Novavax said Friday that its COVID-19 vaccine is being tested in a clinical trial sponsored by the National Institutes of Health.
Novavax Inc. is still awaiting U.S. regulators’ review of its Covid-19 vaccine. But the Gaithersburg company is not waiting to position that candidate for the future it’s betting on — including as a booster.
Novavax has long contended that its two-shot vaccine would also work well as a booster, but it’s still not authorized in the U.S. even for primary immunization. The biotech officially applied at the end of January after a dragged-out lead-up and multiple delays to its original timeline. It’s now waiting for the FDA’s review and, in addition, plans to seek full approval for that vaccine in the U.S. in the second half of 2022, Novavax CEO Stanley Erck said on a company earnings call earlier this month.
But outside of the U.S., Novavax has earned authorizations for its coronavirus vaccine with 12 regulatory agencies across 38 countries, with plans to sell its product under the Covovax brand in Bangladesh and India and under the Nuvaxovid brand in Canada, Singapore, New Zealand, Australia, South Korea and the United Kingdom, among others. It has also secured an emergency use listing from the World Health Organization, which gives it the possibility of reaching another 130 countries. The company intends for its vaccine to be used as a primary defense against the virus, and as a booster and in pediatric populations specifically.
And under those assumptions, the company is forecasting total revenue of $4 billion to $5 billion for this year, up significantly from the $1.15 billion it reported for 2021.