MRNA-1345 Vaccine Approved: FDA & Adult Immunization
- The Food and Drug Administration has given the green light to mRNA-1345 (mRESVIA), Moderna's respiratory syncytial virus (RSV) vaccine, for use in high-risk adults aged 18 to 59.
- RSV leads to roughly 60,000 to 160,000 hospitalizations and 6,000 to 10,000 deaths annually among older adults.
- stéphane Bancel, Moderna's chief executive officer, hailed the approval as "an important step forward" in protecting vulnerable populations from severe RSV illness, noting that RSV poses a serious...
The FDA has approved moderna’s mRNA-1345 mRESVIA vaccine, a significant advancement in respiratory syncytial virus (RSV) protection for high-risk adults aged 18-59, expanding access to this crucial immunization.This news follows the earlier approval for those 60 and older, marking an important step in safeguarding vulnerable populations from severe illness. The vaccine utilizes cutting-edge mRNA technology, targeting the prefusion F glycoprotein to neutralize the virus and protect against lower respiratory tract disease, offering a proactive measure against a serious health threat. News directory 3 keeps you informed on the latest in adult immunization updates. Discover what’s next in RSV prevention.
Moderna RSV Vaccine Approved for High-Risk Adults Aged 18-59
Updated June 15, 2025
The Food and Drug Administration has given the green light to mRNA-1345 (mRESVIA), Moderna’s respiratory syncytial virus (RSV) vaccine, for use in high-risk adults aged 18 to 59. This follows the FDA’s May 2024 approval of the same vaccine for adults 60 and older, aimed at preventing lower respiratory tract disease caused by RSV infection.
RSV leads to roughly 60,000 to 160,000 hospitalizations and 6,000 to 10,000 deaths annually among older adults. The CDC notes that RSV poses a significant threat, especially to older individuals and those with chronic conditions or those in nursing homes. While RSV can manifest as mild, cold-like symptoms in adults and older children, severe infections can lead to fever, severe cough, wheezing, rapid or labored breathing, and bluish skin discoloration.
stéphane Bancel, Moderna’s chief executive officer, hailed the approval as “an important step forward” in protecting vulnerable populations from severe RSV illness, noting that RSV poses a serious health risk to adults with certain chronic conditions.
The Role of mRNA-1345 in RSV Protection
The mRNA-1345 vaccine uses mRNA technology to combat RSV. It delivers a genetic sequence that codes for a stabilized prefusion F glycoprotein, a protein on the RSV virus’s surface that is essential for cell entry. This prefusion form is a prime target for neutralizing antibodies and is consistent across RSV-A and RSV-B subtypes. the vaccine employs the same lipid nanoparticles (LNPs) used in Moderna’s COVID-19 vaccine.
Phase 3 Study Results
The FDA’s approval was based on a phase 3 clinical trial (NCT06067230) assessing