December 5, 2023

A pharmacist prepares a booster shot of the Covid-19 vaccine during a Chicago Department of Public Health event at the Southwest Senior Center in Chicago, Illinois, Sept. 9, 2022.

Scott Olson | Getty Images

FDA’s Covid strains selected for next round of lead Pfizer, modern and Novaks A new vaccine is expected to be available in time for the fall — a decisive victory for vaccine makers as they prepare to compete against each other.

FDA Friday suggestion The three companies will produce a single-strain vaccine against the omicron subvariant XBB.1.5, one of the most immune-evading Covid variants to date.

The strain was said to account for nearly 40% of all Covid cases in the U.S. in early June, but that percentage is slowly declining data From the Centers for Disease Control and Prevention.

But under pressure to deliver a new vaccine by the fall, Pfizer, Moderna and Novavax began developing versions of their vaccine against XBB.1.5 five months before the FDA’s decision. Preliminary data presented by the companies last week showed that their vaccines produced strong immune responses against all XBB variants.

The FDA’s strain selection means the companies won’t have to scramble to produce vaccines against entirely different strains, which delays delivery.

Pfizer said Thursday it will be able to offer a vaccine against XBB.1.5 by July. Moderna and Novavax did not provide specific timelines for their releases.

Still, the FDA’s decision means all three companies are likely to deliver updated vaccines on time.

A vaccine against XBB.1.5 appears to be “the most feasible way to get to the finish line early without delaying availability,” Dr. Melinda Wharton, a senior official at the National Centers for Immunization and Respiratory Diseases, told an FDA advisory committee meeting this week. Four.

The U.S. is expected to shift distribution of Covid vaccines to the private sector as soon as the fall, when the federal government’s free vaccine supply is expected to run out. Manufacturers will sell the updated vaccine directly to health care providers, not the government.

that doesn’t include Johnson & Johnson, once the leading Covid vaccine developer.The company’s lens is no longer available Rare but serious coagulation side effects have been reported in the United States.

For Pfizer and Moderna, the commercial market is an opportunity to leverage more distribution channels than government contracts.

But the companies still expect Covid-related sales to decline this year as the world emerges from the pandemic with fewer people dependent on vaccines and treatments. Pfizer expects Covid vaccine revenue to fall to $13.5 billion this year from $37.8 billion in 2022.

Moderna expects its only available product, the Covid vaccine, to bring in at least $5 billion in revenue. The vaccine generated $18.4 billion in revenue last year.

For Novavax, the commercial market is critical to its survival in 2023 and beyond. The cash-strapped company won U.S. approval for emergency use only last year amid regulatory and manufacturing delays.

Now, one of Novavax’s top priorities is capturing commercial market share after falling behind Pfizer and Moderna. The FDA’s strain selection positions Novavax as a serious contender against these household names.

The company hopes to generate $1.06 billion to $1.24 billion in sales of its Covid vaccine this year. That’s slightly less than the $1.5 billion Novavax generated last year.

But all three companies still face the same hurdle: It’s unclear how many Americans will roll up their sleeves for the newer vaccines later this year, even if they are delivered on time.

Since the latest boosters from Pfizer and Moderna were approved last September, only about 17 percent of the U.S. population, or about 56 million people, have received them, according to the CDC.