The United States will start vaccinating teens aged 12 to 15 as the approval of Pfizer/BioNTech’s coronavirus vaccine has been extended to include this age group.
The U.S. Food and Drug Administration (FDA) expanded the emergency use authorisation (EUA) originally issued on December 11, 2020, for administration in individuals 16 years of age and older, it announced in a press release on Monday.
“The FDA’s expansion of the EUA is a significant step in the fight against the Covid-19 pandemic,” said Acting FDA Commissioner Janet Woodcock, M.D, adding that this action “allows for a younger population to be protected and bringing us closer to returning to a sense of normalcy and to ending the pandemic.”
Last Wednesday, Canada became the first country to approve the Pfizer coronavirus vaccine for this age group.
In the next few days, over 20,000 pharmacies will be able to vaccinate these teens, in two injections, three weeks apart, containing the same dosage as the adult vaccine. The doses will then be sent to pediatricians.
The FDA’s approval was based on available safety data from a US clinical trial including 2,260 participants ages 12 through 15 years old, of which 1,131 participants received the vaccine and 1,129 received a placebo.
Last week, President Biden had stressed the crucial role of adolescent vaccination for the continuation of the US immunisation campaign and that he would start the vaccinations of this age group once the FDA announced the approval.