Novavax updated Covid vaccine wins FDA, CDC backing, paving way to reach Americans within days

and Moderna. Dado Ruvic | ReutersNovavax‘s updated Covid vaccine won the backing of U.S. regulators on Tuesday, putting the shot on track to roll out weeks after new jabs from

Pfizer

and

Moderna

reached Americans.

The Food and Drug Administration authorized Novavax’s single-strain vaccine, which targets omicron subvariant XBB.1.5, for emergency use in people ages 12 and up.

The Centers for Disease Control and Prevention is now including Novavax’s shot in the same recommendation it issued last month for updated vaccines from Pfizer and Moderna. That recommendation says all Americans ages six months and older can receive an updated Covid jab.

Novavax said in a statement that doses of the shot will likely be available within the next few days.

“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 next few days, people in the U.S. will be able to get an updated Novavax shot at major pharmacies, doctors’ offices, clinics, and government entities. Novavax’s shot uses a decades-old method of fighting the virus using protein-based technology. Novavax’s shot fends off the virus with protein-based technology, a decades-old method used in routine vaccinations against hepatitis B and shingles.

Around 2 million Americans have received the updated Covid vaccines from Pfizer and Moderna 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 has already seen a spike in hospitalizations and cases. Although levels are still far below the previous Covid wave in the U.S. it is the first significant increase since last winter. Masks have been mandated for some businesses and schools. The rise in cases is due to newer strains that are spreading across the country as XBB.1.5 slowly declines. The CDC reported that Eris, a strain of omicron, accounted for 29,4% of all cases by Saturday. A Novavax spokesperson stated last month that its new Covid vaccination generated a “broad immunity response” against Eris as well as another fast-spreading omicron strain called XBB.1.16.6 – both of which were descendants of omicron. It’s not clear if the new vaccine from Novavax will protect against BA.2.86, which is a highly-mutated strain of omicron that health officials are closely monitoring despite its low number of cases. Novavax said last month that it was still testing the vaccine against BA.2.86.

The launch of Novavax’s new shot comes after months of the U.S. Covid health emergency. The end of the Covid public health emergency in the U.S. has led to a shift where all three manufacturers are now selling their updated shots directly through healthcare providers, and competing for market share. Prior to this, the government bought vaccines at a discounted price from manufacturers to give away to all Americans. During a meeting held last month, Novavax stated that the list price for its vaccine was $130 per dosage. The Bridge Access Program of the Biden Administration will offer Covid vaccines to uninsured or underinsured individuals at no charge. It’s not clear how many Americans are going to take up the challenge and get the new vaccines offered by Novavax Pfizer Moderna.