Novavax finally got their application submitted for Emergency Use Authorization in the USA, just at the very end of 2021 (like the last day of the year). It seems to be on track for approval, maybe next month.
It is not just the USA however, Novavax kept slipping the date they planned to submit for regulatory approval, all around the world. It got the nickname “Nevervax” because of those schedule slips.
The dam is breaking big time for Novavax approvals though. They just got approved in Korea in recent days, and have been approved in India, Indonesia and the Philippines, as well as by the WHO (which gets them into over a hundred countries). The EU has signed contracts for delivery, and Indonesia has begun receiving (10 million doses) and administering them.
They expect to ramp up production to around 200 million doses per month in the first quarter.
Novavax hasn’t yet submitted a complete EUA application. They finalized the data by submitting the outstanding manufacturing component but the FDA requires 30 days to review the data before it will accept the EUA application, so this won’t be done until the end of the month. Then it will take weeks to review before approving, if it bothers.