Novavax, which reaped $1.6 billion from the federal government last year to develop and manufacture a COVID-19 vaccine, is reportedly struggling to meet quality standards.
The company has had a run of production problems that lowered the quality of the vaccine, displeasing the FDA and throwing a wrench into the global push to supply shots to low- to middle-income countries, unnamed sources said in a Politico story.
Purity levels for the company’s vaccine have come in around 70% versus the agency's guidelines that generally expect a batch of COVID-19 vaccines to be at least 90% pure, the sources said.
“They rushed the process,” one source told the publication. “It’s hard to make. And they can’t make it.”
Shares of Novavax tanked on the New York Stock Exchange, falling more than 15% to just over $135 per share in afternoon trading.
Earlier this year, Novavax and the Serum Institute of India mutually committed to providing more than 1.1 billion doses to the international consortium COVAX that is focused on supplying vaccines to poorer nations.
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After the Politico story, Novavax responded that it expects to complete several regulatory submissions in the next few weeks, including in the U.K, Europe, Canada, Australia and New Zealand. The biotech expects to file for emergency use authorization with the FDA by the end of the year.
“We are confident that our vaccine will soon play a significant role in the global COVID-19 vaccine arsenal, differentiated by its potential to help address two major issues slowing the world’s ability to end the pandemic: global distribution challenges and vaccine hesitancy,” Stanley Erck, Novavax’s president and CEO, said in a statement.
Addressing the pandemic in low-income regions has become a global political issue as countries like the U.S., Japan and those in the EU have high vaccination rates and widespread availability, whereas Kenya has a vaccination rate of just 2.3% and Ethiopia 0.8%, according to an aggregate of data.
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Novavax began to stumble a year ago when it delayed the PREVENT-19 trial by two months because of manufacturing issues. By April, Erck said the company was running into problems—as other manufactures have—getting raw materials such as large, sterile bags used to grow vaccine cells.
By late spring, the company said it would delay filing with the FDA because of its its inability to show regulators its manufacturing process was consistent across different facilities.