SARS-CoV-2 Vaccine Moves Into Phase 2 Study
A Massachusetts based biotechnology company pioneering messenger RNA (mRNA) vaccines announced progress in testing a SARS-CoV-2 coronavirus preventive vaccine.
“The imminent Phase 2 study (600 participants) start is a crucial step forward as we continue to advance the clinical development of mRNA-1273, our vaccine candidate against SARS-CoV-2,” said Stéphane Bancel, Moderna’s Chief Executive Officer, in a financial press statement.
“With the goal of starting the mRNA-1273 pivotal Phase 3 study early this summer, Moderna is now preparing to potentially have its first Biologics License Application (BLA) approved as soon as 2021.”
“We are 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.”
The U.S. Food and Drug Administration (FDA) completed its review of the Company’s Investigational New Drug (IND) application for its novel coronavirus (SARS-CoV-2 or COVID-19) vaccine candidate (mRNA-1273) allowing it to proceed to the Phase 2 study.
The Company is finalizing the protocol for the Phase 3 study, which is expected to begin in the early summer of 2020.
mRNA-1273 is an mRNA vaccine candidate against the novel coronavirus SARS-CoV-2 encoding for a prefusion stabilized form of the Spike (S) protein.
The S protein complex is necessary for membrane fusion and host cell infection and has been the target of vaccines against the coronaviruses responsible for Middle Eastern Respiratory Syndrome and Severe Acute Respiratory Syndrome.
Headquartered in Cambridge, Mass., Moderna currently has various strategic alliances for development programs.
Precision Vaccinations publishes coronavirus vaccine development news.