Novavax asks for FDA meeting after first global authorization for COVID-19 vaccine: CEO

·Senior Reporter
·2 min read

Novavax (NVAX) is getting some momentum for its two-dose COVID-19 vaccine, starting with a series of emergency use fillings globally and the first authorization in Indonesia this month.

The company is on track to file with the U.S. Food and Drug Administration (FDA) by the end of the year, and has already called for a meeting with the agency to move forward, according to CEO Stanley Erck.

Erck told Yahoo Finance Live on Wednesday that the company expects to hear back from the FDA "very soon" and believes Novavax could receive up to five authorizations in the coming 6-8 weeks globally. But a majority of its distribution of actual doses is likely to start at the beginning of 2022.

"We do expect to be able to ship to Indonesia, and perhaps one or two other countries before the end of the year. But the majority of our production is scheduled for the first quarter," Erck said.

The company has scaled up production and estimates it will have 2 billion doses per year starting next year.

"We're going to go from zero to a very large scale very quickly," Erck said.

Novavax has applied for emergency use with the World Health Organization, the U.K., Canada, Australia, New Zealand and has completed a rolling submission with the European Union. With a majority of the world's population still unvaccinated, Novavax is poised to play a role in areas that are especially hard to reach with mRNA vaccines, which have more demanding storage and shipping requirements.

The company's use of protein-based technology, compared to mRNA, has made it slower to ramp up production and testing. But its efficacy is comparable, boasting 90% efficacy against earlier strains of the virus.

The company has delayed its timeline for various reasons — including manufacturing and issues with partners — throughout the year. But Erck has said that the recent filings should signal an end to the series of delays. 

While Pfizer (PFE)/BioNTech (BNTX) have received the most authorizations from the FDA for boosters and children, Moderna (MRNA) faces a delay in its authorization for the younger people, as the FDA needs time to analyze reports of myocarditis. The only other authorized vaccine in the U.S., from Johnson and Johnson (JNJ), has faced concerns over blood clots, and the FDA and Centers for Disease Control and Prevention recently authorized boosters encouraging use of mRNA vaccines, with studies showing they provide higher efficacy.

All told, Novavax has set its sights on the global market, and anticipates its first product will be in arms soon — including for booster doses in the U.S.

"We expect our authorization to include boosting throughout 2022 and beyond," Erck said.

Follow Anjalee on Twitter @AnjKhem

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