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EMA Committee for Medicinal Products for Human Use Adopts Positive Opinion Recommending Authorization of Moderna's COVID-19 mRNA Vaccine Targeting the SARS-CoV-2 Variant LP.8.1

1. Moderna's updated COVID-19 vaccine targets LP.8.1 variant for 2025-2026 season. 2. Positive opinion from EMA paves way for potential European Commission authorization. 3. Updated vaccines crucial for protecting vulnerable populations against COVID-19. 4. Applications for the updated vaccines are pending review globally. 5. Moderna leveraging mRNA technology for accelerated vaccine developments.

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FAQ

Why Bullish?

The positive EMA opinion increases the likelihood of successful vaccine rollout, similar to past approvals that boosted MRNA's stock following initial COVID-19 vaccine successes.

How important is it?

The article highlights pivotal regulatory progress and strategic positioning, essential for MRNA's financial outlook in a competitive vaccine market.

Why Long Term?

Long-term demand for updated COVID-19 vaccines could stabilize Moderna’s revenue over multiple seasons, building on the company's previous success with seasonal vaccines.

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Moderna's updated COVID-19 mRNA vaccine will be available for the 2025-2026 vaccination season, pending a European Commission authorization decision 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 marketing authorization for an updated formulation of the COVID-19 vaccine Spikevax®, targeting the SARS-CoV-2 variant LP.8.1, for active immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals six months of age and older. Following the CHMP's positive opinion, the European Commission will make a marketing authorization decision on Moderna's updated COVID-19 vaccine for the 2025-2026 season."The CHMP's positive opinion on our updated COVID-19 vaccine targeting the SARS-CoV-2 variant LP.8.1 is an important milestone in our ongoing effort to protect people across the European Union," said Stéphane Bancel, Chief Executive Officer of Moderna. "COVID-19 continues to place a significant burden on vulnerable populations and healthcare systems. Updated vaccines can be an important tool for protecting individuals and societies."The CHMP decision is based on a combination of manufacturing and preclinical data, as well as previous clinical, non-clinical and real-world evidence supporting the efficacy and safety of Moderna's COVID-19 vaccines. The updated vaccine composition aligns with guidance from various global health authorities, which have identified the LP.8.1 strain as an appropriate update to the COVID-19 vaccine composition for the 2025-2026 vaccination season.Additional regulatory applications for Moderna's updated COVID-19 vaccines targeting LP.8.1 are under review around the world.About ModernaModerna 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 StatementsThis 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 COVID-19 vaccine targeting the SARS-CoV-2 variant LP.8.1; and the opportunity for Moderna to sell COVID-19 vaccines to up to 17 participating European Union countries over a four-year period. 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, 2024 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 ContactsMedia:Clothilde CailletDirector, Country and Europe Communications Lead[email protected]Investors:Lavina TalukdarSenior Vice President & Head of Investor Relations+1 617-209-5834[email protected]SOURCE: Moderna, Inc.

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