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Novavax CEO: 'We will be filing within the next few days' with FDA

·Senior Reporter
·2 min read
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Novavax (NVAX) is finally ready to submit its application for emergency use authorization (EUA) in the U.S., and could do so as early as this week, according to CEO Stanley Erck.

"We will be filing within the next few days in the U.S.," Erck told Yahoo Finance Live on Tuesday.

The company has made significant progress on its path to its first commercial product, the two-dose COVID-19 vaccine, marking three major milestones in the past week.

Novavax has now received four emergency use approvals, including a listing from the World Health Organization, making it the ninth vaccine authorized by the agency, as well as conditional marketing in the European Union. In addition, the company announced administering its first dose in Indonesia Tuesday, where it recently received emergency use authorization.

Erck said the company anticipates beginning delivery of its COVID-19 vaccines to the European Union by January, and has a target production output of 2 billion doses for this year. It already shipped, through its manufacturing partner Serum Institute of India, 20 million doses to Indonesia.

"In addition to shipping the doses to Indonesia, we're prepared to ship doses ... to Europe, starting next month," he added.

Novavax also has manufacturing partners in South Korea and Japan and owns a facility in the Czech Republic. The company has emergency use submissions pending in Japan, India, Australia, New Zealand, Canada, Singapore, the U.K. and United Arab Emirates.

In the U.S., the company has lagged behind competitors in getting to the finish line, running into manufacturing issues — which have since been resolved — as well as delays from interactions with the FDA.

While the company faces stiff competition from mRNA vaccines from Pfizer (PFE)/BioNTech (BNTX) and Moderna (MRNA), its efficacy data is similar, and its technology sets it apart from others. The CDC recently issued guidance giving preference to mRNA doses, citing concerns over blood clots after Johnson & Johnson (JNJ) vaccines, which uses a similar platform to AstraZeneca (AZN).

The shift could open up the U.S. market, which is hovering at 65% vaccinated for ages 5 and up, according to the latest CDC data.

"Our hope is that the U.S. will look at this as an important new vaccine and approve it in due time," Erck said.

The company hasn't yet revealed data on how the vaccine stands up to Omicron, but is also working on an Omicron-specific dose.

While the new milestones have positively impacted the company's stock price, Erck anticipates it will in due course.

"I've taught my folks not to look at it on a day-to-day basis, as we take care of our business it will find it's way," Erck said.

He added that he hopes the FDA will make a decision on emergency use early in 2022.

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