FDA Authorizes Pfizer Vaccine For Ages 12 And Older

DENVER, CO — The Food and Drug Administration approved the Pfizer coronavirus vaccine Monday for emergency use for people ages 12 and older.

“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," Gov. Jared Polis said in a statement.

"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," the statement read.

"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.”

Many Colorado middle and high schools have seen a recent surge of coronavirus cases, Polis said. Vaccinating students will help the state's battle against the pandemic.

Shots could begin as soon as a federal vaccine advisory committee issues recommendations for using the two-dose vaccine in 12- to 15-year-olds, expected Wednesday. Any vaccine provider that receives a Pfizer allocation will be able to administer the vaccine to that age group, Colorado public health officials said.

“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 Janet Woodcock, acting FDA commissioner, in a statement.

“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.”

Between March 1, 2020, and April 30, 2021, around 1.5 million people ages 11 to 17 were infected with the coronavirus, according to the Centers for Disease Control and Prevention.

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The Food and Drug Administration declared the Pfizer vaccine is safe and offers strong protection for younger teens based on testing of more than 2,000 U.S. volunteers ages 12 to 15. The study found no cases of COVID-19 among fully vaccinated adolescents compared to 18 among kids given dummy shots. More intriguing, researchers found the kids developed higher levels of virus-fighting antibodies than earlier studies measured in young adults.

The younger teens received the same vaccine dosage as adults and had the same side effects, mostly sore arms and flu-like fever, chills or aches that signal a revved-up immune system, especially after the second dose.

Children are far less likely than adults to get seriously ill from COVID-19 yet they still have been hard-hit by the pandemic. They represent nearly 14 percent of the nation's coronavirus cases. At least 296 have died from COVID-19 in the U.S. alone and more than 15,000 have been hospitalized, according to a tally by the American Academy of Pediatrics.

Experts say children must get the shots if the country is to vaccinate the 70 percent to 85 percent of the population necessary to reach what's called herd immunity.

The Associated Press contributed to this report.