Moderna (NSDQ:MRNA) announced today that it committed funds to increase its COVID-19 vaccine manufacturing capacity to up to 3 billion doses for 2022.
Cambridge, Mass.-based Moderna’s new funding commitments would increase supply at its owned and partnered manufacturing facilities up to that 3 billion-dose capacity, depending upon the mix between the authorized Moderna COVID-19 vaccine at the 100 μg dose level and potentially lower doses of the company’s variant booster candidates and pediatric vaccines, if authorized, according to a news release.
The company said it plans to use its existing cash balance to fund the investments in the increased manufacturing. The move will double drug substance manufacturing at Lonza’s contract drug manufacturing facility in Switzerland, more than double the formulation, fill/finish and drug substance manufacturing at Rovi’s facility in Spain, and yield a 50% increase in drug substance at Moderna’s U.S. plants.
Moderna plans to begin investing in its owned and partnered factories this year before ramping up at the end of 2021 and in early 2022. The company expects the investments to increase safety stock of raw materials and finished product used to deliver the vaccines.
In addition to the announced uptick in 2022 manufacturing capacity, Moderna said it raised its 2021 manufacturing supply forecast to between 800 million and 1 billion doses. The increases announced today add to the previously announced increases in formulation and fill/finish in the U.S. with Catalent and Sanofi, while the company is in advanced negotiations for other agreements, it said.
The company also noted that the investment could be vital with the expected need for booster vaccinations in 2022 and beyond. Moderna projected that waning immunity will affect vaccine efficacy within 12 months, adding that certain variants have started neutralizing antibody titers and could result in infections among those already vaccinated.
“As we follow the rapid spread of SARS-CoV-2 variants of concern, we believe that there will continue to be significant need for our mRNA COVID-19 vaccine and our variant booster candidates into 2022 and 2023. We are hearing from governments that there is no technology that provides the high efficacy of mRNA vaccines and the speed necessary to adapt to variants while allowing reliable scalability of manufacturing. Today we have announced that our investments in Europe, including Spain, France and Belgium, Switzerland, and the U.S. will allow us to deliver up to 3 billion doses in 2022, depending on the mix of product between primary series of vaccination and variant boosters,” Moderna CEO Stéphane Bancel said in the release. “We thank our manufacturing partners for their work and their commitment. Together with our partners, Moderna is committed to continuously developing best-in-class variant boosters so we can end this pandemic as fast as possible.”
Moderna also announced that ongoing development data for the current formulation of its mRNA vaccine could support a three-month refrigerated (2-8°C) shelf life for the vaccine in alternative formats, which would make for easier distribution to doctors’ offices and other smaller settings if authorized. The current approval is for up to one month of storage at those refrigerated temperatures and up to seven months in a standard freezer (-20°C). Other formulations that could see the refrigerated shelf life increased even further are in development.