Why hasn't Novavax's COVID-19 vaccine been approved yet?

Covax, the World Health Organization-backed global vaccine distribution campaign, says the COVID-19 vaccine being developed by Novavax has potential to help incolulate the world . But the Gaithersburg, Md.-based company is having a difficult time proving it can manufacture a vaccine that meets regulators’ quality standards.

Eight things to know:

1. Novavax was founded in 1987 to focus on vaccine development, but it has never brought a vaccine to market.
   
   
2. The biotech was awarded two key deals from the federal government in 2020: $1.74 billion from Operation Warp Speed to produce 100 million doses and $60 million from the Department of Defense to produce 10 million doses.
   
   
3. Covax will likely fall short of its goal to provide more than 2 billion doses to lower- and middle-income countries by the end of 2022 by more than 1 billion doses, according to Politico. The campaign relies on Novavax as a key supplier.
   
   
4. The industry standard for vaccine purity is understood to be at least 90 percent, but Novavax's vaccine has recently shown purity levels hovering around 70 percent, an anonymous source familiar with the biotech's manufacturing process told Politico.
   
   
5. Silvia Taylor, Novavax's senior vice president of investor relations and corporate affairs, told Politico the biotech's testing methods have been "validated," but she didn't answer questions about whether the FDA had approved them.
   
   
6. Novavax is on track to manufacture 150 million doses a month by the end of 2021, according to Ms. Taylor. She also said the biotech plans to file for the vaccine's FDA emergency use authorization by the end of 2021.
   
   
7. The anonymous U.S. officials who spoke to Politico about Novavax's manufacturing problems did not share Ms. Taylor's optimism. They said the biotech's production problem will be more difficult to fix than the problems that shut down the Emergent plant that was manufacturing impure Johnson & Johnson COVID-19 vaccine doses earlier this year.
   
   
8. On Nov. 1, Indonesia became the first country to grant emergency use authorization to Novavax's vaccine.