Pfizer, Moderna and Novavax are getting ready for the autumn launch
A pharmacist prepares to administer booster shots for Covid-19 during a Chicago Department of Public Health event at the Southwest Senior Center in Chicago, Illinois September 9, 2022.
Scott Olson | Getty Images
The US Food and Drug Administration’s selection of the Covid strain for the next round of vaccinations Pfizer, Modern And Novavax on track to deliver new vaccines in time for the fall – a crucial victory for vaccine makers preparing to compete against each other.
On Friday, the FDA advised the three companies to manufacture single-strain vaccines targeting the Omicron subvariant XBB.1.5, one of the most immune-evading Covid variants to date.
This strain accounted for almost 40% of all Covid cases in the US in early June, but that proportion is slowly declining, according to data from the Centers for Disease Control and Prevention.
However, under pressure to release new vaccines by the fall, Pfizer, Moderna, and Novavax began developing versions of their XBB vaccines 1.5 months before the FDA’s decision. Preliminary data provided by these companies last week suggests their vaccines elicit strong immune responses against all XBB variants.
FDA’s strain selection means companies don’t have to bother manufacturing vaccines that target an entirely different strain, which would delay the time of delivery.
Pfizer announced Thursday that it will be able to fire a shot against XBB.1.5 by July. Moderna and Novavax have not given specific timelines for their releases.
Still, the FDA’s decision means all three companies are likely to deliver their updated vaccines on time.
Shots targeting XBB.1.5 “appear to be the most viable for getting to the finish line early without experiencing availability delays,” said Dr. Melinda Wharton, a senior official at the National Center for Immunization and Respiratory Diseases, at an FDA Advisory Committee meeting Thursday.
The US is expected to shift Covid vaccine distribution to the private sector as early as the fall, when the federal government’s stockpile of free vaccines is expected to run out. Manufacturers sell their updated vaccines directly to healthcare providers, not the government.
That doesn’t include Johnson&Johnson, a once-leading developer of Covid vaccines. The company’s vaccines are no longer available in the US after reports of rare but serious side effects related to blood clotting.
For Pfizer and Moderna, the commercial market is an opportunity to expand into more distribution channels than was possible under government contracts.
However, both companies continue to expect Covid-related sales to fall this year as the world emerges from the pandemic and fewer and fewer people rely on vaccines and treatments. Pfizer expects sales of Covid vaccines to fall to $13.5 billion this year from $37.8 billion in 2022.
Moderna expects sales of at least $5 billion from its Covid vaccine, the only product available. The vaccine generated sales of $18.4 billion last year.
For Novavax, the commercial market is critical to its survival into 2023 and beyond. The financially troubled company only received US approval for its emergency-use Covid vaccine last year due to delays in regulation and manufacturing.
Now, one of Novavax’s top priorities is gaining commercial market share after lagging behind Pfizer and Moderna. The FDA’s strain selection positions Novavax as a serious competitor to these well-known names.
The company hopes to post sales of $1.06 billion to $1.24 billion from its Covid vaccine this year. That’s slightly less than the $1.5 billion that Novavax made last year.
But the three companies still face the same hurdle: It’s unclear how many Americans will roll up their sleeves to get updated vaccines later this year, even if those shots are delivered on time.
According to the CDC, only about 17% of the US population — about 56 million people — have received the latest booster shots from Pfizer and Moderna since they were approved in September.