Novavax COVID-19 vaccine gets emergency use authorization in US
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Novavax COVID-19 vaccine gets emergency use authorization in US
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Novavax COVID-19 vaccine gets emergency use authorization in US
The U.S. Food and Drug Administration (FDA) has authorized the emergency use of the Novavax COVID-19 vaccine, adjuvanted, for the prevention of COVID-19 in individuals 12 years of age and older.
The vaccine is the first protein-based non-mRNA COVID-19 vaccine option in the U.S.
The Novavax COVID-19 vaccine, adjuvanted, contains the spike protein of the SARS-CoV-2 virus and an adjuvant called Matrix-M, which enhances the immune response.
The spike protein is produced in insect cells and the adjuvant is derived from the soapbark tree.
The vaccine is authorized for a two-dose primary series and a first booster dose for certain individuals at least 6 months after completing the primary vaccination with an authorized or approved COVID-19 vaccine. The vaccine can be stored at refrigerated temperatures, which may facilitate its distribution and administration.
The emergency use authorization was based on non-clinical data showing that the vaccine induced functional immune responses against various variants of the SARS-CoV-2 virus, including XBB.1.5, XBB.1.16 and XBB.2.3. The vaccine also stimulated both antibody and cellular immunity, which may provide a broad protection against COVID-19.
Novavax expects doses will be available in thousands of locations across the U.S. in the coming days, including CVS Pharmacy and Rite Aid. Individuals can find the vaccine at us.novavaxcovidvaccine.com or vaccines.gov.
The FDA has not approved or licensed the Novavax COVID-19 vaccine, adjuvanted, but has authorized it for emergency use under an EUA. The EUA is effective until the declaration that circumstances exist justifying the authorization of the emergency use of drugs and biologics for prevention and treatment of COVID-19 is terminated or the EUA is revoked.
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Novavax: The recombinant protein COVID-19 vaccine against XBB.1.5 has received emergency use authorization from the FDA for vaccination of people aged 12 years or above.
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Advantages: Although it is a traditional vaccine, it also uses “lipid nanoparticles + pre-fusion conformation S antigen design”; therefore, the protective power is not inferior to Pfizer’s mRNA vaccine; it does not require ultra-low temperature storage and has fewer adverse events.
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Eric Topol once said frankly: Even if it takes a while, he is willing to take Novavax
protein vaccine
Novavax COVID-19 vaccine gets emergency use authorization in US
(source:internet, reference only)
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