Moderna Announces Additional Capital Investments to Increase Global Manufacturing Capacity for COVID-19 Vaccine
Moderna Announces Additional Capital Investments to Increase Global Manufacturing Capacity for
February 24, 2021
New capital investments at Moderna’s manufacturing facilities expected to increase 2022 capacity to approximately 1.4 billion doses at the 100 μg
Moderna also increases its 2021 base plan to 700 million doses and is working to supply up to 1 billion doses in 2021
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Feb. 24, 2021-- Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA
(mRNA) therapeutics and vaccines, announces it is making new capital investments to increase capacity at its owned and partnered manufacturing
facilities, which it expects will increase global 2022 capacity to approximately 1.4 billion doses of its COVID-19 vaccine, assuming a 100 μg dose. The
investments will enable additional production of the current Moderna COVID-19 Vaccine and provide flexibility in addressing production of potential
vaccine boosters that may be needed to address emerging variants of SARS-CoV-2.
The Company has already begun adding this capacity at its owned and partnered manufacturing facilities. Given a six- to nine-month timeframe to add
capacity and an additional timeframe to permit regulatory validation and ramp-up, it is estimated that up to 12 months may be necessary before the
additional production is available.
“We believe from our discussions with governments around the world that there will continue to be significant demand for our COVID-19 vaccine and
we now are committed to materially increasing our manufacturing capacity. Because of the high efficacy of our COVID-19 vaccine and our ability to
quickly develop variant vaccines to help boost the immune system of vaccinees, there is increased demand. We are investing in this additional
capacity to help us increase production and allow for flexibility in manufacturing potential vaccine boosters to address emerging variants of the virus,”
said Stephane Bancel, Chief Executive Officer of Moderna. “Today we also announced our strategy around clinical testing of different booster
vaccines. We expect our additional capital investments to drive our capacity to 1.4 billion doses for 2022, assuming the current 100 μg dose. If our
variant vaccine booster requires a lower dose, such as 50 μg, we could have more than 2 billion doses of capacity for 2022.”
The 2022 capacity of up to 1.4 billion doses reflects an assumption of a 100 μg dose. The 2022 output will depend on the dose of the booster. The
Company plans to study a dose range of 50 μg and lower for variant-based boosters and an additional booster of mRNA-1273. If the effective dose for
a booster is 50 μg, then the 2022 supply could be significantly higher than 1.4 billion doses. The total 2022 supply will depend on the mix between the
authorized COVID-19 Vaccine at 100 μg and the dose level authorized for a booster. In the event that the Company dedicates its entire 2022 capacity
to a 50 μg boost, the Company could supply up to 2.8 billion doses in fiscal year 2022. The maximum output will be determined as the Company more
fully develops its booster product strategy.
Moderna also announces it is increasing its base plan for 2021 manufacturing from 600 million doses to 700 million doses globally. Moderna is
exploring other approaches to potentially improve throughput and is working to further optimize its operations to potentially deliver up to 1 billion doses
in fiscal year 2021.
The Company has shipped approximately 60 million doses globally including approximately 55 million doses shipped to the U.S. Government to date
and the first approximately 4 million doses shipped from its ex-U.S. supply chain. This ex-U.S. supply chain was established one quarter behind the
U.S. supply chain and is in the process of ramping up.
An additional approximately 33 million doses have been produced in the U.S. and are filled in vials and in the final stages of production and testing
before release. Moderna expects to complete delivery of the first 100 million doses to the U.S. Government by the end of the first quarter 2021, the
second 100 million doses by the end of May 2021 and the third 100 million doses by the end of July 2021.
Since the end of 2020, the Company has doubled its monthly deliveries to the U.S. government, and is working to double them again by April to more
than 40 million doses per month. As the Company works to meet these goals, it is continually learning and working closely with its partners and the
federal government to identify ways to address bottlenecks and accelerate production. For example, one of the recently identified constraints on the
production process has been the capacity of the fill-and-finish process. To reduce this constraint, Moderna studied the possibility of adding more doses
to each vial of vaccine. Doing so would improve output because it allows complete manufacturing to run more quickly and it reduces the need for
consumable materials that are in high demand. The FDA has provided positive feedback on this proposal, and the Company is pursuing a plan that
may allow up to 15 doses to be drawn from each vial. This will allow the Company to produce and deliver additional doses more quickly. Moderna will
continue to collaborate with its manufacturing partners and the federal government to increase the efficiency of its production process without
compromising quality or safety.
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 300 million doses of the Moderna
COVID-19 Vaccine, and has options to purchase 200 million additional doses.
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, which was
co-developed by Moderna and investigators from the 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 Moderna COVID-19 Vaccine was dosed on March 16, 2020, 63 days from sequence selection to Phase 1 study
dosing. On May 12, 2020, the U.S Food and Drug Administration granted the Moderna COVID-19 Vaccine Fast Track designation. On May 29, 2020,
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 the vaccine. On July 8, 2020, the Phase 2 study completed enrolment. 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, 2020 in The New England Journal of
Medicine. On July 28, 2020, results from a non-human primate preclinical viral challenge study evaluating the vaccine were published in The New
England Journal of Medicine. On July 14, 2020, 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 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 3, 2020, 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 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
authorization for its COVID-19 vaccine from health agencies in Canada, Israel, the European Union, the United Kingdom, Switzerland, Singapore and
Qatar. Additional authorizations are currently under review in other countries and by the World Health Organization.
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
mRNA-1273 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 mRNA-1273 under U.S. Department of Defense contract no. W911QY-20-C-0100.
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.
Moderna COVID-19 Vaccine is investigational and not approved by FDA.
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. Additional adverse reactions, some of which may be serious, may
become apparent with more widespread use of the Moderna COVID-19 Vaccine.
Available data on Moderna COVID-19 Vaccine administered to pregnant women are insufficient to inform vaccineassociated
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.
In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the promising-but-stillunproven
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.
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 investments and initiatives to increase supply and manufacturing capacity for the Moderna COVID-19
Vaccine; the timeline for such capacity increases; regulatory approvals for expanding manufacturing capacity; future demand for the Moderna
COVID-19 Vaccine; the efficacy of the Moderna COVID-19 Vaccine; the Company’s ability to quickly develop effective vaccines in response to variants
of the SARS-CoV-2 virus; the dosage for boosts of the Moderna COVID-19 Vaccine or vaccines developed in response to variants; the impact of
different dosage levels on supply capabilities; and the potential for the U.S. government to exercise its option to purchase additional doses of the
Moderna COVID-19 Vaccine. 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; the Moderna COVID-19 Vaccine may prove less effective
against variants of the SARS-CoV-2 virus, or the Company may be unsuccessful in developing future versions of its vaccine against these variants;
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 forwardlooking
statements are based on Moderna’s current expectations and speak only as of the date hereof.
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Director, Corporate Communications
Senior Vice President & Head of Investor Relations
Source: Moderna, Inc.