The US FDA granted the EUA based on data from the Phase 3 PREVENT-19 clinical trial, in which the adjuvanted Covid-19 vaccine showed 90.4% efficacy with a positive safety profile
Novavax’ Covid-19 vaccine authorised in US. (Credit: pearson0612 from Pixabay)
Novavax has secured the US Food and Drug Administration (FDA) emergency use authorisation (EUA) for its adjuvanted Covid-19 vaccine, also called NVX-CoV2373.
The US-based biotechnology company can now provide a two-dose primary series of its vaccine to prevent Covid-19 in individuals aged 18 years and above.
NVX-CoV2373 is considered both a protein subunit vaccine and a virus-like particle vaccine, while the company calls it a ‘recombinant nanoparticle vaccine’.
The vaccine has been authorised by various countries worldwide and received an emergency use listing from the World Health Organization (WHO), for use in people aged 18 and above.
Its administration is not advised for individuals with a known history of a severe allergic reaction to any component of the adjuvanted vaccine.
Novavax president and chief executive officer Stanley C Erck said: “Today’s FDA emergency use authorisation of our Covid-19 vaccine provides the U.S. 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 US FDA granted the EUA based on data from the Phase 3 PREVENT-19 clinical trial, conducted with nearly 30,000 adult participants in the US and Mexico.
In the Phased 3 study, the adjuvanted Covid-19 vaccine showed 90.4% efficacy with a positive safety profile, said Novavax.
The adverse reactions associated with the administration of the vaccine include injection site pain/redness/swelling, fatigue, muscle pain, headache, joint pain, nausea, and fever.
The PREVENT-19 trial co-lead professor Karen Kotloff said: “Patients and providers in the U.S. now have access to a protein-based Covid-19 vaccine backed by data that have demonstrated efficacy, safety, and tolerability.
“Offering more vaccine technologies and options in our vaccination portfolio, including those built upon technologies that have been successfully used for years, will hopefully help to increase our country’s vaccination rate.”
Recently, the US Department of Health and Human Services (HHS), in collaboration with the Department of Defence, reached an agreement to secure 3.2 million doses of the Novavax’ Covid-19 vaccine.
The US government intends to distribute the vaccine doses to the states, jurisdictions, federal pharmacy partners, and federally qualified health centres, free of cost.
In addition to the FDA authorisation, a policy recommendation from US Centres for Disease Control and Prevention (CDC) is required for public distribution of the vaccine.
Its vaccine manufacturing partner Serum Institute of India (SII) has manufactured and shipped the Covid-19 vaccine doses to the US, said Novavax.