RCS - Moderna Inc - EMA Issues Positive Opinion

ModernaAnnouncement

19/10/2022 17:45

For best results when printing this announcement, please click on link below:
http://newsfile.refinitiv.com/getnewsfile/v1/story?guid=urn:newsml:reuters.com:20221019:nRSS4698Da&default-theme=true

RNS Number : 4698D  Moderna Inc  19 October 2022

EMA Issues Positive Opinion

EMA Committee for Medicinal Products for Human Use Issues Positive Opinion
Recommending Authorization for the Use of Spikevax (mRNA-1273) in Children 6
Months - 5 Years in the European Union

Announcement follows CHMP's previous decision to issue a positive opinion
recommending marketing authorization for Moderna's COVID-19 vaccine to include
children 6 years of age and older

Two-dose series takes one month to complete, with similar vaccine efficacy
estimates against Omicron to those seen in adults

CAMBRIDGE, MA / ACCESSWIRE / October 19, 2022 / Moderna, Inc.
(https://pr.report/JEgXYNPC) (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 issued a positive opinion recommending a variation to the
conditional marketing authorization (CMA) to include a 25 µg two-dose series
of Spikevax (mRNA-1273) for active immunization to prevent coronavirus disease
2019 (COVID-19) caused by SARS-CoV-2 in children 6 months to 5 years.
Following the CHMP's positive opinion, the European Commission will make an
authorization decision on the use of Spikevax in children ages 6 months to 5
years.

"This recommendation by the CHMP reaffirms the effectiveness and safety of
mRNA-1273 and provides parents across Europe with another option to protect
their young children against COVID-19, a group at high risk of infection and
where additional health prevention measures may not always be feasible," said
Stéphane Bancel, Moderna's Chief Executive Officer. "We are grateful to the
CHMP for their review and look forward to an authorization decision from the
European Commission."

Positive interim results from the Phase 2/3 KidCOVE study
(https://pr.report/wBGCerHf) showed a robust neutralizing antibody response in
the 6-month to 5 years of age group after a two-dose primary series of
mRNA-1273 and a favorable safety profile. The antibody titers in the
pre-specified 6 months to 23 months and 2 years to 5 years of age sub-groups
met the statistical criteria for similarity to the adults in the COVE study,
which satisfied the primary objective of the study. Preliminary efficacy
analysis on PCR-confirmed cases collected during the Omicron wave showed
similar efficacy estimates against Omicron in the 6-month to 5 years of age
group to those in adults after two doses of mRNA-1273.

The KidCOVE study is being conducted in collaboration with the National
Institute of Allergy and Infectious Diseases (NIAID), part of the National
Institutes of Health (NIH), and the Biomedical Advanced Research and
Development Authority (BARDA), part of the Office of the Assistant Secretary
for Preparedness and Response at the U.S. Department of Health and Human
Services. The ClinicalTrials.gov identifier is NCT04796896.

mRNA-1273 has been authorized for active immunization to prevent COVID-19
caused by SARS-CoV-2 in children aged 6 months to 5 years in a number of
countries worldwide, including Australia, Canada, and the US. In addition,
Spikevax bivalent Original/Omicron BA.1 (mRNA-1273.214), a bivalent vaccine
candidate that contains mRNA-1273 and a vaccine candidate targeting the
Omicron variant of concern (BA.1), is approved as a booster dose for active
immunization to prevent COVID-19 caused by SARS-CoV-2 in individuals 12 years
of age and older, who have previously received at least a primary vaccination
course against COVID- 19.

Authorized Use

Spikevax (elasomeran mRNA vaccine) has been granted Conditional Marketing
Authorization by the European Commission, based upon the recommendation of the
European Medicines Agency, and is indicated for active immunization to prevent
coronavirus disease 2019 (COVID-19) caused by SARS-CoV-2 in individuals 6
months of age and older. A booster dose may be given at least three months
after the second dose for people aged 12 years and older.

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
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 auto-immune
diseases. Moderna has been named a top biopharmaceutical employer by Science
for the past seven years. To learn more, visit www.modernatx.com
(https://pr.report/L5xa7-VT) .

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: development of the Company's COVID-19 Vaccine (mRNA-1273, or
Spikevax); the potential approval of the vaccine in children ages 6 months - 5
years by the European Commission following the positive recommendation from
the European Medicines Agency's Committee for Medicinal Products for Human
Use; and the safety, efficacy, and tolerability of the vaccine in children
ages 6 months to 5 years. 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 fiscal year ended December 31, 2021 and Quarterly Report on Form
10-Q for the quarterly period 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.
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 hereof.

Moderna Contacts:

Media:

Luke Mircea Willats

Director, Corporate Communications
Luke.Mirceawillats@modernatx.com (mailto:Luke.Mirceawillats@modernatx.com)

Investors:

Lavina Talukdar

Senior Vice President & Head of Investor Relations

617-209-5834
Lavina.Talukdar@modernatx.com (mailto:Lavina.Talukdar@modernatx.com)

SOURCE: Moderna, Inc.

 

This information is provided by Reach, the non-regulatory press release distribution service of RNS, part of the London Stock Exchange. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact
rns@lseg.com (mailto:rns@lseg.com)
 or visit
www.rns.com (http://www.rns.com/)
.

Reach is a non-regulatory news service. By using this service an issuer is confirming that the information contained within this announcement is of a non-regulatory nature. Reach announcements are identified with an orange label and the word “Reach” in the source column of the News Explorer pages of London Stock Exchange’s website so that they are distinguished from the RNS UK regulatory service. Other vendors subscribing for Reach press releases may use a different method to distinguish Reach announcements from UK regulatory news.

RNS may use your IP address to confirm compliance with the terms and conditions, to analyse how you engage with the information contained in this communication, and to share such analysis on an anonymised basis with others as part of our commercial services. For further information about how RNS and the London Stock Exchange use the personal data you provide us, please see our
Privacy Policy (https://www.lseg.com/privacy-and-cookie-policy)
.   END  NRAGPGAWUUPPGQB