US regulators on Monday expanded the use of Pfizer’s COVID-19 vaccine to children as young as 12, offering a way to protect the nation’s adolescents before they head back to school in the fall and paving the way for them to return to more normal activities.
Shots could begin as soon as Thursday, after a federal vaccine advisory committee issues recommendations for using the two-dose vaccine in 12- to 15-year-olds. An announcement is expected Wednesday.
Most COVID-19 vaccines worldwide have been authorized for adults. Pfizer’s vaccine is being used in multiple countries for teens as young as 16, and Canada recently became the first to expand use to 12 and up. Parents, school administrators and public health officials elsewhere have eagerly awaited approval for the shot to be made available to more kids.
“This is a watershed moment in our ability to fight back the COVID-19 pandemic,” Dr. Bill Gruber, a Pfizer senior vice president who’s also a pediatrician, told The Associated Press.
The Food and Drug Administration declared that the Pfizer vaccine is safe and offers strong protection for younger teens based on testing of more than 2,000 US volunteers ages 12 to 15. The agency noted there were no cases of COVID-19 among fully vaccinated adolescents compared with 16 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.
Pfizer’s testing in adolescents “met our rigorous standards,” FDA vaccine chief Dr. Peter Marks said. “Having a vaccine authorized for a younger population is a critical step in continuing to lessen the immense public health burden caused by the COVID-19 pandemic.”
Pfizer and its German partner BioNTech recently requested similar authorization in the European Union, with other countries to follow.
The latest news is welcome for US families struggling to decide what activities are safe to resume when the youngest family members remain unvaccinated.
“I can’t feel totally comfortable because my boys aren’t vaccinated,” said Carrie Vittitoe, a substitute teacher and freelance writer in Louisville, Kentucky, who is fully vaccinated, as are her husband and 17-year-old daughter.
The FDA decision means her 13-year-old son soon could be eligible, leaving only her 11-year-old son unvaccinated. The family has not yet resumed going to church, and summer vacation will be a road trip so they do not have to get on a plane.
“We can’t really go back to normal because two-fifths of our family don’t have protection,” Vittitoe said.
President Joe Biden said Monday’s decision marked another important step in the nation’s march back to regular life.
“The light at the end of the tunnel is growing, and today it got a little brighter,” Biden said in a statement.
Pfizer is not the only company seeking to lower the age limit for its vaccine. Moderna recently said preliminary results from its study in 12- to 17-year-olds show strong protection and no serious side effects. Another US company, Novavax, has a COVID-19 vaccine in late-stage development and just began a study in 12- to 17-year-olds.
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