Pfizer Inc said on Monday its COVID-19 vaccine provided strong long-term protection against the virus in a late-stage study conducted among adolescents aged 12 to 15 years.
A two-dose series of the vaccine was 100% effective against COVID-19, measured seven days through over four months after the second dose, the company said in a press release. Among 2,228 participants in the clinical trial, there were 30 confirmed cases of symptomatic COVID-19 – all among placebo recipients, and none in the group that had received the vaccine.
The long-term data will support planned submissions for full-regulatory approval of the vaccine in the age group in the United States and worldwide.
Pfizer and BioNTech will seek clearance for a 30 micrograms dose of the vaccine for those aged 12 and above.
The vaccine was authorized for emergency use in people aged 12-15 years by the U.S. Food & Drug Administration in May, and granted full approval for use in people aged 16 and above in August.
Health Canada approved the Pfizer-BioNTech vaccine for youth 12 and older in May 2021.