no myocarditis, an inflammation of the heart; but this remains a point of vigilance. Indeed, it took millions of injections of messenger RNA vaccines in adults and young people to uncover this very rare side effect, which seems to affect teenage boys a little more. So does it also exist among 5-11 year olds, with the (less concentrated) vaccine assigned to them? The deployment of vaccination in this age group in the United States will help to find out. In any case for the FDA, the benefits of the vaccine outweigh the possible risks in these children.

"

As a mother and physician, I know that parents, caregivers, teachers and children have been anxiously awaiting this clearance

," Janet Woodcock, acting commissioner of the FDA, said in a statement.

As a mother and a physician, I know that parents, caregivers, school staff, and children have been waiting for today's authorization.

Vaccinating younger children against # COVID19 will bring us closer to returning to a sense of normalcy.

https://t.co/wq6BkbC0mI

- Dr. Janet Woodcock (@DrWoodcockFDA) October 29, 2021

The European Medicines Agency is also reviewing an application for authorization of Pfizer's vaccine for this age group.

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