The Food and Drug Administration (FDA) has given its endorsement to Novavax’s revised Covid vaccine, on track to be launched shortly after Pfizer and Moderna’s new vaccines reached the US population. The FDA has approved Novavax’s single-strain vaccine, designed to combat the omicron subvariant XBB.1.5, for emergency use in people aged 12 and above.
The Centers for Disease Control and Prevention (CDC) is incorporating Novavax’s vaccine into its recommendation from last month for updated vaccines from Pfizer and Moderna. This guideline states that all Americans aged six months or older can receive an updated Covid jab.
Novavax announced that the vaccine doses will likely be available within a few days. “Today’s authorization of Novavax means individuals 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. He added that individuals in the U.S. can go to pharmacies, physicians’ offices, clinics, and various government entities to receive an updated Novavax vaccine.
Public health officials view Novavax’s vaccine as a beneficial alternative for those who don’t wish to take messenger RNA shots from Pfizer and Moderna, which educate cells to produce proteins that trigger an immune response against Covid. Novavax’s shot uses protein-based technology, a method used in routine vaccinations against hepatitis B and shingles for decades.
Approximately 2 million Americans have received the updated Covid vaccines from Pfizer and Moderna so far, according to the Biden administration last week. Still, eager patients have encountered unexpected insurance delays and availability issues.
Nonetheless, all three shots are expected to assist the U.S in combating Covid spread this fall and winter when the virus typically spreads at higher levels.
The country is already experiencing increased cases and hospitalizations. Although levels are far below previous Covid waves in the U.S., it’s the first significant increase since last winter and has even led to the reinstatement of mask mandates for some businesses and schools.
The rise is propelled by newer strains of the virus that are gaining prevalence nationwide as XBB.1.5 gradually declines. This includes EG.5, or Eris, an omicron strain that accounted for 29.4% of all cases as of Saturday, according to CDC data.
Last month, a Novavax spokesperson stated that its new Covid vaccine elicited a “broad immune response” against Eris and another rapidly spreading strain called XBB.1.16.6 – both descendants of omicron. It remains uncertain whether the company’s new vaccine will protect against BA.2.86, a highly mutated omicron strain that health officials are monitoring closely despite its small number of cases.
The launch of Novavax’s new shot comes months after the end of the U.S. Covid public health emergency. All three manufacturers will now sell their updated shots directly to healthcare providers and compete for commercial market share.
Novavax stated during the advisory meeting last month that its vaccine’s list price is $130 per dose. Federal and corporate programs aim to bridge the gap for uninsured Americans, including the Biden administration’s Bridge Access Program, which will provide Covid vaccines at no cost to underinsured and uninsured people.
It remains unknown how many Americans will actually take the new vaccines from Novavax, Pfizer, and Moderna. However, approximately 42% of Americans surveyed by the CDC in August expressed they “definitely will” or “probably will” get a Covid shot this fall, according to Dr. Megan Wallace, a CDC epidemiologist.