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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.
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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.
Crypto Whales Are Loading Up — Are You?
New research shows the biggest crypto buyers are back. And this time? They could hold for the possibility that Bitcoin will surpass $100,000 in 2024. You don’t want to miss the next massive crypto bull run like we saw in 2020 and 2021. To know exactly what’s going on and what to buy… Get Access To Benzinga’s Best Crypto Research and Investments For Only $1.