How did the US Food and Drug Administration (FDA) decide to release the coronavirus vaccines Modern (NASDAQ: MRNA) and the Pfizer (NYSE: PFE)–BioNTech (NASDAQ: BNTX) team? Is it important for investors to closely monitor FDA advisory committee meetings as new coronavirus vaccines are approved? Dr Bruce Gellin of the Sabin Vaccine Institute joins Olivia Zitkus and Corinne Cardina of Fool.com’s Healthcare and Cannabis Bureau on a Dec. 18 delivery of Nar Live to answer these questions and more.
Olivia Zitkus: I think we’re going to start by just talking about the use of vaccines over the last two weeks. Just last week, an FDA advisory committee reviewed the vaccine candidate from Pfizer and BioNTech, and the FDA granted an emergency permit (EUA). Now, health workers at the front have already started receiving the vaccination this week. Yesterday, the committee met again to look at Moderna’s vaccine candidate and finally they voted to recommend approvals for this vaccine as well. Last night, the FDA confirmed that it would work to award the EUA, which we hope will take some time. Of course, this panel of independent experts generally looks at safety and efficiency. But Dr. Gellin, we wonder at a finer level what these experts judge in terms of these vaccines.
Dr. Bruce Gellin: Thank you for doing this. I mean, I thought since I had the vaccines 24-7, I thought I was the only one who realized that vaccines were in the news all the time. Now they are in the news all the time. As I suspected, there will be other issues you want to talk about. But recently, these two meetings have been the FDA’s advisory committee for the past few weeks. I think the few things about it are really important. One is the fact that there is such a thing as an advisory committee. A foreign expert meets in public, which is also not something any other country does, to look at the data, kick the tires, ask questions to the manufacturer, ask questions to the FDA and give their advice to give, what the FDA can do. Therefore, people are a little confused that it is an advisory committee that gives advice. Is the FDA making decisions? What we saw last week and what we’ll probably see later today or early tomorrow is the FDA’s decision to approve another vaccine for COVID.
Zitkus: Great, thank you. In terms of what they seek and discuss in these meetings. Corinne and I talked about how they streamed it live on YouTube, and you can just jump in whenever you want. Many of the discussions were around age groups that the vaccine was designed to treat the diversity of participants and trials. Are there other issues we think we can look for?
Gellin: What they do – and all this information is there – is not that easy to digest. But all the information is there a few days in advance, which is actually the complete data package from the manufacturer. Things they do not allow to the public or do not provide to the public are own issues regarding manufacturing techniques. For the rest of it, all the data they want the FDA needs to see is to make a decision on promoting a vaccine. The focus has largely been on these phase III clinical trials, which are these core trials to determine how well a vaccine works. Built on top of all the other information the companies have gathered from animal studies, laboratory studies and earlier phase studies, and gives an idea of the immune response and the safety of the vaccine. That is, all the information from the advisory committee was asked to say, “Given all this, what do you think? Is it a vaccine that we may use more widely in these emergencies?”