Novavax (NVAX) is waiting for its COVID-19 vaccine to be authorized in the U.S., but with authorizations now in three major markets globally, the biotech company says it's making its mark on the pandemic.
"We're going to make a significant impact on this Covid pandemic," CEO Stanley Erck told Yahoo Finance Tuesday.
"The market for primary vaccination — two-dose vaccination which is now being talked about as three-dose vaccination — is unsatisfied," Erck said.
"It's not exclusively low income countries, because high income countries need this. We need to get past the vaccine hesitancy," he added.
If the definition for 'fully-vaccinated' changes to three doses, for both Novavax and mRNA vaccines, it could mean a complete reset in vaccination completions globally.
Erck, who spoke at the JPMorgan annual health care conference this week, says the company is going to meet a production speed of 200 million doses per month by the end of the first quarter.
It has already begun shipments to Europe, which should total 27 million by the end of the first quarter, as well as a batch of 10 million doses to Indonesia — the site of its first shots in arms.
Chief commercial officer John Trizzino told Yahoo Finance that Novavax wasn't going to provide specific guidance on the total number of doses for the year, largely because it is still waiting for more authorizations to come through, which would impact the total doses.
As of Wednesday, Novavax has received use authorization in South Korea, Indonesia, India, Europe and the Philippines, and emergency use listing from the World Health Organization. It is still awaiting authorization in South Africa, Australia, New Zealand, Singapore, Japan, UAE, U.K. and Canada. It is also waiting to get the green light to file for emergency use with the U.S. Food and Drug Administration, after submitting the necessary data at the end of 2021.
Through the WHO emergency listing, the company's vaccine is now available to 170 countries.
"We worked really hard over the past two years … and now it's time to introduce our product to the world," Trizzino said.
Manufacturing hurdles
Novavax was a struggling late-stage biotech when the pandemic started, but it pivoted to focus on the pandemic with the help of global philanthropies and the U.S. government.
The company was working on a Phase 3 clinical trial for its flu vaccine and had failed to bring an RSV vaccine to market.
"We, because of our RSV failures prior to that, we basically started with no manufacturing capacity. So, you're starting out in the hole, if you will, and we had to scale up very, very quickly," Trizzino said.
The company's manufacturing problems contributed significantly to a delayed timeline in the past year. Trizzino said it was a significant challenge to have to manage eight global sites at one time.
"Why didn't we just focus on one facility and slam dunk it? Well, what would have been the right facility to pick? So, it was more effort than we had assumed to tech transfer to multiple facilities," he said.
In addition, the vaccine platform, while it offers easy to store and transport benefits, is complicated to make.
"It's a complicated assay, and we underestimated what it would take to develop those assays," Trizzino said.
Normally, it would have taken the company four to six years to scale up to where it has in the past two, he said.
Now, a partnership with the Serum Institute of India — which is also producing AstraZeneca's (AZN) vaccine— is helping the company make up for lost time.
In fact, if the vaccine is authorized in the U.S., it will be based off of the same data sent to other global health authorities, relying on the Serum Institute's manufacturing quality for doses.
"So it would be Serum product that we would use in the U.S.," Trizzino said, noting that while the company is U.S.-based, its "success or failure as a company…is not exclusively based in the U.S."
Global vaccine market
Trizzino said that the company's global focus does not mean the company will be only a provider to low income countries.
"People misunderstand the market. It's not the typical vaccine launch where in year one we get launched in the U.S., and two or three years later it gets launched in Europe, and three to five years later it gets launched to the rest of the world. It's all at once," Trizzino said.
The company lost an opportunity to play a major role in the initial wave of vaccines in the U.S., but it still has a small market — as the country hovers at 66% of the eligible population fully vaccinated — as well opportunity globally.
Trizzino said that represents a 180 million dose opportunity in primary doses alone in the U.S. Add to that primary doses and boosters globally and the total is a 4 billion dose opportunity.
The potential doesn't stop there, Trizzino said, noting there could be additional boosters or annual revaccination on the table.
"Now, we're not saying we're going to capture all that. But what people should take away is that the trend line is that there's an increase in demand for vaccines, not a decrease," Trizzino added.
The pricing strategy, meanwhile, does not reflects traditional tiered rollout of vaccines, where the U.S. can end up paying double what Europe pays. Instead, the pricing is based on a country's ability to pay.
"Basically, Europe and the U.S. are paying the same price for doses right now. So people kind of need to reset their expectations about the way that they think about the commercial market, and what the demand profile looks like," Trizzino said.
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