Novavax hits speed bump — again — on its quest for vax approval

May 12, 2021

A few weeks ago, Novavax appeared to be on the brink of filing for an FDA approval for its COVID-19 vaccine, potentially becoming the fourth OK'd in the U.S. Now the company says that a number of manufacturing-related shortages could delay its quest for approval for months.

According to a report in the Wall Street Journal, the company is having a difficult time securing enough supplies of 2,000-liter bags, purification filters and raw materials needed to grow proteins for its vaccine. The company is also still in the process of validating its manufacturing process at its production facilities with the FDA.

Although Novavax has already produced 30-40 million doses of its vaccine, the company is on contract with the U.S. government to supply 110 million doses and has other supply agreements overseas. The company had been aiming on cranking out 150 million doses a month by the third quarter, but has had to push back its goal to the fourth quarter.

Novavax now expects to apply for FDA approval by September. 

This setback is the latest in a string of stumbling blocks faced by the company, which has never had a drug product approved by the FDA. Last year, the company was forced to delay the launch of its late-stage trials twice due to scale-up issues. Then in January, as other vaccines won approval, Novavax struggled to find enough participants for its phase 3 trials.

 Early analysis of a study in the UK showed that Novavax’s shot was nearly 90 percent effective at providing protection from COVID-19. The company is planning to release the results of a 30,000-participant study conducted in the U.S. and Mexico in a few weeks after it analyzes the 144 confirmed cases of COVID-19 among the volunteers.