Novavax, Inc. (NASDAQ:NVAX) shares recovered some lost ground in Tuesday premarket trading after slumping almost 13% on Monday on news that it missed out on US Food and Drug Administration (FDA) approval for its new Covid-19 booster vaccine.
The FDA signed off on updated jabs from Pfizer and its German partner BioNTech, and Moderna on Monday, with Novavax telling Reuters that its vaccine is still under review.
Deployment of Pfizer and Moderna’s vaccines is expected to start this month.
Novavax’s shares have been on a rollercoaster, surging more than 13% on August 22 after it said its vaccines generated a broad immune response against the now-dominant EG.5, or Eris, variant of the virus, with trial results suggesting it may also be effective against other variants.
"Novavax is ready for the commercial delivery of our updated protein-based non-mRNA COVID vaccine this fall, and we are working closely with the FDA on its review of our Emergency Use Authorization application," Novavax president and CEO John Jacobs said in a news release on Monday.
"Pending FDA authorization and CDC recommendation, Novavax’s vaccine will be widely available in major US pharmacies, through Group Purchasing Organizations and through various government entities such as Vaccines for Children, as an option for individuals aged 12 and older to protect themselves against new variants this fall.”
The company is expected to present its vaccine data before a panel of advisors to the Centers for Disease Control and Prevention on Tuesday.
Ahead of the opening bell, its shares were 3.3% up at $8.01.
Contact the author at stephen.gunnion@proactiveinvestors.com