Pfizer Asks FDA To Green Light Vaccination For Children 5 to 11

NEW YORK — Pfizer-BioNTech asked the U.S. Food And Drug Administration on Thursday to green light the use of its two-dose COVID-19 vaccine in children between the ages of 5 to 11.

"We and @BioNTech_Group officially submitted our request to @US_FDA for Emergency Use Authorization (EUA) of our #COVID19 vaccine in children 5 to <12," the drugmaker tweeted on Thursday.

The request follows single-dose COVID vaccine maker Johnson & Johnson asking the Food and Drug Administration to allow booster shots of its COVID-19 vaccine for those ages 18 and older. The federal government has already authorized a single booster dose of the Pfizer COVID-19 vaccine for those who received their second dose six months ago.

Gov. Kathy Hochul said this week that pediatricians should be ready. She asked pediatricians to enroll so when the green light is given to vaccinate children, there is no delay.

"Our focus remains keeping kids in schools, returning people to work, and reopening New York safely," Hochul said. "We all know the best way to ensure our continued progress is to get more shots in arms."

Pfizer shots could be given to children in a matter of weeks if approval is granted, according to the Associated Press. It would be the first COVID vaccine available to kids under 12 in the nation and could help protect over 28 million people in the nation, the New York Times reports.

An independent review panel is slated to debate Pfizer's evidence on Oct. 26. A decision is expected sometime between Halloween and Thanksgiving.

Pfizer has previously said that children between 5 and 11 are to recieve a third of the adult dose.

Read more: Pfizer Says Low COVID Vaccine Dose Is Good For Kids 5 To 11

In total, Pfizer tested its COVID vaccine on 4,500 children worldwide, with 2,268 participants enrolled in the 5-11 age group. The children demonstrated a strong immune response one month after the second dose, said Pfizer. Further, the COVID-19 vaccine was well tolerated, with side effects generally comparable to those observed in participants 16 to 25 years old.

"We are pleased to be able to submit data to regulatory authorities for this group of school-aged children before the start of the winter season," said Dr. Ugur Sahin, CEO and co-founder of BioNTech, in a statement. "The safety profile and immunogenicity data in children aged 5 to 11 years vaccinated at a lower dose are consistent with those we have observed with our vaccine in other older populations at a higher dose."

At a press briefing in September, Hochul discussed vaccinations for children and the push to vaccinate kids 12 to 17.

"We cannot do anything to endanger our children," she said. "It's like putting your kids in a car on a busy highway with no seat belt, or sending out a young, inexperienced driver and saying, 'Good luck.' Keeping them unvaccinated in a global pandemic is something I can't fathom as a parent."

Vaccinations, she said, are akin to seat belts, bike helmets and car seats.

When asked if she would mandate vaccinations for young people in that age group, Hochul said, "I'm open to all options."

She said her initial inclination was to make the decision voluntary for parents. But if circumstances change and the numbers continue to go up, "I'm willing to consider anything," she said.

When asked about news regarding Pfizer's announcement that the CDC has said the vaccination, at a lower dose, was safe for children 5 to 11, Hochul said she was willing to let science and CDC recommendations drive decisions, along with multiple layers of review in New York.

"I'm excited about this possibility if I'm the parent of a 5-year-old," Hochul said.

With reporting by Nicole Rosenthal, Carly Baldwin and Alexis Tarazzi.