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Results from clinical trials of Pfizer / BioNTech’s Covid-19 vaccine have shown that it is 100% effective and is well tolerated in young people aged 12 to 15, the companies said on Wednesday.
Pfizer / BioNTech plans to submit the data to the U.S. Food and Drug Administration as soon as possible for expanded authorization for emergency use of the two-dose vaccine.
In a phase 3 trial involving 2,260 participants aged 12 to 15 in the United States, the vaccine elicited strong antibody responses one month after the second dose, exceeding those shown in people aged 16 to 25 in previous trials, reported Pfizer / BioNTech. The vaccine is currently licensed in the United States for emergency use in people 16 years of age and older.
The researchers observed 18 cases of Covid-19 among the 1,129 participants who received a placebo, and none among the 1,131 participants who received the vaccine. The data has not yet been peer reviewed.
Pfizer / BioNTech added that the side effects seen in people aged 12 to 15 were similar to those seen in those aged 16 to 25. Participants will be monitored for protection and safety for two years after their second dose.
“We share the urgency to extend the authorization for use of our vaccine to younger populations and we are encouraged by the clinical trial data on adolescents aged 12 to 15 years,” said Albert Bourla, CEO of Pfizer.
“We plan to submit this data to the 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 group. of age before the start of the next school year. ”
A separate Phase 1/2/3 study of the Pfizer / BioNTech vaccine in children aged 6 months to 11 years was launched last week, when the first participants aged 5 to 11 received an injection.
Pfizer / BioNTech plans to start dosing children 2 to 5 years old next week and work their way through participants aged 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 on children aged 12 to 17 and 6 months to 11 years old.
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