What happened
Shares of BioNTech (BNTX +0.93%) were jumping 8.6% as of 3:13 p.m. EDT on Friday. The nice pop came after the biotech and its partner Pfizer (PFE 0.92%) announced that they have initiated a rolling submission of a regulatory application with the Food and Drug Administration for approval of their COVID-19 vaccine.
So what
The Pfizer-BioNTech COVID-19 vaccine became the first vaccine to win Emergency Use Authorization (EUA) from the FDA in December 2020. The two partners are also the first to file for full FDA approval for a COVID-19 vaccine.
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Full FDA approval will be required for the company's COVID-19 vaccine to remain on the market once the pandemic ends and the EUA program is concluded. The process for full approval will take a longer period of time, typically 10 months. However, Pfizer and BioNTech have requested Priority Review. If this request is granted, the FDA will make an approval decision within six months of the acceptance of the regulatory filing.
Today's news is just the latest in a string of positive developments for BioNTech. The stock is now up more than 120% year to date.
Now what
The next step for BioNTech and Pfizer is to submit the manufacturing and facility data that the FDA requires for review. The companies also await an FDA decision on expanding the EUA currently in place for their COVID-19 vaccine to include adolescents ages 12 to 15.
