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Johns Hopkins Biocontainment Unit medical director Dr. Brian Garibaldi joins Yahoo Finance’s Zack Guzman to discuss the latest news regarding Moderna’s coronavirus vaccine as the drug shows ‘promising’ safety and immune response results.
JACK GUZMAN: Look at the Moderna-- the vaccine front, there. I want to start the show on that topic, since that's really where we saw futures even last night, really, start to spike. An interesting result from that, in terms of all of the patients, as I said, showing early-stage optimism there in terms of building a robust immune response in that. And joining us for more on what this all means in terms of how we might be headed in the right direction, getting a handle on treatments here, and really turning the tide on the coronavirus front is Dr. Brian Garibaldi, Johns Hopkins Biocontainment Unit Medical Director. He joins the show once again.
Dr. Garibaldi, always love chatting with you. And I just want to start with your take right now on that optimism that we're getting from the Moderna trial. As I said, a lot stronger, I think, would be fair to say in terms of the immune response scene. I know it's early, but this is the data that we saw a few months ago when the company shared it itself, now published in the New England Journal of Medicine. That's peer-reviewed. So what's your take on how big of a deal this is?
BRIAN GARIBALDI: Yeah. I mean, I think this is really good news. This is exactly what you'd want to see in a phase I trial of a vaccine that has a chance to be clinically effective. You know, all the patients at different levels of dosing develop an initial antibody response, and then in response to a booster 28 days later, they had an even more robust immune response. And it wasn't just that the antibodies themselves were present in the patients who received the vaccine, but when you took those antibodies out and saw whether or not they were able to neutralize SARS-CoV-2, the virus that causes COVID-19, they had effectiveness in neutralizing it.
So this is a great first start, and I think really paves the way to the important phase 3 trials that hopefully will get started in the coming months to really start looking not just at safety, but also at efficacy. I think it is important to remember that this is only 45 patients. And while there were no clear major adverse events there, at higher doses, some patients did have some side effects that will be important. So it'll be interesting to see what the final dosing strategy will be.
And obviously, we need to see, number one, does this prevent disease in patients who get it? But also, number two, when we start giving this to lots and lots of people, we're talking, you know-- for an effective vaccine, we're going to be giving doses to millions and millions of people. We need to really know what the long-term safety profile is going to be. But this is exactly the start that you'd want to have to for this type of vaccine.
JACK GUZMAN: And I think that's why we're seeing markets so optimistic about it today. And of course, it's not the only trial. We also have been watching other vaccine candidates out there. Another one also delivering optimism is the AstraZeneca trial there that we've seen reports that they will be soon reporting optimistic results-- positive news regarding the same thing when we think about the immune response here-- for that vaccine as well.
But I just want to stress, because the FDA did set that 50% efficacy guideline here for what they want to see out of a vaccine, we talked with a doctor yesterday stressing that even the flu vaccine, really, in the best years over the last decade end up seeing only about 60% efficacy. I mean, just again to kind of hit the point, you're seeing an immune response in all 45 patients in this trial. It seems like, from someone who, of course, doesn't have the same medical background as you do, that that does really seem very, very strong.
BRIAN GARIBALDI: No, I think it's encouraging early results. What we don't know is how long will that response last, right? You know, we've seen in survivors of SARS-CoV-2 that antibody levels tend to wane after several months. And so we don't know the answer to the question if you've had it once, are you going to be immune to it again?
And that's really the question of the next phase of trials, is does this antibody response in these initial volunteers in this trial-- does that lead to a long-lasting response in terms of having those antibodies? And in your body, will those antibodies prevent infection? And that's why we need to do the larger studies. But again, I think this is a great start, and adds hope to the possibility that this will be one of the vaccines that might be effective.
JACK GUZMAN: There was also, I guess, kind of worrying-- if that's the optimistic news that we have to report, there might also be worries in terms of people in the medical community right now wondering about a certain move that was confirmed by the Department of Health and Human Services to CNN, when it seems like the new data that we've been watching here in terms of hospital data on coronavirus patients will be routed to the Trump administration first instead of going to the CDC and the Department of Health and Human Services. I'd be curious, as a medical professional here, whether or not you see any reason as to why that might happen, and why you would want to kind of circumvent the agency-- the specific government agency-- that is exactly created to handle things like this?
BRIAN GARIBALDI: Yeah. So you know, I think it goes back to the way that we create and collect this data. So even with all the modern technology that we have today, much of the data metrics that are reported to the CDC and now will be reported to HHS directly, a lot of that depends on humans inputting that data. And so I think there certainly is an opportunity to look at the way in which we report this data to improve both accuracy and efficiency. Whether or not that needs to move outside of the CDC and move to a different agency, I think that's the key question here.
And what everyone's interested to see is, number one, how is this new reporting system going to be different? Is it going to be more efficient? Are we going to get data that has fewer lag time between reporting and being able to have that data available for actionable implementation?
But also, I think everyone really wants to see, is the data still going to be transparent? Are we going to have free and easy access to this data? How often is it going to be reported to the public? What will the access of hospitals be to that data?
You know, this is something in the state of Maryland where, you know, our state health department actually reports that data on to the CDC and now to HHS. The hospitals still have access to that data. But I think it remains to be seen what that's going to look like on a national front, and the concerns about whether or not there will be complete transparency.
And I think we'll know in the coming days. So I think people are worried about that. But we just haven't seen yet what the new system is going to really look like in practice, to know whether or not those concerns are founded or not.
JACK GUZMAN: Yeah. I mean, before we see that effect, it might also just fuel critics so far of the CDC that really, a lot of people have said kind of has taken a backseat in terms of whether or not they should be doing more right now. A lot of that criticism has been aimed at CDC Director Robert Redfield, who yesterday, I would say-- I don't think it would be a stretch to say-- kind of came out more strongly than we've ever seen him come out in advocating for mask use.
He was chatting with the Journal of the American Medical Association about masks. And really, he said if we got all Americans to wear masks, we could really get a handle on this pandemic in just a matter of four to eight weeks. I want to play what he said and get your take on the other side. Here's what he had to say.
ROBERT REDFIELD: It is just continuing to mount. To really get to the point, as we did in the editorial that we wrote about universal masking, the time is now. If we could get everybody to wear a mask right now, I really do think over the next four, six, eight weeks we could bring this epidemic under control.
JACK GUZMAN: Dr. Garibaldi, I mean, you just heard from CDC director Robert Redfield there. And it seems like now is the time, in his words. We may have known that a couple of weeks ago. But what's your take on how strong he's coming out now in really saying this is the time to really make this happen?
BRIAN GARIBALDI: Well, I think it's great. I mean, I think as you sort of intimated, you know, we may have passed that point of saying that this is the time. You know, I think early on, there was concern that if we said everyone should mask up, that we wouldn't have enough masks to provide frontline providers and responders with the medical grade masks that they needed. I think we still have concerns about getting access to gear, but I think it's very clear that this outbreak is out of control in most areas of the country, and one of the ways that we can combat it is by people taking individual ownership of it, protecting themselves, protecting those around them, and not seeing that so much as a personal liberty issue, but as a as a responsibility to protect your loved ones, your friends, your families, your neighbors, and your communities.
But that's only part of it, right? I mean, you know, wearing masks will be helpful. But the personal decisions that people make in their own lives and the activities they engage in are also equally important. But I think we also need to get back to the fundamental importance of testing.
So for example, you know, Maryland has been doing really well in terms of the virus, although we're now starting to see an uptick again. But one of the issues that we've encountered in the last several weeks is that the time from getting a test to getting the results of that test has now grown, in some cases, as high as a week. Right? And you can't do effective contact tracing if you have to wait five to seven days to get a valuable test result.
And so mastering important personal behavior is important, but again, I think testing and access to the data that then drives decisions are going to be critical. So all of these things are tied together. And I'm glad to see that he said it. And I think we all need to act upon it and start doing our part, if we haven't already.
JACK GUZMAN: Yeah. And just one last point there, too, on the masking front. I mean, we saw Walmart come out today and say that it's going to be requiring masks at all its stores. It joins a list of a few other retailers, if we think about the Dollar Tree, Best Buy, some of these other major retailers, here, who are now moving ahead of the CDC in terms of mandating masks. I'm not sure a lot of people would say Walmart or Dollar Tree are really bastions of public health in this country compared to the CDC. What's your take on maybe how they're moving ahead in terms of mandating masks, and what that says about how slow our response has been on a national level?
BRIAN GARIBALDI: Well, I think it's great to see, right? I mean, I think we all need to do our part in trying to get control of this epidemic. And lots of people rely on going to those stores to get the things they need in their daily lives. And I think if they step up and say this is important, and people begin to see that this is something that it is necessary to protect themselves and others, I think it's great that they're taking that first step. And I hope that they get the local government-- state, federal, local government support to be able to continue to do that, because it is for the public good.
JACK GUZMAN: All right. There you go. And before people attack me for attacking Walmart's health standards, you know, I love going there and using all the health centers and checkups there, too. But Dr. Garibaldi, I appreciate you taking the time to chat with us. Thanks again.
BRIAN GARIBALDI: Always a pleasure.