The US Food and Drug Administration (FDA) is said to be on the verge of approving the coronavirus vaccine from Pfizer and BioNTech for children and adolescents between the ages of 12 and 15.
The green light is expected to be given early next week, a federal government official told CNN.
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On April 9, the alliance of American and German laboratories filed with the FDA an emergency extension request for its vaccine for this age group.
This extension procedure makes it possible to bypass the slower procedures of convening the independent advisory committee until a vote is taken.
“While the FDA cannot predict how long its assessment of the data and information will take, the agency will review the request as quickly as possible using its in-depth, science-based approach,” the FDA said in a report. -mail to CNN last week.
100% efficiency according to Pfizer
FDA officials are currently reviewing data submitted by Pfizer, including the results of the clinical trial involving 2,260 young people between the ages of 12 and 15.
Pfizer had claimed, in support of this study, that its vaccine was 100% effective and that it was well tolerated.
The Pfizer vaccine is currently licensed for people 16 years of age and older in the United States.
The extension of vaccination to adolescents could open the US vaccination campaign to millions more, when 55% of adults have received one to two doses.
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Pfizer and Moderna are both testing their vaccines in children as young as 6 months old and plan to seek FDA clearances covering infants and young children during the year. Maryland-based lab Novavax announced Monday that it had expanded its Phase 3 trial to a group of 3,000 children aged 12 to 17 across the United States. They will receive either the candidate vaccine or the placebo in two doses 21 days apart. The Novavax vaccine has not yet received authorization for emergency use in the United States.