Moderna Receives MHRA Marketing Authorization for RSV Vaccine

Moderna, Inc. (NASDAQ:MRNA), a leader in the development of mRNA vaccines and therapeutics, has received marketing authorization from the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK for its respiratory syncytial virus (RSV) vaccine, mRESVIA® (mRNA-1345). This authorization allows the vaccine to be used in adults aged 60 years and older, protecting them from lower respiratory tract disease caused by RSV infection. The MHRA's decision follows the positive opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) and is valid in all 27 EU member states, as well as Iceland, Liechtenstein, and Norway.

RSV is a highly contagious seasonal respiratory virus that causes significant morbidity and mortality in elderly adults. In the UK, RSV is estimated to cause approximately 175,000 GP appointments, 14,000 hospitalizations, and 8,000 deaths in adults aged 65 years and older each year. The MHRA's authorization of mRESVIA® is an important milestone for public health and highlights Moderna's mRNA leadership, as it marks the first time an mRNA vaccine has been approved for a disease beyond COVID-19 in Europe.

The marketing authorization for mRESVIA® is based on positive data from the Phase 3 clinical trial ConquerRSV, a global study conducted in approximately 37,000 adults aged 60 years or older in 22 countries. 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% (95.88% CI 66.0%, 92.2%). In a supplementary analysis with 8.6 months of median follow-up, mRNA-1345 maintained durable efficacy, with sustained VE of 63.3% (95% CI: 48.7%, 73.7%) against RSV-LRTD, including two or more symptoms. VE was 74.6% (95% CI, 50.7, 86.9) against RSV-LRTD with ≥2 symptoms, including shortness of breath, and VE was 63.0% (95% CI, 37.3%, 78.2%) against RSV LRTD including three or more symptoms. The stringent statistical criterion of the study, a lower bound on the 95% CI of >20%, continued to be met for both endpoints.

The most commonly reported solicited adverse reactions were injection site pain, fatigue, headache, myalgia, and arthralgia. In May 2024, the U.S. Food and Drug Administration (FDA) approved mRESVIA® (mRNA-1345) for the same indication, marking Moderna's second approved mRNA product. Moderna has filed for mRNA-1345 marketing authorization applications in multiple markets worldwide.

Moderna's Chief Executive Officer, Stéphane Bancel, commented on the MHRA's authorization, stating, "The MHRA's approval of our RSV vaccine is an important milestone for public health and highlights Moderna's mRNA leadership. This 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."

Moderna's shares dipped slightly on the approval announcement, likely due to the revised efficacy of mRESVIA®. However, analysts at William Blair estimate that mRESVIA® could eventually capture around 27% of the US market, which would translate to $1.5 billion in revenue in 2033. Assuming a similar market share in the UK, mRESVIA® could potentially generate significant revenue for Moderna in the UK market.

In conclusion, the MHRA's marketing authorization of mRESVIA® is a significant step forward in the fight against RSV, a leading cause of lower respiratory tract infections and pneumonia in elderly adults. With its unique mRNA technology and pre-filled syringe design, mRESVIA® offers a convenient and effective solution for protecting older adults from the severe consequences of RSV infection. As the first mRNA vaccine approved for a disease beyond COVID-19 in Europe, mRESVIA® further solidifies Moderna's position as a leader in the development of innovative vaccines and therapeutics.