TIDM0A45
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.
(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 ug
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 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 .
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
Investors:
Lavina Talukdar
Senior Vice President & Head of Investor Relations
617-209-5834
Lavina.Talukdar@modernatx.com
SOURCE : Moderna, Inc.
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