EMA Committee for Medicinal Products for Human Use (CHMP) Adopts Positive Opinion Recommending Authorization for the Use of the Moderna COVID-19 Vaccine in Adolescents (12-17 Years of Age) in the European Union
July 23 2021 - 9:06AM
Business Wire
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) adopted a positive opinion
recommending marketing authorization for Moderna’s COVID-19 vaccine
(Spikevax) to include adolescents 12 years of age and older.
Spikevax is the trade name authorized by the European Medicines
Agency (EMA) for the Moderna COVID-19 vaccine.
“The CHMP recommendation of the authorization of our COVID-19
vaccine for use in individuals 12 years of age and older in the
European Union is a positive step forward toward authorization of
our vaccine in this age group,” said Stéphane Bancel, Chief
Executive Officer of Moderna. “As we help to combat the pandemic,
we hope to be able to help get adolescents safely back to school
this fall.”
Following the CHMP’s positive opinion, the European Commission
will consider authorizing the use of the Moderna COVID-19 Vaccine
in adolescents ages 12 years of age and older.
On June 10, Moderna announced data from the ongoing Phase 2/3
study, which enrolled 3,732 participants ages 12 to less than 18
years in the U.S. The study met its primary endpoint, successfully
bridging immune responses to those observed in the COVE efficacy
study in adults. After two doses of the Moderna COVID-19 vaccine,
no cases of COVID-19 were observed in the vaccine group using the
case definition from the adult Phase 3 COVE study, compared to four
cases in the placebo group, resulting in a vaccine efficacy of 100%
starting 14 days after the second dose using the U.S. Centers for
Disease Control and Prevention’s (CDC) primary definition of
COVID-19 infection. The Moderna COVID-19 vaccine was generally well
tolerated with a safety and tolerability profile consistent with
the Phase 3 COVE study in adults. The majority of adverse events
were mild or moderate in severity. The most common solicited local
adverse event was injection site pain. The most common solicited
systemic adverse events after the second dose of mRNA-1273 were
headache, fatigue, myalgia and chills.
Safety data continue to accrue, and the study continues to be
monitored by an independent safety monitoring committee. All
participants will be monitored for 12 months after their second
injection to assess long-term efficacy and safety. The Company will
revise the age range to capture adolescent data in its ongoing and
planned post-authorization studies. Moderna has submitted data from
the Phase 2/3 study to a peer-reviewed publication. These data have
also been submitted to health authorities around the world and the
Company expects authorizations for adolescents in the coming
weeks.
Moderna is also conducting a Phase 2/3 study, called the KidCOVE
study, of mRNA-1273 in children ages 6 months to less than 12
years.
About the Moderna COVID-19 Vaccine
The Moderna COVID-19 Vaccine is an mRNA vaccine against COVID-19
encoding for a prefusion stabilized form of the Spike (S) protein.
On December 18, 2020, the U.S. FDA authorized the emergency use of
the Moderna COVID-19 Vaccine in individuals 18 years of age or
older. Moderna has received emergency (or other conditional,
interim or provisional) authorization for use of its COVID-19
vaccine in adults from health agencies in more than 50 countries
and an Emergency Use Listing (EUL) from the World Health
Organization (WHO). Moderna has filed for emergency (or other
conditional, interim or provisional) authorization for use of its
COVID-19 vaccine in adolescents with global health agencies.
AUTHORIZED USE
Spikevax (COVID-19 Vaccine Moderna) has been granted conditional
marketing authorisation by the European Commission for active
immunisation to prevent COVID-19 caused by SARS-CoV-2 in
individuals 18 years of age and older.
About Moderna
In 10 years since its inception, Moderna has transformed from a
science 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 six modalities, a
broad intellectual property portfolio in areas including mRNA and
lipid nanoparticle formulation, and an integrated manufacturing
plant that allows for both clinical and commercial production at
scale and at unprecedented speed. 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 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. Today, 24 development programs
are underway across these therapeutic areas, with 15 programs
having entered the clinic. Moderna has been named a top
biopharmaceutical employer by Science for the past six 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: the Company’s development of
a vaccine to protect against the SARS-CoV-2 virus (mRNA-1273, also
referred to as the Moderna COVID-19 Vaccine or Spikevax), the
potential for the Moderna COVID-19 Vaccine to prevent COVID-19
disease in adolescents; the safety profile for the Moderna COVID-19
Vaccine in adolescents; and the potential for additional
authorizations for the administration of the Moderna COVID-19
Vaccine to adolescents by the European Medicines Agency and other
regulatory authorities and the timing for those authorizations. 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 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20210723005309/en/
Moderna Contacts Media: Colleen Hussey Director,
Corporate Communications 617-335-1374 Colleen.Hussey@modernatx.com
Investors: Lavina Talukdar Senior Vice President & Head
of Investor Relations 617-209-5834
Lavina.Talukdar@modernatx.com
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