European Commission Purchases Additional 150 Million Doses of Moderna’s COVID-19 Vaccine for Delivery in 2022
June 22 2021 - 9:06AM
Business Wire
New contract to enable European countries
access to updated COVID-19 vaccine booster candidates
Total of 460 million doses ordered by the
European Commission
Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering
messenger RNA (mRNA) therapeutics and vaccines, today announced
that the European Commission has purchased an additional 150
million doses of Moderna’s COVID-19 vaccine, including the ability
to purchase other COVID-19 vaccine candidates from Moderna’s
pipeline. This purchase brings the European Commission’s confirmed
order commitment to 460 million doses. Under the terms of the
agreement, delivery of Moderna’s updated variant booster vaccine
candidate will begin in 2022. Purchase under this agreement is
subject to regulatory approval of the booster vaccine candidates by
the European Medicines Agency (EMA).
“We appreciate the collaboration with the European Commission
for these additional doses of the Moderna COVID-19 vaccine, which
could be used for primary vaccination, including of children, or
possibly as a booster if that becomes necessary to continue to
defeat the pandemic,” said Stephane Bancel, Moderna’s Chief
Executive Officer. “We are encouraged by the initial booster data,
which reinforce our confidence that our booster strategy should be
protective against current variants. We will remain proactive as
the virus evolves by leveraging the flexibility of our mRNA
platform to stay ahead of emerging variants.”
Moderna remains on track to meet its quarterly delivery
commitments to the European Union in 2021, as the Company continues
to build out its supply chain in Europe.
Initial data from Moderna’s Phase 2 study in the U.S. showed
that a single 50 µg dose of mRNA-1273 or mRNA-1273.351 given as a
booster to previously vaccinated individuals increased neutralizing
antibody titer responses against SARS-CoV-2 and two variants of
concern, B.1.351 (first identified in South Africa) and P.1 (first
identified in Brazil). A booster dose of mRNA-1273.351, the
Company’s strain-matched booster, achieved higher neutralizing
antibody titers against the B.1.351 variant of concern than a
booster dose of mRNA-1273. Safety and tolerability profiles
following third dose booster injections of 50 µg of mRNA-1273 or
mRNA-1273.351 were generally comparable to those observed after the
second dose of mRNA-1273 in the previously reported Phase 2 and
Phase 3 studies. A manuscript describing these preliminary results
was submitted as a preprint to medRxiv and will be submitted for
peer-reviewed publication upon completion of the multivalent
mRNA-1273.211 booster arm.
Authorized Use
The European Commission granted a conditional marketing
authorization (CMA) for COVID-19 Vaccine Moderna, based upon the
recommendation of the European Medicines Agency (EMA) for use of
the COVID-19 Vaccine Moderna for active immunization to prevent
COVID-19 caused by SARS-CoV-2 virus in individuals 18 years of age
and older.
About the COVID-19 Vaccine Moderna
The COVID-19 Vaccine Moderna (referred to in the U.S. as the
Moderna COVID-19 Vaccine) is an mRNA vaccine against COVID-19
encoding for a prefusion stabilized form of the Spike (S) protein.
On November 30, 2020, Moderna announced the primary efficacy
analysis of the Phase 3 study of the vaccine conducted on 196
cases.
On November 30, 2020, the Company also announced that it filed
for Emergency Use Authorization with the U.S. FDA and a Conditional
Marketing Authorization (CMA) application with the European
Medicines Agency.
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 also received emergency (or other conditional,
interim or provisional) authorization for use of its COVID-19
vaccine from health agencies in Canada, Israel, the European Union,
the United Kingdom, Switzerland, Singapore, Qatar, Taiwan, the
Philippines, Thailand, Brunei, Paraguay, Japan, South Korea 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 health agencies in the European Union,
Canada, the U.S., Switzerland and Japan.
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 14 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 COVID-19 Vaccine Moderna and the Moderna COVID-19
Vaccine); the Company’s agreement with the European Commission for
the supply additional doses of the vaccine in 2022; the Company’s
timely satisfaction of its delivery commitments for the vaccine;
the anticipated number of doses capable of being produced from the
Company’s production lines within the European Union; and the
safety and efficacy of the vaccine at different doses and for
variant-specific formulations of the vaccine. 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/20210622005731/en/
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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