Only a week after Pfizer and BioNTech’s preliminary data readout of its COVID-19 vaccine suggested a 90% efficacy rate, Moderna reported interim efficacy data for its vaccine of 94.5%. This is particularly excellent news given the surge of the disease and the distribution difficulties surrounding the Pfizer-BioNTech effort.
Both of these vaccine candidates require two doses about 28 days apart. The Pfizer-BioNTech vaccine requires storage at about -94 degrees F, which requires specialized freezers. The Moderna vaccine is stable at 36 to 46 degrees F, about the temperature of a standard home or medical refrigerator, for up to 30 days and can be stored for up to six months at -4 degrees F.
If both of these vaccines receive emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) in the upcoming weeks, it will provide health care providers with flexibility and more manufacturing capabilities.
Moderna’s Phase III trial underwent its first independent, interim data analysis conducted by a National Institutes of Health (NIH)-appointed Data Safety Monitoring Board (DSMB). The DSMB informed Moderna the trial had met the statistical criteria in the study design for efficacy, demonstrating efficacy of 94.5%. The COVE Phase III trial enrolled more than 30,000 patients in the U.S. and was being run in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID) and the Biomedical Advanced Research and Development Authority (BARDA).
The primary endpoint of the trial was based on analysis of COVID-19-positive cases confirmed two weeks after the second vaccine dose. The first interim analysis was built on 95 cases, with 90 cases of positive COVID-19 in the placebo group compared to five cases seen in the vaccinated group.