Pfizer (NYSE:PFE) and BioNTech (NSDQ: BNTX) plan to formally seek FDA emergency authorization in the coming weeks for the use of their Comirnaty (BNT162b2) vaccine in children 5 to 11.
The news came today as the companies announced the submission of initial Phase 2/3 trial data to FDA.
The companies last week announced that the vaccine had favorable immunogenicity and tolerability in children 5 to 11.
Vaccine recipients in the clinical trial received a 10-μg dose of mRNA, which is one-third of the amount the company had studied in 16 to 25 year-olds.
Pfizer and BioNTech also plan to submit the data to a peer-reviewed journal.
The companies expect data from younger children as soon as the fourth quarter of the year.
“We are pleased to be able to submit data to regulatory authorities for this group of school-aged children before the start of the winter season,” said Dr. Ugur Sahin, CEO of BioNTech, in a statement. “The safety profile and immunogenicity data in children aged 5 to 11 years vaccinated at a lower dose are consistent with those we have observed with our vaccine in other older populations at a higher dose.”
Some researchers and regulators have worried about rare cases of myocarditis in younger BNT162b2 vaccine recipients, which appear to be most common in boys.
In May, FDA amended the EUA for the vaccine to include adolescents 12–15.
In the U.K., the Joint Committee on Vaccination and Immunisation (JCVI) had expressed reservations about recommending the BNT162b2 to healthy children aged 12 to 15. The committee noted in a statement that it believes “the benefits from vaccination are marginally greater than the potential known harms.” It also stated that “there is considerable uncertainty regarding the magnitude of the potential harms.” JCVI recommended vaccinating children with immunosuppression, type 1 diabetes, congenital heart disease and other health conditions.