Jul 16, 2020
Moderna Advancing COVID-19 Vaccine into Phase III after Positive Initial Clinical Results
Posted by Omuterema Akhahenda in categories: biotech/medical, health
Moderna, Inc.’s COVID-19 vaccine candidate mRNA-1273 will advance to a 30,000-participant Phase III trial later this month, following publication of additional positive Phase I data from a study led by the National Institutes of Health (NIH)’s National Institute of Allergy and Infectious Diseases (NIAID).
Moderna said its closely-watched COVID-19 vaccine candidate mRNA-1273 will advance to a 30,000-participant Phase III trial later this month, following publication of additional positive Phase I data from a study led by the NIH’s National Institute of Allergy and Infectious Diseases (NIAID).
The Phase III “COVE” study (NCT04470427) is expected to begin registration at study centers nationwide beginning on July 21 with study initiation set for six days later. The primary endpoint of the randomized, 1:1 placebo-controlled trial will be the prevention of symptomatic COVID-19 disease. Key secondary endpoints include prevention of severe COVID-19 disease as defined by the need for hospitalization, and prevention of infection by SARS-CoV-2, Moderna said.