Former CEO, Novavax
Novavax Begins Shipping Covid Vaccine to Europe
Novavax Inc. has shipped the first doses of its Covid-19 vaccine to Europe, marking the drug company's entry into a potentially large new market. He calls this a "big milestone for the company." He talks about when the vaccine could be approved in Canada and the U.S. He spoke to Bloomberg's Jon Erlichman and Matt Miller.
About Stanley Erck
Stanley Erck, who served as CEO of Novavax until his retirement in early 2023, oversaw the company's transition from a clinical-stage biotech to a commercial vaccine manufacturer during the COVID-19 pandemic. In a January 2023 interview, Erck stated that the company had grown from fewer than 100 employees and less than $100 million in funding to over 2,000 employees and more than $1 billion in cash, and had generated $2 billion in revenue in 2022. He described the company's COVID-19 vaccine as "best-in-class" in terms of efficacy, safety, and stability, and noted that it had been approved in 47 countries. Erck also said the U.S. was "the last country" to approve the vaccine, and that the company was working with the FDA to expand its label for all age groups and booster use. Throughout 2021 and 2022, Erck frequently discussed the company's manufacturing scale-up and global distribution strategy. He stated that Novavax had built manufacturing capacity in eight countries, including partnerships with the Serum Institute of India, and aimed to produce "a couple billion doses" per year. Erck emphasized the vaccine's advantages, including storage at refrigerated temperatures and a nine-month shelf life. He also noted that the company was developing a combined flu-COVID vaccine and an Omicron-specific variant vaccine. On the company's financial outlook, Erck projected full-year 2022 revenue of $4 to $5 billion, though the company later slashed that guidance by about 50% due to lower-than-expected demand, particularly from the COVAX facility.
Transcript (12 segments)
✨ AI-enhanced transcript with speaker attribution
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Interviewer0:00
As Matt was alluding to, we've got some news today that the company announced it started shipping the first doses of its COVID-19 vaccine to Europe, making the drug company's entry into that market. The President and CEO of Novavax, Stan Erck, joins us now to talk a little bit more about these developments. Stan, thanks very much for being with us. Let's start on the news in Europe and how you got to this point where these shipments could be sent to Europe.
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Stanley Erck0:27
Sure, thank you. It's a big milestone for the company. We actually started shipping our first product last month into low- and middle-income countries by shipping 10 million doses to Indonesia, and we've started vaccinating there, so that's a first for the company. We followed that up with shipments to the UK starting today, and we're going to continue that throughout the first quarter. We're planning on shipping 27 million doses there, and just a few days ago we got an increase in that order from 27 million, adding 42 million doses in the second quarter, so there's a lot of pent-up demand for our vaccine. On top of that, we're waiting for approvals within the next 30, 60, 90 days from places like Australia, Canada, the UK, and hopefully the US in that time period, so it's a big transition for the company.
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Interviewer1:21
What kind of efficacy are we looking at in this vaccine, Stan, and also tell us about the COVAX commitment you've made because it's a billion dollar commitment.
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Stanley Erck1:30
Sure. It's not a billion dollar commitment, it's a billion dose commitment. Sorry, billion dose commitment, very different. That's very big for us because in part we had funding from world organizations that funded part of the work in the early days. We decided that we would follow the policy of equitable global access, so we wanted to get doses out into the low- and middle-income countries as soon as possible, and we've done that. We've done that first, and that's going to be a big part of our business going forward. And on the efficacy, we have at least the best on par or the best efficacy vaccine. We got 96 to 100% efficacy in our Phase 3 clinical trials when you measure it against the original strain of Wuhan, but when you measure it against variants, which we were able to do in our Phase 3 trials, you got anywhere from 86% to 96% efficacy, so we have a really good vaccine, coupled with the fact that it's very tolerable, we have a very benign safety profile. We think we've got a good match, and on top of all that, we can ship the vaccine using refrigerated temperatures, it has a nine-month shelf life, so it's got a lot of favorable characteristics that are going to help us get the product shipped and used globally.
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Interviewer3:05
Stan, what is the story with a lot of people complaining about boosters? They don't want to go and get shots all the time, but we do go and get flu shots every year, right? I'm hoping that at some point I'll be able to get a combination yearly booster. Is this a possibility with your vaccine?
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Stanley Erck3:29
It's a great question because it fits exactly with what we're doing. In fact, we started a combination trial back last September, knowing that these two could be used together possibly in an annual seasonal vaccine. We know now that it has become more and more clear that you're going to need to boost COVID. We don't know quite whether the boost is going to be in six months or every year like flu is, but we put them together. We did an animal study that showed that they both worked well. We started a human trial in September, and we're going to get data in a couple months on our combination flu-COVID vaccine, and the goal is to get that into the marketplace in a couple years. That would be a great breakthrough so that everybody could get just one shot with a combination vaccine a year.
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Interviewer4:17
Stan, given that you have this European milestone and I'm sure people in North America are watching that very closely on the regulatory front, you alluded to that earlier. All these other markets where you've applied for approvals, can you give us an update on the FDA process, at least what you know at this point, and even here in Canada in terms of what your expectations are for the approval process from here?
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Stanley Erck4:37
Sure. Canada has been an important partner of ours as well early on. In both Canada and the US, we filed our complete package of data to the regulatory agencies. Canada has been working very closely with some of the other regulatory agencies in Europe and is evaluating our application right now. In the US, the same thing. We've filed all of our CMC data. There was an official guidance by the US FDA that you have to wait 30 days from filing those data before you actually do the official act of asking for an Emergency Use Authorization. That will come at the end of January, and then it will be up to the regulators to determine how long they need to take to review the process.
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Interviewer5:26
In terms of other things that you're working on, Stan, what else is there, or are you completely focused on COVID-19 right now?
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Stanley Erck5:33
No, in fact we have a panoply of respiratory vaccines. We've got RSV, we've got flu, we've got COVID. They could all eventually be in one single syringe and take an annual vaccine for all of these. We've done trials in all populations, including elderly folks and pregnant women for RSV. We've got a very effective platform for respiratory vaccines, and on top of that we've got a malaria vaccine that's in Phase 3 clinical trials with our partner Serum Institute. So we've got a very potent platform of vaccines.
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Interviewer6:18
Very quickly, Stan, before we go, I know you've fielded a lot of questions on this COVID-19 vaccine and its effectiveness versus Omicron, but at what point, given what's happened with the Omicron variant being more focused on that kind of treatment, you've been working on that. What can you tell us on that front?
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Stanley Erck6:35
Sure. What we found out are two things. One is that we found that our current vaccine, we call it 2373, has broad protection against a number of variants and makes broad antibody responses, including to what's circulating now, Delta and Omicron. The second part is that the moment we heard about Omicron, we started working on that vaccine. In December, we actually made a vaccine, we put it into GMP production, which is where you start scaling up production. We're doing that right now, with the expectation that we'll start a human trial this quarter. Then we have to look at the data. It may be that our current vaccine 2373 is sufficiently potent against Omicron that it's better not to change the vaccine, or it may be that we need an Omicron-specific booster. Time and data will tell us that, and we'll let everybody know after we've talked with world health organizations about the best way to go.