Pfizer-BioNTech has announced that its two-dose COVID-19 vaccine is safe and effective in children aged between 5 and 11, in a major step toward providing school-age kids with some protection from the virus.
The companies confirmed in a statement that data collected in a trial including more than 2,000 children proved that the vaccine is “safe, well tolerated, and showed robust neutralizing antibody responses.” The results come as case numbers in children are exploding—they now account for around one in every five new cases recorded in the United States.
Pfizer-BioNTech will now submit the data to the Food and Drug Administration with the aim of obtaining emergency-use authorization. If successful, children could start getting shots before Halloween.
Pfizer Chairman Albert Bourla said: “Since July, pediatric cases of COVID-19 have risen by about 240 percent in the U.S.—underscoring the public health need for vaccination. 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.”
The results are based on a Phase 2/3 trial that saw 2,268 children receive two doses of the Pfizer vaccine 21 days apart. The drug makers said the children were administered smaller doses of the vaccine than those given to people aged 12 and older, but trial data showed that the antibody responses were similar to those recorded in studies of people age 16 to 25.
The companies didn’t provide detailed data from the trial with their announcement, and the findings haven’t yet been peer-reviewed. However, vaccine experts have welcomed the potentially game-changing results.
Kristin Oliver, a pediatrician at Mount Sinai Hospital who specializes in child vaccines, told The New York Times: “There’s going to be a huge number of parents who are going to heave a big sigh of relief when they hear this... We’ve been waiting for these kids to be protected.”
Ugur Sahin, CEO of BioNTech, said he was “pleased” that the company is on track to rollout a vaccine for kids before the winter, and said: “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.”
The data will now be sent to the FDA, as well as other regulators around the world, with the aim of gaining emergency-use authoritzation to give the vaccine to school-age children before an anticipated winter surge. Trial results for children younger than 5 are expected later this year.
Nearly 5.3 million children in the U.S. have tested positive for COVID since the start of the pandemic—around 15 percent of all cases.