Kids between 12 and 15 years old can now receive Pfizer COVID vaccine, FDA announces

In a long-awaited decision, children between 12 and 15 years old can now receive the two-dose Pfizer-BioNTech coronavirus vaccine after months of research deemed the shot safe and effective for the age group, federal health officials announced Monday.

The U.S. Food and Drug Administration amended the emergency use authorization already set for the shot — the first COVID-19 vaccine authorized in the U.S. — opening it up to millions of more Americans. Until now, only people ages 16 and older were allowed to get the vaccine.

Acting FDA Commissioner Janet Woodcock said in a statement that the expansion is a “significant step in the fight against the COVID-19 pandemic.”

“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,” Woodcock said. “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.”

CDC advisers are scheduled to meet Wednesday to recommend how the Pfizer vaccine should be used among the age group, The Washington Post reports. After CDC director Rochelle Walensky approves those recommendations, the vaccine can start being administered.

The vaccine will be administered to the age group through two doses given three weeks apart, the FDA says — the “same dosage and dosing regimen” for those 16 years and older.

Canada became the first country to authorize the Pfizer vaccine on Wednesday for children aged between 12 and 15.

Evidence shows children are more likely to have mild cases of COVID-19, while young kids are less likely to spread the virus than adults. But they can still infect others around them, and although rare, some kids may experience severe disease. Vaccinating children is also important when it comes to herd immunity — when enough people are immune to COVID-19 that the virus’s spread is unlikely.

“Now that we can vaccinate those kids, it’s going to make it much, much easier to get those kids back to school without the anxiety associated with whether or not there are going to be outbreaks at that level,” Dr. Anthony Fauci, President Joe Biden’s chief medical adviser, told NBC News’ “TODAY” last week.

The move stemmed from a late stage trial that showed the shot reduced risk of coronavirus infection in children 12 to 15 years old by 100%, meaning no vaccinated kids were infected.

It’s a stunning boost in protection against COVID-19 compared to people between 16 and 25 years old, who benefit from a 95% reduction in infection risks after receiving their second, final dose, the companies said in March.

Side effects were similar to those experienced in adults and included injection site pain (84%), fatigue (63%), headache (55%), muscle pain (38%), chills (32%), joint pain (24%), fever (14%), injection site swelling (10.5%) and nausea (1%).

No serious allergic reactions were reported among the 2,260 kids in the study with or without histories of past coronavirus infections.

The companies did not mention how well the vaccine worked against the more contagious coronavirus variants, but the variants have been spreading during the late stage trial period.

Pfizer and BioNTech have also vaccinated the first group of kids in their study of those between 6 months and 11 years old. This study is separated into three age groups: children aged 5 to 11 years, 2 to 5 years, and 6 months to 2 years.

All the kids in the study will “continue to be monitored for long-term protection and safety for an additional two years after their second dose,” the companies said.

Pfizer recently said on a quarterly earnings call that it expects to apply for emergency use authorization from the FDA to administer the vaccine to children ages 2 to 11, The New York Times reported last week.

Moderna announced in March that children between 6 months and 12 years old have started to receive its vaccine in a mid- to late-stage study. The company plans to enroll about 6,750 children in the U.S. and Canada.

More than 115.5 million people ages 16 and older as of May 10 are fully vaccinated against COVID-19, about 35% of the population, according to a Centers for Disease Control and Prevention tracker.

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