Pfizer's Covid Vaccine Is Safe In Kids 5-11, Trial Data Shows

Pfizer and BioNTech’s Covid-19 vaccine was found to be safe and effective in producing a robust antibody response in children ages 5 to 11 years old, the pharmaceutical companies announced Monday. In light of the results, Pfizer has said it plans to submit the data to regulatory agencies like the Food and Drug Administration (FDA) as soon as possible, in hopes of getting its Covid-19 vaccine approved for use in children under the age of 12.

“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 Monday. “Since July, pediatric cases of Covid-19 have risen by about 240% in the U.S. — underscoring the public health need for vaccination.”

According to Pfizer and BioNTech, the 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 issued Monday.

“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.”

While an exact timeline for FDA approval remains impossible to predict, 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 fall.

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.