Vaxart is Working to Develop an Oral Vaccine for Norovirus, Which Affects 20 Million Americans Every Year

As the days of summer wind down, parents prep children for a new school year while others revel in the upcoming return of the holidays. Although fall may be the “cozy season,” the spread of norovirus is an unwelcome, but common, marker of this time of year. One of out every five cases of gastrointestinal illness is caused by norovirus, which spreads through food, water, contaminated surfaces and by people who are infected. Although norovirus is highly contagious, there is currently no cure and the illness it causes can be fatal for young children and the elderly. Vaxart, a South San Francisco-based company, says the search for a norovirus vaccine addresses a highly unmet need and the company is currently developing the only oral vaccine tablet for it.

August is National Immunization Awareness Month, and in recognition of this national campaign we spoke with Andrei Floroiu, CEO of Vaxart. Floroiu has been with the company since 2020, and as an accomplished pilot he founded the nonprofit Fly for MS, where volunteer pilots flew around the world to raise funds and awareness for patients with multiple sclerosis.

Your background is in engineering and finance. How did you get into life science?

I think how I got into biotech—almost by chance—is perhaps less interesting than why stayed. I was at McKinsey & Company in New York, and started to work on some biopharma engagements, and later moved to Wall Street and started to invest in biopharma. I realized that because most people in biopharma are scientists or former doctors, drug development is a very creative process. It’s almost like a piece of art that an artist creates. And oftentimes, that leads to emotional attachment and biases.

I observed that for successful biotech companies, it wasn’t necessarily the science that made them very successful—it was making the right strategic decisions and allocating capital in the right way. Optimizing those things came natural to me by my formation. I’m more outwards looking. Once I was in the field and learned that this skillset is useful, that kept me in the industry.

Why is the company focused on developing an oral vaccine for norovirus? Why go with a pill versus a versus an injection?

We would like to see a world where more people can get more easily vaccinated with better vaccines all around the world. A needle vaccine is limiting in many ways—many people don’t like the needle. They don’t like the pain. You have to go somewhere to get vaccinated. They are logistically challenging to distribute in the furthest corners of the world. We’ve seen that from some of the surveys—that others have done and that we’ve commissioned—that a pill would actually lead to more people getting vaccinated because it’s much more accessible, and vaccination would happen quicker, which is very important in pandemics.

What we’ve discovered is that it’s not just the form factor that’s important. Our pill vaccine works very differently than injectable vaccines, and we are testing our thesis that it could work better and could provide you with better protection. The pill activates your mucosal immunity—in the nose and mouth—which is how many of the airborne viruses affect us, whether it’s COVID or the flu. We’ve actually seen in a clinical trial that compared our flu vaccine to a leading injectable, there are signs that our vaccine could be more protective than the injectable, and it may also reduce transmission of a virus. That’s the big picture across our programs. Right now, norovirus is one of our programs, along with flu and pan-coronavirus vaccines we are also developing. Norovirus infects you through your gut, and that’s also where our vaccine gets activated. We’re the only company that is developing an oral norovirus vaccine. Just so you have an idea of what that pill looks like, it’s a little smaller than an aspirin.

Our pill is also the most environmentally friendly vaccine form. I’m surprised that the environmental impact of an injectable vaccine was not brought up during COVID—with billions of vaccines being administered, that’s a lot of medical waste.

The CDC says norovirus is the leading cause of foodborne and gastrointestinal illness in the U.S. But there are misconceptions about the virus, one of which is that it mainly affects confined spaces such as cruise ships. What are some other misconceptions?

Norovirus definitely does not just spread on cruise ships. It spreads wherever people congregate in close proximity—schools, restaurants, and military bases, for example. The impact is very high to two groups of people: children and the elderly. For children under the age of five, 15 percent of them get norovirus annually. They bring it home and they’re going to infect their parents, who will have to take time off from work. For the elderly, noroviruses cause around a thousand deaths annually. The biggest problem with norovirus is the economic impact that it causes, which is about $10 billion a year here in the U.S. alone, and there is no current vaccine for it.

It gets transmitted through food, often through infected food workers handling food. Kids also try to put everything in their mouth, so the transmissibility there is a lot higher. It’s a nasty disease once you get it. To have severe diarrhea and vomiting for two to four days is very unpleasant.

If it’s so common and easily spread, why is there no vaccine for it? Is there anything particular about this virus that has made finding a vaccine for it so difficult?

The first thing is, up until a few years ago, there was a lack of awareness. Until recently, people didn’t realize this is a significant unmet need. The second thing is in order to develop a vaccine, you want to test its efficacy and this virus is very hard to grow in the lab. Third, there is no proven animal model to test vaccine candidates pre-clinically, which makes predicting efficacy more difficult. All of these things make the development of a vaccine more challenging, longer, and more expensive.

How does your vaccine candidate works? And what phase is it in?

There are two predominant strains of norovirus that cause the vast majority of the infections both here in the U.S. and globally. Our candidate includes those two—G11 and G24. The norovirus vaccine conceptually works the same as all our other vaccines, which is you take a pill with a glass of water, it goes into your gut, and there it activates your mucosal lining of the gut. And the mucosal surfaces apparently are all linked. So, you’ll see an immune response in the gut, in the mouth, the nose, and the lungs, as well as an immune response in the blood. When our scientists compared the immune responses that we see from our vaccine to the immune responses of people that got infected with norovirus, they look very similar. So that made them very excited about this and led them to believe that the vaccine could protect against norovirus.

We completed a Phase 2 dose-ranging study in early July, where we compared two doses of the vaccine. We are in the process of a double-blinded Phase 2 Challenge Study with the G.1.1 strain and our corresponding vaccine candidate. We used the norovirus virus and infected people, half of whom were vaccinated with the active vaccine, half with placebo. We expect to unblind the study and see the results this quarter. Once we have those results, that data will be key to understanding the efficacy of the vaccine and will inform our next steps with this vaccine candidate.

Professionally, what would you say is your biggest challenge right now?

It’s a very difficult environment for biotech. It’s been like that for over a year. This is a very capital-intensive business, and the stock market hasn’t been friendly to biopharma companies and that’s been challenging. This has an internal impact too—people that work at biopharma companies, including our own, are more worried and anxious about the future than they have been. The challenge is to try to work with organizations (like Biocom California) to tell both investors as well as government bodies that we definitely need more innovation in the vaccine space. We’ve seen that the COVID pandemic caught us unprepared. We made progress, but we are still nowhere compared to where I think we need to be. Just trying to keep the spotlight on the vaccine sector from fading away is what I see as most important right now for us in the industry.

What piece of advice would you give to a young person who says that they want to start a career in this industry?

I would definitely encourage them to pursue it. It can be very rewarding because of the impact that you can make on people’s lives—it’s very exciting to be part of making that impact. Obviously, you can be a scientist, and while we do need more scientists, being a scientist is not the only way to work in biopharma—there are exciting roles across the board. You can be in finance, HR, data science, etc. If you want an area of focus you can practice that in biotech as it will continue to be a growth industry. There are plenty of reasons for young people to give biotech a look.

August is National Immunization Awareness Month. What does this month mean to you, and why is it important that we celebrate it?

It’s important to note that vaccines to a large degree restored our lives, and we have to acknowledge their general importance [in preventing death and illness] as well as the need for more innovation. For such a long time, vaccines have been considered the ‘backwater’ of biotech, which is why COVID caught us in the place where it did—we were having to scramble. We humans have very short memories. There is a very big risk that we’re going to repeat a mistake we’ve made before as we’re taking the attention away from the need to innovate in vaccines. I think we can use this month to acknowledge the importance of vaccines in our lives and the need for better vaccines and innovation, such as one day being able to get vaccinated simply by taking a pill with a glass of water.