The United States’s regulator is expected to authorise Pfizer-BioNTech’s COVID-19 vaccine for children aged 12 to 15 by next week, according to a federal official and a person familiar with the process, setting up shots for many before the beginning of the next school year.
The announcement by the US Food and Drug Administration (FDA) is set to come a month after the company found that its shot, which is already authorised for those age 16 and older, also provided protection for the younger group.
The federal official, speaking to The Associated Press news agency on the condition of anonymity to preview the FDA’s action, said the agency was expected to expand its emergency use authorisation for the two-dose vaccine by early next week, perhaps sooner.
The person familiar with the process, who spoke to AP on condition of anonymity to discuss internal matters, confirmed the timeline and added that it is expected the FDA will approve the jab’s use for even younger children sometime this autumn.
The FDA action will be followed by a meeting of a federal vaccine advisory committee to discuss whether to recommend the shot for 12- to 15-year-olds. Shots could begin after the Centers for Disease Control and Prevention (CDC) adopts the committee’s recommendation. Those steps could be completed in a matter of days.
The New York Times first reported on the expected timing for the authorisation.
Signs of promising findings
Pfizer in late March released preliminary results from a vaccine study of 2,260 US volunteers aged 12 to 15, showing there were no cases of COVID-19 among fully vaccinated adolescents compared with 18 among those given dummy shots.
Children had side effects similar to young adults, the company said. The main side effects are pain, fever, chills and fatigue, particularly after the second dose. The study will continue to track participants for two years for more information about long-term protection and safety.
Pfizer is not the only company seeking to lower the age limit for its vaccine. Results also are expected by the middle of this year from a US study of Moderna’s vaccine in 12- to 17-year-olds.
But in a sign that the findings were promising, the FDA already allowed both companies to begin US studies in children 11 and younger, working their way to as young as six months old.