FDA expands the EUA Pfizer COVID-19 vaccine to include ages 12-15
(KKTV) - On Monday, the FDA expanded the EUA for the Pfizer-BioNTech COVID-19 Vaccine for the prevention of COVID-19 to include adolescents 12 to 15 years of age. The FDA amended the EUA issued on Dec. 11, 2020 for administration in individuals 16 years of age and older.
“FDA has determined that Pfizer-BioNTech COVID-19 Vaccine has met the statutory criteria to amend the EUA, and that the known and potential benefits of this vaccine in individuals 12 years of age and older outweigh the known and potential risks, supporting the vaccine’s use,” the FDA wrote on Twitter.
Shots could begin soon once a federal vaccine panel issues recommendations for using the vaccine in 12- to 15-year-olds.
Click here for more information on receiving a vaccine in Colorado.
“The FDA’s expansion of the emergency use authorization for the Pfizer-BioNTech COVID-19 Vaccine to include adolescents 12 through 15 years of age is a significant step in the fight against the COVID-19 pandemic,” said Acting FDA Commissioner Janet Woodcock, M.D. “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.”
According to Gov. Jared Polis, final approval may be granted as soon as Wednesday.
“I am thrilled that, thanks to the FDA’s decision, all Coloradans ages 12-15 are one step closer to being eligible to receive the COVID-19 vaccine. For younger Coloradans, this doesn’t just mean getting much-needed protection from this disease, it also means even safer classrooms and after-school activities, the opportunity to visit with friends and family without guilt, and the chance to get closer to life as we knew it,” Gov. Polis said in a statement. “This last year hasn’t been easy for Colorado students, and I’m glad to see that even more will now be able to live without fear as they head into the summer and this next school year. We are hopeful that final approval will be granted as soon as Wednesday and 12-15 year olds can start getting protected by the end of this week.”
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