What happened
On Thursday, the price of one of the more volatile coronavirus vaccine stocks, Novavax (NVAX -4.58%), headed sharply for the ground. The slump followed the disheartening news that a major regulatory decision on one of the company's products will likely be handed down later than expected. At the close of the session, the stock was down by more than 17%.
So what
The Food and Drug Administration (FDA) said Thursday that it must review changes to Novavax's production processes as part of its overall authorization process for the NVX-CoV2373 coronavirus vaccine.
In a statement to financial news channel CNBC, the FDA said that Novavax informed it last Friday that the company had made changes to that process.
"FDA will carefully review this and any additional information submitted by the firm as part of its ongoing assessment and prior to authorizing the vaccine for emergency use," Abby Capobianco, a spokesperson for the regulator, told CNBC.
As this almost certainly will mean a delay in the FDA's decision on authorization, it represents quite the rapid come-down for investors. On Tuesday, the FDA's Vaccines and Related Biological Products Advisory Committee voted overwhelmingly in favor of recommending that the agency grant Emergency Use Authorization (EUA) for NVX-CoV2373.
In a media statement, Novavax said that it had updated the FDA about its manufacturing process. It has not yet made any official comment about the expected delay that could result from the agency's new consideration.
Now what
Novavax can be considered a laggard in the coronavirus vaccine race, as three other jabs have been either authorized or fully approved for use in the U.S. The last thing any of the vaccine specialist's investors probably want to hear is that there's been yet another setback in the company's efforts to get NVX-CoV2373 approved. It's little wonder, then, that the market reacted so negatively to the FDA's news Thursday.
