The Food and Drug Administration on Monday authorized the first coronavirus vaccine for emergency use in children ages 12 to 15, expanding access to the Pfizer-BioNTech shot.
It marks a major milestone in the push to vaccinate more Americans and to fully reopen schools in the fall.
“This is a promising development in our fight against the virus. If you are a parent who wants to protect your child, or a teenager who is interested in getting vaccinated, today’s decision is a step closer to that goal,” President Biden said.
Acting FDA Commissioner Janet Woodcock said, “parents and guardians can rest assured that the agency undertook a rigorous and thorough review of all available data.”
Pfizer said its two-shot vaccine was 100% effective in protecting against COVID-19 in a trial of more than 2,200 children between the ages of 12 and 15.
Adolescents and teenagers can be part of the chain of transmission in their communities even though hospitalization and death from the coronavirus are rare in the age group.
Monday’s decision had been highly anticipated as educators, parents and elected officials grapple with how to reopen schools fully to in-person learning.
Vaccinating younger persons will also help the U.S. reach widespread immunity to the virus, though it is not clear how many parents will seek the shots out for their kids.
A Kaiser Family Foundation poll in April found 30% of parents of children ages 12-15 say they will get their child vaccinated as soon as it is available, abtout 25% say they will wait and see how the rollout goes, and 18% plan to get their child vaccinated if their school requires it.
Nearly a quarter say they will definitely not get their child vaccinated.
Pfizer’s vaccine was approved for ages 16 and up in December.
The two-dose version from Moderna and a one-shot vaccine from Johnson & Johnson are approved for ages 18 and older. Both drugmakers are testing their vaccines in persons 12 and older.
Mr. Biden’s coronavirus team last week said it would make the Pfizer vaccine immediately available to adolescents, once approved, through existing distribution channels and pediatricians’ offices.
Pediatricians have a long track record of administering childhood vaccinations of all kinds.
As it stands, nearly half of the U.S. population — 46% — has received at least one dose of a COVID-19 vaccine and more than a third — 35% — are fully vaccinated, according to the Centers for Disease Control and Prevention.
That’s far short of “herd immunity” levels that are somewhere between 70% and 90% but the vaccine push is having an effect, with the rolling daily average of U.S. cases dropping to around 40,000
States and cities are starting to relax capacity limits and other COVID-19 restrictions due to the progress.
“The safe and effective vaccines are curbing the spread of the virus, saving thousands of lives, and allowing millions of Americans to start returning to a closer to normal life,” said Mr. Biden, who took over the rollout after the vaccines were developed under former President Donald Trump. “The light at the end of the tunnel is growing, and today it got a little brighter.”