Moderna on Tuesday said it reached an agreement with the US government to supply millions of doses of its coronavirus vaccine candidate mRNA-1273. The award of up to $1.525 billion is for the manufacturing and delivery of 100 million doses of the vaccine, including incentive payments for timely delivery, with the deal also including an option to purchase up to another 400 million doses.
The agreement is on top of a previous award of up to $955 million from the US that went toward supporting development of the vaccine, including a recent commitment of up to $472 million from the Biomedical Advanced Research and Development Authority (BARDA). The US government said Americans will receive mRNA-1273 at no cost for the vaccine itself, although as is customary with government-purchased vaccines, healthcare professionals could charge for the cost of administering it.
Last month, an interim analysis of a phase 1 study found that mRNA-1273 induced “robust” neutralizing antibody titers in all 45 study subjects, and also elicited Th1-biased CD4 T-cell responses, while producing only mild-to-moderate side effects, typically after the second dose. Meanwhile, a phase 3 trial got under way recently, and will test the mRNA-based vaccine against placebo in approximately 30,000 participants.
Scaling up production
“We appreciate the confidence of the US government in our mRNA vaccine platform,” said CEO Stéphane Bancel, adding “we are scaling up our manufacturing capability with our strategic partners, Lonza, Catalent and ROVI, to address this global health emergency.” Moderna indicated late last month that it remains on track to deliver about 500 million doses of mRNA-1273 a year, and possibly up to 1 billion doses annually, beginning in 2021.
Meanwhile, Moderna recently lost a US patent challenge brought against Arbutus Biopharma over the latter’s lipid nanoparticle delivery technology, potentially affecting mRNA-1273. In a recent regulatory filing, Moderna disclosed there was a possibility it was not the first company to make “inventions claimed” in its patent applications, including those for mRNA-1273, and as a result, it “may be unable to secure desired patent rights, thereby losing exclusivity.”