FDA approves Novavax updated Covid vaccine

The Food and Drug Administration on Tuesday approved Novavax‘s updated Covid vaccine for emergency use in people ages 12 and up, putting the shot on track to roll out weeks after new jabs from Pfizer and Moderna reached Americans.

Novavax’s new single-strain vaccine, which targets omicron subvariant XBB.1.5, still needs an updated recommendation from the Centers for Disease Control and Prevention before patients can access it at pharmacies, health centers and other distribution sites.

The company said in a statement it expects a recommendation from the CDC “imminently.” Doses of the shot will likely be available within the next few days, Novavax added.

“Novavax’s authorization today means people will now have the choice of a protein-based non-MRNA option to help protect themselves against Covid-19, which is now the fourth leading cause of death in the U.S.,” said Novavax CEO John Jacobs in the statement. “In the coming days, individuals in the U.S. can go to major pharmacies, physicians’ offices, clinics and various government entities to receive an updated Novavax vaccine.” 

Public health officials see Novavax’s vaccine as a valuable alternative for people who don’t want to take messenger RNA shots from Pfizer and Moderna, which teach cells how to make proteins that trigger an immune response against Covid. Novavax’s shot fends off the virus with protein-based technology, a decades-old method used in routine vaccinations against hepatitis B and shingles.

Last month, the FDA and CDC greenlit XBB.1.5 shots from Pfizer and Moderna for all Americans ages six months and older. Those broad eligibility guidelines will likely apply to Novavax’s updated shot as well, CDC official Dr. Demetre Daskalakis said during a meeting of advisors to the agency last month.

Around 2 million Americans have received the updated Covid vaccines from both companies so far, the Biden administration said last week, even as patients eager to get their dose have been met with unexpected insurance delays and availability issues.

Regardless, all three shots are expected to help the U.S. combat the spread of Covid this fall and winter, when the virus usually spreads at higher levels. 

The nation is already seeing a surge in cases and hospitalizations. While levels remain far below previous Covid waves in the U.S., it’s still the first notable uptick since last winter and has even prompted the return of mask mandates for a handful of businesses and schools. 

The rise is driven by newer strains of the virus that are gaining ground nationwide as XBB.1.5 gradually declines. That includes EG.5, or Eris, an omicron strain that accounted for 29.4% of all cases as of Saturday, according to the CDC. 

A Novavax spokesperson said last month its new Covid vaccine generated a “broad immune response” against Eris and another fast-spreading strain called XBB.1.16.6 – both of…