Early data for a COVID-19 vaccine candidate from Pfizer and BioNTech were better than expected. In this video, part of a series on the scientific and investment implications of COVID-19, Portfolio Manager Daniel Lyons and Research Analyst Agustin Mohedas explain why the results are so encouraging and what it could mean for the trajectory of the pandemic.
This week, Pfizer and BioNTech delivered preliminary data for their novel COVID-19 vaccine candidate, showing a roughly 90% reduction in symptomatic infection rates in a late-stage clinical trial – a remarkable result.
The outcome is promising not just for Pfizer and BioNTech’s vaccine, but also for other vaccines under development that target the same receptor binding domain the virus uses to enter human cells.
Multiple vaccine approvals could help bring an end to the global pandemic and would come at a critical time as new cases of the disease accelerate around the world.
Michael McNurney: Hi, welcome to Janus Henderson's ongoing series on the COVID crisis. My name is Michael McNurney, and today I'm joined by Dr. Dan Lyons and Dr. Agustin Mohedas. For the first time in what seems like a very long time, we have outstanding news. There have been developments on the vaccine front that seem very positive. Dan, can you give us an update on what we've learned about vaccine development?
Daniel Lyons: We actually, just this week, had promising data from the Pfizer and BioNTech vaccine program for COVID where they reported that the vaccine is remarkably effective, basically showing a 90% drop in the rate of symptomatic COVID infection. And this is from a trial that enrolled roughly 44,000 participants so far and accrued around 94 cases of COVID to date. So, we're really excited that this validates that you can make a vaccine against COVID because it wasn't really known what level of activity there would be.
McNurney: Dan, I think the really remarkable aspect of this is we're using an mRNA vaccine, which is a novel approach to fighting this disease. Can you talk to us more about the way that Pfizer and BioNTech have approached developing a vaccine?
Lyons: Yes, so the approach they used is one of the four really promising approaches that we've highlighted in the past. And one of the reasons we've been optimistic about vaccine development is that there are multiple modalities being targeted here. But one thing that most of the programs have in common is that they're trying to develop an immune response against the receptor binding domain of the COVID virus and, as a result, trying to prevent its ability to enter into cells and infect them. So, it's really encouraging to see this clinical activity from this first program because that has positive implications for other programs because they also generate antibodies against the same part of the virus.
What an mRNA vaccine is, it basically uses a construct of messenger RNA to basically produce proteins from the virus and induce an immune response. And mRNA is uniquely suited to a really rapid response because once you have the sequence of the virus, you can very quickly design constructs that you can use in vaccine programs. And, in fact, there's one other late-stage program from Moderna that will report out later this month that uses the same construct. But basically, the way the approach works is, after injection of the messenger RNA with a priming dose and then a boost, you're able to induce a really solid antibody response against a virus and also generate a T-cell response. And this early clinical data shows that type of immune response is really effective at preventing COVID infection.
McNurney: Dan, can you talk to us about the timeline? We've heard some initial estimates, but from your perspective, what does the timeline look like for giving the vaccine to the population?
Lyons: So, with this early result, the companies are beginning the steps for filing an emergency-use authorization with the FDA [Food and Drug Administration]. And within the next couple of weeks, they'll have all the data they need in order to finish that filing. And what they've said is that they hope to have that authorization in place by year-end, where there will be a smaller number of doses available, around 50 million doses in the December timeframe. And as you said, over the course of next year, they will ramp to over 1 billion cumulative doses by the end of 2021 for this program.
McNurney: Now, Agustin, not all the news is positive. We've seen an uptick in cases here in the United States, as well as in other countries. Can you talk to us about the state of the disease as it exists today?
Agustin Mohedas: Yes, that's right, Mike. And, you know, this vaccine data couldn't come at a better time. We're seeing in Europe cases rising at a very, very fast rate. They're experiencing a very significant second wave. Europe brought the pandemic under control quite well with lockdown measures and social-distancing measures. And they had brought the case counts down to very low levels. However, during the summer months, people eased up on their social distancing and this allowed community spread to begin. And community spread starts off very slowly at first but then rises exponentially. And now we're seeing that across Europe, and we're seeing countries like the UK, France and others taking more serious lockdown measures in order to try to get that community spread under control.
Now in the U.S., you know, we've taken a very different approach. Every state has kind of done different things, and so what we've seen is the pandemic start in the East Coast, work its way through the Sun Belt, now really working its way through the midwestern states, mountain states and further out west. But, really, we're seeing rising cases throughout the country. I think almost every state is seeing rising cases. And so, we're seeing a much broader spread and, thus, we're hitting record numbers almost every day.
McNurney: Now one of the other things that we've noted is it seems that the death rate is dropping a little bit. Is that because of treatments like remdesivir?
Mohedas: Yes. So recently, Gilead received full approval for remdesivir. This is an antiviral therapy that's given to patients that have severe COVID-19. It's shown to reduce the length of stay in the hospital, so it gets people out of the hospital faster. We've seen other approaches, such as antibody treatments, that have shown similarly good data. And yes, treatments like remdesivir, physicians’ better knowledge of how to treat patients – even the right settings to use on ventilators, for example – all this has been figured out in real time and has brought the case fatality rate down by probably around half; it's difficult to exactly measure. But as cases are rising and we're seeing record hospitalizations in the U.S. and now in Europe as well, it's likely we're going to see more deaths, unfortunately, on a daily basis versus the summer months. And so, these vaccines couldn't really come at a better time.
McNurney: Dan, this progress really underscores the amount of innovation that's happening within the [health care] sector. What is the prognosis, if you will, what is the outlook for health care stocks?
Lyons: Yeah, no, I think the progress on the COVID vaccine and more broadly in therapeutics is huge for the sector. One, I think it highlights the amount of innovation that the biopharma industry can bring to bear on a problem. And so, we've seen the whole industry respond, bringing vaccines and therapeutics. So, it highlights the value of biopharma. Also, getting solutions for COVID is really going to help a lot of the medical device stocks and those related industries that have been suffering because normal hospital procedures are down substantially, as hospital beds are reserved for patients with COVID. So, we're expecting to see a rebound across many of the medical device sectors as well.
McNurney: We mentioned this is the first time that we've used an mRNA vaccine. What would you say to those who may be reluctant to take the vaccine because it is a new modality, plus the fact that the clinical trials happened quite quickly?
Lyons: Yeah, one thing that I should have highlighted earlier is just the safety data that's been observed so far, and we'll get more of this over the course of time. But so far, the safety profile has been remarkably clean and well tolerated for this vaccine. Also, mRNA vaccines have been used across a large number of patients in some cancer vaccine studies prior to their use as a broader vaccine technology. So, for me personally, I would like to see all that safety data out there, which it will be very shortly. I'm also really encouraged that the FDA has been very focused on the safety profile for all these vaccines and will require the companies to have lots of follow-up on all the patients that are in the studies. And so for me, I would feel comfortable, I think in the first half of next year in getting vaccinated based on the amazing efficacy that's been seen so far and the very clean safety and tolerability profile that so far has been reported.
McNurney: Thank you very much gentlemen for your time.
mRNA, or messenger RNA, carries the genetic information copied from DNA to other parts of the cell for processing. The mRNA approach to fighting COVID-19 uses the mRNA to elicit an immune response to build immunity.
A T-cell, or T-lymphocyte, is a type of white blood cell that is involved in controlling and shaping the body's immune response to infection.
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