Shares of Novavax (NASDAQ:NVAX) were tanking 12.8% lower as of 10:43 a.m. EDT on Wednesday. The steep decline came after Politico reported that Novavax "faces significant hurdles in proving it can manufacture a shot that meets regulators' quality standards."
Politico's anonymous sources reportedly stated that Novavax's "issues are more concerning than previously understood." These sources expressed their view that the company could take until the end of 2022 to resolve its manufacturing issues and win regulatory authorizations and approvals.
This Politico story is definitely bad news for Novavax -- if it's true. However, the company released a public statement on Wednesday morning responding to the article. Novavax said that it remains confident in its ability to produce vaccines at high quality levels.
The company also confirmed that it expects to complete regulatory filings "within the next couple of weeks" in the United Kingdom, Europe, Australia, Canada, and New Zealand. Novavax still anticipates filing for U.S. Emergency Use Authorization of its COVID-19 vaccine before the end of this year.
This quick response from Novavax helped the vaccine stock recover somewhat. Shares of Novavax fell as much as 24.4% earlier Wednesday morning.
Investors won't have to wait very long to know if Novavax's confidence about its regulatory filings timeline is warranted. Those submissions, however, won't necessarily mean that the company has fully resolved all manufacturing issues. Regulatory agencies will have the final say on that matter. However, Novavax's shares would almost certainly rebound sharply when the EUA filings are completed.