US-based biotechnology company Moderna has received the European Commission (EC) marketing authorisation for its respiratory syncytial virus (RSV) vaccine, mRESVIA.
mRESVIA is an mRNA-based RSV vaccine indicated to protect adults aged 60 years and above from lower respiratory tract disease caused by RSV infection.
The EC marketing authorisation follows the Positive Opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP).
The authorisation was based on positive data from the Phase 3 ConquerRSV clinical trial in nearly 37,000 adults, aged 60 years and above, in 22 countries.
In the primary analysis, the RSV vaccine showed 83.7% vaccine efficacy (VE) against RSV lower respiratory tract disease (LRTD).
Also, mRNA-1345 maintained durable efficacy, with sustained VE of 63.3% against RSV-LRTD, including two or more symptoms, in a supplementary analysis.
The most common adverse reactions in the clinical trial include injection site pain, fatigue, headache, myalgia, and arthralgia.
The authorisation allows Moderna to market its RSV vaccine in all 27 EU member states, along with Iceland, Liechtenstein, and Norway.
Moderna CEO Stéphane Bancel said: “The European Commission’s approval of mRESVIA is an important milestone for public health and highlights Moderna’s mRNA leadership.
“The approval marks the first time an mRNA vaccine has been approved for a disease beyond Covid-19 in Europe.
“mRESVIA safeguards older adults against severe RSV outcomes and is uniquely offered in a pre-filled syringe to enhance ease of administration, which can reduce vaccine preparation time and administrative errors.”
In a separate development, Moderna has received Japan’s Ministry of Health, Labour, and Welfare (MHLW) approval for an updated formulation of its Covid-19 mRNA vaccine Spikevax.
The updated formulation of Spikevax targets the SARS-CoV-2 variant JN.1.
In May this year, Japan’s health ministry recommended updated Covid-19 vaccines to target the JN.1 family of Omicron subvariants, for the national immunisation program (NIP).
Japan’s NIP provides Covid-19 vaccination to individuals aged 65 and older, along with qualifying individuals aged 60 to 64.
Bancel said: “We appreciate the Ministry of Health, Labour, and Welfare approval decision for our updated Covid-19 mRNA vaccine.
“It is important that people are vaccinated with the latest updated Covid-19 vaccines that can protect against circulating strains.
“With Covid-19 vaccination becoming a routine inoculation similar to seasonal flu vaccines, individuals will be able to receive their updated Covid-19 vaccine alongside their flu vaccine this fall.”
Last month, Moderna partnered with Mitsubishi Tanabe Pharma to support the co-promotion of its mRNA respiratory vaccines in Japan, including its Covid-19 vaccine Spikevax.
