Exclusive report says Novavax quality issues run deep

Oct. 20, 2021

An exclusive report from Politico said Novavax faces significant hurdles in proving it can manufacture its COVID-19 vaccine candidate to regulators’ quality standards — an issue that will delay production and result in a COVAX supply shortfall.

Citing several anonymous sources familiar with discussions between Maryland-based Novavax and the Biden administration, as well as those familiar with Novavax’s manufacturing process, the report claims that the vaccine maker's analytics and testing issues are "more concerning than previously understood."

Sources told Politico that Novavax's methods used to test vaccine purity have fallen short of regulators’ standards. Ideal purity levels for the FDA are at least 90%. But Novavax purity levels are hovering around 70%, according to Politico sources.

Back in Feb., Novavax announced a deal with Gavi, the Vaccine Alliance, to provide 1.1 billion doses of NVX-CoV2373, Novavax’s recombinant protein-based COVID-19 vaccine candidate, for the COVAX facility. Novavax also has a $1.6 billion deal with the U.S. government to provide 100 million doses.

The company's ongoing production woes are no secret. The drugmaker has been plagued by production issues from the start. Last Nov., Novavax had to push back the start of its late-stage vaccine trial while dealing with issues related to scaling up manufacturing.

Novavax fired back on the Politico article with a press statement, confirming its confidence in meeting regulatory filing timelines but not directly addressing any of the quality concerns. "In response to a recent news article citing anonymous sources, Novavax confirms our confidence in our ability to deliver our high-quality vaccine. Further, we underscore our ongoing commitment to the stringent standards of production and manufacturing for our recombinant nanoparticle protein-based COVID-19 vaccine candidate with Matrix-M™ adjuvant," said the statement. Novavax confirmed that its global supply chain is expected to achieve a capacity of 150 million doses per month by the end of the fourth quarter. 

The vaccine maker said it expects to complete multiple ongoing rolling regulatory submissions within the next couple of weeks in key markets, including the UK, Europe, Canada, Australia and New Zealand. Together with the Serum Institute of India, Novavax has filed for authorization in India, Indonesia and The Philippines, as well as for Emergency Use Listing (EUL) with the World Health Organization (WHO).