Dr. Sara Andrabi, Assistant Professor of Emergency Medicine at Baylor College of Medicine, joins Yahoo Finance’s Zack Guzman to discuss COVID-19 vaccine outlook as Johnson & Johnson pauses its trial after an 'unexplained illness' from one of its volunteers.
ZACK GUZMAN: Meantime, want to shift our focus over to the numbers that we are getting on the pandemic front, because the trend continues, ladies and gentlemen, in terms of the rising case counts across the US, the latest number here rising to 41,929, nearly 42,000 new cases. Again, the trend moving higher, and on the vaccine front, we've got some interesting news that had spooked some people who have been watching the vaccine development race here as Johnson & Johnson announced they hit a pause further dosing in all of its clinical trials in that Phase III mission to develop its own candidate for a vaccine after a participant in that study developed an unexplained illness. It followed a pause to the AstraZeneca trial that remains halted here in the US after a patient in that trial also developed an unexplained illness. And here to join us now to talk a little bit more about that is Dr. Sara Andrabi, Assistant Professor of Emergency Medicine at Baylor College of Medicine.
Doctor, I appreciate you taking the time. I know you're very busy, and specifically to this Johnson & Johnson news, I just want to kind of caveat and point out two things. One, the company did not say if its patient received the placebo or the vaccine candidate, so that's important to point out. And two, I mean, the Johnson & Johnson trials the largest of the ones that are coming through here with 60,000 patients, and it's not completely uncommon to see that stops and pauses as you get these to kind of reflect on what's going on, so what did you make of the news when we got it?
DR SARA ANDRABI: Well, Hi, Zack. Thank you so much for having me today. I want to take a step back first and kind of talk about the different phases, you know, as you talk about the clinical developmental stage of vaccines, and it's a three phase process. So during Phase I, you have small groups of people who received the trial vaccine. In Phase II, the clinical study is expanded, and the vaccine is given to people who have characteristics such as age and physical health similar to those for whom the vaccine is intended. During Phase III, researchers look for any signs of possible side effects that may have gone undetected in the earlier patient research. Because of its large size, this phase is considered the most important study phase for picking up less common side effects and establishing safety, and that's the phase that we're in with this Johnson & Johnson trial.
And like you mentioned, there are a few major vaccine trials that are out there, Johnson & Johnson's Phase III trial started in September, and it's one of six of the COVID vaccine trials being tested in the US and one of four in the most advanced phases. As of yesterday, it became the second to have a period of temporary hold on vaccine trials while the company investigates whether the recipient's potentially unexplained illness is a side effect of the vaccine. To allow for participant privacy, we don't have many details about the illness, but we do know physicians and a safety monitoring panel are working on determining what may have caused that illness.
Companies are required to investigate any serious or unexpected reaction that occurs during testing. Given that such tests are done on tens of thousands of people, some medical problems are not unusual. And like you said, one of the first steps they take when doing these investigations is to determine that that patient receive the vaccine or the placebo, which is an inert substance that's injected into the patient. And so these temporary stoppages of large medical studies are relatively common, but few ever are made public. However, given this pandemic we're in, these trials are under a magnifying glass of sorts with all eyes on these trials, and I think it's reassuring to see companies pausing the trials to investigate these events to further ensure appropriate safety.
ZACK GUZMAN: Yeah, no, it's important things to note there as we move forward in this Phase III trial, and obviously, this is exactly why you have these stop gaps in place to see what's going to happen before you roll out and not rush it. That's kind of why the FDA and these biopharma companies have come out and said, look, we're going to try and make this safe. But outside of the developments on the vaccine front, there's a couple other things that people have been watching, mainly President Trump, of course, let's not forget, man tested positive for COVID-19 not too long ago, resuming his rallies there on the campaign trail last night in Sanford, Florida. It was outdoors, not a lot of masks were worn there. Even Governor Ron DeSantis was there in person giving high fives without a mask.
But meanwhile, the president's son, Eric Trump, hosted rallies in Wisconsin-- indoors, mind you-- and VP Pence is hosting a rally today in the state, and I don't want to make it a political discussion here, doctor, because so help me God if we have to deal with that again today, but let's focus on the facts, because Wisconsin right now is the fourth highest number of new daily cases in the US, hospitalizations are going up, deaths are going up, the positivity rate on tests in the state is nearly 20% compared to New York's 1%. So given all those facts can you defend or think of any reasons as to why hosting indoor rallies in a state like that might be smart right now?
DR SARA ANDRABI: Yeah, you know, to kind of go back to Trump, you know, Trump has been criticized for holding in-person campaign rallies, and it's a signature component of his 2016 campaign. Leading health experts, including those in his own administration, have said the gatherings are unsafe during the pandemic because of the heightened risk of the transmission of the virus. I mean, yesterday's rally in Florida had no mask requirements and no social distancing. They were distributing hand sanitizer and masks, but they were going directly into people's pockets, not being utilized appropriately.
And if you look at Florida, they have a 10% positivity rate, which is about twice the national average right now. He will be going to Iowa soon where the positivity rate is 18%. Attendees from yesterday's rally even said that if the president wore a mask and asked others to do so, they would actually listen and put on a mask. Everyone who attends a Trump rally signs a liability waiver that if they get sick they won't hold Trump responsible, which implies there's a risk and begs the question that is the president morally correct for exposing individuals to that risk?
ZACK GUZMAN: Yeah, and lastly, I just want to wrap up here too with the reports that the US has recorded its first patient here to contract COVID-19 twice. We have seen reports of that happening before from researchers in Hong Kong, but here in the US we had not seen that yet. So I mean, when you think about that being a risk in kind of the efforts to get this pandemic under control, that would obviously be very problematic seeing as the whole idea of a vaccine would to make sure these patients can develop antibodies to fight this. But if that doesn't happen and people who have already contracted COVID-19, it's clear to connect the dots there and see that being a problem. So what do you make of that new case here in that being reported if that is going to happen, you could get it twice, how serious of an issue might that be?
DR SARA ANDRABI: Yes, so you know, it's interesting, because I feel like we're still learning so much about this virus every day, and we're learning about maybe people potentially getting reinfected, and that's why, you know, people talk about this like miracle vaccine that's going to come out. And provided enough people can get one, the vaccine may slow a pandemic that's already killed a million people worldwide. It's tempting to look at the first vaccine like President Trump does as on and off switch that's going to bring back life as we know it, but they may only provide moderate protection, low enough to make it prudent to keep wearing a mask, right? So randomized placebo controlled trials are widely considered the gold standard for evaluating the safety and efficacy of a new vaccine. And in these trials, participants are randomized to receive either the vaccine under investigation or a placebo like we talked about.
The first vaccine authorization could hamper ongoing trials of its competitors. Some volunteers are unsure, you know, if they got the experimental vaccine or the placebo, so they may drop out of ongoing trials to get the authorized vaccine, which will slow down research. And Doctor Slaoui of Operation Warp Speed said in a statement that once a vaccine is authorized, trials that have not yet started or had just began recruiting volunteers would be restricted to groups that were not approved to receive that authorized vaccine. So because that first wave of vaccines is likely to go to health care workers or other high risk groups, this policy could mean that groups would not be allowed to participate in those new clinical trials. So while we have research coming out, there's a lot of, you know, kind of restrictions to what we're able to do and find out.
ZACK GUZMAN: Yeah, and there's a lot here to keep our eyes on, and I appreciate you coming on to help break it all down for us. Dr. Sara Andrabi, Assistant Professor of Emergency Medicine at Baylor College of Medicine, thanks again, and be well.