Pfizer will seek okay for kid vax
Kids from 2-11 could be eligible for a COVID-19 vaccine this fall.
Pfizer on Tuesday said it plans in September to apply for emergency use authorization from the Food and Drug Administration to inoculate younger children against the fast-spreading disease just as the new school year begins.
The company revealed its plans to Wall Street analysts and reporters during its quarterly earnings call, CNN reported.
“We expect to have definitive readouts and submit for an [emergency use authorization] for two cohorts, including children age 2-5 years of age and 5-11 years of age, in September,” Pfizer CEO Alert Bourla said in prepared remarks cited by CNN.
The two-shot coronavirus treatment has so far been approved for use in all adults and older teens — and the latest emergency approval could allow for distribution to adolescents between 12 and 15, The Associated Press reported, citing a federal official and a person familiar with the process.
Pfizer in late March released preliminary results from a vaccine study of 2,260 U.S. volunteers in the age bracket, showing there were no cases of COVID-19 among fully vaccinated adolescents compared with 18 among those given placebo shots. The initial results showed “100% efficacy” in children as young as 12 with side effects similar to those that have appeared in young adults — pain, fever, chills and fatigue — particularly after the second dose.
The initial rush to inoculate targeted older Americans because the young were at a significantly lower risk of serious side effects from COVID-19. Nevertheless, young people now make up a significant portion of new cases in the United States, as most adults have been vaccinated and indoor activities have been mostly allowed to resume.
Following approval from the FDA, a meeting of a federal vaccine advisory committee will discuss whether to recommend the shot for 12-to-15-year-olds. Shots could begin after the Centers for Disease Control and Prevention adopts the committee’s recommendation. Those steps could be completed in a matter of days.