The Food and Drug Administration said Pfizer’s coronavirus vaccine can be given to kids 12 to 15 years old — making it the first shot available for Americans younger than 16.
The timing of the agency’s decision means that many high schoolers could be vaccinated by the time the next school year starts. Expanding vaccine eligibility to younger teens will also aid the Biden administration’s push to vaccinate as many Americans as quickly as possible.
“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,” acting FDA Commissioner Janet Woodcock said in a statement.
Several states have said they are prepared to begin this week to administer the shot to 12- to 15-year-olds. That category includes nearly 17 million adolescents nationwide, roughly half of whom are people of color, according to an analysis of government data by the Kaiser Family Foundation.
Up to this point, Pfizer’s vaccine had been authorized only for those 16 and older. The two other Covid-19 vaccines available in the U.S., from Moderna and Johnson & Johnson, are allowed for adults 18 and up.
“Today’s expansion of our EUA represents a significant step forward in helping the U.S. government broaden its vaccination program and help protect adolescents ages 12 – 15 before the start of the next school year,” Pfizer CEO Albert Bourla said in a statement.
Background: Pfizer and its development partner BioNTech said in late March that their vaccine was 100 percent effective in preventing Covid-19 in a trial of 2,300 U.S. kids ages 12 to 15, making it slightly more effective for that age group than for adults. The study also revealed that younger teens developed higher antibody levels post-vaccination than did adults.
No teen who received the vaccine in a late-stage trial developed Covid-19, the companies said. By contrast, 18 teens in the placebo group became infected.
Other vaccine makers, including Moderna and Johnson & Johnson, are currently studying their vaccines’ safety and efficacy in teens and younger children but have not yet released results from those trials.
FDA said Monday that its vaccine advisory committee will meet on June 10 to discuss its approach to allowing the use of Covid-19 vaccines for children younger than 16, particularly kids age 11 and under.
In the meantime, Canada last week became the first country to authorize the Pfizer-BioNTech vaccine for 12- to 15-year-olds. The companies have also sought permission from the European Medicines Agency to market the vaccine to this age group in Europe.
What’s next: Pfizer and BioNTech are studying the safety and efficacy of their vaccine in children from 6 months to 11 years old. The companies hope to have results for children ages 2 to 11 by September. Pfizer and BioNTech applied Friday for full U.S. approval of its vaccine for people 16 to 85.