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The US Food and Drug Administration’s top vaccine official overrode agency experts in May to recommend against the broad use of two Covid-19 vaccines, newly released documents show.
Nuvaxovid includes an engineered fragment of the spike protein itself—albeit one without the genetic material that causes actual disease.
The FDA has approved Nuvaxovid to prevent COVID-19 in adults 65 years and older and high-risk individuals 12 through 64 years.
Marketing Authorization replaces conditional Marketing Authorization and is first for Novavax in the EU Marketing Authorization includes use of Nuvaxovid™ as a ...
The approval comes amid regulatory upheaval under HHS head Robert F. Kennedy Jr., who has pushed for changes around mRNA ...
Nuvaxovid contains purified protein antigen and can neither replicate, nor can it cause COVID-19. Nuvaxovid is packaged as a ready-to-use liquid formulation in a vial containing ten doses.
While the company recorded $88.3M in revenue for Q4 with a ~70% YoY slump exceeding the consensus by ~3.9M, its product sales, driven by its Nuvaxovid COVID shot, plunged ~80% YoY to $50.1M.
But Nanoflu, and Nuvaxovid's potential EUA in the booster market, present the best opportunities for the company. Don't give up just yet Novavax's market cap is only $3.1 billion as of this writing.
Nuvaxovid is also available for use as a booster in adults aged 18 and older in the U.S., European Union, Japan, Australia, New Zealand, Switzerland, and Israel.
Novavax’s COVID-19 vaccine is authorized for use in more than 40 markets around the world. The trade name Nuvaxovid has not yet been approved by the U.S. Food and Drug Administration (FDA). It ...
Nuvaxovid contains purified protein antigen and can neither replicate, nor can it cause COVID-19. Nuvaxovid is packaged as a ready-to-use liquid formulation in a vial containing ten doses.