The Pfizer-BioNTech alliance's Covid vaccine is safe and effective for children aged six months to five years with the injection of three doses, the two companies said in a statement Monday.
Pfizer-BioNTech said it evaluated three doses, given at three micrograms each, in a clinical trial and found the vaccine elicited a strong immune response.
Side effects were similar in the vaccine and placebo groups.
Effectiveness was 80.3%, according to a preliminary estimate.
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“We are pleased that our formula for younger children, which we carefully measured at one-tenth the adult dose, was well tolerated and produced a strong immune response,” commented Albert Bourla, CEO of Pfizer, quoted in a press release.
Children less dangerously affected
This announcement comes as the US Medicines Agency (FDA) plans three meetings in June to study the authorization of the Pfizer vaccine for children under 5, and that of Moderna for children under 6.
The FDA was originally scheduled to evaluate the Pfizer vaccine given in two doses in February, but data showed it did not elicit a strong enough immune response in children aged two to four.
She then asked to see the data for a third injection.
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The youngest children are the only age group not yet eligible for coronavirus vaccines in most countries.
A serious health condition related to Covid-19 is very rare in children under five.
In the United States, 477 deaths have been recorded in this age group since the start of the pandemic, or about 0.1% of all deaths.
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In addition, like adults, some children who have been infected with the coronavirus can develop a long Covid, with new, continuous or recurrent symptoms, in particular mental confusion and fatigue.