Moderna Investing To Increase Supply of COVID-19 VaccineBy
Moderna, a biopharmaceutical company developing messenger RNA (mRNA) therapeutics and vaccines, reports that it is making new funding commitments to increase supply of its COVID-19 vaccine at its owned and partnered manufacturing facilities to be able to deliver up to 3 billion doses in 2022, depending on the product mix between primary series of vaccination and variant boosters.
The investments will more than double supply from the company’s ex-US supply chain and involves investments in Europe, including Spain, France and Belgium, and Switzerland, and will also increase production in the US.
These investments allow for the following: (1) a doubling of drug-substance manufacturing for the vaccine at Lonza’s site in Visp, Switzerland through the addition of three additional drug-substance manufacturing lines; (2) a more than doubling of formulation, fill–finish, and drug-substance manufacturing at Rovi, a pharmaceutical company and CDMO, in Spain; and (3) and a 50% increase of drug-substance production at Moderna’s facilities in the US.
In May 2020, Lonza and Moderna announced a 10-year strategic collaboration agreement to enable the manufacture of Moderna’s COVID-19 vaccine and additional Moderna products in the future. Since then, Lonza has installed three production lines at its Visp site and one further production line in its facility in Portsmouth, New Hampshire. It is anticipated that the new manufacturing lines will each have a production capacity equivalent to the existing lines and are expected to be operational in the earlier part of 2022.
For Rovi, the investments involve the installation of two new production lines and equipment for compounding, filling, automatic visual inspection, labelling, and packaging that will provide additional fill–finish capacity for Moderna’s COVID-19 vaccine to supply markets outside the US. These lines, located at Rovi’s facility in San Sebastián de los Reyes (Madrid), will come into operation in the fourth quarter of 2021, be fully operational in the first half of 2022, and will more than double the number of vials for which there is fill–finish capacity at the facility.
When completed, all of the investments will also result in an increase in safety stock of raw materials and finished product used to deliver committed volumes. Moderna will begin making investments at its owned and partnered manufacturing facilities in 2021, with increased production from these investments expected to ramp up in late 2021 and early 2022. In addition, Moderna raised its 2021 manufacturing supply forecast to between 800 million to 1 billion doses.
These increases are in addition to recently announced increases in formulation and fill–finish in the US with Catalent and Sanofi. In addition, Moderna reports it is in advanced negotiations for other agreements as well.
Increased supply to address variants
Moderna says that these investments to increase supply are necessary due to an expected need for booster vaccinations in 2022 and beyond. The company highlighted published studies predicting that waning immunity will impact vaccine efficacy within 12 months and other studies that showed variants of concern have lower starting neutralizing antibody titers and may lead to breakthrough infections among those already infected or vaccinated, thereby compounding the potential need for variant boosters in the coming years.
Moderna announced earlier this year (2021) that it is testing SARS-CoV-2 variant vaccines and multivalent vaccine boosters. The company says that as it observes results from its ongoing variants clinical trials, it can more fully develops its booster product strategy. The amount of the additional supply depends on the mix between the 100-μg dose level of the vaccine and potentially lower doses of the company’s variant booster candidates and pediatric vaccines, if authorized. With that data, the company says it will be in a position to better estimate supply ranges for 2022, which will be based, in significant part, on product mix across single-dose boosters, primary (two-dose) vaccination series for adults, and primary (two-dose) series for the pediatric population, which may be at lower dose levels.
Development of vaccine with improved shelf life
Moderna also reported data that showed that its COVID-19 vaccine could support a three-month refrigerated (2-8 °C) shelf life for the vaccine in alternative formats to facilitate easier distribution to doctor’s offices and other smaller settings, if authorized. Currently, the Moderna COVID-19 vaccine is approved for storage up to one month at refrigerated temperatures (2-8 °C) and up to seven months in a standard freezer (-20 °C). The company is working on formulations of the vaccine and a next-generation vaccine candidate that it believes will extend refrigerated shelf life even further.