Pfizer’s COVID-19 vaccine appears safe and nearly 91 percent effective at preventing symptomatic infections in 5- to 11-year-olds, according to study details released Friday as the US considers opening vaccinations to that age group.
The companies studied a 10 microgram vaccine dose in children ages 5 to 11, a third of the dose used for adults and older children. The study tracked 2,268 kids in that age group who got two shots three weeks apart of either a placebo or the low-dose vaccine.
The lower dose was chosen to minimize side effects and because it still prompts a strong immune response, the companies said.
In addition, no new safety problems were identified in the companies' studies. No cases of heart inflammation were observed in the main study, but only a few thousand children were included in the research, so that sort of rare problem wouldn't necessarily be detected.
Advisers to the Food and Drug Administration are expected to publicly debate the study evidence next week. If the agency ultimately authorizes the shots, the Centers for Disease Control and Prevention will make the final decision on who should receive them.
Meanwhile, Pfizer Covid-19 vaccines are already authorized for anyone 12 or older.
The companies studied a 10 microgram vaccine dose in children ages 5 to 11, a third of the dose used for adults and older children. The study tracked 2,268 kids in that age group who got two shots three weeks apart of either a placebo or the low-dose vaccine.
The lower dose was chosen to minimize side effects and because it still prompts a strong immune response, the companies said.
In addition, no new safety problems were identified in the companies' studies. No cases of heart inflammation were observed in the main study, but only a few thousand children were included in the research, so that sort of rare problem wouldn't necessarily be detected.
Advisers to the Food and Drug Administration are expected to publicly debate the study evidence next week. If the agency ultimately authorizes the shots, the Centers for Disease Control and Prevention will make the final decision on who should receive them.
Meanwhile, Pfizer Covid-19 vaccines are already authorized for anyone 12 or older.
