Novavax to complete data submission to FDA by year-end for authorization of its coronavirus vaccine


By Jacqueline Howard, CNN

Biotech company Novavax plans to submit full data to the United States Food and Drug Administration soon for a possible emergency authorization for its coronavirus vaccine, CEO Stanley Erck told CNN on Friday. ‘a telephone interview.

“We’ll have a case in the United States hopefully before the end of the year,” Erck said.

If the FDA gives the green light, the first 100 million doses of the protein-based vaccine will be ready to ship upon clearance, Erck said.

Novavax’s vaccine, called NVX-CoV2373, is made using slightly more conventional methods than vaccines already licensed in the United States. It uses small, lab-made pieces of coronavirus to boost immunity – an approach some people may be more familiar or comfortable with.

“In the United States, I think the primary market in 2022 will be to provide a vaccine, our normal two-dose regimen, to a lot of people who have been reluctant to get other vaccines,” Erck said. “And to provide a reminder.”

The Novavax coronavirus vaccine could be used to stimulate someone who initially received the Pfizer / BioNTech, Moderna or Johnson & Johnson vaccines, Erck said.

On Monday, Novavax announced that Indonesia has become the first country to grant an emergency use authorization for its coronavirus vaccine. So far, Novavax has applied for authorization in several other countries, including the UK, Australia, Canada, New Zealand, the European Union, India and the Philippines.

On Thursday, Novavax announced that it had completed the process of submitting its vaccine’s emergency use list to the World Health Organization.

“We’ve actually filed applications with nine regulators over the past half-dozen weeks,” Erck said. “And that culminated in our first one where we got approval.”

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