The Food and Drug Administration is allowing the Phase II trial of one of the leading vaccine programs for Covid-19 to proceed, while a Phase III trial is expected to start in the coming months, the company developing it said Thursday.
In its first quarter 2020 earnings, Cambridge, Massachusetts-based Moderna said the FDA had completed the review of its application to advance the vaccine, mRNA-1273, into Phase II testing and allowed it to proceed. That study is expected to begin shortly, with a presentation stating that it would be within the current second quarter. In addition, Moderna said it is finalizing the protocol of its Phase III study and expects it to start in the early summer.
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“The imminent Phase II study start is a crucial step forward as we continue to advance the clinical development of mRNA-1273, our vaccine candidate against SARS-CoV-2,” Moderna CEO Stephane Bancel said in a statement. “With the goal of starting the mRNA-1273 pivotal Phase III study early this summer, Moderna is now preparing to potentially have its first [biologics license application] approved as soon as 2021.”
Shares of Moderna were up 8.4% on the Nasdaq in midday trading Thursday.
The company had announced the filing of its application to start the Phase II trial last Tuesday, saying that the agency’s decision would hinge on the support of safety data from the ongoing Phase I study, which is being sponsored by the National Institute of Allergy and Infectious Diseases. However, while the Phase I study has completed enrollment of three dosing cohorts – receiving the vaccine at 25, 100 and 250 micrograms – and is expanding to an additional six in older and elderly adults, the company has not released those safety data publicly.
The Phase II trial will enroll 600 participants divided into two cohorts, one comprising those aged 18-55 and another of people aged 55 and older.
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On Friday, Moderna said it had partnered with Swiss contract manufacturer Lonza on a 10-year deal for large-scale manufacturing of mRNA-1273 and other products. The companies will open manufacturing suites at Lonza’s U.S. and Swiss plants and manufacture supplies of the vaccine at both. Following technology transfer in June, manufacturing will start in July, with plans to ultimately manufacture up to 1 billion doses per year, based on the currently assumed dose of 50 micrograms. Moderna’s previously announced $483 million funding deal with the federal Biomedical Advanced Research and Development Authority, which is designed to fund mRNA-1273’s development through registration, will partially cover the manufacturing.
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