Moderna, Inc., a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, announces it is making new capital investments to increase capacity at its owned and partnered manufacturing facilities, which it expects will increase global 2022 capacity to approximately 1.4 billion doses of its COVID-19 vaccine, assuming a 100 μg dose. The investments will enable additional production of the current Moderna COVID-19 Vaccine and provide flexibility in addressing production of potential vaccine boosters that may be needed to address emerging variants of SARS-CoV-2.
The Company has already begun adding this capacity at its owned and partnered manufacturing facilities. Given a six- to nine-month timeframe to add capacity and an additional timeframe to permit regulatory validation and ramp-up, it is estimated that up to 12 months may be necessary before the additional production is available.
“We believe from our discussions with governments around the world that there will continue to be significant demand for our COVID-19 vaccine and we now are committed to materially increasing our manufacturing capacity. Because of the high efficacy of our COVID-19 vaccine and our ability to quickly develop variant vaccines to help boost the immune system of vaccinees, there is increased demand. We are investing in this additional capacity to help us increase production and allow for flexibility in manufacturing potential vaccine boosters to address emerging variants of the virus,” said Stephane Bancel, Chief Executive Officer of Moderna. “Today we also announced our strategy around clinical testing of different booster vaccines. We expect our additional capital investments to drive our capacity to 1.4 billion doses for 2022, assuming the current 100 μg dose. If our variant vaccine booster requires a lower dose, such as 50 μg, we could have more than 2 billion doses of capacity for 2022.”
The 2022 capacity of up to 1.4 billion doses reflects an assumption of a 100 μg dose. The 2022 output will depend on the dose of the booster. The Company plans to study a dose range of 50 μg and lower for variant-based boosters and an additional booster of mRNA-1273. If the effective dose for a booster is 50 μg, then the 2022 supply could be significantly higher than 1.4 billion doses. The total 2022 supply will depend on the mix between the authorized COVID-19 Vaccine at 100 μg and the dose level authorized for a booster. In the event that the Company dedicates its entire 2022 capacity to a 50 μg boost, the Company could supply up to 2.8 billion doses in fiscal year 2022. The maximum output will be determined as the Company more fully develops its booster product strategy.
Moderna also announces it is increasing its base plan for 2021 manufacturing from 600 million doses to 700 million doses globally. Moderna is exploring other approaches to potentially improve throughput and is working to further optimize its operations to potentially deliver up to 1 billion doses in fiscal year 2021.
The Company has shipped approximately 60 million doses globally including approximately 55 million doses shipped to the U.S. Government to date and the first approximately 4 million doses shipped from its ex-U.S. supply chain. This ex-U.S. supply chain was established one quarter behind the U.S. supply chain and is in the process of ramping up.
An additional approximately 33 million doses have been produced in the U.S. and are filled in vials and in the final stages of production and testing before release. Moderna expects to complete delivery of the first 100 million doses to the U.S. Government by the end of the first quarter 2021, the second 100 million doses by the end of May 2021 and the third 100 million doses by the end of July 2021.
Since the end of 2020, the Company has doubled its monthly deliveries to the U.S. government, and is working to double them again by April to more than 40 million doses per month. As the Company works to meet these goals, it is continually learning and working closely with its partners and the federal government to identify ways to address bottlenecks and accelerate production. For example, one of the recently identified constraints on the production process has been the capacity of the fill-and-finish process. To reduce this constraint, Moderna studied the possibility of adding more doses to each vial of vaccine. Doing so would improve output because it allows complete manufacturing to run more quickly and it reduces the need for consumable materials that are in high demand. The FDA has provided positive feedback on this proposal, and the Company is pursuing a plan that may allow up to 15 doses to be drawn from each vial. This will allow the Company to produce and deliver additional doses more quickly. Moderna will continue to collaborate with its manufacturing partners and the federal government to increase the efficiency of its production process without compromising quality or safety.
The Moderna COVID-19 Vaccine received Emergency Use Authorization from the U.S. Food and Drug Administration (FDA) on December 18, 2020 and Moderna began supplying to the government shortly thereafter. The U.S. Government has agreed to purchase 300 million doses of the Moderna COVID-19 Vaccine, and has options to purchase 200 million additional doses
