Moderna on Wednesday announced it was scaling down manufacturing of its COVID vaccine, an updated version of which was approved this week by U.S. regulators, to align with lower post-pandemic demand and help the Cambridge, Mass.-based company sooner hit its target of 75% to 80% gross margin growth. But it also hints at the difficulty in hitting government-sought production goals for its vaccine.
Developing vaccines for this pandemic posed unique challenges, making it hard to predict how fast companies could produce enough new medicines to meet demand. That’s because process steps that usually happen sequentially were accelerated, in some cases, to make it possible to get vaccines out faster. Based on limited data, companies invested billions in plants and manufacturing equipment, a much lower level of certainty than they usually require.
For instance, the companies that Pfizer and BioNTech signed up with to supply them with COVID-19 vaccines had existing plant capacity that they could use to ramp up production quickly. But Moderna, which had a smaller facility in Massachusetts that was used to make smaller batches of the vaccine for clinical trials, didn’t have such an advantage. So it teamed with Lonza, a global contract drug manufacturer (CDMO), to do what is known as “process scale-up” for it. That means standardizing the equipment and processes each new plant would need to operate to produce a consistent drug product to speed up expansion.
In addition to the scaling-up work it has done with Lonza, Moderna has also added its facilities. In August 2020, it opened a plant in Australia to produce drug substances and perform fill and finish. In February 2021, it did the same in Japan with Takeda. And it has agreements with SK Bioscience in South Korea and KM Biologics in India to do the same.
But that still leaves Pfizer and Moderna with considerable hurdles to clear in delivering 100 million vaccine doses to the government this year. They’ve been supplying about 4.3 million per week in recent weeks, but to meet their contracts, they will need to up that number to 7.5 million a week or more.
Moderna doesn’t release weekly or monthly production estimates, so it needs to be clarified how it can increase its output to hit its target. But it says it will negotiate tiered pricing for low-income countries, which will charge $32 to $37 per dose compared with the $70 to $120 it plans to charge in developed nations. And it’s working with the Global Access Facility, a nonprofit that aims to reduce global vaccine inequities to ensure the vaccine is available at a lower price for poorer nations. The group is negotiating with the Trump administration for additional funding to help achieve its goal.
