Novavax has signed an agreement with the US Department of Health and Human Services (HHS), in partnership with the Department of Defense, under which the US government will procure 3.2 million doses of the company’s Covid-19 vaccine, NVX-CoV2373, in the initial stage.
The order is contingent on the vaccine obtaining Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) as well as the Centers for Disease Control and Prevention (CDC) recommendation.
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A protein-based vaccine, NVX-CoV2373 is created from the genetic sequence of the SARS-CoV-2 virus’ initial strain.
It is formulated with the company’s saponin-based Matrix-M and also comprises a purified protein antigen.
Following authorisation, the vaccine will be offered for free to jurisdictions, states, federal pharmacy partners and health centres that are federally qualified.
In June this year, the Vaccines and Related Biological Products Advisory Committee of the FDA voted to recommend granting an FDA EUA for the vaccine in people aged 18 years and above.
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By GlobalDataPresently, the EUA application for the vaccine submitted by the company is being reviewed by the FDA.
Novavax president and CEO Stanley Erck said: “We are pleased to come one step closer to potentially offering our vaccine to physicians, healthcare organisations, and consumers who have been awaiting a protein-based vaccine option.
“We are grateful for the US Government’s ongoing support and partnership to bring Novavax’s Covid-19 vaccine to the US, and we look forward to the FDA’s decision on an emergency use authorization.”
Last week, the European Commission approved the expanded conditional marketing authorization for Novavax’s Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), in the European Union for use in adolescents aged 12 to 17 years.
