- Pfizer and BioNTech have officially asked U.S. regulators for emergency clearance of their coronavirus vaccine in children between 5 and 11 years old, making the developers the first to seek authorization for younger kids.
- Thursday's announcement, which Pfizer made on Twitter, comes nine days after the companies said they had started submitting data to the Food and Drug Administration in support of their application, which, if authorized, could make more than 28 million children in the U.S. eligible for vaccination.
- The FDA has already scheduled an Oct. 26 advisory panel to discuss the vaccine's potential authorization in kids, more and more of whom have been infected and hospitalized as the delta variant spread and the school year began. Clearance is reportedly expected in November, though the evaluation could be complicated by turnover within the agency's vaccine review office.
The spread of the delta variant has heightened the urgency to make children eligible for vaccination against COVID-19.
Before delta, infections among children accounted for a lower share of COVID-19 cases. According to the American Academy of Pediatrics, for example, about one in six Americans infected since the beginning of the pandemic was under 18 years. However, as the delta variant surged and more adults were vaccinated, the share of young people infected increased to nearly one in four last month.
Though severe illness and death from COVID-19 are still rarer among children, hospitalizations have begun to rise as more kids have become infected. It's also unclear what percentage of kids with mild disease experience symptoms for several months or more, a condition known as long COVID.
Vaccinations could help curb the rise of those cases, and might begin as soon as next month if regulators judge the benefits are worth the risks — chiefly, a type of heart inflammation called myocarditis that can occur in rare instances after immunization. Myocarditis is also associated with COVID-19.
On Sept. 20, Pfizer said study results had indicated the vaccine was safe and that it spurred immune responses in kids that were comparable to what was observed in young adults. The dose children received was one-third the dose given to adults.
Pfizer hasn't yet disclosed detailed results from the study. It also hasn't said whether researchers documented any cases of myocarditis.
Moderna, meanwhile, is testing a smaller dose of its coronavirus vaccine in the same age group. Moderna has reportedly said that data should be available by the end of the year.
The FDA previously authorized Pfizer's vaccine for 12- to 15-year-olds in May.
In addition to deciding whether to recommend vaccinations for children, the FDA's advisory committee is set to weigh whether people who received Moderna's or Johnson & Johnson's shots should get a booster dose. A two-day meeting is scheduled for next week.