Raises lower end of global manufacturing plan
for 2021 from 500 million doses previously to 600 million doses
Continues to invest and hire in order to
deliver up to 1 billion doses in 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, increasing its
base-case global production estimate from 500 to 600 million doses
for 2021. Moderna said it is continuing to invest and add staff to
build up to potentially 1 billion doses for 2021.
The Company said it expects about 100 million doses to be
available in the United States by the end of the first quarter of
2021, with 200 million doses total available by the end of the
second quarter. Moderna reported that approximately 18 million
doses have been supplied to the U.S. Government to date. The
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. Additional vaccine
doses have also been supplied to the Canadian government following
authorization by Health Canada's Interim Order on December 23,
2020.
“Our effectiveness in providing early supply to the U.S. and
Canadian governments and our ability to increase baseline
production estimates for 2021 are both signals that our scale up of
mRNA vaccine production is a success,” said Juan Andres, Chief
Technical Operations and Quality Officer at Moderna. “I want to
thank the many private and government collaborators, contractors
and the hundreds of Moderna staff who have been working
thoughtfully and tirelessly to accomplish this.”
Moderna is partnered with Lonza Ltd. for production inside and
outside the United States. Fill-finish services are provided by
Catalent Inc. in the U.S., and by ROVI and Recipharm outside the
U.S. 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. The Canadian Government has agreed
to purchase 40 million 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 National
Institute of Allergy and Infectious Diseases’ (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, 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, 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.
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 July 28, 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, 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, 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 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) and on December 30, interim safety
and primary efficacy results from the Phase 3 trial were published
in The New England Journal of Medicine. On December 18, 2020, the
FDA authorized the emergency use of the Moderna COVID-19 Vaccine in
individuals 18 years of age or older.
Authorized Use
The Moderna COVID-19 Vaccine has been authorized for emergency
use in the U.S. by the 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 and has been authorized by Health Canada for
the immunization of Canadians 18 years of age and older under an
Interim Order. Moderna has submitted the final Conditional
Marketing Authorization Application (CA) following rolling
submissions with the European Medicines Agency (EMA) and several
other regulatory agencies around the world.
About Moderna
Moderna is advancing messenger RNA (mRNA) science to create a
new class of transformative medicines for patients. mRNA medicines
are designed to direct the body’s cells to produce intracellular,
membrane or secreted proteins that can have a therapeutic or
preventive benefit and have the potential to address a broad
spectrum of diseases. The company’s platform builds on continuous
advances in basic and applied mRNA science, delivery technology and
manufacturing, providing Moderna the capability to pursue in
parallel a robust pipeline of new development candidates. Moderna
is developing therapeutics and vaccines for infectious diseases,
immuno-oncology, rare diseases, cardiovascular diseases, and
autoimmune and inflammatory diseases, independently and with
strategic collaborators.
Headquartered in Cambridge, Mass., Moderna currently has
strategic alliances for development programs with AstraZeneca PLC
and Merck & Co., Inc., as well as the Defense Advanced Research
Projects Agency (DARPA), an agency of the U.S. Department of
Defense, and BARDA. 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 against the novel coronavirus, and the timeline and scale
for manufacturing and distribution 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;
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
emergency use authorization applications may be filed 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210104005175/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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