Pfizer COVID vaccine safe for 5- to 11-year-olds, data shows
Pfizer and BioNTech said Monday that data shows the companies’ COVID-19 vaccine is safe and effective for children ages 5 to 11.
“We are eager to extend the protection afforded by the vaccine to this younger population, subject to regulatory authorization, especially as we track the spread of the delta variant and the substantial threat it poses to children,” Pfizer chairman and CEO Albert Bourla said in a statement. “Since July, pediatric cases of COVID-19 have risen by about 240% in the U.S. – underscoring the public health need for vaccination.”
There were 2,268 participants ages 5 to 11 in the trial, which used a smaller dose of the two-dose regimen that is given to people 12 years old and older.
“In participants 5 to 11 years of age, the vaccine was safe, well-tolerated and showed robust neutralizing antibody responses,” the companies said in a news release.
Pfizer and BioNTech plan to share their data with the U.S. Food and Drug Administration, the European Medicines Agency and other regulators, and will submit a request for emergency use authorization in the United States.
Once the companies share safety results and file for emergency use authorization, it could take weeks or months for the FDA to review the information and make a decision.
“Now the work begins to review the data and determine how to best proceed to protect children from this awful disease,” said Dr. Ned Ketyer, a pediatrician at Allegheny Health Network Pediatrics – Pediatric Alliance. “Parents are very eager to get their children immunized from COVID-19, and a majority of the American public has actually embraced the vaccine very well. But for parents to give their children a new vaccine, they have to feel it’s effective and safe, and the only they’ll get that is to see experts looking at the data.”
Around 12.7 million children under the age of 18 – about 54% of 12- to 17-year-olds – have received at least one dose of a COVID vaccine, according to the American Academy of Pediatrics, as of Sept. 15.
“But that’s still a lot of eligible children who haven’t been vaccinated,” said Ketyer, noting the continuing vaccine hesitancy among Americans.
Meanwhile, the average U.S. daily death toll from COVID-19 over the last seven days surpassed 2,000 as of Sept. 19, the first time since March 1 that deaths have been so high.
As of Monday, 672,738 Americans have died from COVID-19.
COVID cases have surged in the U.S. in recent months. In total, more than 5.3 million children in the U.S. have tested positive for COVID – around 15% of all cases as of Sept. 9 – according to the AAP.
Said Ketyer, “Yesterday, more than 2,000 people died from COVID. That is shocking. Everybody should be shocked by that. And more than 95% of those deaths were people who were unvaccinated. Those are preventable deaths. It’s clear the vaccine is effective and safe, and it’s easily available, and the side effects, if there are any, are mild. (The vaccine) is the safest route to get the pandemic over with and to get us back to as normal a life as possible.”
The FDA approved the Pfizer vaccine for people ages 16 and older in August. It is currently authorized for emergency use in children ages 12 to 15.
“These trial results provide a strong foundation for seeking authorization of our vaccine for children 5 to 11 years old, and we plan to submit them to the FDA and other regulators with urgency,” Bourla said.
Results from two other ongoing trials – one of children ages 2 to 5 and one of children 6 months to 2 years old – are expected as soon as later this year, the companies said.
Pfizer has also received emergency use authorization from the FDA to give a third dose of vaccine to certain patients 12 years of age and older who are immunocompromised.
But a panel advising the federal government on vaccines recently rejected President Joe Biden’s suggestion to roll out booster shots for all Americans, recommending that for now, a third dose should only be given to those 65 and older or those at high risk of severe COVID-19.