Pfizer and BioNTech announced Monday that their coronavirus vaccine has shown to be safe and effective in low doses among young children ages 5-11, triggering a strong immune response.
The findings come after a highly anticipated trial, as surges in cases due to the delta variant have made for a rocky start to the school year for those too young to be vaccinated, as well as for anxious parents and school staff. And although a vaccine for children still requires emergency use authorization from the Food and Drug Administration, the trial results bring young kids one step closer to getting the shot.
“Since July, pediatric cases of COVID-19 have risen by about 240 percent in the U.S. – underscoring the public health need for vaccination,” Albert Bourla, chairman and chief executive officer of Pfizer said in a statement. “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 most recent phase of the trial included more than 2,200 participants in the age group. According to the companies, the trial demonstrated “strong immune response in this cohort of children” a month after the second dose, which compares well with the results of participants ages 16 to 25. Additionally, the vaccine was “well tolerated” by those studied, who experienced side effects comparable to those observed in the 16-25 age group. The companies plan to submit the trial results to the FDA for approval as soon as possible.