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 an 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 to use 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 FDA will likely mull the rare risk of heart inflammation associated with mRNA vaccines in younger people. However, cases of myocarditis linked to such vaccines tend to be mild, according to a study in the NEJM.
The companies expect data from younger children as soon as the fourth quarter of the year. Some researchers and regulators have expressed concern over rare cases of myocarditis in younger BNT162b2 vaccine recipients, which appear to be most common in boys.
Moody’s Investors Service released a report surmising that that boosters and vaccines for children will not have a credit impact on the pharma sector as several nations already deals in place that would cover many doses for children.
Pfizer and its partner BioNTech are likely to continue dominating the overall COVID-19 vaccine landscape, concluded Moody’s analyst Michael Levesque in the report. “These revenues enhance Pfizer’s credit profile, primarily in the form of higher earnings this year, and higher cash on hand,” Levesque added.
Filed Under: clinical trials, Drug Discovery, Drug Discovery and Development, Infectious Disease