Moderna Korea said on the 19th that the respiratory syncytial virus (RSV) messenger ribonucleic acid (mRNA) vaccine "mRESVIA pre-filled syringe (PFS)" has been approved by the Ministery of Food and Drug Safety. It is the first mRNA platform vaccine in Korea for RSV prevention.
The mRESVIA pre-filled syringe was approved to prevent lower respiratory tract disease (LRTD) caused by RSV in adults 60 and older and in high-risk adults ages 18 to under 60. RSV can range from cold-like symptoms to severe lower respiratory tract infections such as pneumonia, and the disease burden is known to be particularly high among older adults and adults with underlying conditions.
The approval was based on results from a phase 3 clinical trial of about 37,000 adults ages 60 and older in 22 countries, including Korea. No significant safety concerns were identified in the trial.
Kim Sang-pyo, head of Moderna Korea, said, "RSV is a major respiratory disease that can lead to hospitalization and severe complications among older adults and adults with underlying conditions," adding, "The mRESVIA pre-filled syringe is Moderna's second product approved in Korea, following the COVID-19 vaccine, and it is meaningful that mRNA technology can now contribute to public health by preventing RSV."