Moderna Inc. has again highlighted its partnership work with Wilmington-based PPD Inc. (Nasdaq: PPD) as the firm hits another milestone in the race to reach regulatory approvals for a COVID-19 vaccine.
Massachusetts-based Moderna announced Monday that the independent, National Institutes of Health-appointed Data Safety Monitoring Board (DSMB) for the phase 3 study of its mRNA-1273 vaccine candidate has informed Moderna that "the trial has met the statistical criteria pre-specified in the study protocol for efficacy, with a vaccine efficacy of 94.5%," according to a news release.
Moderna's mRNA-1273 is a vaccine candidate against COVID-19 co-developed by Moderna and investigators from the National Institute of Allergy and Infectious Diseases' (NIAID) Vaccine Research Center.
The study of this vaccine, known as the COVE study, enrolled more than 30,000 participants in the U.S. and is being conducted in collaboration with 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.
PPD, a global contract research organization, has played a role in the "successful execution of the COVE study," officials said in a release.
The efficiency rating included a study of 95 trial participants with COVID-19 cases.
"The primary endpoint of the Phase 3 COVE study is based on the analysis of COVID-19 cases confirmed and adjudicated starting two weeks following the second dose of vaccine. This first interim analysis was based on 95 cases, of which 90 cases of COVID-19 were observed in the placebo group versus 5 cases observed in the mRNA-1273 group, resulting in a point estimate of vaccine efficacy of 94.5% (p <0.0001)," according to the release. "A secondary endpoint analyzed severe cases of COVID-19 and included 11 severe cases (as defined in the study protocol) in this first interim analysis. All 11 cases occurred in the placebo group and none in the mRNA-1273 vaccinated group."
There was no report of significant safety concerns, and the majority of adverse events were mild or moderate in severity.
Pfizer and its partner in a separate coronavirus vaccine candidate study, BioNTech, reported last week a more than 90% effectiveness among 94 trial patients.
Moderna officials said that as more cases accrue leading up to the final analysis, the firm expects the point estimate for vaccine efficacy might change. Moderna plans to submit data from the full phase 3 COVE study to a peer-reviewed publication, stated the release.
“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, in the release.
Moderna officials said the firm intends to submit for an Emergency Use Authorization (EUA) with the FDA in the coming weeks and anticipates having the EUA informed by the final safety and efficacy data with a median duration of at least 2 months.
The firm also plans to submit applications for authorizations to global regulatory agencies.
"Moderna is working with the U.S. Centers for Disease Control and Prevention (CDC), Operation Warp Speed and McKesson (NYSE: MCK), a COVID-19 vaccine distributor contracted by the U.S. government, as well as global stakeholders to be prepared for distribution of mRNA-1273, in the event that it receives an EUA and similar global authorizations," officials said.
By the end of 2020, the Moderna officials said they expect to have approximately 20 million doses of mRNA-1273 ready to ship in the U.S. It is on track to manufacture 500 million to 1 billion doses globally in 2021, stated the release.
"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," Bancel said in the release. "We remain committed to and focused on doing our part to help end the COVID-19 pandemic.”