FOOD AND DRUG ADMINISTRATION (FDA) Center for Biologics Evaluation and Research (CBER) 161st Vaccines and Related Biological Products Advisory Committee (VRBPAC) Meeting
Type Journal Article Date October 22, 2020 Url: www.fda.gov/media/143982/download
DR. COHN:Thank you. I just want to thank Dr. Routh for her great presentation and clarify one point, which is just for the public record that the federal government cannot mandate vaccines. So mandates have been shown to increase coverage in some settings, but the federal government would not be mandating use of these vaccines. Organizations, such as hospitals, with licensed products do have capability of asking their workers to get the vaccine. But in the setting of an EUA, patients and individuals will have the right to refuse the vaccine.
DR. ANNUNZIATO: Hi. Thank you very much. I wanted to address some of the points and questions that Amanda Cohn and that Dr. Nelson had brought up because we, and I know others, have — do have experience conducting placebo-controlled trials for approved and available vaccines. And there are a couple of critical considerations that you really need to keep in mind when you’re doing studies in this way.1 2 So of course the trial objectives need to address important clinical, scientific questions. And that’s the situation that we’re talking about here. And as part of the informed consent process, participants have to receive clear information about the availability of an approved vaccine for them and that they can receive the vaccine outside of the clinical trial that they’re being asked to participate in, that they may receive placebo or an unapproved vaccine if they join the study, and how long they’re being asked not to be vaccinated with an approved vaccine that they’re otherwise, you know, could access. And when I say the informed consent process, this is something that happens, as you all probably know, not just when a subject or a volunteer first joins the trial. But as the scientific knowledge and the availability of vaccines or treatments evolve during the conduct of the trial, the consent process 15 16 17 18 19 20 385 w w w.trans criptione tc. comneeds to be, you know, done again so to say, subjects are reconsented to make sure that they’re aware of the most current information.1 2 3 So, you know, we think that these principles would apply if a vaccine were to be granted an EUA or a full approval for COVID and — but we really need to also think about the feasibility of conducting placebo-controlled studies if in fact there is a vaccine available to the general population, or even to specific segments of the population by an EUA. 4 5 6 7 8 9 10 So this is really going to depend on the specific, I would say indication, but maybe it’s really the recommendation, you know, how the EUA approved vaccine would be administered, who would be able to access it, whether or not all the countries that are participating in your trial have approved vaccine provisions as well, and the availability of the vaccine, you know, to the different specific groups who are in your study.11 12 13 14 15 16 17 18 19 There are a couple other really unique aspects to this situation that have really struck me in listening to people talk today that’s going to create additional challenges for investigators and sponsors of these studies. And these might not be actually overcome-able. We’ll have to see and think carefully about it. But the great public attention that’s being given to this vaccine, to these vaccine development programs, and the strong perception that you know, based on a variety of concerns may in fact preclude continuation of some of these placebo-controlled studies. We’ll just have to monitor and watch this carefully. In fact, if vaccines do become available to the entire U.S. population, I think we heard earlier today that the projections are that, you know, by next summer that may in fact be a reality. And so as I said, you know, this is something we’ll have to monitor and watch. But just in general, you know, typically you are able to continue your studies under these circumstances.