Although Pfizer (NYSE: PFE) and Modern (NASDAQ: MRNA) If they have obtained emergency permits (EUA) for their respective COVID-19 vaccines, clinical studies on the vaccines are still ongoing. One major issue on these studies was reviewed during the U.S. Food and Drug Administration (FDA) Advisory Committee on the submission of the EUA from Moderna. Hierin Motley Fool Live video recorded on December 18, 2020, discusses Corinne Cardina, head of health care and cannabis, and author Keith Speights of Fool.com the one big dilemma facing Moderna and Pfizer with their COVID-19 vaccine trials.
Corinne Cardina: Keith, let’s talk about a few things that came up in this advisory panel. It was actually something that dr. Gellin discussed, what I want to start with. Blinding. This is an interesting ethical question.
If you do have all these volunteers who gave time and donated themselves to be part of these trials, then the FDA comes in and says, “Yes, it’s effective.” These people roam the world and are not vaccinated. So can you talk a little bit about what ‘placebo arm depletion’ means and where the FDA stands on this?
Keith Speights: Certainly. These studies are therefore what are called double-blind studies. What this means is that the study participants do not know whether they are receiving the actual vaccine or not receiving placebo. Nor do the health workers who administer the vaccines. They do not know it either.
The reason it is set this way is to prevent any prejudice from creeping in. There may be this placebo effect if you think you are getting a medication or a vaccine, and it causes your reactions to be better than you would normally do. That is why they do this double-blindness.
The problem here is therefore, in order, now we know that the vaccine from Moderna seems to be safe and effective, very effective. If you are participating in this study and it turns out that you received the placebo and not the vaccine, you really do not want to walk around, as you said, Corinne, not to get the vaccine.
So what Moderna wants to do is that they want to give immediate access to these participants who have received the placebo. If they want, they can continue to get the actual vaccine. The FDA has a small dilemma there because they want more information. They want to study the effects of the vaccine on people who have no longer taken the vaccine. It is, I think, more brilliant to work with Moderna’s plans.
You guessed it, this is an ethical dilemma because people deserve it to be able to choose whether or not they get the vaccine. I think it could be detrimental to future studies if participants who end up in a placebo group do not have the option because I think it may make people less likely to participate in these studies in the future.
Corinne Cardina: Absolutely. There are pros for decompression, there are cons for decompression, so it will definitely be something to keep an eye on.