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EMA Committee for Medicinal Products for Human Use adopts positive opinion and recommends marketing authorisation of Moderna’s RSV vaccine mRESVIA(R)

EMA Committee for Medicinal Products for Human Use adopts positive opinion and recommends marketing authorisation of Moderna’s RSV vaccine mRESVIA(R)
EMA Committee for Medicinal Products for Human Use adopts positive opinion and recommends marketing authorisation of Moderna’s RSV vaccine mRESVIA(R)

CAMBRIDGE, MA / ACCESSWIRE / June 28, 2024 / Moderna, Inc. (Nasdaq:MRNA) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the granting of marketing authorization in the European Union for mRESVIA (mRNA-1345). The mRNA vaccine against respiratory syncytial virus (RSV) is intended to protect adults aged 60 years and older against lower respiratory tract disease caused by RSV infection. Following the positive CHMP opinion, the European Commission will make a decision on the authorization of mRESVIA.

“The positive opinion from the EMA CHMP for mRESVIA underscores the innovation and adaptability of our mRNA platform,” said Stéphane Bancel, Chief Executive Officer of Moderna. “mRESVIA protects older adults from severe RSV and is uniquely offered in a prefilled syringe to simplify administration, which can save healthcare professionals time and reduce administrative errors. With mRESVIA, we continue to make significant progress in addressing the global public health challenges posed by respiratory diseases, and we look forward to the European Commission’s decision on an EU-wide marketing authorization.”

RSV is a highly contagious seasonal respiratory virus and a leading cause of lower respiratory tract infections and pneumonia. The disease particularly affects infants and older adults. In the European Union, RSV infections are responsible for approximately 160,000 adult hospital admissions each year, with 92% of these admissions affecting adults aged 65 years and over. (1)

The CHMP positive opinion on mRESVIA is based on positive data from the ConquerRSV Phase 3 clinical trial, a global study conducted in approximately 37,000 adults aged 60 years or older in 22 countries. The primary analysis with an average of 3.7 months of follow-up showed a vaccine efficacy (VE) against RSV lower respiratory tract disease (LRTD) of 83.7% (95.88% CI 66.0%, 92.2%). These results were published in The New England Journal of Medicine. In a supplementary analysis with an average of 8.6 months of follow-up, mRNA-1345 maintained durable efficacy with a sustained VE of 63.3% (95% CI: 48.7%, 73.7%) against RSV-LRTD including two or more symptoms. The VE was 74.6% (95% CI, 50.7, 86.9) against RSV-LRTD with ≥2 symptoms, including shortness of breath, and the VE was 63.0% (95% CI, 37.3%, 78.2%) against RSV LRTD with three or more symptoms. The study’s stringent statistical criterion of a lower limit of the 95% CI of >20% was still met for both endpoints. The most commonly reported adverse reactions were injection site pain, fatigue, headache, myalgia, and arthralgia.

In June 2024The U.S. Food and Drug Administration (FDA) has approved mRESVIA (mRNA-1345) to protect adults ages 60 and older from lower respiratory tract illness caused by RSV infection. The approval was granted under breakthrough therapy designation and is Moderna’s second approved mRNA product. Moderna has submitted marketing authorization applications for mRNA-1345 in several markets worldwide.

About mRESVIA ® (Respiratory syncytial virus vaccine)

mRESVIA ® is an RSV vaccine consisting 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 as it helps the virus enter host cells. The prefusion conformation of the F protein is an important target of potent neutralizing antibodies and is highly conserved among 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 leading the development of the field of mRNA medicine. By advancing mRNA technology, Moderna is reinventing how medicine is made and transforming the way we treat and prevent disease for everyone. Working at the intersection of science, technology and health for more than a decade, the company has developed medicines with 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 Moderna’s values ​​and mindset to responsibly transform the future of human health, Moderna is committed to delivering the greatest possible impact to people through mRNA medicines. For more information about Moderna, 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 approval of Moderna’s RSV vaccine mRESVIA by the European Commission, the efficacy and safety of the mRNA-1345 vaccine, the potential of mRESVIA to reduce the burden of disease from RSV, and Moderna’s pending regulatory filings 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, that 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 Moderna’s subsequent filings with the 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 obligation to update or revise any forward-looking statements contained in this press release, whether as a result 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
[email protected]

Investors:
Lavina Talukdar
Senior Vice President and Head of Investor Relations
617-209-5834
[email protected]

(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) researchers. Estimating the number of hospital admissions in adults in the European Union due to respiratory syncytial virus. 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.

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