Pfizer Asks FDA To Allow Covid Vaccine Use For Kids As Young As 5

Pfizer and BioNTech have filed a formal request with the Food and Drug Administration (FDA) to expand its emergency use authorization of their Covid-19 vaccine to include children age 5 to 11, Pfizer announced in a tweet Thursday. The pharmaceutical companies submitted clinical trial data to the FDA late last month after reporting positive topline results from their pediatric trials. According to Pfizer and BioNTech, their Covid-19 vaccine was found to be safe and effective in children aged 5 to 11, producing a robust antibody response with well-tolerated side effects.

“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,” Pfizer tweeted Thursday. “With new cases in children in the U.S. continuing to be at a high level, this submission is an important step in our ongoing effort against Covid-19. We’re committed to working with the FDA with the ultimate goal of helping protect children against this serious public health threat.”

According to Pfizer and BioNTech, thousands of children participating in the trial received two 10-microgram doses of the companies’ Covid-19 vaccine 21 days apart. While that’s a smaller dose than the two 30-microgram doses that have been administered to adults and children 12 years old and up, the antibody response recorded in young children was comparable to those found in individuals aged 16 to 25.

Overall, the 10-microgram dose was found to be well-tolerated by children age 5 to 11. In fact, Pfizer and BioNTech reported Monday the side effects reported in children were found to be generally comparable to those observed in older participants aged 16 to 25. As a result of its safety, tolerability, and immunogenicity, Pfizer said the 10-microgram dose was “carefully selected” as the preferred dose for young children in a press release.

“These trial results provide a strong foundation for seeking authorization of our vaccine for children 5 to 11 years old,” Bourla said. “We plan to submit them to the FDA and other regulators with urgency.”

On Sept. 28, Pfizer announced it had submitted trial data to the FDA and planned to submit data to the European Medicines Agency (EMA) and other world regulatory authorities soon. While the FDA will likely take a few weeks to review the pharmaceutical companies’ data, former FDA commissioner and current Pfizer board member Dr. Scott Gottlieb previously told CNN a Covid-19 vaccine could be approved for children ages 5 to 11 years old by Halloween.

What’s more, FDA officials said earlier this month that the regulatory agency would aim to review any clinical trial data regarding Covid-19 vaccines in children “likely in a matter of weeks rather than months,” meaning authorization could come sometime in the early fall. The timing of Pfizer and BioNTech’s recent data submission could see children gaining access to a Covid-19 vaccine as early as the end of October.

The results of Pfizer and BioNTech’s pediatric clinical trial come as the American Academy of Pediatrics (AAP) reports nearly 5.3 million children have tested positive for Covid-19 since the pandemic began in March 2020. According to AAP, children now make up 15.5% of all Covid-19 cases.

“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 released alongside trial results on Sept. 20. “Since July, pediatric cases of Covid-19 have risen by about 240% in the U.S. — underscoring the public health need for vaccination.”

Data regarding the vaccine's efficacy in children under the age of 5 is expected from Prizer and BioNTech later this year.