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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.
The article goes on to state the following:
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.
Albert Bourla, chairman and chief executive officer of Pfizer said, in the press release, “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. 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.”
Reporter Meg Tirrell tweeted Wednesday, “A potential #covid19 vaccine in time for back-to-school. Pfizer shows 100% efficacy in kids ages 12-15 (18 cases on placebo, 0 on vaccine, among 2,260 in trial.)”
— Meg Tirrell (@megtirrell) March 31, 2021
Pfizer tweeted, “Today, with @BioNTech_Group, we announced positive topline results in adolescents 12-15 years of age from the Phase 3 Pfizer-BioNTech #COVID19 vaccine study. The Pfizer-BioNTech COVID-19 vaccine has not been approved or licensed by the U.S. FDA but has been authorized for emergency use to prevent COVID-19 in individuals 16+. See conditions of use: cvdvaccine.com.”
— Pfizer Inc. (@pfizer) March 31, 2021
BREAKING: Pfizer says COVID-19 vaccine protects kids as young as 12, which could open door for expanded use in children by fall. https://t.co/uvpjePQP1c
— The Associated Press (@AP) March 31, 2021
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