Novavax has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA). Covid-19 vaccine.
An EUA for the Novavax adjuvanted COVID-19 vaccine (NVX-CoV2373) has been granted for the provision of a two-dose primary series for active immunization aimed at preventing disease in individuals aged 18 years and older.
Novavax President and CEO Stanley Erk said: “Today’s emergency use authorization of our Covid-19 vaccine by the FDA gives the US access to the first protein-based vaccine against Covid-19.
“This approval reflects the strength of the efficacy and safety data for our Covid-19 vaccine and underscores the critical need to offer another vaccine option to the US population as the pandemic continues.”
The FDA granted EUA to the vaccine based on data from the pivotal phase III PREVENT-19 clinical trial in nearly 30,000 subjects aged 18 years and older in the US and Mexico.
Doses of the adjuvanted Novavax COVID-19 vaccine were shipped from the Serum Institute of India and are now available in the US.
Novavax is now seeking a policy recommendation from the Centers for Disease Control and Prevention (CDC) for the use of the vaccine.
Once the product is on the market and a policy recommendation is received from the CDC, immunizations will begin with the adjuvanted Novavax Covid-19 vaccine as the primary series.
The Novavax COVID-19 vaccine has also received conditional approval for use in people aged 18 and over by multiple regulatory agencies worldwide, including the European Commission (EC) and the World Health Organization (WHO) Emergency Use List.
Earlier this month, the European Commission granted extended conditional marketing authorization (CMA) approval for Novavax’s Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), in the European Union (EU) for adolescents aged 12 to 17 years.