The U.S. Food and Drug Administration (FDA) has approved Moderna’s mRESVIA, an mRNA vaccine that will protect adults aged 60 and older from respiratory syncytial virus (RSV), a lower respiratory tract disease that kills 6,000 to 10,000 people aged 65 and above each year.
This approval marks the first time an mRNA vaccine has been authorized for a condition other than COVID-19.
mRESVIA contains an mRNA sequence encoding a stabilized glycoprotein that targets and neutralizes antibodies crucial for fighting off RSV infections. It provides health care professionals with a new tool in combating RSV, complementing existing RSV vaccines from GSK and Pfizer for the same age group.
Vaccine Maintains 84 percent Effectiveness at 3-Month Mark
The FDA approval of Moderna’s mRESVIA vaccine was based on the results of a phase 3 clinical trial involving 37,000 adults aged 60 and older. Half of the participants received the vaccine, while the other half received a placebo.
The trial demonstrated that mRESVIA was 83.7 percent effective in preventing RSV-associated lower respiratory tract disease with at least two symptoms and 82.4 percent effective in preventing the same condition with at least three symptoms. Against RSV-linked acute respiratory illness, the vaccine’s efficacy stood at a notable 68.4 percent, with the confidence interval spanning 50.9 to 79.7 percent.
Although some side effects, such as fatigue, headache, muscle pain, and joint pain, were reported, the study’s authors concluded that a single dose of mRESVIA resulted in no evident safety concerns and led to a lower incidence of RSV-related lower respiratory tract disease and acute respiratory disease compared to the placebo group.
RSV is a highly contagious virus that spreads seasonally, typically during winter, causing lower respiratory tract infections that can progress to pneumonia. It poses a significant threat to infants, young children, and older adults, with approximately 60,000 to 160,000 older adults requiring hospitalization each year due to RSV infections.
Rhe new mRESVIA vaccine, which will be available in pre-filled syringes to improve administration and reduce the risk of errors, should be accessible to health care providers and patients in the U.S. for the 2024-2025 respiratory virus season, according to Moderna.
The results of the study were published in the New England Journal of Medicine in December 2023.
RSV Vaccine Recommendations
The U.S. Centers for Disease Control and Prevention recommends that people aged 60 and above receive a single dose of the RSV vaccine.
The ideal time for vaccination is in late summer or early fall, just before the onset of the RSV season when the virus typically begins to spread within communities, according to the CDC.
The CDC advises pregnant women to get the RSV vaccine between weeks 32 and 36 of their pregnancy.
The vaccination is also recommended for infants aged 8 months or younger who were born during the RSV season, as well as infants and children between 8 and 19 months old who are entering their second RSV season.
