Novavax announced on Monday that it has filed for emergency use authorization of its COVID-19 vaccine for US adults, Reuters reported.
The filing is based on data provided to the US Food and Drug Administration last month and results of two late-stage trials in the United States, Mexico and the UK that showed the protein-based vaccine had an overall efficacy of about 90%, the company said.
"We believe our vaccine offers a differentiated option... that can be an alternative to the portfolio of available vaccines to help fight the COVID-19 pandemic,” said Novavax Chief Executive Officer Stanley Erck in a statement quoted by Reuters.
Novavax's vaccine uses a different technology than the mRNA vaccines from Pfizer/BioNTech and Moderna, or the Johnson & Johnson one-dose shot.
Novavax has had to delay its US submission multiple times due to development and manufacturing setbacks.
Data released in June from a late-stage US trial showed the vaccine was more than 90% effective against a variety of concerning coronavirus variants, including Delta.
Early data published in late December suggests the vaccine is also effective against the Omicron variant, which is now the dominant version of the virus in the United States and most of the world.
The US submission follows authorizations for the vaccine from the European Medicines Agency and the World Health Organization.
Israel last week inked a contract with Novavax, under which Israel will buy five million COVID-19 vaccine doses from the company. The deal includes the option for an additional five million doses.
The vaccines are due to arrive in Israel in the coming months, pending regulatory approval.
Meanwhile on Monday, the FDA granted full approval to the Moderna coronavirus vaccine for use on adults.
The FDA had previously granted full approval to Pfizer's coronavirus vaccine, which is also an mRNA vaccine, in August 2021. In October the FDA extended that approval to children over the age of five.