CAMBRIDGE, Mass.—Following on the heels of Pfizer's announcement regarding promising efficacy for its COVID-19 vaccine candidate, Moderna Inc. provided the public with more good news: the independent NIH-appointed Data Safety Monitoring Board (DSMB) for its Phase 3 vaccine study reported that the trial met its pre-specified statistical criteria for efficacy, demonstrating a vaccine efficacy of 94.5 percent. The COVD study consists of more than 30,000 participants in the United States and is being conducted in collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services. Moderna has also partnered with the contract research organization PPD.
mRNA-1273 is an mRNA vaccine encoding for a prefusion stabilized form of the SARS-CoV-2 Spike protein, and was codeveloped by Moderna and investigators from NIAID's Vaccine Research Center.
The primary endpoint for the study is based on the analysis of COVID-19 cases confirmed and adjudicated starting two weeks following the second dose of vaccine. These data come from the first interim analysis, which was based on 95 cases of COVID-19, with 90 cases observed in the placebo group and five cases in the mRNA-1273 group. The 95 cases included 15 adults aged 65 years and over, as well as 20 participants from diverse demographics, including 12 Hispanic or Latinx, four Black, three Asian American and one multiracial.
A secondary endpoint for this study looked at severe COVID-19 cases, as defined by the study protocol. Eleven severe cases were included in the interim analysis, all of which were observed in the placebo group.
The DSMB also reviewed available safety data, with no significant safety concerns reported. The vaccine was generally well tolerated, with the majority of adverse events ranked as mild or moderate in severity. Grade 3 (severe) events greater than or equal to 2 percent in frequency after the first dose included injection site pain (2.7 percent), and after the second dose included fatigue (9.7 percent), myalgia (8.9 percent), arthralgia (5.2 percent), headache (4.5 percent), pain (4.1 percent) and erythema/redness at the injection site (2.0 percent), all of which were generally short-lived.
“This is a pivotal moment in the development of our COVID-19 vaccine candidate. Since early January, we have chased this virus with the intent to protect as many people around the world as possible. All along, we have known that each day matters. This positive interim analysis from our Phase 3 study has given us the first clinical validation that our vaccine can prevent COVID-19 disease, including severe disease,” said Stéphane Bancel, CEO of Moderna.
“This milestone is only possible because of the hard work and sacrifices of so many. I want to thank the thousands of participants in our Phase 1, Phase 2 and Phase 3 studies, and the staff at our clinical trial sites who have been on the front lines of the fight against the virus. They are an inspiration to us all. I want to thank the NIH, particularly NIAID, for their scientific leadership including through years of foundational research on potential pandemic threats at the Vaccine Research Center that led to the discovery of the best way to make Spike protein antigens that are being used in our vaccine and others’. I want to thank our partners at BARDA and Operation Warp Speed who have been instrumental to accelerating our progress to this point,” Bancel continued. “Finally, I want to thank the Moderna team, our suppliers and our partners, for their tireless work across research, development and manufacturing of the vaccine. We look forward to the next milestones of submitting for an EUA in the U.S., and regulatory filings in countries around the world, while we continue to collect data on the safety and efficacy of the vaccine in the COVE study. We remain committed to and focused on doing our part to help end the COVID-19 pandemic.”
Regarding that EUA, or Emergency Use Authorization, Moderna reports that it intends to submit its application in the next few weeks as well as applications for authorizations to global regulatory agencies. The EUA is expected to be informed by final efficacy and safety data, which will feature 151 cases and a median duration of at least two months. Moderna expects to have roughly 20 million doses of mRNA-1273 ready to ship in the United States by the end of the year, with the goal of producing 500 million to 1 billion doses globally next year.
In addition, Moderna also announced that data have shown that mRNA-1273 can remain stable at 2° to 8°C (36° to 46°F) for 30 days, which is the temperature of a standard medical or home refrigerator. The vaccine candidate remains stable at -20° C (-4°F) for up to six months, at the aforementioned temperature for up to 30 days, and at room temperature for up to 12 hours.
“We believe that our investments in mRNA delivery technology and manufacturing process development will allow us to store and ship our COVID-19 vaccine candidate at temperatures commonly found in readily available pharmaceutical freezers and refrigerators,” stated Juan Andres, chief technical operations and quality officer at Moderna. “We are pleased to submit these extended stability conditions for mRNA-1273 to regulators for approval. The ability to store our vaccine for up to 6 months at -20° C including up to 30 days at normal refrigerator conditions after thawing is an important development and would enable simpler distribution and more flexibility to facilitate wider-scale vaccination in the United States and other parts of the world.”