Pfizer, Moderna and Novavax gear up for fall rollout

Puts the FDA’s covid strain selection up for the next round of shots PfizerAnd accident And novafax On track to deliver new hits just in time for fall — a crucial win for vaccine makers as they prepare to compete against each other.

Food and Drug Administration on Friday advised The three companies that make single-strain punches are targeting the omicron variant XBB. 1.5, one of the most immuno-elusive Covid variants yet.

This strain accounted for nearly 40% of all Covid cases in the US in early June, but that percentage is slowly declining, according to data From the Centers for Disease Control and Prevention.

But facing pressure to deliver new doses by the fall, Pfizer, Moderna and Novavax began developing versions of their vaccines that target XBB 1.5 months before the FDA’s decision. Preliminary data presented by those companies last week indicates that their hits produce strong immune responses against all XBB variants.

The FDA’s choice of strain means that companies won’t have to scramble to manufacture shots that target an entirely different strain, which could delay delivery timing.

Pfizer said Thursday that it will be able to launch a round targeting XBB.1.5 by July. Moderna and Novavax have not provided specific timelines for their releases.

However, the FDA’s decision means that all three companies will likely deliver their updated punches on time.

Shots targeting XBB.1.5 appear to be “the most feasible for crossing the finish line early without delaying availability,” Dr. Melinda Wharton, a senior official at the National Center for Immunization and Respiratory Diseases, told the FDA advisory committee meeting. Thursday.

The US is expected to shift distribution of the Covid vaccine to the private sector once in the fall, when the federal government’s supply of free shots is expected to run out. Manufacturers will sell their updated supplements directly to healthcare providers rather than to the government.

This does not include Johnson & JohnsonLeading Covid Vaccine Developer. Company snapshots It is no longer available In the United States following reports of rare but serious blood clotting side effects.

For Pfizer and Moderna, the commercial market represents an opportunity to tap into more distribution channels than under government contracts.

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

Moderna expects revenue of at least $5 billion from the Covid vaccine, its only available product. The jab made $18.4 billion in revenue last year.

For Novavax, the commercial market is critical to its survival through 2023 and beyond. The cash-strapped company secured US approval for its Covid vaccine under emergency use only last year due to regulatory and manufacturing delays.

Now, one of Novavax’s top priorities is capturing commercial market share after lagging behind Pfizer and Moderna. The FDA’s selection of the strain positions Novavax as a viable competitor against those familiar names.

The company hopes to raise between $1.06 billion to $1.24 billion in Covid vaccine sales this year. That’s slightly less than the $1.5 billion Novavax shot produced last year.

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

Only about 17% of the US population — about 56 million people — have received the latest Pfizer and Moderna boosters since their approval in September, according to the CDC.