Moderna Receives European Commission Approval for RSV Vaccine mRESVIA(R)

Rhea-AI Summary

Moderna's mRNA RSV vaccine, mRESVIA®, has received European Commission approval for adults aged 60 and older. This marks the first mRNA vaccine approved beyond COVID-19 in Europe. The approval is based on the Phase 3 ConquerRSV trial, which showed 83.7% vaccine efficacy against RSV lower respiratory tract disease. With 8.6 months median follow-up, efficacy remained at 63.3%. RSV causes about 160,000 hospital admissions annually in the EU, with 92% in adults 65+. mRESVIA is uniquely offered in a pre-filled syringe for easier administration. The vaccine was previously approved by the FDA in May 2024.

Positive

• European Commission approval for mRESVIA vaccine for adults 60+
• First mRNA vaccine approved beyond COVID-19 in Europe
• 83.7% vaccine efficacy in Phase 3 trial
• Sustained efficacy of 63.3% after 8.6 months
• Pre-filled syringe offering for easier administration
• FDA approval already obtained in May 2024

Negative

• None.

Medical Research Analyst

The EC approval of mRESVIA for RSV prevention in older adults is a significant advancement. With an impressive 83.7% initial vaccine efficacy against RSV lower respiratory tract disease, declining to 63.3% after 8.6 months, it shows strong and durable protection. The vaccine's efficacy in preventing more severe cases (74.6% for cases with shortness of breath) is particularly noteworthy. This could substantially reduce the estimated 160,000 annual RSV-related hospital admissions in the EU, potentially leading to significant healthcare cost savings and improved quality of life for older adults.

Financial Analyst

Moderna's expansion beyond COVID-19 vaccines marks a important diversification of its product portfolio. The mRESVIA approval opens up a substantial market opportunity, given the high incidence of RSV in older adults. With 92% of RSV hospitalizations occurring in those 65 and over, this demographic represents a large, recurring customer base. The pre-filled syringe format could provide a competitive edge, potentially leading to preferential adoption by healthcare providers. While revenue projections aren't provided, this approval could significantly boost Moderna's financial outlook, reducing its reliance on COVID-19 vaccine sales and potentially stabilizing its long-term revenue streams.

Market Research Analyst

The approval of mRESVIA represents a strategic win for Moderna in the competitive vaccine market. As the first mRNA vaccine approved for a non-COVID-19 disease in Europe, it reinforces Moderna's leadership in mRNA technology and could pave the way for future applications. The large-scale Phase 3 trial involving 37,000 adults across 22 countries provides robust evidence of efficacy and safety, which could boost consumer and healthcare provider confidence. With approvals now in both the US and EU, Moderna is well-positioned to capture a significant share of the global RSV vaccine market, potentially outpacing competitors and setting new standards in vaccine development and delivery.

CAMBRIDGE, MA / ACCESSWIRE / August 23, 2024 / Moderna, Inc. (NASDAQ:MRNA) today announced that the European Commission (EC) has granted marketing authorization for mRESVIA® (mRNA-1345), an mRNA respiratory syncytial virus (RSV) vaccine, to protect adults aged 60 years and older from lower respiratory tract disease caused by RSV infection. The marketing authorization follows the Positive Opinion from the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP). The authorization is valid in all 27 EU member states, as well as Iceland, Liechtenstein and Norway.

"The European Commission's approval of mRESVIA 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," said Stéphane Bancel, Chief Executive Officer of Moderna. "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."

RSV is a highly contagious seasonal respiratory virus and a leading cause of lower respiratory tract infections and pneumonia. It causes a particularly high burden of disease in infants and older adults. In the European Union, RSV is estimated to cause approximately 160,000 hospital admissions in adults each year, with 92% of these admissions occurring in adults aged 65 and over.¹

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 ages 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%), with these results published in The New England Journal of Medicine. 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) to protect adults aged 60 years and older from lower respiratory tract disease caused by RSV infection. The approval was granted under a breakthrough therapy designation and marked Moderna's second approved mRNA product. Moderna has filed for mRNA-1345 marketing authorization applications in multiple markets worldwide.

About mRESVIA^® (Respiratory Syncytial Virus Vaccine)

mRESVIA^® is an RSV vaccine that consists of an mRNA sequence encoding a stabilized prefusion F glycoprotein. The F glycoprotein is expressed on the surface of the virus and is required for infection by helping the virus to enter host cells. The prefusion conformation of the F protein is a significant target of potent neutralizing antibodies and is highly conserved across both RSV-A and RSV-B subtypes. The vaccine uses the same lipid nanoparticles (LNPs) as the Moderna COVID-19 vaccines.

About Moderna

Moderna is a leader in the creation of the field of mRNA medicine. Through the advancement of mRNA technology, Moderna is reimagining how medicines are made and transforming how we treat and prevent disease for everyone. By working at the intersection of science, technology and health for more than a decade, the company has developed medicines at unprecedented speed and efficiency, including one of the earliest and most effective COVID-19 vaccines.

Moderna's mRNA platform has enabled the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases and autoimmune diseases. With a unique culture and a global team driven by the Moderna values and mindsets to responsibly change the future of human health, Moderna strives to deliver the greatest possible impact to people through mRNA medicines. For more information about Moderna, please visit modernatx.com and connect with us on X (formerly Twitter), Facebook, Instagram, YouTube and LinkedIn.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including statements regarding: the authorization by the European Commission of Moderna's RSV vaccine mRESVIA; the vaccine efficacy and safety of mRNA-1345; the potential for mRESVIA to reduce disease burden from RSV; and Moderna's pending marketing authorization applications for mRNA-1345. The forward-looking statements in this press release are neither promises nor guarantees, and you should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties, and other factors, many of which are beyond Moderna's control and which could cause actual results to differ materially from those expressed or implied by these forward-looking statements. These risks, uncertainties, and other factors include, among others, those risks and uncertainties described under the heading "Risk Factors" in Moderna's Annual Report on Form 10-K for the fiscal year ended December 31, 2023, and in subsequent filings made by Moderna with the U.S. Securities and Exchange Commission, which are available on the SEC's website at www.sec.gov. Except as required by law, Moderna disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release in the event of new information, future developments or otherwise. These forward-looking statements are based on Moderna's current expectations and speak only as of the date of this press release.

Moderna Contacts

Media:
Luke Mircea-Willats
Senior Director, International Communications
Luke.mirceawillats@modernatx.com

Investors:
Lavina Talukdar
Senior Vice President & Head of Investor Relations
+1 617-209-5834
Lavina.Talukdar@modernatx.com

¹Osei-Yeboah R, Spreeuwenberg P, Del Riccio M, Fischer TK, Egeskov-Cavling AM, Bøås H, van Boven M, Wang X, Lehtonen T, Bangert M, Campbell H, Paget J; Respiratory Syncytial Virus Consortium in Europe (RESCEU) Investigators. Estimation of the Number of Respiratory Syncytial Virus-Associated Hospitalizations in Adults in the European Union. J Infect Dis. 2023 Nov 28;228(11):1539-1548. doi: 10.1093/infdis/jiad189. PMID: 37246742; PMCID: PMC10681866.

SOURCE: Moderna, Inc.

View the original press release on accesswire.com

FAQ

What is the efficacy of Moderna's mRESVIA (MRNA) vaccine against RSV?

The Phase 3 ConquerRSV trial showed an initial vaccine efficacy of 83.7% against RSV lower respiratory tract disease. After 8.6 months of median follow-up, the sustained efficacy was 63.3%.

When did Moderna (MRNA) receive European Commission approval for mRESVIA?

Moderna received European Commission approval for mRESVIA, its RSV vaccine, on August 23, 2024.

What age group is Moderna's mRESVIA (MRNA) approved for in Europe?

mRESVIA is approved in Europe to protect adults aged 60 years and older from lower respiratory tract disease caused by RSV infection.

How is Moderna's mRESVIA (MRNA) vaccine uniquely offered?

mRESVIA is uniquely offered in a pre-filled syringe to enhance ease of administration, which can reduce vaccine preparation time and administrative errors.