Clinical trial results of Pfizer/BioNTech’s Covid-19 vaccine showed its efficacy is 100% and it is well tolerated in youths ages 12 to 15, the companies said Wednesday.
Pfizer/BioNTech plan to submit the data to the US Food and Drug Administration as soon as possible for expanded emergency use authorization of the two-dose vaccine.
In a Phase 3 trial of 2,260 participants ages 12 to 15 years in the US, the vaccine elicited strong antibody responses one month after the second dose, exceeding those demonstrated in people ages 16 to 25 in previous trials, Pfizer/BioNTech reported. The vaccine is currently authorized in the US for emergency use in people ages 16 and older.
Researchers observed 18 Covid-19 cases among the 1,129 participants who were given a placebo, and none among the 1,131 participants who were given the vaccine. The data has yet to be peer reviewed.
Pfizer/BioNTech added that the side effects observed in people ages 12 to 15 were similar to those seen in 16 to 25-year-olds. The participants will be monitored for protection and safety for two years after their second dose.
“We share the urgency to expand the authorization of our vaccine to use in younger populations and are encouraged by the clinical trial data from adolescents between the ages of 12 and 15,” said Pfizer CEO Albert Bourla.
“We plan to submit these data to FDA as a proposed amendment to our Emergency Use Authorization in the coming weeks and to other regulators around the world, with the hope of starting to vaccinate this age group before the start of the next school year.”
A separate Phase 1/2/3 study of the Pfizer/BioNTech vaccine in children ages 6 months to 11 years launched last week, when the first participants ages 5 to 11 received a shot.
Pfizer/BioNTech plans to begin dosing 2 to 5-year-olds next week and work its way down to participants ages 6 months to 2 years. The company aims to enroll 4,644 children in the trial and expects results by the end of 2021.
Moderna is also testing its Covid-19 vaccine in adolescents and children, in two clinical trials of children ages 12 to 17 and those ages 6 months to 11 years.
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