Moderna Confirms Discussions with U.S. Government for Additional 100 Million Doses of the Moderna COVID-19 Vaccine
January 27 2021 - 8:20AM
Business Wire
Would bring total to 300 million doses ordered
by the U.S government to date
Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering
messenger RNA (mRNA) therapeutics and vaccines today confirmed that
the Company is in discussion with the U.S. government to purchase
an additional 100 million doses of the Moderna COVID-19 Vaccine for
delivery in the third quarter of 2021.
To date, the U.S. government has agreed to purchase 200 million
doses of the Moderna COVID-19 Vaccine. This new purchase would
bring the U.S. government’s confirmed order commitment to 300
million doses.
Moderna will continue to leverage the Company’s U.S.-based
manufacturing infrastructure to supply the Moderna COVID-19 Vaccine
to the U.S. government. The Moderna COVID-19 Vaccine received
Emergency Use Authorization from the U.S. Food and Drug
Administration (FDA) on December 18, 2020 and Moderna began
supplying to the government shortly thereafter.
AUTHORIZED USE IN THE UNITED STATES:
The Moderna COVID-19 Vaccine has been authorized for emergency
use by the U.S. Food and Drug Administration (FDA) for active
immunization to prevent coronavirus disease 2019 (COVID-19) caused
by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in
individuals 18 years of age and older.
IMPORTANT SAFETY INFORMATION
- Do not administer the Moderna COVID-19 Vaccine to individuals
with a known history of severe allergic reaction (e.g.,
anaphylaxis) to any component of the Moderna COVID-19 Vaccine.
- Appropriate medical treatment to manage immediate allergic
reactions must be immediately available in the event an acute
anaphylactic reaction occurs following administration of the
Moderna COVID-19 Vaccine. Monitor Moderna COVID-19 Vaccine
recipients for the occurrence of immediate adverse reactions
according to the Centers for Disease Control and Prevention
guidelines (https://www.cdc.gov/vaccines/covid-19/).
- Immunocompromised persons, including individuals receiving
immunosuppressive therapy, may have a diminished response to the
Moderna COVID-19 Vaccine.
- The Moderna COVID-19 Vaccine may not protect all vaccine
recipients.
- Adverse reactions reported in a clinical trial following
administration of the Moderna COVID-19 Vaccine include pain at the
injection site, fatigue, headache, myalgia, arthralgia, chills,
nausea/vomiting, axillary swelling/tenderness, fever, swelling at
the injection site, and erythema at the injection site.
- Available data on Moderna COVID-19 Vaccine administered to
pregnant women are insufficient to inform vaccine-associated risks
in pregnancy. Data are not available to assess the effects of
Moderna COVID-19 Vaccine on the breastfed infant or on milk
production/excretion.
- There are no data available on the interchangeability of the
Moderna COVID-19 Vaccine with other COVID-19 vaccines to complete
the vaccination series. Individuals who have received one dose of
Moderna COVID-19 Vaccine should receive a second dose of Moderna
COVID-19 Vaccine to complete the vaccination series.
- Additional adverse reactions, some of which may be serious, may
become apparent with more widespread use of the Moderna COVID-19
Vaccine.
- Vaccination providers must complete and submit reports to VAERS
online at https://vaers.hhs.gov/reportevent.html. For further
assistance with reporting to VAERS, call 1-800-822-7967. The
reports should include the words " Moderna COVID- 19 Vaccine EUA "
in the description section of the report.
About Moderna
In 10 years since its inception, Moderna has transformed from a
science research-stage company advancing programs in the
promising-but-still-unproven field of messenger RNA (mRNA), to an
enterprise with its first medicine having treated millions of
people, 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 13 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 statements regarding the purchase by
the U.S. government of additional doses of the Moderna COVID-19
Vaccine from the Company. In some cases, forward-looking statements
can be identified by terminology such as “will,” “may,” “should,”
“could,” “expects,” “intends,” “plans,” “aims,” “anticipates,”
“believes,” “estimates,” “predicts,” “potential,” “continue,” or
the negative of these terms or other comparable terminology,
although not all forward-looking statements contain these words.
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, among others: the fact that there has never been a
commercial product utilizing mRNA technology approved for use; the
fact that the rapid response technology in use by Moderna is still
being developed and implemented; the safety, tolerability and
efficacy profile of the Moderna COVID-19 Vaccine observed to date
may change adversely in ongoing analyses of trial data or
subsequent to commercialization; despite having ongoing
interactions with the FDA or other regulatory agencies, the FDA or
such other regulatory agencies may not agree with the Company’s
regulatory approval strategies, components of our filings, such as
clinical trial designs, conduct and methodologies, or the
sufficiency of data submitted; Moderna may encounter delays in
meeting manufacturing or supply timelines or disruptions in its
distribution plans for the Moderna COVID-19 Vaccine; whether and
when any biologics license applications and/or additional emergency
use authorization applications may be filed in various
jurisdictions and ultimately approved by regulatory authorities;
potential adverse impacts due to the global COVID-19 pandemic such
as delays in regulatory review, manufacturing and clinical trials,
supply chain interruptions, adverse effects on healthcare systems
and disruption of the global economy; and those other risks and
uncertainties described under the heading “Risk Factors” in
Moderna’s most recent Quarterly Report on Form 10-Q 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/20210127005537/en/
Moderna
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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