The U.S. Food and Drug Administration has completed its review of Moderna’s Investigational New Drug (IND) application for its SARS-CoV-2 vaccine candidate known as mRNA-1273, enabling the Cambridge, MA company to progress its vaccine candidate to Phase II expected to start soon. The next phase will include 600 participants while the company is finalizing its Phase III study planned to start in early summer.
The Phase I Study
Moderna’s Phase I study targeted 105 participants and sought a number of primary outcome measures such as first and foremost the frequency of adverse events (safety focus).
Fed Capital Injection
Moderna’s stock rose when word came out of a federal deal securing the company $483 million. The clinical stage biotech pioneering messenger RNA (mRNA)-based therapeutics and vaccines secured a commitment up to $483 million from the Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ADPR) with the U.S. Department of Health and Human Services to accelerate the company’s mRNA vaccine candidate targeting SARS-CoV-2.
The recent news was picked up by several media, including WBUR. Stephane Bancel, Moderna’s Chief Executive Officer was quoted, “The imminent Phase 2 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. With the goal of starting the mRNA-1273 pivotal Phase 3 study early this summer, Moderna is now preparing to potentially have its first 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.”