Pfizer Inc (NYSE:PFE) is trading lower Monday 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 and BioNTech (NASDAQ:BNTX) extended their rolling submission to the FDA seeking to amend the Emergency Use Authorization of the Pfizer-BioNTech COVID-19 vaccine to include children aged six months to four years old.
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 the aforementioned 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.
Pfizer is one of the world's largest pharmaceutical companies. Its prescription drugs and vaccines account for a majority of the company's revenue today.
See Also: FDA Postpones Adcomm For Pfizer's COVID-19 Vaccine For Youngest Kids
PFE Price Action: Pfizer has traded as low as $33.36 and as high as $61.71 over a 52-week period.
The stock was down 3.13% at $49.19 at time of publication.
Photo: Felton Davis from Flickr.
