mRNA RSV Vaccine Recommended in Europe

Moderna, Inc. today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the granting of marketing authorization in the European Union (EU) for mRESVIA® (mRNA-1345), an mRNA respiratory syncytial virus (RSV) vaccine, to protect older adults.

Following the CHMP's positive opinion, the European Commission will decide on the authorization of mRESVIA.

In the EU, RSV is estimated to cause approximately 160,000 hospital admissions in adults each year.

"The positive opinion from the EMA CHMP for mRESVIA highlights the innovation and adaptability of our mRNA platform," said Stéphane Bancel, Chief Executive Officer of Moderna, in a press release on June 28, 2024. "mRESVIA safeguards older adults against severe RSV outcomes and is uniquely offered in a pre-filled syringe to enhance ease of administration...."

In May 2024, the U.S. Food and Drug Administration (FDA) approved mRESVIA, which uses the same lipid nanoparticles as the Moderna COVID-19 vaccines.

As of June 30, 2024, the FDA has approved three vaccines and one monoclonal antibody (Beyfortus) to prevent RSV in people.

As of May 22, 2024, the CDC's RSVVaxView reported that the overall RSV vaccination rate among pregnant women was about 17.8%, and an estimated 24.4% of adults 60 years and older reported receiving an RSV vaccine.