mRNA-1273 could be available to UK population
as early as March 2021
Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering
messenger RNA (mRNA) therapeutics and vaccines to create a new
generation of transformative medicines for patients, today
announced a supply agreement with the government of the United
Kingdom to supply mRNA-1273, its COVID-19 vaccine candidate,
beginning in March 2021 if it is approved for use by UK regulatory
authorities. This agreement comes as the UK continues its efforts
to secure access to safe and effective COVID-19 vaccines.
“We appreciate the collaboration with the UK Government as with
many other governments and other key partners around the world,”
said Stéphane Bancel, CEO of Moderna. “For almost a decade, Moderna
has invested in creating and developing a novel platform for
designing and manufacturing a new class of mRNA-based vaccines. We
are proud of our progress including the positive first interim
analysis from our Phase 3 COVE study recently released. As we
advance the clinical development of mRNA-1273, this continues to be
a pivotal moment for us all.”
Yesterday, Moderna announced that the independent, U.S.
NIH-appointed Data Safety Monitoring Board (DSMB) for the Phase 3
study of mRNA-1273, has informed Moderna that the trial has met the
statistical criteria pre-specified in the study protocol for
efficacy, with a vaccine efficacy of 94.5%. This study, known as
the COVE study, enrolled more than 30,000 participants in the U.S.
and is being conducted in collaboration with the National Institute
of Allergy and Infectious Diseases (NIAID), part of the National
Institutes of Health (NIH), and the Biomedical Advanced Research
and Development Authority (BARDA), part of the Office of the
Assistant Secretary for Preparedness and Response at the U.S.
Department of Health and Human Services.
On October 27, 2020, Moderna received confirmation that the
Medicines and Healthcare products Regulatory Agency (MHRA) in the
United Kingdom started the rolling review process of mRNA-1273.
The investments in this proprietary platform have enabled
Moderna to expeditiously create, manufacture and clinically develop
mRNA-1273 in support of the global response to the current COVID-19
pandemic. Moderna continues to scale up its global manufacturing to
be able to deliver approximately 500 million doses per year and
possibly up to 1 billion doses per year, beginning in 2021. The
Company is working with its strategic manufacturing partners, Lonza
of Switzerland and ROVI of Spain, for manufacturing and fill-finish
outside of the United States. This is a dedicated supply chain to
support Europe and countries other than the United States that
enter into purchase agreements with Moderna.
To learn more about Moderna’s work on mRNA-1273, visit
www.modernatx.com/COVID19.
About the Phase 3 COVE Study
The Phase 3 COVE trial is a randomized, 1:1 placebo-controlled
study testing mRNA-1273 at the 100 µg dose level in 30,000
participants in the U.S., ages 18 and older. The primary endpoint
is the prevention of symptomatic COVID-19 disease. Key secondary
endpoints include prevention of severe COVID-19 disease and
prevention of infection by SARS-CoV-2. The trial will continue to
accrue additional data relevant to safety and efficacy even after
an EUA is submitted. The final estimates of vaccine efficacy for
both primary and secondary endpoints will depend on the totality of
data that will accumulate to inform the final analysis. Moderna
worked closely with BARDA and the NIH, including NIAID’s COVID-19
Prevention Network (CoVPN), to conduct the Phase 3 COVE study under
Operation Warp Speed. Moderna’s partner PPD (Nasdaq: PPD), a
leading global contract research organization providing
comprehensive, integrated drug development, laboratory and
lifecycle management services, has also been essential to the
successful execution of the COVE study.
The Phase 3 COVE study was designed in collaboration with the
FDA and NIH to evaluate Americans at risk of severe COVID-19
disease and completed enrollment of 30,000 participants ages 18 and
older in the U.S. on October 22, including those at high risk of
the severe complications of COVID-19 disease. The COVE study
includes more than 7,000 Americans over the age of 65. It also
includes more than 5,000 Americans who are under the age of 65 but
have high-risk chronic diseases that put them at increased risk of
severe COVID-19, such as diabetes, severe obesity and cardiac
disease. These medically high-risk groups represent 42% of the
total participants in the Phase 3 COVE study. The study also
included communities that have historically been under-represented
in clinical research and have been disproportionately impacted by
COVID-19. The study includes more than 11,000 participants from
communities of color, representing 37% of the study population,
which is similar to the diversity of the U.S. at large. This
includes more than 6,000 participants who identify as Hispanic or
LatinX, and more than 3,000 participants who identify as Black or
African American.
About mRNA-1273
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 NIAID’s 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 NIH on February 24, 42 days from sequence selection. The
first participant in the NIAID-led Phase 1 study of mRNA-1273 was
dosed on March 16, 63 days from sequence selection to Phase 1 study
dosing. On May 12, the FDA granted mRNA-1273 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 mRNA-1273 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 mRNA-1273 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 mRNA-1273 was published in The New
England Journal of Medicine. mRNA-1273 currently is not approved
for use by any regulatory body.
BARDA 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
provide up to $1.525 billion to purchase supply of mRNA-1273 under
U.S. Department of Defense Contract No. W911QY-20-C-0100.
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 potential vaccine (mRNA-1273) against the novel coronavirus,
mRNA-1273's efficacy and its ability to prevent infection or
mitigate symptoms of COVID-19, the safety profile for mRNA-1273,
further changes to mRNA-1273’s efficacy as the study continues, the
Company’s plans to seek regulatory approval for the use of
mRNA-1273 in the U.S. and other jurisdictions, and the Company’s
anticipated production of mRNA-1273. 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 fact that the safety
and efficacy of mRNA-1273 has not yet been established; 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; 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/20201117005857/en/
Moderna Contacts
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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