EMA Committee For Medicinal Products For Human Use Adopts Positive Opinion Recommending Marketing Authorization Of Moderna’s RSV Vaccine, mRESVIA(R)

Rhea-AI Summary

Moderna has announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has given a positive opinion on the marketing authorization for mRESVIA (mRNA-1345), their mRNA vaccine for respiratory syncytial virus (RSV). This vaccine is intended for adults aged 60 and older to protect against lower respiratory tract disease caused by RSV. The decision by the European Commission on the authorization of mRESVIA is pending.

RSV is a significant cause of lower respiratory infections and pneumonia, particularly affecting older adults. The CHMP's positive opinion is based on Phase 3 clinical trial data from the ConquerRSV study, which involved about 37,000 adults aged 60 and above in 22 countries. The trial showed a vaccine efficacy (VE) of 83.7% against RSV lower respiratory tract disease with a median follow-up of 3.7 months. With an 8.6-month follow-up, the vaccine showed sustained efficacy of 63.3%.

In May 2024, the U.S. FDA approved the vaccine under a breakthrough therapy designation. Moderna has also filed for marketing authorizations in various additional markets globally.

Positive

• The EMA CHMP adopted a positive opinion for mRESVIA, recommending marketing authorization in the EU.
• The Phase 3 clinical trial data showed 83.7% vaccine efficacy (VE) against RSV lower respiratory tract disease (LRTD) with 3.7 months of follow-up.
• The vaccine maintained durable efficacy with a VE of 63.3% at 8.6 months of follow-up.
• The U.S. FDA approved mRESVIA in May 2024 under a breakthrough therapy designation.

Negative

• None.

Financial Analyst

Moderna's mRESVIA vaccine receiving a positive opinion from the EMA CHMP is a significant milestone for the company, especially considering the market potential for RSV vaccines in the EU. A positive decision from the European Commission could open up a lucrative revenue stream for Moderna, which is important given the high costs associated with mRNA technology. For context, Moderna's other mRNA products have shown considerable revenue growth and the addition of mRESVIA could further bolster the company's financial standing.

With an aging population in the EU, the demand for effective RSV vaccines is likely to be strong. The Phase 3 trial data indicating a vaccine efficacy of 83.7% and 63.3% over different follow-up periods adds to investor confidence. However, investors should also note the potential for market competition from other pharmaceutical companies developing RSV vaccines.

In the short term, the positive opinion and potential EMA approval can lead to a positive stock price movement due to increased investor optimism. In the long term, the revenue generated from mRESVIA sales will depend on how well it performs in the market compared to competitors and its adoption rates in clinical settings.

Medical Research Analyst

From a medical perspective, the positive opinion on mRESVIA is noteworthy given the burden of RSV in older adults. The data from the Phase 3 clinical trial, including a 63.3% sustained vaccine efficacy over 8.6 months, is robust and highlights the vaccine's potential to make a significant impact on public health.

Another important aspect is the vaccine's unique delivery method via a pre-filled syringe, enhancing ease of administration and potentially improving compliance rates among healthcare providers. This reduces the scope for administrative errors, which is a key factor in clinical settings.

However, it is important for investors to consider the adverse reactions reported, such as injection site pain and fatigue. While these are common for vaccines, their frequency could affect patient acceptance. The long-term safety profile will need continuous monitoring.

The EMA's stringent criteria for approval and the positive data published in a high-impact journal like The New England Journal of Medicine further validate the vaccine's potential efficacy and safety. This provides a solid foundation for investor confidence in the medical soundness of mRESVIA.

Market Research Analyst

The European market for RSV vaccines presents a substantial opportunity, driven by the high incidence rate of RSV-related hospital admissions among older adults. The estimate of 160,000 hospital admissions annually and the high proportion of these in adults aged 65 and over underlines the market demand for effective RSV vaccines in the EU.

Moderna’s strategic focus on the older demographic aligns with the aging population trend in Europe, which is important for long-term market penetration and growth. The ability to secure EMA approval could lead to strong market adoption, especially if the vaccine's efficacy and safety profile holds up under real-world conditions.

However, market dynamics should be monitored closely, particularly the presence and progress of competing products in the pipeline. Moderna’s established reputation and the innovative mRNA platform are competitive advantages, but competition in the vaccine market is intense and pricing strategies will play a critical role in capturing market share.

Investors should watch for upcoming regulatory decisions in other markets, as global approvals could significantly impact the overall revenue potential and market strategy for mRESVIA.

CAMBRIDGE, MA / ACCESSWIRE / June 28, 2024 / Moderna, Inc. (Nasdaq:MRNA) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the granting of marketing authorization in the European Union 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. Following the CHMP's positive opinion, the European Commission will adopt a decision on the authorization of mRESVIA.

"The positive opinion from the EMA CHMP for mRESVIA highlights the innovation and adaptability of our mRNA platform," 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 save healthcare professionals time and reduce administrative errors. With mRESVIA, we continue to make significant strides in addressing global public health challenges posed by respiratory diseases, and we look forward to the decision on an EU-wide marketing authorization from the European Commission."

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 CHMP positive opinion 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 potential 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
617-209-5834
Lavina.Talukdar@modernatx.com

^[1] Osei-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 latest update on Moderna's RSV vaccine, mRESVIA?

The EMA's Committee for Medicinal Products for Human Use has adopted a positive opinion recommending the marketing authorization of mRESVIA in the EU.

What is the efficacy of Moderna's RSV vaccine, mRESVIA?

The Phase 3 ConquerRSV study showed a vaccine efficacy of 83.7% against RSV lower respiratory tract disease with 3.7 months of follow-up, and 63.3% efficacy with 8.6 months of follow-up.

Has Moderna's RSV vaccine, mRESVIA, been approved by the FDA?

Yes, the U.S. FDA approved mRESVIA in May 2024 under a breakthrough therapy designation.

What age group is Moderna's RSV vaccine, mRESVIA, intended for?

mRESVIA is intended for adults aged 60 years and older to protect against lower respiratory tract disease caused by RSV.

How many participants were involved in the clinical trial for Moderna's RSV vaccine, mRESVIA?

The Phase 3 clinical trial, ConquerRSV, involved approximately 37,000 adults aged 60 years or older across 22 countries.