UK MHRA authorization is based on a rolling
review of COVID-19 Vaccine Moderna data, including data from the
Phase 3 COVE study
UK government secured an additional 10 million
doses for a total of 17 million doses of the vaccine with supply
beginning in early 2021
Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering
messenger RNA (mRNA) therapeutics and vaccines, today announced
that the UK’s Medicines and Healthcare products Regulatory Agency
(MHRA) has approved its mRNA vaccine against COVID-19 (COVID-19
Vaccine Moderna) for use under Regulation 174. The temporary
authorization permits the supply of COVID-19 Vaccine Moderna in
Great Britain and is based upon the advice of the UK Commission on
Human Medicines.
“We appreciate the confidence shown by the UK MHRA in COVID-19
Vaccine Moderna with this decision, which marks an important step
forward in the global fight against COVID-19,” said Stéphane
Bancel, Chief Executive Officer of Moderna. “I want to thank the
MHRA and the Commission on Human Medicines’ reviewers for their
tireless efforts. The authorization of a product developed by
Moderna is a significant milestone on the Company’s 10-year
journey, and I would like to thank all our colleagues that have
helped us get to this point.”
The United Kingdom government has also exercised its option to
purchase an additional 10 million doses of the COVID-19 Vaccine
Moderna, bringing its confirmed order commitment to 17 million
doses. The first deliveries of the COVID-19 Vaccine Moderna to the
UK from Moderna’s dedicated non-U.S. supply chain are expected to
commence early in 2021.
The UK is the fifth jurisdiction to authorize COVID-19 Vaccine
Moderna, following the United States on December 18, 2020, Canada
on December 23, 2020, Israel on January 4, 2021 and the European
Union on January 6, 2021. Additional authorizations are currently
under review in a number of countries including Singapore and
Switzerland.
The decision from the MHRA is based on a rolling submission of
data that was announced on October 27, 2020. The MHRA based its
authorization on the totality of scientific evidence shared by the
Company, including a data analysis from the pivotal Phase 3
clinical study announced on November 30.
To learn more about Moderna’s work on the COVID-19 Vaccine
Moderna, visit www.modernatx.com/COVID19.
About the COVID-19 Vaccine Moderna
The COVID-19 Vaccine Moderna (referred to in the U.S. as 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 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
the Moderna COVID-19 Vaccine was dosed on March 16, 63 days from
sequence selection to Phase 1 study dosing. On May 12, the U.S Food
and Drug Administration 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 the
vaccine. On July 8, 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 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) application 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).
Authorized Use
The COVID-19 Vaccine Moderna has been authorized by the
Medicines and Healthcare products Regulatory Agency (MHRA), based
upon the recommendation of the Commission on Human Medicines, which
authorizes the COVID-19 Vaccine Moderna for active immunization to
prevent COVID-19 caused by SARS-CoV-2 virus in individuals 18 years
of age and older.
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 plans for the supply
and distribution of the Moderna COVID-19 Vaccine to the United
Kingdom. 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/20210108005274/en/
Moderna:
Media: Harriet Barham Director, FTI Consulting +32
474-819-629 Harriet.Barham@fticonsulting.com
modernamedia@fticonsulting.com
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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