EMA Committee for Medicinal Products for Human Use Adopts Positive Opinion Recommending Authorization of Moderna’s Updated Covid-19 Vaccine in The European Union

The positive opinion follows the recommendation from regulators and global public health bodies to develop monovalent XBB.1.5 COVID-19 vaccines for autumn/winter 2023 vaccination campaigns

Clinical trial data from research assay confirmed Moderna’s updated COVID-19 vaccine showed an 8.7 to 11-fold increase in neutralizing antibodies against circulating variants, including BA.2.86, EG.5, and FL.1.5.1 variants

CAMBRIDGE, MA / ACCESSWIRE / September 14, 2023 / 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 Spikevax, its updated COVID-19 vaccine containing spike proteins for the XBB.1.5 sublineage of SARS-CoV-2 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 an authorization decision on the use of Moderna’s updated COVID-19 vaccine for autumn/winter 2023.

“The CHMP’s positive recommendation for our updated COVID-19 vaccine is a key milestone given we see increasing transmission of SARS-CoV-2 across Europe. Our updated COVID-19 vaccine generates a strong human immune response against circulating variants, including BA.2.86, EG.5, and FL.1.5.1, and will be a critical tool for protection,” said Stéphane Bancel, Chief Executive Officer of Moderna. “We are working with governments across Europe to include our updated COVID-19 vaccine in national vaccination programs, to ensure a diversified portfolio that provides vaccine choice and access to single dose vial formats, which can limit waste.”

Moderna has generated clinical data of its monovalent XBB.1.5 vaccine candidate showing an immune response against XBB sublineages XBB.1.5, XBB.1.16, and XBB.2.3.2, in addition to BA.2.86, EG.5 and FL.1.5.1 variants. Public health authorities are vigilantly monitoring the BA.2.86 variant, a highly mutated strain of COVID-19 with over 30 mutations as compared to prior Omicron strains, with some governments accelerating COVID-19 vaccination campaigns due to its potential to break through protective immunity generated from previous COVID-19 vaccination or infection.

The most common solicited local adverse event for Moderna’s updated COVID-19 vaccine was injection site pain. The most common solicited systemic adverse events include fatigue, headache, myalgia, arthralgia, and chills. Moderna’s updated COVID-19 vaccine’s safety profile is consistent with previous Spikevax formulations.

Moderna has received authorizations for its updated COVID-19 vaccine in the U.S., Canada, Japan, and Taiwan to date and has submitted regulatory applications worldwide.

About Moderna

In over 10 years since its inception, Moderna has transformed from a research-stage company advancing programs in the field of messenger RNA (mRNA), to an enterprise with a diverse clinical portfolio of vaccines and therapeutics across seven modalities, a broad intellectual property portfolio and integrated manufacturing facilities that allow for rapid clinical and commercial production at scale. Moderna maintains alliances with a broad range of domestic and overseas government and commercial collaborators, which has allowed for the pursuit of both groundbreaking science and rapid scaling of manufacturing. Most recently, Moderna’s capabilities have come together to allow the authorized use and approval of one of the earliest and most effective vaccines against the COVID-19 pandemic.

Moderna’s mRNA platform builds on continuous advances in basic and applied mRNA science, delivery technology and manufacturing, and has allowed the development of therapeutics and vaccines for infectious diseases, immuno-oncology, rare diseases, cardiovascular diseases and auto-immune diseases. Moderna has been named a top biopharmaceutical employer by Science for the past eight years. To learn more, visit www.modernatx.com.

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 regarding: the potential authorization by the European Commission of Moderna’s updated COVID-19 vaccine for autumn/winter 2023; the expectation that the European Commission’s authorization decision will come shortly; the ability of Moderna’s updated COVID-19 vaccine to induce an immune response against circulating variants of interest and provide protection for autumn/winter 2023; the safety profile of Moderna’s updated COVID-19 vaccine; and Moderna’s regulatory application submissions worldwide for its updated COVID-19 vaccine. 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 those other risks and uncertainties described under the heading “Risk Factors” in Moderna’s Annual Report on Form 10-K for the year ended December 31, 2022, filed with the U.S. Securities and Exchange Commission (SEC) and in subsequent filings made by Moderna with the SEC, 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

SOURCE: Moderna, Inc.

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