Moderna’s mRNA-based RSV vaccine safe, effective for older adults
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Key takeaways:
- Phase 2/3 data showed that the mRNA-1345 vaccine was effective in preventing RSV in adults 60 years.
- No safety concerns were evident in the study.
Moderna’s messenger RNA-based respiratory syncytial virus vaccine was safe and reduced RSV-related disease among older adults in a phase 2/3 trial, according to data published in The New England Journal of Medicine.
Moderna initially publicized data from the trial in January and used the results to initiate a rolling submission process with the FDA in July. If approved, it would be the third RSV vaccine available in the United States.
“The clinical spectrum of respiratory syncytial virus (RSV) disease ranges from mild upper respiratory symptoms to severe lower respiratory tract disease,” Eleanor Wilson, MD, senior director of clinical development at Moderna, and colleagues wrote. “Older adults are at increased risk for RSV-related complications and death owing to age-related immunosenescence and a higher prevalence of underlying conditions.”
According to the study, an estimated 5.2 million cases of RSV infection led to 470,000 hospitalizations and 33,000 in-hospital deaths among adults 60 years and older living in high-income countries in 2019. They added that the “societal burden” and health care utilization associated with RSV infection in older adults are “substantial.”
“As the worldwide population ages, the burden of RSV infection is expected to increase — a situation that highlights the need for an RSV vaccine in this population,” the authors wrote.
To assess mRNA-1345, an mRNA-based RSV vaccine from Moderna, Wilson and colleagues are conducting a phase 2/3 randomized, double-blind, placebo-controlled trial, during which participants aged 60 and older were randomly assigned 1:1 to receive one dose of the vaccine or a placebo.
According to the study, the primary efficacy end points are prevention of RSV-associated lower respiratory tract disease with at least two signs or symptoms and with at least three signs or symptoms.
Between Nov. 17, 2021, and Oct. 31, 2022, 35,541 participants were randomly assigned — 17,793 to the mRNA-1345 group and 17,748 to the placebo group.
In the primary analysis, 64 cases of RSV-associated lower respiratory tract disease with at least two symptoms were confirmed — nine in patients who received mRNA-1345 and 55 who received placebo — yielding a vaccine efficacy of 83.7% (95.88% CI, 66-92.2).
They also identified 20 cases of RSV-associated lower respiratory tract disease with at least three symptoms — three in the mRNA-1345 group and 17 in the placebo group — yielding a vaccine efficacy of 82.4% (96.36% CI, 34.8-95.3). For RSV-associated acute respiratory disease, 26 cases were reported in patients who had received mRNA-1345 and 82 in the placebo group. According to the study, this showed a vaccine efficacy of 68.4% (95% CI, 50.9-79.7)
In the safety analysis, researchers found that participants in the mRNA-1345 group had a higher incidence of solicited adverse reactions compared with those in the placebo group (58.7% vs. 16.2%), as well as systemic adverse reactions (47.7% vs. 32.9%). They added, though, that most reactions were mild to moderate in severity.
In a related editorial, Amanda C. Cohn, MD, and Aron J. Hall, DVM, MSPH, both of the CDC’s National Center for Immunization and Respiratory Diseases, wrote that these findings leverage “important innovations in vaccine development.” Moving forward, they wrote, an important consideration will be how much protection an mRNA vaccine provides during subsequent RSV seasons and if boosting will be necessary.
References:
- Cohn AC, et al. N Engl J Med. 2023;doi:10.1056/NEJMe2311862.
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