Moderna Therapeutics has partnered with the federal government to create an mRNA-based COVID-19 vaccine it hopes to speed through clinical trials and right into production. One problem with that plan? The partners couldn't find a manufacturer willing to take on the risks for little financial reward—until now.
Moderna and Lonza struck a deal to flesh out manufacturing suites at two Lonza facilities to boost production of Moderna's mRNA vaccine candidate, dubbed mRNA-1273, the companies said Friday.
The agreement will initially bring suites online at Lonza facilities in the U.S. and Switzerland, with technology transfer set to begin in June. With the manufacturing apparatus in place, Moderna hopes to begin batch production at the U.S. site as early as July.
If all goes to plan, the partners will continue to build out additional manufacturing sites that could bring Moderna's capacity up to 1 billion shots per year, the drugmakers said.
"This long-term strategic collaboration agreement will enable Moderna to accelerate, by 10 times, our manufacturing capacity for mRNA-1273 and additional products in Moderna’s large clinical portfolio," Moderna CEO Stéphane Bancel said in a release. "Lonza’s global presence and expertise are critical as we scale at unprecedented speed."
Earlier this week, Moderna announced its FDA submission to start phase 2 and later-stage trials of mRNA-1273 based on the strength of ongoing phase 1 testing for the vaccine. Friday, Moderna said it had received early feedback on the design of the phase 2 study, which is scheduled to begin dosing in the second quarter.
Moderna hopes to enroll 600 healthy patients to evaluate the shot's safety and efficacy with doses administered 28 days apart.
Lonza stepping up to the plate answers a major question for Moderna and development partner the National Institutes of Health (NIH)––namely, who would provide the manufacturing muscle for a potential vaccine.
Back in February, National Institute of Allergy and Infectious Diseases Director Anthony Fauci said the NIH and Moderna could have an mRNA vaccine ready to go within a year, but they wouldn't have the production power to produce the needed number of doses on their own.
Fauci outlined the hurdles to bringing in a manufacturing partner, including the “opportunity cost” of sacrificing profitable products it would otherwise manufacture, Fauci said at the time. It's a dynamic that's "very difficult and very frustrating," he added.
But Moderna isn't the only horse in the race for a COVID-19 vaccine, and other players are also stepping up with wide-ranging production deals.
Thursday, AstraZeneca snared global manufacturing and distribution rights to Oxford's adenovirus-based COVID-19 shot, which leapfrogged into front-runner status when it began human trials last week.
The vaccine candidate, initially developed by the Jenner Institute and Oxford Vaccine Group, is scheduled to advance to late-stage trials by mid-2020, AstraZeneca said in a release. Phase 1 data from five trial centers in the southern U.K. could read out as early as May.
Johnson & Johnson earlier this week inked a second major manufacturing deal—this time with Catalent—to boost capacity for its vaccine candidate, which it hopes to move into human trials in September. Catalent will hire an additional 300 workers at an Indiana plant starting in July with the goal of reaching 24/7 manufacturing schedules by January.