Dive Brief:
- Moderna may be able to supply as many as 3 billion doses of its coronavirus vaccine next year, announcing Thursday plans for a series of investments that it says will increase capacity at its U.S. production facilities and overseas manufacturing partners.
- The total number of shots will depend on how many the Massachusetts biotech supplies at the currently authorized dose versus pediatric or booster formulations, which could require a lower dose. The investments, Moderna said, will increase drug substance production by 50% at the company’s U.S. sites and double capacity at a Lonza factory in Switzerland and a Rovi plant in Spain.
- Moderna’s plans are a sign the company views the pandemic lasting multiple years, particularly as virus variants continue to emerge and become more prevalent. The company has begun testing of a variant-specific booster shot as well as a multivalent shot.
Dive Insight:
Moderna’s planning for a significant expansion in manufacturing from this year, when it expects to deliver between 800 million and 1 billion doses. Previously, Moderna had said it could produce 1.4 billion doses next year, so the 3 billion represents a more than doubling from February.
In the U.S., the company shipped its 100 millionth dose on March 29 and expects to deliver another 100 million by the end of May. A third 100 million are due by the end of July. As of Wednesday, 128 million doses had been delivered and 102 million have been administered, according to data collected by the Centers for Disease Control and Prevention.
The U.S. has invested roughly $6 billion to fund the development, testing and manufacturing of Moderna’s vaccine. The newly announced investments, however, will be funded by the company’s cash balance, Moderna said.
Alongside its 3 billion dose target for next year, Moderna also gave another update that should give governments and public health officials greater confidence in a stable supply. The company said it now has data showing the vaccine can remain stable at standard refrigerator temperatures for up to three months, triple the current shelf life of one month.
If the Food and Drug Administration agrees to update the shot’s labeling, the longer stability could aid distribution through smaller vaccination sites that have fewer people coming through without risking wasted doses. The stability of messenger RNA vaccines like Moderna’s at refrigerator and standard freezer temperatures was a top worry early in the vaccination campaign, but those concerns have since eased somewhat.
Moderna’s manufacturing expansion is also a response to signs that additional vaccinations could be needed to keep coronavirus immunity at sufficiently high levels.
The company says its analyses indicate immunity from an initial course of vaccination will wane after about a year, requiring booster shots to maintain thereafter. Emerging variants, meanwhile, trigger lower immune responses in vaccinated people, raising the risks of “breakthrough” infections and making booster development more important.
Vaccinations have also so far been focused on adults, as none of the three authorized shots are cleared for use in children under age 16. Millions of children in the U.S. still need coronavirus shots to further guard against school outbreaks. Work on pediatric formulations is underway but, as they may contain smaller doses, Moderna says its total manufacturing capacity can’t be forecast with precision.
