MODERNA RECEIVES MEDICINES AND HEALTHCARE PRODUCTS REGULATORY AGENCY (MHRA)AUTHORISATION FOR UPDATED COVID-19 VACCINE
Spikevax XBB.1.5 is indicated for ac ve immunisa on to prevent COVID-19 caused by SARS-CoV-2
in individuals 6 months of age and older
Preliminary clinical data show that Moderna’s XBB.1.5 monovalent vaccine induces an immune
response across mul ple circula ng variants, including EG.5, FL.1.5.1, and BA.2.86
Updated vaccine to be available in the UK as part of the 2023 autumn booster programme

LONDON, UK. — (ACCESS WIRE) — SEPTEMBER 15, 2023 — Moderna, Inc. (NASDAQ:MRNA) today
announced that the Medicines and Healthcare products Regulatory Agency (MHRA) has authorised
its updated COVID-19 vaccine (mRNA-1273.815), for the XBB.1.5 variant of SARS-CoV-2.
With the MHRA decision, Moderna will begin shipping doses to the UK, with updated vaccines
expected to be available as part of the autumn booster programme, priori sed for use in people atgreatest risk of serious illness from COVID-19.
“As we enter a peak respiratory virus season, COVID-19 con nues to present a serious health risk,
par cularly among vulnerable popula ons. With the primary circula ng strain con nuing to mutate,updated vaccines could be cri cal to protec ng the popula on and allevia ng strain on the NHS thisseason,” said Darius Hughes, UK General Manager of Moderna. “We are delighted that the MHRA
has acted to ensure the UK public can access our updated COVID-19 vaccine which has an importantrole to play in protec ng people from COVID-19 and helping avoid severe disease andhospitalisa on.”In June, the United States Food and Drug Administra on (FDA) and the European Medicines Agency(EMA) recommended that the strain composi on for 2023 to 2024 COVID-19 vaccines be updated toa monovalent XBB-lineage. The approval from the MHRA is based on clinical trial data from Modernashowing that its updated vaccine resulted in robust immune responses across mul ple XBB
sublineages, including XBB.1.5 and XBB.1.16. In August, Moderna announced addi onal clinical trial
data which showed the company's updated COVID-19 vaccine elicited an immune response in
humans against EG.5 (“Eris”) and XBB.1.16 – responsible for more than 26% and nearly 22% of
current UK cases, respec vely. Last week, the company shared addi onal clinical trial data
con rming that the updated vaccine also elicited a human immune response against BA.2.86.
Moderna has received authorisa ons for its updated COVID-19 vaccine in the United States, Canada,
Japan, Taiwan and the European Union to date and has submi ed regulatory applica ons worldwide.
ENDS
Notes to editors:
About Moderna
In over 10 years since its incep on, Moderna has transformed from a science research-stagecompany advancing programs in the eld of messenger RNA (mRNA), to an enterprise with a diverse
clinical por olio of vaccines and therapeu cs across seven modali es, a broad intellectual property
por olio in areas including mRNA and lipid nanopar cle formula on, and an integrated
manufacturing plant that allows for rapid clinical and commercial produc on at scale. Moderna
maintains alliances with a broad range of domes c and overseas government and commercialti

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UK-COV-2300024 Date of prepara on: September 2023

collaborators, which has allowed for the pursuit of both ground-breaking science and rapid scaling ofmanufacturing. Most recently, Moderna's capabili es have come together to allow the authorized
use of e ec ve vaccines against the COVID-19 pandemic.
Moderna's mRNA pla orm builds on con nuous advances in basic and applied mRNA science,delivery technology and manufacturing, and has allowed the development of therapeu cs andvaccines for infec ous diseases, immuno-oncology, rare diseases, cardiovascular diseases, and autoimmune diseases. To learn more, visit www.modernatx.com.
Moderna contact:
Emma Gilgunn-Jones
Director, UK Communica ons
emma.gilgunn-jones@modernatx.com
Investors:
Lavina Talukdar
Senior Vice President & Head of Investor Relations
Lavina.Talukdar@modernatx.com

SOURCE: Moderna, Inc.

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