U.S. Government Purchases Additional 200 Million Doses of Moderna’s COVID-19 Vaccine
June 16 2021 - 8:00AM
Business Wire
Total of 500 million doses ordered by
the U.S government to date, including 110 million doses
for delivery in the fourth quarter of 2021 and 90 million doses for
delivery in the first quarter of 2022
Additional doses will ensure the U.S.
government continues to receive the Moderna COVID-19 Vaccine
through the first quarter of 2022
Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering
messenger RNA (mRNA) therapeutics and vaccines, today announced
that the U.S. government has purchased an additional 200 million
doses of Moderna’s COVID-19 vaccine, including the option to
purchase other COVID-19 vaccine candidates from Moderna’s
pipeline.
This purchase brings the U.S. government’s confirmed order
commitment to 500 million doses including 110 million doses
expected to be delivered in the fourth quarter of 2021 and 90
million expected to be delivered in the first quarter of 2022. As
of June 14, Moderna has supplied 217 million released doses of the
vaccine to the U.S. government.
“We appreciate the collaboration with the U.S government 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 Stéphane Bancel, Chief Executive Officer of
Moderna. “We remain focused on being proactive as the virus evolves
by leveraging the flexibility of our mRNA platform to stay ahead of
emerging variants.”
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 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 received
emergency (or other conditional, interim or provisional)
authorization for use of its COVID-19 vaccine in adults from health
agencies in Canada, Israel, the European Union, the United Kingdom,
Switzerland, Singapore, Qatar, Taiwan, the Philippines, Thailand,
Brunei, Paraguay, Japan, South Korea, Botswana 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.
The Biomedical Advanced Research and Development Authority
(BARDA), part of the Office of the Assistant Secretary for
Preparedness and Response (ASPR) within the U.S. Department of
Health and Human Services (HHS) is supporting the continued
research and development of the Company’s COVID-19 vaccine
development efforts with federal funding under contract no.
75A50120C00034. BARDA is reimbursing Moderna for 100 percent of the
allowable costs incurred by the Company for conducting the program
described in the BARDA contract. The U.S. government has agreed to
purchase supply of mRNA-1273 under U.S. Department of Defense
contract no. W911QY-20-C-0100.
AUTHORIZED USE
Moderna COVID-19 Vaccine is authorized for use under an
Emergency Use Authorization (EUA) 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/clinical-considerations/managing-anaphylaxis.html).
- 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.
- Severe allergic reactions, including anaphylaxis, have been
reported following administration of the Moderna COVID-19 Vaccine
during mass vaccination outside of clinical trials.
- 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.
Click for Fact Sheet for Healthcare Providers Administering
Vaccine (Vaccination Providers) and Full EUA Prescribing
Information for more information.
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 the Moderna COVID-19 Vaccine); and the agreement by
the U.S. Government to purchase an additional 200 million doses of
the Moderna COVID-19 Vaccine and the timing for anticipated
delivery of those doses. 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210616005529/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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