RCS - Moderna Inc - EMA Committee for Medicinal Products for Human Use

ModernaAnnouncement

16/12/2022 12:45

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RNS Number : 0411K  Moderna Inc  16 December 2022

EMA Committee for Medicinal Products for Human Use (CHMP) Recommends the Use
of Moderna's BA.1 Targeting Bivalent COVID-19 Booster in Children (6-11 Years)
In the European Union

The recommendation is based on clinical data for Moderna's bivalent
Omicron-targeting COVID-19 vaccine, mRNA.1273.214

Moderna's bivalent Omicron-targeting COVID-19 vaccines (mRNA.1273.214 (BA.1)
& mRNA.1273.222 (BA.4-5)) are approved for use in individuals 12 years of
age and older in the European Union

Both bivalents have been shown to trigger a superior antibody response
compared to a booster dose of mRNA-1273, the Company's prototype vaccine,
against Omicron (BA.4-5) in Phase 2/3 clinical trials

CAMBRIDGE, MA / ACCESSWIRE / December 16, 2022 / Moderna, Inc.(Nasdaq:MRNA), a
biotechnology company pioneering messenger RNA (mRNA) therapeutics and
vaccines, today announced that the European Medicines Agency's (EMA) Committee
for Medicinal Products for Human Use (CHMP) has adopted a positive opinion
recommending a variation to the marketing authorization (MA) to include a
booster dose of Spikevax bivalent Original/Omicron BA.1 (mRNA-1273.214), at
the dose level for children (6-11 years) of 12.5mcg/12.5mcg (0.25 mL) at least
three months after the last prior dose of a COVID-19 vaccine.

"The recommendation to authorize the use of a booster dose of mRNA-1273.214 in
children ages 6-11 is crucial to providing protection against Omicron and the
emergence of new variants of concern, which is especially important during the
winter period in Europe when respiratory diseases are on the rise," said
Stéphane Bancel, Chief Executive Officer of Moderna. "We are grateful to the
CHMP for their review of our submission and look forward to an authorization
decision from the European Commission."

The pediatric application is based on clinical trial booster data for
Moderna's original vaccine, Spikevax, which was administered to over a
thousand participants. The application described data from a 25 μg booster
dose administered to children ages 6 to 11 years old following a completed
primary series of the Moderna COVID-19 vaccine. In addition, the application
included clinical trial data from a Phase 2/3 studying mRNA-1273.214
(https://pr.report/nsRiemcy) .

In November 2022 (https://pr.report/fVjT9hma) , Moderna announced that its
bivalent Omicron-targeting booster candidates (mRNA-1273.214 and
mRNA-1273.222) trigger a superior antibody response compared to a booster dose
of mRNA-1273, the Company's prototype vaccine, against Omicron (BA.4-BA.5) in
Phase 2/3 clinical trials. Both bivalent vaccines also met non-inferiority
immunogenicity criteria to the original strain.

A Phase 2/3 trial evaluating mRNA-1273.214 as booster and primary series in
children 6 months through 5 years of age is currently underway, with initial
results expected in early 2023.

About Moderna

In 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 in areas
including mRNA and lipid nanoparticle formulation, and an integrated
manufacturing plant that allows 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 autoimmune
diseases. Moderna has been named a top biopharmaceutical employer by Science
for the past eight years. To learn more, visit www.modernatx.com
(https://pr.report/5LiyRBUT) .

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 Company's development of bivalent vaccine candidates against
COVID-19 (mRNA-1273.222 and mRNA-1273.214); the ability of mRNA-1273.214 to
protect children against COVID-19; the ability of mRNA-1273.214 and
mRNA-1273.222 to induce higher neutralizing antibody titers against Omicron
variants in adults than the Company's vaccine candidate against the ancestral
strain of SARS-CoV-2 (mRNA-1273); and the pending authorization of
mRNA-1273.214 in the European Union for administration in children ages 6-11
following the CHMP's positive opinion. 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 most
recent Annual Report on Form 10-K and the Quarterly Report on Form 10-Q for
the quarter ended March 31, 2022, each 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
(https://pr.report/6fDA3adQ) . 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

Director, Corporate 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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