The Food and Drug Administration authorized the Pfizer-BioNTech COVID-19 vaccine for 12- to 15-year-olds within the U.S. — the primary to be licensed for kids below age 16.
On Monday, the FDA amended its earlier emergency use authorization for the Pfizer vaccine — which solely allowed inoculation of these 16 and up — to include the younger age group.
This vital change will permit youthful college students to return to in-person faculty extra safely within the fall.
About 1.5 million youngsters age 11 to 17 have had reported circumstances of COVID-19, per the FDA. Children typically have “milder” circumstances than adults.
In a late March information launch, Pfizer stated that its examine of the vaccine’s use in members 12 to fifteen years previous discovered that it was secure and extremely effective in stopping COVID-19 circumstances.
The firm has begun trials to check the vaccine, which is run in two doses three weeks aside, with youngsters below age 11.
“It is very important to enable them to get back to everyday school life and to meet friends and family while protecting them and their loved ones,” Ugur Sahin, CEO of BioNTech, stated within the launch.
The different two vaccines at the moment licensed to be used within the U.S. — Moderna and Johnson & Johnson — have thus far been authorized for folks aged 18 and up.
Acting FDA commissioner Janet Woodcock referred to as the brand new vaccine authorization for youthful folks “a significant step in the fight against the COVID-19 pandemic,” including within the company’s information launch: “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.”
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