Pfizer (NYSE:PFE) and its German partner BioNTech (NASDAQ:BNTX) reported incredible efficacy data from a phase 3 trial for their mRNA coronavirus vaccine candidate last Monday. While the 90% figure inspired much hope, investors should know this was interim data that have not yet been peer-reviewed. This week, Moderna (NASDAQ:MRNA) reported equally impressive results for its vaccine candidate that takes a similar approach.

We talked to Dr. Leo Nissola about what this hopeful development means for the world and for investors.

 

 

Corinne Cardina: For the next 15 minutes, I am so excited to welcome Dr. Leo Nissola, a Medical Doctor, as well as an Immunotherapy Scientist. Leo, here you are.

Leo Nissola: Hi there.

Cardina: Nice to meet you.

Nissola: Nice to meet you as well. Can you hear me OK?

Cardina: I can. Welcome to Fool Live. Fools, we're going to talk through the next 15 minutes about all the excitement in the coronavirus vaccine development race and dive into some of the big question on everyone's mind. Basically, on Monday, we had some really exciting news.

Nissola: We did.

Cardina: Pfizer and its German partner BioNTech. They released a press release and they shared new information with the public about their COVID-19 vaccine candidates. A couple of caveats is data has not yet been peer-reviewed, but it's been heralded as proof-of-concept for these vaccines that take an mRNA approach. Right now, the early data indicates the efficacy, meaning that it accomplishes its goal of preventing COVID-19, it's more than 90%. For context, the Food and Drug Administration (FDA) had said 50% would be good enough. Dr. Nissola, can you tell us more about what we found out from Pfizer and BioNTech on Monday.

Nissola: Yeah. Of course, I'm happy to be here. Thanks for having me. I'm very excited about the COVID-19 vaccine as everyone else and ready for life to go back to normal. I think we started the week with some exciting news from Pfizer. The current COVID-19 statistics are shocking in the United States. We have exceeded over 100,000 cases a day with deaths nearing average of 1,000 people a day. That's very grim. Right now, there are over 59,000 people hospitalized with COVID in the United States, and out of those, more than 11,000 with severe disease. Pfizer's vaccine has a different concept from your average vaccine. It tries to use something called neutralizing antibodies. Just the fact that a vaccine that is mostly based into inducing neutralizing antibodies, protects from symptomatic infection. It's fantastic! For everyone else that's not a doctor or a scientist, you don't have to know what a neutralizing antibody is. It's basically a defense cell, and a defense cell that work with an infectious agent or a pathogen that gets into your body like a virus. It neutralizes its effect, and it neutralizes its potential biologically. This neutralization makes the agent no longer infectious. What this has proven is that many other vaccines are likely to work as well. Moderna's vaccine is almost identical in the concept of Pfizer's. The fact that their vaccine has shown to be over 90% effective. It's pretty exciting.

Cardina: It is. I think a lot of people are very encouraged by this new information. As I said, it is very preliminary. Are there any specific data points that you're going to be watching when more of this data comes out and it is peer-reviewed?

Nissola: Of course. Yeah. Well, they have send out test release based on the 94 confirmed cases of COVID-19 at their interim analysis, we have yet to see the published study results. We want to see the raw data, we want to see the paper being peer-reviewed. We want to just make sure that we are on board with the fantastic news. There's nothing out there that has been proven to work so far. Although, we have 38 great candidates in Phase 1 studies and 11 in Phase 2. Anything that works, it's good news out. First, is results from this Phase 3 trial has to be seen in the context of how you came about. Preclinically, Pfizer had shown results that their vaccine worked in non-human primates. In early clinical trials, their vaccine induced good neutralizing antibody responses. That's what this vaccine does well. Now, in addition to that, we get interim efficacy results that are in the 90% range. Any percentage's pretty good. It might be even higher, but we haven't seen the data, so it can potentially be lower too. It's very important to manage expectations there.

Cardina: Absolutely. You mentioned Moderna already, but this is a company that's taking a pretty much the same approach of using the mRNA. Moderna's stock, it went up on the news. Investors clearly don't think this is a winner-take-all market. I would love to hear your thoughts on how you envision this plays out in terms of distribution. When do you think a vaccine might be available to the public? Are there certain groups of people who are going to get the vaccine first? Are we're going to have rolling different kinds of vaccines coming out? We'd love to hear your insights.

Nissola: Yeah. I think there are many questions that remain. We don't know. You can still get asymptomatically infected while you have received Pfizer's vaccine. That's an important question. Meaning, is it clear that this vaccine is effective at preventing infection altogether? That might be a matter in the longer run, and we will see if it cuts down on transmission. But it's not required to protect at-risk individuals against severe disease outcomes. Though, Pfizer has enrolled adults and older adults in their trial. Right now, we don't know how the efficacy breaks out. It protects older individuals and younger people the same way. Knowing how the process works, we understand how vaccine trials work. These trials can determine if a vaccine protects against a coronavirus, but also if it protects against severe disease. That's a very important point to take into account. Moderna's vaccine is following the same biological rationale or scientific rationale of Pfizer's and its good news for them too.

Cardina: Absolutely. You mentioned there's still a lot of things that we don't know. I think one of the things that people are concerned about, particularly as it relates to the mRNA vaccine is the cold chain. These specific types of vaccines, they have to be kept ultra cold. That means that your neighborhood pharmacy won't necessarily have the right refrigeration to distribute these. Do you have any thoughts about how we should be thinking about distribution of these mRNA vaccines if they come to fruition?

Nissola: Yeah. It's big challenge logistically to deliver a vaccine for 330 million Americans. Let alone a vaccine that requires that. Those are two logistical nightmares. The fact that it requires refrigeration, I'm not that concerned about for many reasons. In cancer research, we use drugs and molecules that require quite the preparation for them. We are able to deliver that to patients across the country in clinical trials. Pharmaceutical companies have been doing this for a very long time. Of course, it's not your flu vaccine that you can just walk around the corner. We are first stepping into the realm of coronavirus' vaccines for COVID-19. That said, what worries me more, it's not the logistical hurdle of delivery of vaccine that requires refrigeration, but what concerns me more, is who's going to get this vaccine first and how we're going to prioritize the populations that should receive the vaccine in the first beginning of the distribution. Is that going to be healthcare workers? Is that going to be essential workers? Are we going to give it to elderly and high-risk populations? Right now, I think the country demands bold experimentation then, the same goes with science. We have to try and sometimes, it fails and sometimes we get it right. Pfizer really is saying there is a 90% chance of being right, I'm very hopeful. I think we should all cherish this potential good news.

Cardina: Absolutely. While maintaining a realistic lens on things. I have another thought. We talked about at-risk demographics. But a lot of contracts have been signed with some of the biggest governments in the world; the U.S., Canada, the U.K., Japan, and so these countries are securing the first doses for their populations. Do you have any thoughts on what that's going to mean for the rest of the world and places where they don't necessarily have contracts in place? Thinking about South America, Sub-Saharan Africa, is that a concern?

Nissola: Yeah, definitely. Again, for us to be able to get life back to normal, we need a very large number of people to be immune to the coronavirus. That said, we need everyone to get vaccinated and that's very difficult. You see how difficult it is to convince people to just get a regular flu vaccine. I think going to demand, whoever is in charge of the free world again, to have a very bold and decisive vaccination plan. I think we're in a point in time where we should be talking about this every day with our local officials. Where is our county's vaccination plan? Who is going to get the vaccine here first? Because from what I'm seeing and with the data that I've seen so far, the current administration has been letting the states decide how to handle COVID in their area. So I imagine moving forward, that's going to be the same way. I think that is a good time for folks to understand how are their counties handling COVID, because if you look at the data from multiple projects and I've advised COVID Act Now multiple times. When you look at counties like Miami-Dade, for example, they're experiencing active outbreak of coronavirus, with over 39,000 cases per 100,000 people. That's very worrying. That means that most of these folks are not going to wait for the vaccine. They're going to get sick, and they will try to develop antibodies naturally and we know how this vaccine behaves. One example that I usually give to people is that in the beginning of the pandemic, we thought that only people that have underlying conditions would require ventilators and they would require hospitalization, but we have seen so many cases of young and healthy individuals getting sick with the coronavirus and having that affect them in a very negative way. An example I gave is that a friend of mine, he's a world-class lung oncologist in Miami. He got COVID in the beginning of the year while he was working in the hospital and he still experiences COVID symptoms up to today. It's been over six months. Those symptoms can be very severe as well.

Cardina: Yeah, absolutely. Time is of the essence for sure. What would you say is the biggest misconception about the coronavirus vaccine?

Nissola: Well, I think there is a misconception around the value of vaccines in this country and I think this is something that we shouldn't be shy about. I think we should talk about the elephant in the room and talk about the fact that throughout history, we have respected the CDC, we have respected the FDA so much as the beam of light in science, and we trust them and they've been right many, many times. There was an attempt this year to undermine that credibility, which I do not and I don't believe. I think the CDC, the FDA are in charge of making the right decision for Americans, and they have time and time and again, and if approval for a vaccine comes through, we should be behind it. I've heard many people on the media, on TV, on Twitter, talking about waiting a specific period of time to get a vaccine and I'm going the opposite route. I would say if there is a clinical trial for a vaccine candidate in your area, join it. Look at informed consent. Make sure that you are having conversations with your healthcare provider, and if it makes sense, I don't see any reason why folks would not get behind the research. I think that's how we make science happen. I think honestly, those are the unsung heroes of this crisis, people that have volunteered for those clinical studies. Without them, we would not have the news that we're receiving this week.

Cardina: Yes, that is such a great point. I'm so glad you highlighted that. My last question for you, because The Motley Fool, we are investors, what might you say to any investors who are considering buying stock of a company that's working on a COVID vaccine, particularly the mRNA vaccine? So Pfizer, BioNTech, Moderna, do you have any tips?

Nissola: I wish I did, but I don't really. I usually make my choices based on past successes. If a company was able to produce blockbuster drugs that have saved millions of people's lives, that have time and time and again, being on the right side of history, supporting science, advancing treatments, that would tell me that I would trust that company.

Cardina: Yes, absolutely. Looking at their track record is critical to making any investment decisions. Well, thank you so much, Dr. Nissola. I still appreciate all your insights and your time today.

Nissola: Of course.

Cardina: Good luck with everything, and we will keep in touch.

Nissola: Thank you so much for having me.

Cardina: Absolutely. Have a great day.

Nissola: Safe safe, guys. Please wear masks.

This article represents the opinion of the writer, who may disagree with the “official” recommendation position of a Motley Fool premium advisory service. We’re motley! Questioning an investing thesis -- even one of our own -- helps us all think critically about investing and make decisions that help us become smarter, happier, and richer.