The protein-based vaccine candidate is intended to immunise individuals aged 18 years and above against Covid-19.
Developed using Novavax’ recombinant nanoparticle technology, NVX-CoV2373 is engineered from the genetic sequence of the initial SARS-CoV-2 virus strain.
The company stated that the request is based on the pre-clinical, clinical and manufacturing-related (CMC) data that includes the results of two pivotal Phase III clinical trials, PREVENT-19 and an unnamed trial.
Enrolling nearly 30,000 subjects, the PREVENT-19 was conducted in the US and Mexico.
The other trial was conducted in the UK and had approximately 15,000 participants.
In the two studies, the vaccine candidate showed about 90% of overall efficacy as well as a reassuring safety profile, said the company.
Novavax president and CEO Stanley Erck said: “We’re extremely proud of the work of our teams and we look forward to FDA’s review of our EUA request.
“We believe our vaccine offers a differentiated option built on a well-understood protein-based vaccine platform that can be an alternative to the portfolio of available vaccines to help fight the Covid-19 pandemic.
“I’d like to also extend our thanks for the support of the U.S. Department of Health and Human Services and the U.S. Department of Defense for their partnership leading up to today’s milestone of EUA request submission.”
The company stated that many regulatory agencies across the world have granted conditional authorisation to NVX-CoV2373, including the European Commission.
The World Health Organization (WHO) has also issued emergency use listing (EUL) for the vaccine.