Moderna secures FDA approval to advance coronavirus vaccine candidate mRNA-1273 to Phase II testing

Shares in Moderna jumped as much as 16% on Thursday after the company said the FDA is allowing it to move ahead with a Phase II study of its experimental COVID-19 vaccine mRNA-1273. Moderna stated that it will begin the study with 600 participants "shortly" and is finalising the protocol for a Phase III trial to start early this summer, with CEO Stéphane Bancel saying the company is "now preparing to potentially have its first [biologics license application] approved as soon as 2021." 

Bancel added that Moderna is also "accelerating manufacturing scale-up and our partnership with Lonza puts us in a position to make and distribute as many vaccine doses of mRNA-1273 as possible, should it prove to be safe and effective." Last week, the company said it hoped the 10-year Lonza deal would enable it to make up to 1 billion doses per year of the mRNA vaccine against SARS-CoV-2, with the first batches produced by Lonza in the US in July. 

Meanwhile, Moderna noted that it will likely "incur significant expenses this year" related to the development and manufacturing of mRNA-1273, although it expects "a close matching of expenses and reimbursements for those expenses" from its award by the US Biomedical Advanced Research and Development Authority (BARDA). In April, BARDA had awarded Moderna up to $483 million in funding to accelerate development of the COVID-19 vaccine candidate. 

A Phase I study of mRNA-1273, which encodes for a prefusion stabilised form of the Spike (S) protein that protrudes from the coronavirus surface, dosed its first patient in mid-March and is being conducted by the US National Institutes of Health. Earlier this week, Pfizer and BioNTech said the first US participants have been dosed in a Phase I/II trial for their BNT162 vaccine programme to prevent COVID-19. 

Separately, Moderna also posted its first-quarter financial results, with sales coming in at $8.4 million, versus $16 million in the year-ago period. The decrease was attributed in part to "cumulative catch-up adjustments in revenue due to changes in estimated costs for our future performance obligations under…collaboration agreements with Merck & Co. and AstraZeneca." The company also posted a quarterly loss of $124.2 million, compared with a loss of $132.6 million the same time last year. 

Moderna also announced several changes in management roles related to vaccine development, regulatory affairs and infectious diseases. Patrick Bergstedt will join Moderna on June 1 to lead the commercial vaccines portfolio, having most recently served as head of global marketing and commercial operations for vaccines at Merck. Charbel Haber will take on the role of senior vice president for regulatory affairs starting April 21, joining from Biogen where he served as vice president of global safety and regulatory sciences, while Jacqueline Miller was hired to serve as head of infectious disease development as of May 11, joining from GlaxoSmithKline, where she held several leadership roles. 

"We are excited to welcome these three new senior leaders, who bring extensive clinical development, regulatory and commercial experience, as we begin to pivot towards late-stage development and commercialisation," Bancel remarked. 

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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