Europe approves Moderna’s snRNA vaccine against respiratory syncytial virus (RSV)

European Commission gives green light to commercialization Moderna’s mRESVIA mRNA vaccine against respiratory syncytial virus (RSV) for people over 60 years of age. The authorisation comes almost three months after the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion last June on the breakthrough therapy designation.

The vaccine, called mRESVIA (mRNA-1345), First commercially available mRNA against RSV in this age group. Europe has previously approved other vaccines against this respiratory disease: GSK ‘Arexvi’which was given the green light last June for use in the same population as Moderna, and Abrasive from Pfizer, which was approved at least a month later. The latter is also intended for mothers during pregnancy to protect their children.

The burden of disease caused by RSV is particularly high in infants and the elderly. In the European Union, the virus is estimated to cause about 160,000 adult hospitalisations each year, of which 92% are in people over 65 years of age.

Efficiency 84%

The marketing authorization of mRESVIA is based on positive data from the Phase 3 ConquerRSV study, a global clinical trial conducted in approximately 37,000 adults aged 60 years and older in 22 countries. The primary analysis, with a median follow-up of 3.7 months, found vaccine efficacy against RSV lower respiratory disease (LRD) of 84%, the results were published. The New England Journal of Medicine. In a post-hoc analysis with a median follow-up of 8.6 months, mRESVIA demonstrated durable efficacy with 63.3% effectiveness against RSV ETRIs including two or more symptoms.

In May 2024, the U.S. Food and Drug Administration (FDA) approved mRESVIA (mRNA-1345) for people aged 60 and older. The approval was granted under breakthrough therapy designation, with a second approval granted to Moderna.

“mRESVIA protects older adults from serious consequences caused by RSV and offered exclusively in pre-filled syringes to simplify administration, which could reduce vaccine preparation time and reduce administrative errors,” said Stéphane Bancel, the biotech company’s CEO.

“The approval of mRESVIA by the European Commission (EC) is an important milestone for public health and underlines Moderna’s leadership in mRNA. This approval represents the first authorization of an mRNA vaccine against a disease other than Covid-19 in Europe,” said Stéphane Bancel, CEO of Moderna.