Moderna's Vaccine Gets EU Approval for RSV

Coming off the heels of an FDA approval this past May, Moderna’s has received approval from the European Commission for its respiratory syncytial virus (RSV) vaccine, brand named mRESVIA. Hailing the approval, Moderna CEO Stéphane Bancel, stated that the approval was “an important milestone for public health and highlights Moderna’s mRNA leadership…marking the first time an mRNA vaccine has been approved for a disease beyond COVID-19 in Europe.”

Moderna's entry into the RSV vaccine market positions the company as a key player in respiratory virus prevention, expanding its portfolio that already includes vaccines for COVID-19 and other infectious diseases.

The commission's approval of mRESVIA is based on positive phase 3 trial data that was published in the New England Journal of Medicine in December 2023. The ConquerRSV study was conducted in approximately 37,000 adults aged 60 years or older in 22 countries. The study successfully met its primary endpoint against RSV-associated lower respiratory tract disease. The vaccine demonstrated high efficacy against RSV-associated lower respiratory tract disease with at least two signs or symptoms, with percentages ranging from 82.4% to 83.7%. ​ No cases of RSV-associated lower respiratory tract disease were reported in adults aged 80 years or older.

Respiratory syncytial rirus (RSV) is a significant public health concern, particularly during the fall and winter. It’s one of the leading causes of respiratory tract infection in older adults, often leading to hospitalization. For the elderly and immunocompromised individuals, RSV can be particularly dangerous, resulting in severe outcomes.

mRESVIA consists of an mRNA sequence encoding a stabilized prefusion F glycoprotein. The F glycoprotein appears on the virus's surface and is crucial in helping the virus enter host cells.

The prefusion form of the F protein is essential and a primary target for neutralizing antibodies. This form is also highly conserved across the RSV-A and RSV-B viral subtypes. mRESVIA utilizes lipid nanoparticles similar to those used in Moderna's COVID-19 vaccines.

Advances in medical research have brought effective RSV vaccines to the market, such as Arexvy and Abrysvo. Neither is an mRNA vaccine, but both vaccines are indicated to prevent RSV in adults.

The European Commission's approval for signifies a crucial step in public health. This is especially significant given the high incidence of RSV-related hospitalizations and mortality in vulnerable groups in Europe.Over 90% of RSV hospital admissions across the European Union occurred in adults 65 years of age and older, highlighting the urgent need for effective prevention and treatment measures.

Following the European Commission's approval, the next steps will involve rolling out the vaccine in European countries and monitoring its efficacy and safety on an ongoing basis.