Moderna succeeds in early stage human trial of COVID-19 Vaccine
More Good News from Moderna!
Moderna, Inc. a biotechnology company, today announced positive interim clinical data of a vaccine against novel coronavirus (SARS-CoV-2), from the Phase 1 study led by the National Institute of Allergy and Infectious Diseases (NIAID).
At day 43, two weeks following the second dose, the levels of binding antibodies were at the levels seen in blood samples from people who have recovered from COVID-19. Moderna anticipates the dose for the Phase 3 study to be between 25 µg and 100 µg and expects Phase 3 trial initiation in July, subject to finalisation of the clinical trial protocol.
With today’s positive interim Phase 1 data and the positive data in the mouse challenge model, the Moderna team continues to focus on moving as fast as safely possible to start our pivotal Phase 3 study in July and, if successful, file a BLA
Stéphane Bancel, Chief Executive Officer at Moderna.
The Biologics License Application (BLA) is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce.
Funding from the 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
Moderna’s Share price was up 20% on Monday and up 60% over the last 1 month.