Here's What Investors Need to Know About Pfizer and BioNTech's Vaccine Launch

In this video from Motley Fool Live recorded on Dec. 14, Corinne Cardina, bureau chief of healthcare and cannabis, and Fool.com contributor Brian Orelli discuss the launch of the first coronavirus vaccine from Pfizer (PFE 2.40%) and BioNTech (BNTX 0.74%). While the Food and Drug Administration authorized the vaccine, there were some unanswered questions from the advisory committee meeting. They also discuss how difficult it is for investors to estimate the manufacturing side of the rollout.

Corinne Cardina: Let's start with the COVID-19 vaccine news. As I'm sure everybody knows, Pfizer and BioNTech, their vaccine candidate was authorized by the FDA last week. Today, the first American received the vaccine, obviously, outside of trials, and that was a critical care nurse in New York. Brian, when the FDA panel, their advisory committee, when they convened last week, is there anything that came out of that panel that's of particular interests for investors?

Brian Orelli: Yeah. I think there was really three things. First, there's the one-shot versus two-shots debate. So there was a graph that was going around that was in the FDA briefing documents. When they measured the efficacy, they started a week after the second dose, but the FDA presented a graph that showed starting from the very first dose. So you would have expected that the vaccine and placebo group would track each other for the first through the second dose or even through a week after the second dose, and then they would split, but they pretty much split immediately after the first dose. So it seems like the first dose is at least providing some amount of protection, but Pfizer wasn't willing to say that they could just do one dose just because that's not the way the trial was set up, so it's backwards looking, not hypothesis-driven, so they weren't interested in making a formal decision to only go into one dose, and the FDA, not surprisingly, decided to approve the two-dose regimen.

The second thing was, there's a big debate over 16-year-olds versus 18-year-olds as the minimum amount where the thresholds should be on who the authorization should be for. I think some of -- there were four no votes, and I heard at least some of the people afterwards had said the reason why they voted no was because they thought it should be 18 versus 16.

Then the third thing, and I'm not sure how much weighing this got during the meeting, but it was in the briefing documents. There was some evidence of reinfections. So there were, like, over 1,000 people in the trial that had prior COVID-19 and then 19 of them developed COVID-19, and there were 10 in the vaccine group and nine in the placebo group, and all but one of those was between dose one and dose two. So maybe there's not much protection, but definitely there is reinfection. and I think it may depend on how sick you get the first time. So if you're asymptomatic first time, then maybe you don't develop enough antibodies and then you can get reinfected.

Cardina: Absolutely. The Secretary of Health and Human Services, Alex Azar, he went on Fox Business last week, said a lot of different things including that he expects general vaccination for the public beyond these high-priority groups to roll out at the end of February, early March, and that by the second quarter of 2021, everyone who wants a vaccine in the U.S. will be able to get it. Brian, do you think this is an overly rosy outlook, or is it something that could realistically happen?

Orelli: I mean, I think it depends on the manufacturing, it also depends on -- I mean, presumably we're going to have two vaccines at that point because Moderna (MRNA -0.58%) is probably going to get authorized this week. But from an investor perspective, I think it's really hard to tell because the company's only giving how many doses are expected to put out in all of 2021, and so it's hard to know how much of that is coming in the first few months versus over the entire year. I imagine it's probably not going to be linear -- divide that number by 12 and that's how many you'll get in January. It's probably going to be less than that.