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Novavax CEO: If FDA waits for US data, 'the lag will be a couple of months' for its vaccine

Novavax (NVAX) is hoping its trial data from the United Kingdom and South Africa can be aggregated and used to apply for an emergency use authorization (EAU) in the U.S. to help expedite the rollout of its COVID-19 vaccine.

CEO Stanley Erck has pressed to have the U.S. Food and Drug Administration (FDA) weigh the global data, a strategy the agency has used previously, in order to apply for emergency use by next month.

"That decision will cost a month or two ... if they wait for the U.S. data, then the lag will be a couple of months," Erck said.

On an earnings call Monday, company officials said said they hope to have 110 million doses shipped to the U.S. by July.

Erck noted that data for U.K., which accepts rolling submissions of information, is set to analyze data by the end of the month. If the U.S. uses the U.K. data, which shows the vaccine to be 89.3% effective, it could get an emergency use as early as May.

The Phase 3 trial in the U.S., meanwhile, is ongoing and recently fully enrolled with 30,000 participants. Novavax was the first company to provide clinical trial data of a vaccine's efficacy against a concerning strain originating in South Africa (B.1.351), which showed that while the vaccine remained efficacious, it did show reduced efficacy compared to the original strain.

In the interim, the company is ramping up production of its vaccine doses, and Erck anticipates there will be doses on hand to ship out as soon as it receives authorization.

Novavax has partnered with a number of large manufacturers globally, and has billions of dollars in commitments for its vaccine in order to meet the U.S. as well as other dose commitments. The manufacturing partnerships put the company in a position to exceed production of 2 billion doses on an annual basis once maximum capacity is reached, which is likely by the middle of this year, officials said on the earnings call.

Noravax has been a late-stage clinical company for some time, but the pandemic sped up its path to becoming a large commercial company. Erck said 2021 is the year the company is likely to turn a profit.

"We've done something in the last year that probably in normal times would take three to four years to develop," he said.

It went from a company with $100 million in the bank, or about six months' cash, to having more than $1 billion, with more coming in from advance purchase agreements, he said.

"We had 150 total in the company, in the U.S. and in Sweden, and we now have 800 people, and that's all built within the last six to seven months," Erck said.

"We will become, this year ... a revenue-generating, profitable company," he added.

Novavax's COVID-19 candidate vaccine NVX-CoV2373 is administered to a health volunteer. -
Novavax's COVID-19 candidate vaccine NVX-CoV2373 is administered to a health volunteer. -

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