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