A vial labelled “Novavax V COVID-19 Vaccine” is seen on this illustration taken January 16, 2022.
Dado Ruvic | Reuters
The Food and Drug Administration on Tuesday authorized Novavax‘s updated Covid vaccine for emergency use in people ages 12 and up, putting the shot on the right track to roll out weeks after latest jabs from Pfizer and Moderna reached Americans.
Novavax’s latest single-strain vaccine, which targets omicron subvariant XBB.1.5, still needs an updated advice from the Centers for Disease Control and Prevention before patients can access it at pharmacies, health centers and other distribution sites.
The corporate said in an announcement it expects a advice from the CDC “imminently.” Doses of the shot will likely be available inside the subsequent few days, Novavax added.
“Novavax’s authorization today means people will now have the selection of a protein-based non-MRNA choice to help protect themselves against Covid-19, which is now the fourth leading reason behind death within the U.S.,” said Novavax CEO John Jacobs within the statement. “In the approaching days, individuals within 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 beneficial alternative for individuals who don’t desire to take messenger RNA shots from Pfizer and Moderna, which teach cells the way 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 utilized 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 gathering of advisors to the agency last month.
Around 2 million Americans have received the updated Covid vaccines from each firms up to now, the Biden administration said last week, at the same time as patients desirous to get their dose have been met with unexpected insurance delays and availability issues.
Regardless, all three shots are expected to assist the U.S. combat the spread of Covid this fall and winter, when the virus normally spreads at higher levels.
The nation is already seeing a surge in cases and hospitalizations. While levels remain far below previous Covid waves within the U.S., it’s still the primary notable uptick since last winter and has even prompted the return of mask mandates for a handful of companies and schools.
The rise is driven by newer strains of the virus which can be gaining ground nationwide as XBB.1.5 step by step declines. That features EG.5, or Eris, an omicron strain that accounted for 29.4% of all cases as of Saturday, in accordance with the CDC.
A Novavax spokesperson said last month its latest Covid vaccine generated a “broad immune response” against Eris and one other fast-spreading strain called XBB.1.16.6 – each of that are descendants of omicron.
However it’s unclear whether the corporate’s latest vaccine will protect against BA.2.86, a highly mutated omicron strain that health officials are watching closely despite its small variety of cases. Novavax last month said it was still testing its vaccine against BA.2.86.
The rollout of Novavax’s latest shot comes months after the top of the U.S. Covid public health emergency.
The tip of that declaration means all three manufacturers will sell their updated shots on to health-care providers and vie for industrial market share. Previously, the federal government purchased vaccines directly from manufacturers at a reduction to distribute to all Americans at no cost.
Throughout the advisory meeting last month, Novavax said the list price of its vaccine is $130 per dose.
Federal and company programs are aiming to fill the gap for uninsured Americans. That features the Biden administration’s Bridge Access Program, which is able to provide Covid vaccines for free of charge to underinsured and uninsured people.
It’s unclear what number of Americans will actually roll up their sleeves and take the brand new vaccines from Novavax, Pfizer and Moderna.
But roughly 42% of Americans surveyed by the CDC in August said they “definitely will” or “probably will” get a Covid shot this fall, Dr. Megan Wallace, a CDC epidemiologist, said throughout the advisory meeting.
