Europe Approves Moderna's RSV Vaccine For Adults 60 And Over

On Friday, the European Commission approved Moderna, Inc.’s MRNA mRESVIA (mRNA-1345), an mRNA respiratory syncytial virus (RSV) vaccine, to protect adults aged 60 years and older from lower respiratory tract disease caused by RSV infection.

The marketing authorization follows the positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).

Also Read: Moderna Stock Trading Lower On Dismal Guidance, Analysts Cuts Price Targets Noting Competitive Pressure From GSK, Pfizer.

The marketing authorization is based on data from the Phase 3 clinical trial ConquerRSV, a global study conducted in approximately 37,000 adults ages 60 years or older.

The primary analysis with 3.7 months of median follow-up found a vaccine efficacy (VE) against RSV lower respiratory tract disease (LRTD) of 83.7%.

In a supplementary analysis with 8.6 months of median follow-up, mRNA-1345 maintained durable efficacy, with sustained VE of 63.3% against RSV-LRTD, including two or more symptoms.

VE was 74.6% against RSV-LRTD with ≥2 symptoms, including shortness of breath, and 63.0% against RSV-LRTD with three or more symptoms.

In May, the FDA approved Moderna’s mRESVIA to protect adults aged 60 and older from lower respiratory tract disease caused by RSV infection.

The approval was granted under a breakthrough therapy designation, marking the second approved mRNA product from Moderna, the first being the famed COVID-19 vaccine.

Separately, Moderna received approval from the Ministry of Health, Labour and Welfare in Japan for a partial change application for an updated formulation of its COVID-19 mRNA vaccine Spikevax, targeting the SARS-CoV-2 variant JN.1.

In May 2024, a Japanese health ministry panel recommended that COVID-19 vaccines be updated 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 entered into an agreement with Mitsubishi Tanabe Pharma Corporation to support the co-promotion of its mRNA respiratory vaccine portfolio in Japan, including Spikevax, Moderna’s COVID-19 vaccine.

Price Action: MRNA stock was up 0.88% at $81.76 at last check Friday.

Read Next:

• FDA Approves Updated COVID Vaccines From Pfizer And Moderna, But Leaves Out Novavax’s Shot.

Photo: Shutterstock