Moderna Receives Medicines And Healthcare Products Regulatory Agency (MHRA) Authorization For Updated COVID-19 Vaccine Targeting SARS-COV-2 Variant JN.1

Approval follows recommendation from global public health bodies to develop JN.1 COVID-19 vaccines

At present, the JN.1 group of subvariants remain dominant in the UK

The updated vaccine will be available for eligible groups as part of the NHS autumn vaccination program, and will also be available to purchase privately in the UK for the first time

CAMBRIDGE, MA / ACCESSWIRE / September 3, 2024 / Moderna, Inc. (Nasdaq:MRNA) today announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has authorized its updated COVID-19 vaccine targeting the JN.1 variant of SARS-CoV-2.

Following the MHRA decision, doses will be available for eligible groups as part of the NHS autumn vaccination program, which is prioritized for use in people at greatest risk of serious illness from COVID-19.

For the first time in the UK, the updated vaccine, Spikevax® JN.1, will also be available to purchase privately for those who are not eligible for the NHS Autumn vaccination program. The updated vaccine will be available from high street pharmacies, occupational health providers, and private healthcare companies.

"As the SARS-CoV-2 virus continues to evolve, COVID-19 continues to present a serious health risk. Updated vaccines targeting circulating strains play a vital role in helping to protect those most at risk from severe illness and hospitalization, alleviating strain on the NHS," said Darius Hughes, UK General Manager of Moderna. "With today's approval from the MHRA, we are pleased that our updated COVID-19 vaccine will be available to the UK public, both through the NHS autumn vaccination program, as well as being available to purchase privately for the first time."

The approval follows guidance from the World Health Organization (WHO) Technical Advisory Group on COVID-19 Vaccine Composition (TAG-CO-VAC), which recommended that COVID-19 vaccines be updated to target the JN.1 family of Omicron subvariants for the 2024/25 vaccination campaign. At present, the JN.1 group of subvariants remain dominant in the UK.¹

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.

Moderna 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 availability of Moderna's updated COVID-19 vaccine to the UK public; and the ability of Moderna's updated COVID-19 vaccine to provide protection as the SARS-CoV-2 virus continues to evolve. In some cases, forward-looking statements can be identified by terminology such as "will," "may," "should," "could," "expects," "intends," "plans," "aims," "anticipates," "believes," "estimates," "predicts," "potential," "continue," or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. 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, 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

¹ https://ukhsa-dashboard.data.gov.uk/topics/covid-19 - Accessed 02/09/24

SOURCE: Moderna, Inc.