Moderna, a biopharmaceutical company developing messenger RNA (mRNA) therapeutics and vaccines, has signed a pact with UNICEF to supply up to 500 million doses of its COVID-19 vaccine and has signed separate manufacturing agreements with Lonza and Thermo Fisher Scientific for the manufacturing of the vaccine.

Through a long-term agreement with UNICEF, announced last month (May 2021), UNICEF and its procurement partners, including the Pan American Health Organization, will have access to up to 34 million doses of Moderna’s COVID-19 vaccine, to be delivered in the fourth quarter 2021, with an option for up to 466 million doses in 2022. The pact with UNICEF is on behalf of the COVAX Facility, a global initiative for equitable access to COVID-19 vaccines.

New manufacturing pacts with Lonza and Thermo Fisher

Separately, Moderna has entered into an additional agreement with Lonza for drug-substance manufacturing by establishing a new production line at Lonza’s site in Geleen, the Netherlands to support production of an additional 300 million doses per year of Moderna’s updated booster variant vaccine candidate, if authorized, at a 50-µg dose.

In the European Union (EU), in addition to previously announced investments in drug-substance manufacturing with Rovi, a pharmaceutical company and CDMO, in Granada, Spain, Moderna now expects to be able to supply the equivalent of 600 million 50-µg doses per year from production within the  EU. Both new drug-substance lines in the EU are expected to be operational before the end of 2021.

Moderna already works with Rovi and Recipharm, a CDMO, for fill–finish of its COVID-19 vaccine in Europe and recently entered into a manufacturing services and supply agreement with Samsung Biologics in South Korea to provide additional large-scale, commercial fill–finish services. In the US, Moderna also works with Lonza for drug-substance production from Lonza’s site in Portsmouth, New Hampshire and is partnered with Catalent, Baxter BioPharma Solutions, and Sanofi for fill–finish services.

In a separate pact announced this month (June 2021), Moderna entered into an agreement with Thermo Fisher Scientific for fill–finish sterile manufacturing services and supply packaging for Moderna’s COVID-19 vaccine. Under the agreement, Thermo Fisher’s commercial manufacturing site in Greenville, North Carolina will be used for aseptic fill–finish, labeling, and packaging to support the production of hundreds of millions of doses of the vaccine. Production will begin in the third quarter of 2021.

Other COVID-19 vaccine updates

In other vaccine news, Moderna has initiated the rolling submission process with the US Food and Drug Administration (FDA) for a biologics license application (BLA) for the licensure of its mRNA COVID-19 vaccine to prevent COVID-19 in individuals 18 years of age and older.

Moderna will continue to submit data to support the BLA to the FDA on a rolling basis over the coming weeks (as reported on June 1, 2021) with a request for a priority review. Once the rolling BLA submission is complete, the FDA will notify the company when it is formally accepted for review.

Moderna’s COVID-19 vaccine is currently available in the US under an emergency use authorization. To date (as reported on June 1, 2021), according to the US Centers for Disease Control and Prevention, more than 124 million doses of Moderna’s COVID-19 vaccine have been administered in the US.

Source: Moderna (UNICEF), Moderna (Lonza), Moderna (Thermo Fisher), Moderna (BLA), and Lonza