Company has supplied over 30 million doses to
U.S. Government to date
Remains on track to deliver 100 million doses
to the U.S. Government by end of March 2021
Remains on track to deliver 200 million doses
to the U.S. Government by end of June 2021
Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering
messenger RNA (mRNA) therapeutics and vaccines, today provided a
supply update for the Moderna COVID-19 Vaccine, reporting that 30.4
million doses have been supplied to the U.S. Government to date.
The Company continues to work closely with the U.S. Government and
to provide regular updates on supply and production. Approximately
10.1 million doses have been administered in the U.S., according to
the U.S. Centers for Disease Control and Prevention1.
The Company confirms that it is on track to deliver on its
commitment of approximately 100 million doses to the United States
government by the end of the first quarter of 2021, with 200
million doses total available by the end of the second quarter. All
U.S. supply comes from Moderna’s dedicated supply chain in the U.S.
On January 4, the Company announced that it increased its base-case
global production estimate from 500 to 600 million doses for 2021.
Moderna is continuing to invest and add staff to build up to
potentially 1 billion doses for 2021.
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. The U.S. Government has agreed to purchase 200
million doses of the Moderna COVID-19 Vaccine with options for
potential purchase of 300 million additional doses.
About the Moderna COVID-19 Vaccine
The Moderna COVID-19 Vaccine (also referred to as mRNA-1273) is
an mRNA vaccine against COVID-19 encoding for a prefusion
stabilized form of the Spike (S) protein, which was co-developed by
Moderna and investigators from National Institute of Allergy and
Infectious Disease’s (NIAID) Vaccine Research Center. The first
clinical batch, which was funded by the Coalition for Epidemic
Preparedness Innovations, was completed on February 7, 2020 and
underwent analytical testing; it was shipped to the National
Institutes of Health (NIH) on February 24, 2020, 42 days from
sequence selection. The first participant in the NIAID-led Phase 1
study of the vaccine was dosed on March 16, 63 days from sequence
selection to Phase 1 study dosing. On May 12, the FDA granted the
Moderna COVID-19 Vaccine Fast Track designation. On May 29, the
first participants in each age cohort: adults ages 18-55 years
(n=300) and older adults ages 55 years and above (n=300) were dosed
in the Phase 2 study of mRNA-1273. On July 8, the Phase 2 study
completed enrollment.
On July 14, an interim analysis of the original cohorts in the
NIH-led Phase 1 study of the vaccine was published in The New
England Journal of Medicine. On July 28, results from a non-human
primate preclinical viral challenge study evaluating the vaccine
were published in The New England Journal of Medicine. Results from
the second interim analysis of the NIH-led Phase 1 study of the
Moderna COVID-19 Vaccine in the 56-70 and 71+ age groups were
published on September 29 in The New England Journal of Medicine.
On November 30, Moderna announced the primary efficacy analysis of
the Phase 3 study of the vaccine conducted on 196 cases. On
November 30, the Company also announced that it filed for Emergency
Use Authorization with the U.S. FDA and a Conditional Marketing
Authorization (CMA) with the European Medicines Agency. On November
30, the Company announced new data showing that mRNA-1273, its
COVID-19 vaccine candidate, remains stable at 2° to 8°C (36° to
46°F), the temperature of a standard home or medical refrigerator,
for 30 days. On December 3, a letter to the editor was published in
The New England Journal of Medicine reporting that participants in
the Phase 1 study of the Moderna COVID-19 Vaccine retained high
levels of neutralizing antibodies through 119 days following first
vaccination (90 days following second vaccination). On December 18,
2020, the FDA authorized the emergency use of the Moderna COVID-19
Vaccine in individuals 18 years of age or older.
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 Moderna COVID-19 Vaccine with $955
million in 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 the Moderna COVID-19 Vaccine under U.S. Department of Defense
contract no. W911QY-20-C-0100.
Moderna has received authorization for its COVID-19 vaccine from
regulatory authorities in the United States, Canada, Israel, the
European Union, the United Kingdom and Switzerland. Additional
authorizations are currently under review in other countries and by
the World Health Organization. A summary of the Company’s work to
date on COVID-19 can be found here.
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 Company’s
anticipated schedule for the manufacturing and delivery of the
Moderna COVID-19 Vaccine to the U.S. government. 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.
1 https://covid.cdc.gov/covid-data-tracker/#vaccinations
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version on businesswire.com: https://www.businesswire.com/news/home/20210126005653/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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