A vial labeled “Novavax V COVID-19 Vaccine” is seen in this illustration taken on January 16, 2022.
Ruvik Dice | Reuters
NovavaxAn updated coronavirus vaccine won support from U.S. regulators on Tuesday, putting the vaccine on track to be rolled out just weeks after the new shot becomes available. Pfizer and modern The Americans arrived.
The U.S. Food and Drug Administration has authorized Novavax’s single-strain vaccine, which targets the omicron subvariant XBB.1.5, for emergency use in people 12 years and older.
The Centers for Disease Control and Prevention is now including Novavax’s vaccine in the same recommendations it issued last month for updated vaccines from Pfizer and Moderna. The recommendation says all Americans six months and older can receive the newer COVID-19 vaccine.
Novavax said in a statement that doses of the vaccine could become available in the coming days.
Novavax CEO John Jacobs said: “Today’s authorization of Novavax means people can now choose a protein-based, non-mRNA option to help protect themselves against Covid-19, which is currently The fourth leading cause of death in the United States.” states. “In the coming days, individuals in the United States will be able to receive the updated Novavax vaccine at major pharmacies, doctor’s offices, clinics and various government agencies.”
Public health officials view Novavax’s vaccine as a valuable alternative for people who don’t want to receive Pfizer and Moderna’s messenger RNA shots, which teach cells how to make proteins that trigger an immune response against the coronavirus. Novavax’s vaccine protects against the virus through protein-based technology, a decades-old approach used in routine hepatitis B and shingles vaccinations.
The Biden administration said last week that about 2 million Americans have been vaccinated so far with updated COVID-19 vaccines from Pfizer and Moderna, although patients eager to get vaccinated have encountered unexpected insurance delays and supply issues.
Regardless, the three shots are expected to help the U.S. contain the spread of the coronavirus this fall and winter, when the virus typically spreads at higher levels.
The country has already seen a surge in cases and hospitalizations. While levels are still well below previous coronavirus waves in the U.S., it’s still the first significant rise since last winter and even prompted a handful of businesses and schools to reinstate mask mandates.
The increase is being driven by new virus strains circulating across the country 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 spokesperson for Novavax said last month that its new Covid vaccine produced a “broad immune response” against Eris and another fast-spreading strain called XBB.1.16.6, both omicron Descendants.
But it’s unclear whether the company’s new vaccine protects against BA.2.86, a highly mutated omicron strain that health officials are watching closely, although the number of cases is low. Novavax said last month it was still testing its vaccine against BA.2.86.
Novavax’s new vaccine comes months after the U.S. coronavirus public health emergency ended.
The end of the announcement means all three manufacturers will sell their updated vaccines directly to health care providers and compete for commercial market share. Previously, the government purchased vaccines directly from manufacturers at discounted prices and distributed them to all Americans for free.
At an advisory meeting last month, Novavax said its vaccine would be priced at $130 per dose.
Federal and corporate programs are designed to fill the gap for uninsured Americans. That includes the Biden administration’s Bridge Access program, which would make coronavirus vaccines free to the underinsured and uninsured.
It’s unclear how many Americans will actually roll up their sleeves and get the new vaccines from Novavax, Pfizer and Moderna.
But CDC epidemiologist Dr. Megan Wallace told the advisory meeting that a CDC survey in August showed about 42% of Americans said they “definitely” or “probably” would be sick this fall Get the COVID vaccine.