Authorization follows European Medicines Agency
recommendation of COVID-19 Vaccine Moderna
European Commission has secured 160 million
doses; first deliveries to countries will begin next week
Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering
messenger RNA (mRNA) therapeutics and vaccines, today announced
that the European Commission has granted a conditional marketing
authorization (CMA) for COVID-19 Vaccine Moderna, allowing
vaccination programs using the Moderna vaccine to be rolled out
across the European Union. The authorization is based upon the
recommendation of the European Medicines Agency (EMA) for use of
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.
“I want to thank the European Commission for its engagement and
endorsement and the EMA for its recommendation, which is another
significant moment in our company’s history,” said Stéphane Bancel,
Chief Executive Officer of Moderna. “The EMA and the Committee for
Medicinal Products for Human Use reviewers, working over the
holidays, provided a thorough review and comprehensive guidance as
we worked together to achieve this authorization. I am proud of the
role Moderna has been able to play globally in helping to address
this pandemic.”
The European Union is the fourth jurisdiction to authorize
Moderna’s COVID-19 vaccine, following the United States on December
18, 2020, Canada on December 23, 2020 and Israel on January 4,
2021. Additional authorizations are currently under review in
Singapore, Switzerland and the United Kingdom.
On December 18, the EMA exercised its option to increase its
confirmed order commitment by 80 million doses of Moderna’s vaccine
against COVID-19, bringing its confirmed order commitment to 160
million doses. The first deliveries of COVID-19 Vaccine Moderna to
European countries from Moderna’s dedicated non-U.S. supply chain
are expected to begin next week.
The EMA’s Committee for Medicinal Products for Human Use (CHMP)
adopted a positive opinion for COVID-19 Vaccine Moderna based 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 Moderna COVID-19
Vaccine, 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). 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. On
December 23, 2020, Health Canada authorized Moderna’s vaccine
against COVID-19 for the immunization of people 18 years of age and
older under an Interim Order. On January 4, 2021, Israel’s Ministry
of Health (MOH) authorized the importation of the COVID-19 Vaccine
Moderna in Israel.
Authorized Use
The COVID-19 Vaccine Moderna has been granted a Conditional
Marketing Authorization by the European Commission, based upon the
recommendation of the European Medicines Agency, 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 Member States
of the European Union. 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/20210106005629/en/
Moderna: 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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