Johnson and Johnson’s COVID-19 vaccine trials are on hold after a participant developed an “unexplained illness.” Yahoo Finance’s Alexis Christoforous and Brian Sozzi discuss the details and the path to a COVID-19 vaccine with Dr. Anand Parekh, Chief Medical Advisor at the Bipartisan Policy Center.
BRIAN SOZZI: Johnson and Johnson's COVID-19 vaccine trials are on hold after a participant developed an unexplained illness. Let's talk about it with Dr. Anand Parekh, chief medical advisor at the Bipartisan Policy Center. He's also a former deputy assistant secretary at HHS. Dr. Parekh, always good to see you here. Just got some breaking news from J&J's earnings call right now, a J&J executive saying he's, quote, "bullish" on greater than 70% COVID shot efficacy. Your thoughts on that?
ANAND PAREKH: Thanks, Brian. Yeah, you know, I think when we hear these types of comments, I think while it's good to hear, I think we're going to all need to see the data when it comes out. As you know, J&J and a number of other companies are in the midst of phase three clinical trials right now. This is really the key step here-- not only for safety, but most importantly, for efficacy. And so I think we all want to wait and see what the data looks like.
I also understand they've also halted trials because of an unexplained illness amongst one of the study participants. Again, not uncommon-- we've seen this before with AstraZeneca as well. But I think you have to be cautious here and try to understand what causes illness and make sure that it's not related to the vaccine currently being tested.
ALEXIS CHRISTOFOROUS: You know, Doctor, certainly the fact that J&J, AstraZeneca had to halt their trials temporarily-- but it isn't that good news? And shouldn't we take some comfort in that, knowing that they are doing the right thing and that they are not trying to push out a vaccine before it's time and that they're really making sure that it is safe?
ANAND PAREKH: I think that's right, Alexis. Safety comes first. It's absolutely paramount. At the end of the day, even when there is an approved vaccine, the only way we're going to reduce vaccine hesitancy, the only way we're going to make sure there's vaccine confidence and uptake is to ensure that we crossed all the T's, dotted all the I's. So I think this is important. It's an important step, and I think transparency really, really is most important, not only for J&J, but really every single manufacturer out there.
BRIAN SOZZI: Doctor, news such as this, is the reality is that we may just not get a vaccine into early 2021, not just from J&J, but from the other companies working on it as well?
ANAND PAREKH: Well, Brian, as you know, the FDA recently, you know, spoke to manufacturers and put out guidelines. And what they want to really see, prior to approving an emergency use authorization for a vaccine, is really two months sort of median follow-up of these phase three clinical trials. They also want to make sure that the control group, if you will, has at least five severe infections.
Essentially, what they're saying is that they want to make sure that these vaccines that they approve are not only safe, but effective. And so that may take a little bit longer, perhaps, but I think it's important. It's important for the American public, the manufacturers on board. So we may not see sort of an approved vaccine till the end of the year.
And then, of course, you know, in early 2021, we could see multiple vaccines cross that at least initial EUA finish line. But again, that's just one step in the process, Brian, as you know. Vaccine distribution then will take quite a while. We're only going to have limited doses in the beginning. So as I've said for a while now, you know, vaccine administration is really going to be a 2021 really focus. And it could take a better part of 2021, even if everything goes well.
ALEXIS CHRISTOFOROUS: Dr. Parekh, we know President Trump has been saying he is immune now that he was already-- you know, tested positive for COVID-19. But now we're seeing reinvention rates, and there is a man in Nevada who has been reinfected recently. What does that tell you?
ANAND PAREKH: Well, Alexis, I think we need a lot more research. We just don't know too much. There have been maybe a couple, a handful of cases around the world of reinfection, only one that I know of where the second case was more severe. But I think bottom line is we just don't know enough. This is an area of active research. You know, I don't think we can say-- I don't think the president should be, you know, saying, you know, I'm going to be immune for a long time. We just don't know exactly how long immunity lasts, and so I think this is an important area of ongoing research.
BRIAN SOZZI: Doctor, before we let you go, President Trump again touted at a rally last night in Florida that the military is going to work and help get vaccines eventually out to the public. Is the military the silver bullet here? How does it work? What is the process like? And just because the military is involved, will it go smoothly? Is it as simple as they set up a tent in the middle of your town and we all show up there or they come straight to your door? How does it work?
ANAND PAREKH: Well, it's a little bit fuzzy, in terms of the military's role. Obviously, they have been important, with regards to Operation Warp Speed. But it's looking, Brian, like this is a public-private partnership where the government has contracted McKesson, a distributor, to do the distribution into states. States, right now, need to be submitting plans related to where they want a vaccine to be administered.
So I think it's really states coming up with plans, some of it based on what they do every year for flu. But then it's also sort of private distributors, such as McKesson. We also have to realize it's not just the vaccine, but you're going to need all those other ancillary supplies from glass vials to syringes, needles. All that need to be distributed as well.
So I think, Brian, it's going to be a public-private partnership, hopefully building upon current systems. But we're going to have to be more innovative. Some of these vaccine candidates, not only do they require refrigerators or freezers, they need ultra-cold storage. So there are going to be, you know, supply chain, transport-related issues there.
And then of course, to make it even more complicated, some of these vaccines will need two doses 21 to 28 days apart. So you can imagine, if you get a dose, there has to be a tracking system to make sure you come back in a couple weeks for that second dose, which has to be from that same manufacturer. So again, I think it's going to be a public-private partnership here, really unclear what the military's role is going to be once it actually gets out there in the public.