COVID vaccines: Novavax exec talks FDA approval process, supply chains, and pandemic outlook

Novavax Chief Business Officer John Trizzino joins Yahoo Finance Live to discuss the company awaiting an FDA approval for its COVID vaccine, supply chain constraints, and the outlook for COVID-19.

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BRIAN CHEUNG: COVID cases on Memorial Day this year outpaced COVID cases from this time last year, underscoring the continued importance of vaccinations. Novavax seeking to get US authorization for its two-dose vaccine soon. For more on this, let's bring in Novavax chief commercial officer John Trizzino in an exclusive Yahoo Finance interview, as well as our very own Yahoo Finance's Anjalee Khemlani, who's going to join us for this conversation.

John, it's great to have you on the program. June 7, as I understand it, is the meeting. It's the first of four that need to happen for your vaccine to get approved here in the United States. And then at some point, you're going to go on to the CDC. Give us the update on where you stand in that and what's your expectation at the end of all of this.

JOHN TRIZZINO: Yeah, thanks, and thanks for having me. The lead-in was exactly why this is such an important event for us, coming up on the VRBPAC. So FDA's advisory committee, which will assess all of the data that we've submitted to date, will make their assessment and make a recommendation for emergency use authorization to be granted to the FDA. And so it's a culmination of a lot of work and effort that's gone into all of what we've provided with from clinical data that we have a safe and effective vaccine, and that COVID is here to stay. And we now offer an option of the first protein-based vaccine to be authorized for use in the US. And I think we're tremendously excited and optimistic about the outcome of that meeting on Tuesday.

ANJALEE KHEMLANI: John, Anjalee here. Good to have you on. I know that there is a lot of focus about the manufacturing and the doses coming from the Serum Institute of India and being sent over here. Obviously, we live in a world where we know that there are supply chain pressures right now. How do you plan to ensure that these doses make it over quickly and smoothly, and you don't run into any logistics issues?

JOHN TRIZZINO: Yeah, so we've been shipping products since the beginning of the year. And Serum Institute has just been a tremendously valuable partner. They've built out capacity for us over the last couple of years. They are an absolutely world class facility. They've now been inspected by the FDA, and that was a gating event to the VRBPAC meeting. So, 100% confident in their ability to manufacture and deliver. We've been shipping into Europe and Australia and Canada and many other countries around the globe. So, 100% confident in our ability to bring doses into the US. And doses will be in the US in a few short weeks after the emergency use authorization is granted.

ANJALEE KHEMLANI: Walk us through that timeline and whether or not you actually see any doses being produced in the US. Because I know you had to stop production with a US contract manufacturer. Has that relationship completely ended? And are you using any others in the US?

JOHN TRIZZINO: Well, most importantly for the moment is the submission to and review by VRBPAC. And submission to the FDA is based upon the Serum Institute manufacturing a product. You may recall we made a decision in August or September of last year to focus our CMC activities, our manufacturing activities, to Serum Institute so that we could get the regulatory filings submitted as quickly as possible. And that proved to be the right decision. We will be adding and supplementing those regulatory filings for facilities at SK Biosciences and then our own manufacturing site in the Czech Republic in Europe. And that will be, at least for this year, the sites that we'll be using for manufacturing.

ANJALEE KHEMLANI: And what about--

JOHN TRIZZINO: And the product that will be available in the US will come from Serum, at least initially.

ANJALEE KHEMLANI: OK, what about the stock itself for the company? I know you've seen it really on a roller coaster ride since February of last year when you had to really announce that delay. We've seen over the course of the pandemic different vaccine companies experience different interest in investors' sentiment. Right now, really, the company is under pressure for waiting to see that US approval. Do you anticipate that that will sort of boost investor confidence?

JOHN TRIZZINO: Yeah, so the market's fairly unpredictable at the moment, as we all know, right? I think there's a high degree of volatility. We feel like we're trending in a similar way to the many of the other COVID vaccine manufacturers. It's been a downward trend. But it's not reflective of our value. I think we are now in a position to have a successful '22. You remember that we have $4 to $5 billion of revenue guidance for '22. We also believe '22 is an important foundation laying year for us, as we see and look toward what will be a transition out of the pandemic into normal kind of commercial vaccine selling. And that's going to be an important turning point for us as well. We believe we're going to have sustainable revenue generation and be an important part of annual revaccination for COVID into the foreseeable future.

AKIKO FUJITA: Yeah, so John, let's pick up on that point because I know you've been asked a lot about the timing of this product coming to market. We're more than two years into the pandemic in developing countries, at least. Many are on their second booster shot. What does the demand outlook look like for you? And where are you likely to see the biggest demand?

JOHN TRIZZINO: Yeah, you know, again, I refer back to the lead-in. And I think it's critically important for everybody to understand that there's still a high significant amount of virus circulating around the globe and around the US for sure. And so, it's off a bit of the front page and the headline news, but it still is something that we need to be concerned about, we need to focus on. We're not yet sure whether we're going to continue to be six-month boosting or annual boosting. But what we do know is there is going to be a continuing high demand for a vaccine across the globe. And we'll wait to see exactly what that is, but certainly clear need for a vaccine and clear need for vaccination programs.