Pfizer expects to submit for US Food and Drug Administration emergency use authorization for its Covid-19 vaccine for children ages 2 to 11 in September, the company said during its first quarter earnings teleconference on Tuesday.
The pediatric safety and efficacy study in children ages 6 months to 11 years old is ongoing.
Pfizer CEO Albert Bourla said in prepared remarks, adding that the readout and submission for children 6 months to 2 years is expected in the fourth quarter of 2021.
Phase 2 safety data from Pfizer’s ongoing study in pregnant women is expected by late July or early August, Bourla said.
Bourla also said the company expects to hear back shortly on its application for extended EUA for the vaccine to include 12-to-15-year-olds. On Monday, a federal government official said the FDA is poised to authorize the Pfizer coronavirus vaccine for that age group by early next week.