Coronavirus in Context: Vaccine Regulations and Pharma's Safety Pledge

[MUSIC PLAYING] You're watching Coronavirus in Context. I'm Dr. John Whyte, Chief Medical Officer at WebMD. Vaccines certainly are in the news. Vaccine safety is concern for many people.

To help provide some insights into vaccine development, I've asked Dr. Richard Moscicki, he's the Chief Medical Officer of the Pharmaceutical Researchers and Manufacturers of America and a former Deputy Center Director at the US Food and Drug Administration. Dr. Moscicki thanks for joining me.

RICHARD MOSCICKI: A real pleasure, John.

Let's talk about this pledge that the vaccine manufacturers recently issued. And they talked about a pledge to make the safety and well-being of vaccinated individuals the top priority in the development of the first COVID-19 vaccine. And they go on to talk about industry sponsors will be confident in the safety and efficacy of any new vaccine based on data from rigorous, large clinical trials, including the expectation that diverse populations are included.

Now the pledge talks about aspects that actually are required as part of the drug approval process. So what was the impetus, the reason for the manufacturers to feel they needed to issue this public statement?

Well, John I think you-- you said it. This is something they do. This is something they believe in, and this is, uh, standard operating procedure to follow these rigorous testing approaches in clinical trials, um, as well as manufacturing of-- of the products. However, as you started out saying, um, there is clearly concern in the public, uh, within our current political environment about whether there will be undue pressure, both on companies or on the regulators such as the FDA.

And we want to make clear to the public that in fact we are going to follow these rigorous approaches, uh, to assure people that there will be nothing different here. This will be a vaccine that can in fact pass all the right safety and efficacy, um, standards.

You know the pledge talks about the desire for a diverse patient population. But you and I know having worked it together at the FDA, that enrolling minorities in clinical trials can be challenging. And I think we're seeing that as part of COVID-19. How confident are you that we'll have enough of minority populations to know there is no-- what we would call variability of response in different, you know, subgroups?

Well, that's a great question, John. You know, um, I think for a long time industry, FDA, and others have sought to make sure that we increase the number of various underserved populations in clinical trials so that we get that experience. Um, but there are a lot of reasons why historically it's been difficult to do so. There are trust issues in the community. There are financial concerns for many in those same communities. Um, and there are access issues, um, for many of them.

So today, um, the industry is in fact embarked on a very bold initiative to try and address these barriers as best as possible and in general increase, um, the number of these underserved populations in clinical trials. And particularly now with COVID-19 vaccines and treatments, uh, underway and the impact that we've seen on, uh, say, the black community, it's important, uh, that we try to apply these um, these, uh, approaches, uh, now. And I think all the companies are quite, uh, interested in-- in using such approaches that might improve getting us, um, a better sample.

And a lot of people are tying the availability of a vaccine to reopening, whether it's reopening of schools or businesses. But I want to make you aware of a recent poll that we did it at WebMD with results in other, you know, media outlets where they showed that almost 50% of people said they wouldn't get the vaccine at all. Less than 27% of people said they would do it in the first three months.

And the-- the issues are safety in their minds, you know. I'll let you take it first, Dr. Moscicki, you know, before I will. Why do you think we're there? Um, and how do we change that mindset? Because if we don't reach a certain threshold of vaccination in the community, it's not going to have the impact that we need.

Well, I think, unfortunately, there is a segment of our population, which, uh, has fallen victim to, um, a, proposals that, uh, that in fact vaccines have caused, uh, a number of issues that I think scientifically we know they do not. Um, and that has provided a background for some concern. And some of that background seems to be particularly active in social media, ah, today.

I think also, uh, we have been moving with incredible speed, ah, in the industry to try and address the pandemic and to produce these. And I'm sure that some people are concerned that when you move with such speed it may cut corners, for example.

Well, I was going to ask you about that. Are we victims of our own success? You know, processes that took years are now taking months. And are we adequately explaining that to the public? Because it seems like, as you said, we're cutting corners. And it's just like in baking, you can't, you know, cut the temperature down or cut the cooking time or cut the ingredients. I've tried and it's not a good outcome.

Uh, but-- but are we explaining that well enough? I feel like in some ways we're not getting that message out. And we use titles like warp speed, which, you know, when it comes to your body, people might be saying, you know, I don't want something that sounds rushed.

Yeah. Well I think that's important that we get that message out that in fact we're not cutting corners. The difference in why we've been able to do this so fast has a lot to do with the technology that's been developed over time by companies, the investments they've made to be prepared to, ah, use technology to move in a fast way, to work with the FDA and other regulatory agencies, ah, to work in a way that, um, addresses in getting rid of the sort of dead time, if you will.

Yep.

RICHARD MOSCICKI: So that the important time that's being used is used in a rigorous manner. Um, we're not eliminating any of the phases, ah, that are important to testing a product, either before they reach humans, ah, or when they are in fact--

Right.

--in people.

And in some ways because there's so much virus around, it actually provides an opportunity to enroll a sufficient number of people, have them exposed to the virus to test. Isn't that correct? So in some ways the fact that it's so infectious works to our advantage.

Right. You know, so-- so many of the vaccines have already passed what would be an early stage of, um, testing in people, the phase 2. And we've seen, uh, that these vaccines can produce antibodies. These antibodies look like they should be protective. But it is these very large phase 3's tens of thousands of patients where we really get to detect whether there could be any kind of safety signals, uh, where we really get to see, uh, the impact that the virus has to-- I mean, the impact that the vaccine has--

Sure.

--to really, uh, prevent the clinical problems associated with the virus.

Well, let's talk about, you know, the vaccine, you know, trials, phase 3, recent clinical hold. A lot of people are saying, you know what? That shows that the system is working, because they did what they were supposed to do. Put it all on hold, press pause, and make sure that no one else is at risk. Can you comment on that, Dr. Moscicki?

No, I think that's spot on, John. You know, that is exactly what's supposed to happen. That's why you do these phase 3 trials. And when you do see a possible problem, not-- you-- you have to find out, is there a real problem?

Sure.

Are there more-- is there evidence of anything more here? Are there other people who might have had a similar problem and yet weren't detected now that we've detected this problem? Um, and you want to do it before you expose anybody else. And that's why you put it on hold, ah, until you really have a thorough investigation of what you saw.

Is 30,000 enough? That's the number that people tend, you know, talk about in these phase 3 trials. But, you know, in terms of rare events, let's say it's one in 10,000, 1 in 20,000, those might be hard, you know, to determine until you really get it out there, as Dr. Offit will talk about, to the first, you know, few million doses. Is that-- is that a fair assessment? As you know, as we've talked about in the past that what we call these phase 4, you know, trials where it's on market, but we're still surveilling in terms of safety issues.

Sure. Well, look, uh, you know, the phase 3 trials and the phase 2 trials, in addition, will tell you about, ah, side effects that, um, are so common that you really begin to worry about the risk versus the benefit.

Sure.

And that's so important to know. Um, the really rare events, um, yes, it's often necessary to track very carefully what, um, has happened to people who are vaccinated, uh, after a product has been approved, um, because it's possible that there could be these really rare events. And to know about them and to assess continuously do they change the risk versus the benefit of the product.

You're an immunologist by training. I wanted to ask you if you could take a couple of minutes and explain the different way these vaccines are working. You know, some people are believing that, you know, they're being injected with COVID-19. Can you give a few minutes and explain that to the audience?

Right. So you're not being injected with any kind of live virus or a virus that in fact can now cause disease. That is not how any of these-- and there are probably more than seven different ways that these vaccines are putting-- are put together. But none of them bear any chance of giving you COVID-19. And technologies, like mRNA DNA vaccines, these are not combining with your genetic material at all and, uh, pose no meaningful genetic, um, risk, uh, from that standpoint.

Um, instead, what they're doing and what the others are doing is allowing, in the case of the genetic material, it allows your body to produce a protein that could be related to the virus that in-- or is related to the virus, and um, that is a tiny little fragment. But it's an important fragment that can get your body to see it as foreign. And then your body will make antibodies, for example, together with cells that identify it as foreign and can attack it.

And um, you know, in the more standard approaches that are genetic in basis, you're actually using that little tiny protein, for example. Um, and you may combine it with something that in fact will stimulate the immune response against that little tiny protein. Um, and that, when you build up enough of these antibodies and some of these cells that can react to it, then your body when it's confronted with a virus has the ability to very quickly attack and prevent that virus from, uh, infecting.

Now that's-- that's a good primer for the audience in terms of how these vaccines are working. I want to ask you, Dr. Moscicki, what are you hopeful for?

Well, I'm-- I'm obviously hopeful that we soon will have in fact a safe and effective vaccine and safe and effective treatments, um, and whether one comes first or the other, we'll see. We already have, um, treatments that, um, do have an impact, right? I mean, there have been over 1,400 clinical trials--

Wow.

--about substances including 200 from the pharmaceutical industry, ah, that in-- are testing, uh, a number of different agents. And in these trials, we've already seen Remdesivir has an impact. Uh, we already see that old drugs like dexamethasone uh, can really be lifesaving, uh, for many individuals.

And so I-- I'm-- I am confident that as we continue this research and as we continue to work, ah, with the vaccines and the many different vaccines, I should even say, because it gives us a lot of shots on goal. Together with a number of different therapeutic agents, we are going to have some effective ways to combat this virus, um, and ah, bring it, uh, together because I think that science is the way that we will get back to normal.

And that's a good approach. The science is what's going to get us out of this pandemic. But Dr. Moscicki, I want to thank you for taking time today. I want to thank you for your leadership in terms of the drug development process as it relates to vaccine, as well as other therapeutics that you touched upon. It's not just about the vaccine right now. And we look forward to talking more to you about how do we help consumers understand the safety of the vaccination process, that this is not a process that's being rushed, it's playing out as it should, but in many ways it's because of the innovations that we've had over the last few years.

Absolutely, John, those innovations, those improved technologies and the collaborations are what are driving the-- the really legitimate speed and not the cutting of corners. Uh, it's really, again, a very, um, strong, rigorous, scientific process and testing in clinical trials that are being conducted today that I think will get us these.

And we are all dedicated, not just at this moment, not just because there is public concern, but because that is intrinsic to how we do business, um, and how, um, the scientific process works, whether you're in a company or whether you're in an academic institution, and-- or whether you're a regulator.

I think it's very notable that the FDA's, uh, center directors, uh, their career, um, scientists, today also came out with a statement, ah, and very notable that this statement, ah, is again aimed to help the public understand that they see their duty, um, much like the industry does to continue to work in a very rigorous way to assure the safety and efficacy of vaccines.

We're going to check back in with you as we continue to make progress on this. And thank you again. And I want to thank our viewers for watching Coronavirus in Context. I'm Dr. John Whyte.