Wayne State University School of Medicine’s Assistant Dean of Global Affairs Marcus Zervos, M.D. ’79, is among more than 30 COVID-19 vaccine researchers nationwide who teamed up to detail the final results of a study showing that the vaccine remains safe and effective against the virus more than five months after it is given.
“Efficacy of the mRNA-1273 SARS-CoV-2 Vaccine at Completion of Blinded Phase” was published last month in The New England Journal of Medicine. It includes the vaccine efficacy and safety results of the final analysis of the blinded phase of the trial, ending 5.3 months after the second dose, and in additional analyses in important subgroups of interest, as well as findings on the effect of vaccination on asymptomatic infection and on efficacy at various time intervals since vaccination.
The findings are based on a median follow-up of 148 days in the blinded phase and are similar to those observed previously at a median follow-up of 64 days, indicating that the high efficacy of the mRNA-1273 vaccine is maintained in the medium term.
“The immunity does wane after six to eight months depending on the participant, resulting in need for boosters, but remains effective in reducing hospitalization and death,” said Dr. Zervos, division head of Infectious Diseases at Henry Ford Hospital.
In the phase three, observer-blinded, randomized, placebo-controlled trial, adults in medically stable condition were enrolled at 99 sites in the United States. They included those 65 or older and those with coexisting conditions, and various ethnic and racial groups.
Dr. Zervos is the COVID-19 vaccine study’s principle investigator at the Detroit site, with WSU Associate Professor of Pharmacy Practice and Director of Research Paul Kilgore, M.P.H., M.D., FACP, serving as co-investigator.
The Detroit site is a collaboration between WSU and the Henry Ford Health System. “We were among the lead enrolling site and lead enrolling site in diversity enrollment,” Dr. Zervos added.
The national study was funded by the Biomedical Advanced Research and Development Authority, and the National Institute of Allergy and Infectious Diseases; COVE ClinicalTrials.gov number, NCT04470427.