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U.S. Could Authorize Novavax Covid Vaccine—An MRNA Alternative—In February, CEO Says

by todayminutes
January 11, 2022
0

Novavax’s Covid-19 vaccine, already available for use in 170 countries and most well-known for being a non-mRNA vaccine alternative, could be approved for use in the U.S. in February and in up to 10 other countries within 90 days, CEO Stanley Erck told CNBC Monday.

The Maryland-based biotechnology company submitted its final data packages to the U.S. Food and Drug Administration on New Year’s Eve, but won’t be able to request emergency use authorization until January 31, after which the company expects a decision within one month, Erck said.

Erck said the company expects its vaccine to be approved for use in multiple countries over the next 90 days, as the vaccine has recently been submitted for use in Australia, Canada, New Zealand, Singapore, South Africa and the U.K., and with the World Health Organization.

While mRNA vaccines prompt the body’s cells into creating parts of the coronavirus that can trigger the immune system, Novavax’s vaccine introduces a protein from the virus as a nanoparticle that cannot cause illness but stimulates antibody production. Novavax’s vaccine can be stored at room temperature, making it significantly easier to distribute than mRNA vaccines, which must be refrigerated within a particular range. Clinical trials found Novavax’s two-dose vaccine to be 90% effective against the coronavirus, the WHO said.

In November, Indonesia became the first country to issue an emergency use authorization for the vaccine, which has since been made available for use in 170 countries, Erck said. Vaccine shipments are underway in Europe, Novavax announced Monday, with 27 million doses planned for delivery in the first quarter of the year and over 40 million in the second quarter. Novavax is contracted to deliver about 2 billion doses of its vaccine worldwide, Erck said.

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