Novavax Shares Plunge on Report of Covid-19 Vaccine Manufacturing Problems

Maryland-based Novavax has a Covid-19 vaccine that it reported in June was 90.4% effective at preventing symptomatic disease in adults in a large clinical trial. But the company, which has never won approval for a vaccine, has experienced various delays in developing and manufacturing its vaccine.

A new report in Politico cast further doubt on the Novavax vaccine’s effectiveness. Politico said the methods the company uses to test the purity of its vaccine have fallen short of regulators’ standards, with the publication citing multiple people familiar with Novavax’s difficulties.

Novavax issued a statement Wednesday saying it expects to complete ongoing regulatory submissions over the next few weeks in the U.K., Europe and Canada. It said it has already filed for authorization in India and for emergency use with the World Health Organization. The company said it plans to file its vaccine for emergency-use authorization in the U.S. by the end of 2021.

“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 chief executive, said in a statement. 

Novavax has previously pledged to deliver about 1.1 billion doses of the vaccine globally through Covax, the world’s primary effort to supply Covid-19 vaccines to poorer nations. Delays could crimp Covax’s efforts to vaccinate large swaths of the emerging world. 

The U.S. federal government in 2020 invested $1.6 billion in Novavax in hopes it would be a leading Covid-19 vaccine supplier.  

Write to Omar Abdel-Baqui at [email protected]

Corrections & Amplifications
Shares of Novavax lost about a quarter of their value on Wednesday. An earlier version of this article misstated the day as Tuesday. (Oct. 20, 2021)