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Pfizer (NYSE:PFE) and BioNTech (NSDQ: BNTX) announced today that they submitted a request to the FDA to expand authorization of their COVID-19 vaccine to younger children.
Expanded FDA emergency use authorization would allow for the use of the COVID-19 vaccine candidate, which has full FDA approval for people 16 years of age and older, in children aged 5 to 11. It received EUA for adolescents aged 12 to 15 in May.
Last month, the companies announced their plan to formally seek FDA emergency authorization in the coming weeks for the use of their Comirnaty (BNT162b2) vaccine in children 5 to 11, following the submission of initial Phase 2/3 trial data to FDA. Today, in an announcement on Twitter, Pfizer and BioNTech confirmed the official submission of their request for EUA.
With new cases in children in the U.S. continuing to be at a high level, this submission is an important step in our ongoing effort against [COVID-19],” the company wrote in a Twitter thread following the initial announcement. “We’re committed to working with the FDA with the ultimate goal of helping protect children against this serious public health threat.”
The companies expect data from younger children as soon as the fourth quarter of the year. Some researchers and regulators have expressed concern over about rare cases of myocarditis in younger BNT162b2 vaccine recipients, which appear to be most common in boys.