Novavax (NVAX) will be able to pursue emergency use authorization following new information that shows its COVID-19 vaccine is 90% effective.
The company's authorization, which will likely be filed in the third quarter of this year, would make it the fourth to be available in the U.S. if greenlit by the U.S. Food and Drug Administration (FDA).
The Phase 3 trial in the U.S. and Mexico tested the vaccine in 30,000 individuals.It's most differentiating factor was the presence of all coronavirus variants of concern to date. About 82% of participants had one of the four variants — Alpha from the U.K. (B.1.1.7), Beta from South Africa (B.1.351), Gamma from Brazil (P.1) and Delta from India (B.1.671.2) — as well as other variants of interest such as the one which originated in California.
"Since we ran the trial during the period in which variants were circulating, we were able to show efficacy against that. We've got 93% efficacy against the variants," Erck told Yahoo Finance.
The data puts the company in a strong position as it pursues global distribution — a key market in light of wealthier countries largely relying on existing vaccines. The company has several commitments with a range of countries including low-, middle- and high-income nations, Erck said.
"It's big impact early on is going to be ex-U.S.," Erck said of the vaccine, though adding that his company will play a role in the U.S. booster market as well.
Clinical trials to test mixing vaccines, and if different brands can be used for boosters, began this month by the National Institutes of Health.
Meanwhile, the U.S. has become a mixed bag of highly vaccinated and highly unvaccinated populations. For those hesitant of newer platforms like the messenger RNA used by Pfizer (PFE)/BioNTech (BNTX) and Moderna (MRNA), Novavax sees an opportunity.
"I think that there is ... a pocket of people who are waiting for a vaccine that has a more traditional approach. So when we get that approved we will be able to fill that demand," Erck said.
Novavax's timeline has been weighed down by its ability to produce enough vaccines at its eight manufacturing plants globally, in large part to do with some of the supply-chain issues that other vaccine makers faced.
Ideally, all plants should have six months of inventory on hand, but they all currently have a few weeks or a few months available.
Erck, noted however, that some of the pressure on the supply chain is starting to ease.
"We've been constrained for the past six months off and on ... and some really dramatic shortages. That's starting to even out," he said.
Still, the company projects producing 150 million by the end of the year and per year going forward.
"Our expectations, and when we make this forecast...we're expecting we're going to have the raw material supply straightened out by then," Erck said.
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