Moderna said Friday that it hopes to be able to produce up to 1 billion doses per year of its mRNA vaccine mRNA-1273 against SARS-CoV-2 after signing a manufacturing deal with Lonza. "This long-term strategic collaboration agreement will enable Moderna to accelerate, by 10-times, our manufacturing capacity for mRNA-1273," remarked Moderna CEO Stéphane Bancel.
Under the agreed terms, the companies plan to establish manufacturing suites at Lonza's facilities in the US and Switzerland for the manufacture of mRNA-1273. Technology transfer is expected to begin in June, with the first batches of the vaccine candidate produced by Lonza in the US in July. Moderna said that its own manufacturing sites in the US continue to ramp up to prepare for the further clinical development and commercialisation of mRNA-1273.
In March, the first subject in a Phase I study being conducted by the US National Institutes of Health (NIH) was dosed with mRNA-1273, which encodes for a prefusion stabilised form of the Spike (S) protein that protrudes from the viral surface. Participants in the study will receive two doses of the vaccine, given 28 days apart, and will be followed through 12 months after the second immunisation.
The companies noted that as part of the deal, they will set up additional production suites across Lonza's worldwide facilities, with a portion of the funding for the establishment of US manufacturing covered by Moderna's contract with the Biomedical Advanced Research and Development Authority (BARDA). The 10-year collaboration with Lonza also covers additional Moderna products in the future.
Earlier this week, Moderna submitted an investigational new drug application to the FDA for Phase II and late-stage studies of mRNA-1273 if supported by safety data from the Phase I trial. The company noted that the Phase II study is expected to begin in the second quarter and will investigate two doses of the vaccine, each administered as two injections given 28 days apart, versus placebo in 600 healthy adults.
Although vaccines for COVID-19 are still in the development stage, companies are ramping up production to meet the expected demand if they prove successful, with the University of Oxford reaching a deal earlier this week with AstraZeneca. Under the agreement, AstraZeneca will be responsible for global manufacturing of the University of Oxford's potential recombinant adenovirus vaccine, dubbed ChAdOx1 nCoV-19, with a target to produce 100 million doses by the end of the year. Meanwhile, Inovio Pharmaceuticals recently expanded its partnership with Richter-Helm BioLogics to support large-scale manufacturing of the investigational DNA vaccine INO-4800, with an aim to produce 1 million doses by the end of 2020.
For related analysis, listen to our latest podcast from FirstWord executive editors Simon King and Michael Flanagan, which includes a discussion on the race to develop an effective vaccine.
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