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Pfizer and BioNTech announced Wednesday that a Phase 3 trial involving its coronavirus vaccine in adolescents ages 12 to 15 was found to be safe and 100% effective. A press release posted Wednesday said the BNT162b2 vaccine produced “robust antibody responses, exceeding those recorded earlier in vaccinated participants aged 16 to 25 years old,” and that it was well tolerated.
The trial had enrolled 2,260 adolescents and saw 18 cases of COVID-19 among the placebo group, and none in the vaccinated group. Side effects were consistent with those seen in previous trials involving older participants ages 16 through 25. The participants will continue to be monitored for long-term protection and safety over the next two years.
Pfizer said it plans to submit the data to the FDA as part of a request to amend its current Emergency Use Authorization (EUA). The two-dose vaccine was granted EUA in December for those 16 years of age and older.
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“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,” Albert Bourla, chairman and chief executive officer of Pfizer said, in the press release. “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 next school year.”
It is not clear how quickly the FDA would respond to the request, nor, if granted when states would expand eligibility to include younger teens. Across the country, dozens of governors have moved to meet President Biden’s directive to make all adults vaccine-eligible by May 1.
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The company has an additional ongoing trial involving children ages 6 months to 11 years old. The study, which dosed the first participants last week, is evaluating the vaccine’s safety, tolerability and immunogenicity among the younger children as well.
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