Gaithersburg, Maryland-based Novavax, which began developing its protein-based COVID-19 vaccine candidate almost two years ago, has officially filed for approval with the U.S. Food and Drug Administration for its use in the U.S.
The final FDA filing Monday comes months after Novavax had originally intended, and, while it may seem the company is late to the vaccine game, it sees its vaccine filling a void, particularly internationally. It does not require sub-zero storage, making it potentially more accessible to developing countries and remote areas.
It is also not an mRNA vaccine, such as those approved for Pfizer and Moderna.
“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,” said CEO Stanley Erck.
The Novavax vaccine has shown an overall efficacy of 90% in clinical trials. It conducted two Phase 3 trials with 30,000 participants in the U.S. and Mexico and a trial with almost 15,000 participants in the U.K.
To date, Novavax has received conditional approval authorization from the European Union and Emergency Use Listing from the World Health Organization. It has also received authorization in India, and its two-dose vaccine is already being distributed in Indonesia and the Philippines.
Last week, Israel’s Ministry of Health agreed to purchase up to 10 million doses of the COVID-19 vaccine, pending necessary authorizations.
The Novavax filing with the FDA comes the same day the FDA gave full authorization to Moderna’s vaccine, moving it from emergency use authorization. Pfizer received full FDA authorization for its COVID vaccine in August.
