BioNTech SE (NASDAQ:BNTX) is trading lower Monday morning after the U.S. Food and Drug Administration (FDA) requested additional data before approving its COVID-19 vaccine for children aged six months to four years old.
Pfizer Inc (NYSE:PFE) and BioNTech extended their rolling submission to the FDA seeking to amend the Emergency Use Authorization of the Pfizer-BioNTech COVID-19 vaccine to include the aforementioned age group.
In December, the two companies announced that ongoing clinical studies would evaluate a third three microgram dose at least two months after the second dose of the two-dose series in this age group.
Given that the study is advancing at a rapid pace, the companies believe it is important to wait for the three-dose data as the companies continue to believe it may provide a higher level of protection in this age group. The companies expect to have three dose protection data available in early April.
BioNTech is a biotechnology company focusing on developing cancer therapeutics, including individualized immunotherapy, as well as vaccines for infectious diseases, including COVID-19.
See Also: FDA Postpones Adcomm For Pfizer's COVID-19 Vaccine For Youngest Kids
BNTX Price Action: BioNTech has traded as low as $90.29 and as high as $464 over a 52-week period.
The stock was down 8.04% at $157.21 at time of publication.
Photo: x3 from Pixabay.
