Moderna phase 3 trial shows RSV vaccine safe, effective in older adults
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Moderna announced Tuesday that its messenger RNA-based respiratory syncytial virus vaccine has met primary endpoints in a phase 3 trial showing that the vaccine is both safe and highly effective in older adults.
The data come from the phase 3 ConquerRSV study, which enrolled approximately 37,000 adults aged 60 years or older from multiple countries to test the vaccine.
Overall, the study showed that the vaccine was 83.7% (95.88% CI, 66.1%-92.2%) effective against RSV-associated lower respiratory tract disease as defined by two or more symptoms.
The also study showed that the vaccine was generally safe, with the most common side effects being injection-site pain, fatigue and headache.
Based on these results and other data gathered from the study, which Moderna plans to release at a medical meeting later this year, the company intends to submit for regulatory approval in the first half of 2023.
"Today's results represent an important step forward in preventing lower respiratory disease due to RSV in adults 60 years of age and older,” Stéphane Bancel, Moderna's Chief Executive Officer, said in a press release.
“These data are encouraging and represent the second demonstration of positive phase 3 trial results from our [messenger RNA] infectious disease vaccine platform after Spikevax, our COVID-19 vaccine,” Bancel said.
The company is also testing an mRNA vaccine against influenza and has said that its ultimate goal is to create combination vaccines that protect against several respiratory viruses, including influenza, SARS-CoV-2 and RSV. Additionally, the company is testing mRNA-1345 in a phase 1 trial in pediatric populations to address the “significant disease burden” of RSV in children.
Although there is currently no approved vaccine for RSV in adults, Moderna, Bavarian Nordic, GlaxoSmithKline and Pfizer all have candidates in late-stage development.
Healio previously reported that Pfizer’s candidate demonstrated 66.7% (96.66% CI, 28.8%-85.8%) efficacy against RSV-associated lower respiratory tract illness and 85.7% (96.66% CI, 32%-98.7%) efficacy against severe RSV-associated lower respiratory tract illness.
The trial showed that the vaccine was well tolerated with no safety concerns, according to Pfizer. The FDA granted priority review to Pfizer in early December with the expectation of a decision regarding the application in May 2023.
Moderna.
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