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Pfizer, BioNTech Receive FDA Emergency Use Approval to Broaden COVID-19 Vaccine Access for Children

05/11/2021 04:10

07:56 AM EDT, 05/11/2021 (MT Newswires) -- Pfizer (PFE) and BioNTech (BNTX) received approval from US regulators to give their COVID-19 vaccine to children as young as 12 in a move that will help the world's biggest economy widen its inoculation program in its bid to return to normalcy.

The Food and Drug Administration said late Monday that the emergency use authorization for the vaccine would be expanded to include adolescents between the ages of 12 and 15, changing from the approval given in December for people aged 16 and older.

"Parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data, as we have with all of our COVID-19 vaccine emergency use authorizations," said Janet Woodcock, the acting commissioner of the FDA.

In a statement, Pfizer said the FDA decision was made after a trial that enrolled 2,260 children aged 12 to 15, with data showing an efficacy of 100% in those without prior COVID-19 infections. The data has been submitted to other global regulators, including the European Medicines Agency.

"Today's expansion of our EUA represents a significant step forward in helping the US government broaden its vaccination program and help protect adolescents before the start of the next school year," said Pfizer's chief executive, Albert Bourla. "We hope to help bring a sense of normalcy back to young people across the country and around the world."

The new authorization is the first to open up the younger group to COVID-19 vaccination in the US, where the FDA said about 1.5 million cases of the disease in people aged 11 to 17 have been reported between March 2020 and the end of last month.

About 580,000 Americans have died from the respiratory disease that has battered the country's economy with restrictions and shutdowns. Cases have slowed as vaccinations increased, and more than 58% of all Americans have had at least one shot.

The FDA said the most common side effects reported in the youth were similar to those in adult trials, including pain at the injection site, headaches and fever. A pediatric study in children from six months old to 11 years is continuing, the companies said.

Last week, Pfizer and BioNTech began the process of getting full FDA approval for its COVID-19 vaccine, initiating a biologics license application with data to be submitted over the coming weeks.

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