What Should Investors Know About FDA Decisions On COVID Vaccines?

How did the U.S. Food and Drug Administration (FDA) decide to authorize coronavirus vaccines created by Moderna (MRNA -0.47%) and the Pfizer (PFE 0.40%)-BioNTech (BNTX 0.52%) team? Is it important that investors keep a close eye on FDA advisory committee meetings as new coronavirus vaccines come up for approval? Dr. Bruce Gellin of the Sabin Vaccine Institute joined Olivia Zitkus and Corinne Cardina of Fool.com's Healthcare and Cannabis Bureau on a Dec. 18 episode of Fool Live to answer these questions and more.

Olivia Zitkus: I think we're going to start just by talking about some vaccine use from the past two-ish weeks. Just last week, an FDA advisory committee reviewed Pfizer and BioNTech's vaccine candidate, and the FDA granted an Emergency Use Authorization (EUA). Now, frontline healthcare workers have already begin receiving the vaccine this week. Yesterday, the committee reconvened to look at Moderna's vaccine candidate and ultimately they voted to recommend authorizations for this vaccine as well. Last night, the FDA confirmed that it would work toward granting that EUA, which we're expecting some time today hopefully. Of course, broadly, this panel of independent experts are looking at safety and efficacy. But Dr. Gellin, we're wondering on a more granular level, what these experts are evaluating in terms of these vaccines.

Dr. Bruce Gellin: Thanks for doing this. I mean, I thought since I have the vaccines 24-7, I thought I was the only one who realize vaccines were in the news all the time. Now, they're in the news all the time. As I suspected, there will be other issues that you want to talk about. But most recently are these two meetings over the past few weeks from the FDA's advisory committee. I think the couple of things about that are really important. One is the fact that there is such a thing as an advisory committee. An outside experts comes together in public, which is also not something any other country does, to take a look at the data, kick the tires, ask questions of the manufacturer, ask questions of the FDA and give their advice, so what the FDA might do. That's why people are a little confused that this is an advisory committee that provides advice. Is the FDA who decides, makes decisions. What we saw last week and what we're going to see probably later today or early tomorrow, is the FDA's decision about the authorization of another vaccine for COVID.

Zitkus: Great, thank you. In terms of what they're looking for and discussing in these meetings. Corinne and I were talking about how they were streaming them live on YouTube, and you could just hop on whenever you wanted. A lot of the discussion was around age groups, that the vaccine is designed to treat diversity of participants and the trials. Are there other issues that are top of mind that we could be looking for?

Gellin: What they do -- and all of this information is out there -- it's not so easy to digest. But all the information is out there a couple of days before, which is essentially almost the complete data package from the manufacturer. Things that they don't allow for the public or don't provide to the public are proprietary issues about manufacturing techniques. For the rest of it is, all the data they want the FDA to see to make a decision about moving a vaccine forward. The focus was largely on these Phase III clinical trials, which are these pivotal trials to determine how well a vaccine actually works. Built on top of all the other information that the companies have collected from animal studies, and laboratory studies, and earlier phase studies, and give a sense of the immune response and the safety of the vaccine. It's that totality of information at the advisory committee was asked to say, "Given all that, what do you think? Is this a vaccine that we should be allowed to be used more broadly in these emergency situations?"