https://fortune.com/2021/09/24/novavax-who-approval-covid-vaccine-mrna-covax/
But the challenges facing Novavax do not stem from how well the vaccine appears to work. Rather, Novavax has struggled to find a way to produce its shots.
Novavax says it is currently producing COVID-19 vaccines at 20 plants globallyand will have the capacity to make 2 billion vaccines in 2022, but none of the firm's vaccines are currently being used beyond clinical trials.
In the U.S., Novavax has yet to apply to the Food and Drug Administration (FDA) for emergency use authorization and says it may not apply for approval until the fourth quarter of this year after months of delays.
U.S. regulators told the New York Times in August that the hold-up stemmed from poor quality control at Novavax's manufacturing facilities. Novavax later said a contract it signed with the U.S. government has constrained its ability to produce doses. Since July 2020, Novavax has received $1.75 billion from former President Donald Trump’s Operation Warp Speed to develop and manufacture its vaccines. As part of the deal, Novavax says that it was directed to work with manufacturers including the Japanese-owned and U.S.-headquartered pharmaceutical manufacturer Fujifilm Diosynth Biotechnologies, which has slowed production.
