On Monday, the US FDA (Food and Drug Administration) granted emergency use authorization to Pfizer’s COVID-19 vaccine for children aged 12 to 15.
In a statement, Acting FDA Commissioner Janet Woodcock said, “Today’s action allows for a younger population to be protected from COVID-19, bringing us closer to returning to a sense of normalcy and to ending the pandemic,”
“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.”
Individuals aged 16 and over were previously given an emergency use authorization for the Pfizer-BioNTech vaccine by the FDA.
On june 10th, the FDA will hold a meeting on Covid-19 vaccines in children. Pfizer previously stated that the vaccine had 100 percent efficacy and a strong antibody response in trials performed among the younger population. The side effects were close to those of adults.
BioNTech SE and Pfizer had previously stated that they planned to have the vaccine available to children in this age group by the start of the school year next fall. The companies recently announced that their vaccine has received full regulatory approval.
“Having a vaccine approved for a younger population is an important step in continuing to reduce the massive public health burden caused by the Covid-19 pandemic,” Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said.
Between March 1, 2020, and April 30, 2021, 1.5 million Covid-19 cases in people aged 11 to 17 were registered to the Centers for Disease Control and Prevention, according to the FDA.
Late last year, Pfizer won approval for use in people aged 16 and up. According to the CDC, almost 140 million doses of the Pfizer vaccine have been distributed in the United States so far.
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