FDA reportedly plans to authorize Pfizer’s COVID vaccine for teens 12-15 in days
The Food and Drug Administration is planning to authorize the use of Pfizer-BioNTech’s COVID-19 vaccine in adolescents 12 to 15 years old later this week or early next week, according to a report by The New York Times.
The Times cited unnamed federal officials who did not have authorization to speak publicly about the FDA’s plans. If the FDA does authorize use of the vaccine in the teen group in the week, the Centers for Disease Control and Prevention’s vaccine advisory panel will likely meet a day later to review the clinical trial data and make a recommendation on use, the Times reported.
On March 31, Pfizer announced that the vaccine completely protected adolescents ages 12 to 15 against COVID-19 in a small Phase III clinical trial. The vaccine was also well-tolerated in the age group, producing mainly standard side effects. In the 2,260-person trial, 1,131 adolescents ages 12 to 15 received the vaccine, while 1,129 received a placebo. There were 18 cases of symptomatic COVID-19 in the trial, all of which were in the placebo group. The vaccinated group appeared to produce neutralizing antibodies at higher levels than those seen earlier in people ages 16 to 25, Pfizer noted.
