Novavax has obtained the US Food and Drug Administration (FDA) emergency use authorization (EUA) for its Covid-19 vaccine.
The EUA for the Novavax COVID-19 Vaccine, Adjuvanted (NVX-CoV2373) has been granted for providing a two-dose primary series for active immunisation aimed at preventing the disease in individuals aged 18 years and above.
Novavax president and CEO Stanley Erck said: “Today’s FDA emergency use authorization of our Covid-19 vaccine provides the US with access to the first protein-based Covid-19 vaccine.
“This authorisation reflects the strength of our Covid-19 vaccine’s efficacy and safety data, and it underscores the critical need to offer another vaccine option for the US population while the pandemic continues.”
The FDA granted EUA to the vaccine based on data obtained from the pivotal Phase III PREVENT-19 clinical trial in nearly 30,000 subjects aged 18 years and above, in the US and Mexico.
Doses of the Novavax COVID-19 Vaccine, Adjuvanted were shipped from the Serum Institute of India and are now available in the US.
Novavax now requires a policy recommendation from the Centers for Disease Control and Prevention (CDC) for the use of the vaccine.
Once the product is released and policy recommendation is received from the CDC, immunisations will start with the Novavax Covid-19 Vaccine, Adjuvanted as a primary series.
The Novavax COVID-19 vaccine has also received conditional authorization to be used in people aged 18 years and above, from multiple regulatory agencies across the globe, including the European Commission (EC), and the World Health Organization (WHO) emergency use listing.
Earlier this month, the European Commission granted approval for the expanded conditional marketing authorization (CMA) of Novavax’s Covid-19 vaccine, Nuvaxovid (NVX-CoV2373), in the European Union (EU) for adolescents of the age 12 to 17 years.