even though Pfizer (NYSE: PFE) and Modern (NASDAQ: MRNA) have gained emergency use authorization (USA) for their respective COVID-19 vaccines, clinical vaccine studies are still ongoing. An important question about these studies came up during the analysis of the US Food and Drug Administration (FDA) advisory committee on the US submission of Moderna. In that Motley Fool Live video recorded on December 18, 2020, head of health and cannabis office Corinne Cardina and Fool.com writer Keith Speights discuss the major dilemma that Moderna and Pfizer face in their COVID-19 vaccine tests.
Corinne Cardina: Keith, let’s talk about some of the things that came up on this advisory panel. In fact, it was something that Dr. Gellin discussed, is what I want to start with. Unraveling. This is an interesting ethical question.
When you have all these volunteers who have given their time and donated themselves to be part of these tests, the FDA comes in and says, “Yes, it is effective.” These people are walking around the world and are not vaccinated. So, can you talk a little bit about what it means to “unlink the placebo arm” and the FDA’s position on it?
Keith Speights: Right. Therefore, these studies are called double-blind studies. What this means is that study participants do not know whether or not they are receiving the actual vaccine or receiving a placebo. Nor are the health professionals who administer the vaccines. They don’t know that either.
The reason it is configured this way is that it prevents any prejudice from appearing. There may be this placebo effect where you think you are receiving a medication or a vaccine, and it makes your responses better than they normally would be. That’s why they do this double blind.
So the question here is, okay, now we know that Moderna’s vaccine seems to be safe and effective, highly effective. If you are in this study and found that you received the placebo and not the vaccine, you really don’t want to be walking around, like you said, Corinne, because you can’t get the vaccine.
So, what Moderna wants to do is give immediate access to those participants who were receiving the placebo. If they want, they can go ahead and get the real vaccine. The FDA has a small dilemma because it wants to get more data. They want to study the effects of the vaccine against people who have not had the vaccine for a long period of time. They are, I think, more nervous about following Moderna’s plans.
You are right, it is an ethical dilemma because people, they deserve to be able to choose whether or not to get this vaccine. I think it can be detrimental to future studies if participants who end up in a placebo group do not have that option, because I think it can make people in the future less likely to want to participate in those studies.
Corinne Cardina: Absolutely. There are pros in unpacking, there are cons in unpacking, so that will definitely be something to keep an eye on.