American biotechnology company, Moderna, who has developed a vaccine for novel coronavirus (SARS-CoV-2), stated the Phase 1 study showed positive results. The company’s mRNA-1273 vaccine study was led by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH).
The positive result of Phase 1 will help Moderna to plan its Phase 3 study in July and, if successful, file a BLA. Adding to it, Stéphane Bancel, Chief Executive Officer at Moderna, said, “We are investing to scale up manufacturing so we can maximise the number of doses we can produce to help protect as many people as we can from SARS-CoV-2.”
Meanwhile, Tal Zaks, Chief Medical Officer at Moderna, said, “When combined with the success in preventing viral replication in the lungs of a pre-clinical challenge model at a dose that elicited similar levels of neutralising antibodies, these data substantiate our belief that mRNA-1273 has the potential to prevent COVID-19 disease and advance our ability to select a dose for pivotal trials.”
The first clinical batch, which was funded by the Coalition for Epidemic Preparedness Innovations, was completed on February 7, 2020 and underwent analytical testing.
At present, Moderna is finalising the protocol for a Phase 3 study, expected to begin in July 2020.
The company stated Biomedical Advanced Research and Development Authority (BARDA), a division of the Office of the Assistant Secretary for Preparedness and Response (ASPR) within the U.S. Department of Health and Human Services (HHS), supported the planning for the Phase 2 and Phase 3 studies of mRNA-1273. The company is expecting it to support the execution of these studies, as well as the scale-up of mRNA-1273 manufacturing both at the Company’s facilities and its collaborator, Lonza Ltd.
