What's the Next Step for Pfizer and BioNTech's Coronavirus Vaccine?

Health and Healthcare

Published: October 16, 2020 10:46 am

While companies like AstraZeneca or Johnson & Johnson seem to be struggling with their coronavirus vaccines, Pfizer Inc. (NYSE: PFE) and BioNTech S.E. (NASDAQ: BNTX) are just picking up speed. After Pfizer’s CEO provided an update on their COVID-19 vaccine, shares of the two companies saw handy gains on Friday.

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Previously, European regulators launched a rolling review of the companies’ experimental coronavirus vaccine. Also, Pfizer received a Fast Track designation from the U.S. Food and Drug Administration (FDA) back in July as a result of preliminary data from the Phase 1 and Phase 2 studies.

Essentially, CEO Albert Bourla said that the firm would be looking to apply for an Emergency Use Approval (EUA) with the FDA as early as next month, pending ongoing safety and efficacy data.

In a recent blogpost, Bourla commented on these ambitions:

In the instance of Emergency Use Authorization in the U.S. for a potential COVID-19 vaccine, FDA is requiring that companies provide two months of safety data on half of the trial participants following the final dose of the vaccine. Based on our current trial enrollment and dosing pace, we estimate we will reach this milestone in the third week of November. Safety is, and will remain, our number one priority, and we will continue monitoring and reporting safety data for all trial participants for two years.

Pfizer stock traded up over 1% on Friday to $37.05, in a 52-week range of $27.88 to $40.97. The consensus price target is $41.33.

BioNTech stock was up nearly 3%, at $92.94 in a 52-week range of $13.30 to $105.00. Analysts have a consensus price target of $80.88.

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