While the FDA and the Centers for Disease Control and Prevention (CDC) have signed off on updated COVID vaccines for this season, Moderna is already reportedly preparing for lower demand for its shot.
Moderna is speaking with its manufacturing partners to scale back production of its mRNA COVID vaccine Spikevax to cope with the endemic phase of the disease, Moderna’s president and R&D head, Stephen Hoge, said, Reuters reports.
“Over the past couple of years, we’ve been in pandemic mode producing a billion doses a year,” Hoge said, as quoted by Reuters. “We’ve been waiting for the moment when the pandemic was officially behind us that we would need to restructure that manufacturing footprint.”
The discussions are with vial fillers, according to Reuters. Moderna’s manufacturing partners include Thermo Fisher, which offers its fill-finish services through a 15-year strategic collaboration signed last year. Catalent also provides Moderna vial filling and packaging capacity under a 2020 deal. Sanofi agreed in 2021 to perform fill and finish of up to 200 million doses of Moderna’s COVID vaccine.
Separately, Lonza helps manufacture the drug substance for Moderna’s COVID vaccine under a 10-year agreement penned in 2020.
Moderna has been feeling the burn from declining demand for many months. In the second quarter, the Massachusetts company took $674 million in impairment charges over inventory write-downs, idle manufacturing capacity and the cancellation of purchase agreements. The number was $378 million in the first quarter.
Now, because of new interest in the updated monovalent XBB.1.5 COVID shot, the company’s inventory of last year's bivalent version has become obsolete. Customer demand has dropped, too, Moderna said last month.
But cutting back manufacturing scale won’t happen overnight or even in time for this season. Talks with contract manufacturers could extend into 2024, Hoge said.
“These are relationships that we will need for decades to come,” he said, as quoted by Reuters.
For 2023, Moderna expects sales to come within a range of $6 billion to $8 billion, which will rely heavily on the upcoming season. In the first half of the year, product sales were just $2.1 billion at the company.
Plenty of uncertainties lie ahead, given that this is the first season COVID vaccines will transition to a commercial endemic market, Moderna’s chief commercial officer Arpa Garay acknowledged on the company’s second-quarter earnings call.
Previously, Moderna had predicted that demand for COVID shots would reach about 50 million doses in the U.S. this fall. But using flu shots as a proxy, Garay noted that the volume could reach 100 million doses.
Moderna also needs to compete with Pfizer-BioNTech, whose rival shot appears to be more popular. Nearly 404 million doses of the Pfizer-BioNTech vaccine were administered in the U.S., compared with nearly 253 million for Moderna's vaccine, according to the CDC’s COVID vaccination tracker updated in May.
For this season, the starting pistol has already been fired. The FDA on Monday approved the XBB.1.5 shots by Moderna and Pfizer-BioNTech, and the CDC on Tuesday recommended everyone ages 6 months and older get the updated vaccines this fall.