Moderna Announces Amendment to Current Supply Agreement with United Kingdom Government for an Additional 2 Million Doses of m...
November 29 2020 - 8:37AM
Business Wire
UK government has now secured 7 million doses
of mRNA-1273
Agreement reflects Moderna’s commitment to make
its vaccine available in multiple countries
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 UK government for an
additional 2 million doses of mRNA-1273, Moderna’s vaccine
candidate against COVID-19, to the United Kingdom beginning in
March 2021. The UK government has now secured 7 million doses of
mRNA-1273. This confirmation comes as the UK continues its efforts
to secure access to safe and effective COVID-19 vaccines by
establishing a broad portfolio of the most promising vaccines.
“We appreciate the collaboration with the UK government as with
many other governments and other key partners around the world,”
said Stéphane Bancel, Chief Executive Officer 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 the progress on mRNA-1273 we
have made to date including the positive interim analysis from our
Phase 3 COVE study.”
On November 16, Moderna announced that the independent,
NIH-appointed Data Safety Monitoring Board (DSMB) for the Phase 3
study of mRNA-1273, its vaccine candidate against COVID-19, 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.
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 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 terms of the Company’s
anticipated sale of mRNA-1273 to the government of the United
Kingdom; the timing for the delivery of mRNA-1273 to the United
Kingdom; plans to submit an application for regulatory approval for
the distribution of mRNA-1273 to the MHRA; and plans for the
manufacture of mRNA-1273 and the scale of anticipated production.
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, MHRA or other regulatory agencies, the FDA, MHRA 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/20201129005403/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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