The clock is now ticking for a Food and Drug Administration decision on full approval for the COVID-19 vaccine developed by Pfizer (NYSE:PFE) and BioNTech (NASDAQ:BNTX). The vaccine is currently on the market in the U.S. under the FDA's Emergency Use Authorization program. In this Motley Fool Live video recorded on July 21, 2021, healthcare and cannabis bureau editor-analyst Olivia Zitkus and Motley Fool contributor Keith Speights discuss what full FDA approval might mean for Pfizer stock.
Olivia Zitkus: Pfizer -- just last week, the FDA granted Priority Review to the Pfizer-BioNTech COVID vaccine. It's just received an EUA, Emergency Use Authorization so far. The next step is approval. What does this mean? What would the approval mean for Pfizer and its stock?
Keith Speights: First of all, Olivia, the FDA granted what's called Priority Review designation to the Pfizer biotech vaccine. All that means is that the FDA's review process will be shortened. It normally takes 10 months, and with Priority Review, that gets shortened down to six months.
Now, don't expect the FDA to take even six months with this approval decision. The acting FDA commissioner, Janet Woodcock, has already said that the FDA hopes to make a decision well before the goal date. The question is, "How soon will it come?" One FDA official has even told CNN that an approval decision could be made within the next two months. So this could come really quickly.
In terms of what does this mean for Pfizer stock? Probably not much at all. This FDA approval is a foregone conclusion. I doubt that we could find a single industry expert who would predict that the FDA will not approve this vaccine. I think it's as close to a slam dunk as you're going to get in the FDA approval process now. I don't think it will be much for Pfizer stock because it's already built into the share price everyone expects it.
Now, full approval, though, could lead to more Americans receiving the vaccine. I think we could see some increased acceptance perhaps. Some individuals might feel more confident about being vaccinated if they know that the vaccine has full FDA approval instead of just the Emergency Use Authorization.
There could even be some organizations that mandate the vaccine for employees once full FDA approval is given. This probably won't lead to higher sales for Pfizer, though. The U.S. already has ordered more than enough vaccines to fully vaccinate all Americans. So it won't move the needle much at all for Pfizer, but it could be good news for vaccination rates.
Zitkus: Awesome. We're not necessarily looking for anything big in terms of stock price movement or sales. It's more so about an improvement and hopefully, what is, there's still a lack of trust in the vaccine itself and in the institutions. But there's an insane amount of manufacturing and clinical information that goes into an approval like this on top of what was already required for an Emergency Use Authorization. Hopefully, this could improve the mindset of the 1/3 of adults in America who are not yet vaccinated.
Speights: That's right, we certainly hope so.