19 October 2022
EMA Committee For Medicinal Products For Human Use Adopts
Positive Opinion Recommending Authorization Of Moderna's Omicron
BA.4-BA.5 Targeting Bivalent Covid-19 Vaccine In The European
Positive recommendation follows the recent approval of Spikevax
bivalent Original/Omicron BA.1 (mRNA-1273.214), a bivalent booster
vaccine targeting the Omicron BA.1 subvariant, in September
CAMBRIDGE, MA / ACCESS WIRE / 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 adopted a positive opinion recommending conditional
marketing authorization for mRNA-1273.222 (Spikevax bivalent
Original/Omicron BA.4-5) 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. Following the CHMP's positive
opinion, the European Commission will make an authorization
decision on the use of Spikevax bivalent Original/Omicron BA.4-5.
This vaccine now joins Moderna's other updated booster vaccine,
mRNA 1273.214, that targets the BA.1 variant, for use in
individuals 12 years and older.
"The CHMP's positive recommendation for our BA.4/BA.5 bivalent
booster, mRNA-1273.222, provides people across Europe with durable
protection against the major Omicron subvariants in circulation as
we head into the winter months when COVID-19 vaccination becomes
crucial," said Stéphane Bancel, Chief Executive Officer of Moderna.
"We look forward to the European Commission's authorization
Spikevax bivalent Original/Omicron BA.4-5 is a next-generation
bivalent vaccine that contains 25 ug of mRNA-1273 (Spikevax) and 25
ug of a vaccine candidate targeting the Omicron variant of concern
(BA.4/BA.5). Moderna's submission to the EMA is based on
preclinical data for mRNA-1273.222 as well as clinical trial data
from a Phase 2/3 studying Spikevax bivalent Original/Omicron BA.1
(mRNA-1273.214), a bivalent booster vaccine targeting the Omicron
BA.1 subvariant, which recently received EMA approval. A Phase 2/3
clinical trial for mRNA-1273.222 is fully enrolled and currently
underway, with initial data expected later this year.
Moderna has received authorizations for Omicron-targeting
bivalent boosters in the United States, Australia, Canada, Europe,
Japan, South Korea, Switzerland, Singapore, Taiwan, and the UK to
date and has submitted regulatory applications worldwide.
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 both clinical and commercial production at scale.
Moderna maintains alliances with a broad range of domestic and
overseas government and commercial collaborators. 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 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-1273.222, or Spikevax bivalent
Original/Omicron BA.4-5); the European Medicines Agency's (EMA)
Committee for Medicinal Products for Human Use (CHMP) adoption of a
positive opinion recommending conditional marketing authorization
for Spikevax bivalent Original/Omicron BA.4-5 (mRNA-1273.222) as a
booster dose for active immunization to prevent COVID-19 caused by
SARS-CoV-2 in individuals 12 years of age and older; the potential
authorization by the European Commission of mRNA-1273.222 as a
booster dose for immunization to prevent COVID-19; and the
anticipated timing for clinical data readouts from the Phase 2/3
trial of mRNA-1273.222. 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 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.
Luke Mircea Willats
Director, Corporate Communications
Senior Vice President & Head of Investor Relations
SOURCE: Moderna, Inc.
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October 19, 2022 12:56 ET (16:56 GMT)
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