Moderna, Inc. has achieved another significant milestone with the European Commission’s approval of its mRNA respiratory syncytial virus (RSV) vaccine, mRESVIA. This vaccine is intended to protect adults aged 60 years and older from lower respiratory tract disease caused by RSV infection. The marketing authorization follows a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP).
This approval builds upon the FDA’s approval of mRESVIA in May, which granted the vaccine breakthrough therapy designation. This approval marked Moderna’s second approved mRNA product, the first being its renowned COVID-19 vaccine.
The European approval is based on data gathered from the Phase 3 clinical trial ConquerRSV. This global study involved approximately 37,000 adults aged 60 years or older. The primary analysis, with a median follow-up of 3.7 months, revealed a vaccine efficacy (VE) of 83.7% against RSV lower respiratory tract disease (LRTD).
Furthermore, a supplementary analysis with 8.6 months of median follow-up demonstrated that mRNA-1345 maintained durable efficacy. It showed sustained VE of 63.3% against RSV-LRTD, including instances with two or more symptoms. Notably, the VE against RSV-LRTD with ≥2 symptoms, including shortness of breath, was 74.6%. Additionally, the VE against RSV-LRTD with three or more symptoms was 63.0%.
Beyond the RSV vaccine, Moderna has also secured approval for an updated formulation of its COVID-19 mRNA vaccine, Spikevax, in Japan. This updated formulation targets the SARS-CoV-2 variant JN.1. This approval follows a recommendation by a Japanese health ministry panel in May 2024 to update COVID-19 vaccines to target the JN.1 family of Omicron subvariants for the 2024/2025 national immunization program (NIP). The NIP in Japan will offer COVID-19 vaccination to individuals aged 65 and older and qualifying individuals aged 60 to 64.
In July, Moderna further solidified its presence in Japan by entering into an agreement with Mitsubishi Tanabe Pharma Corporation. This agreement will see them co-promote Moderna’s mRNA respiratory vaccine portfolio in Japan, including Spikevax.
These recent approvals and partnerships underscore Moderna’s continued commitment to the advancement of mRNA technology and its dedication to addressing critical public health needs. MRNA stock was up 0.88% at $81.76 at the end of the trading day on Friday.
