Ministry of Health of Israel has secured 6
million doses and first deliveries expected to begin in January
Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering
messenger RNA (mRNA) therapeutics and vaccines, today announced
that Israel’s Ministry of Health (MOH) has given authorization to
import the COVID-19 Vaccine Moderna in Israel.
“Today’s authorization is a landmark moment in our company’s
history and in the global fight against COVID-19,” said Stéphane
Bancel, Chief Executive Officer of Moderna. “This is the third
regulatory authorization for the COVID-19 Vaccine Moderna, and its
first outside of North America. I want to thank the Ministry of
Health of Israel for their efforts, as their team have worked
tirelessly alongside ours to ensure a timely authorization of this
vaccine. We hope to continue to see authorizations in additional
markets in the coming days, weeks and months.”
The MOH has secured 6 million doses of the COVID-19 Vaccine
Moderna. Planned deliveries reflect today’s authorization to supply
the vaccine in Israel, and first deliveries are expected to begin
shortly.
Israel is the third country for which Moderna has received
authorization for its COVID-19 vaccine, following the United States
on December 18, 2020 and Canada on December 23, 2020. Additional
authorizations are currently under review in the European Union,
Singapore, Switzerland and the United Kingdom.
The authorization is given according to Regulation 29 (A)(9):
Medical product designated for pharmaceutical treatment of local
citizens in case of epidemic or contagious disease or protection
from chemical or radioactive substances, according to Regulation 29
of the Pharmacists’ Regulations (Medical preparations) – 1986.
The decision from the MOH is based on a rolling submission of
data and is 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 mRNA-1273, visit
www.modernatx.com/COVID19.
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, has been authorized by Health Canada for
the immunization of Canadians 18 years of age and older under an
Interim Order and now authorization to import by Israel. 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, the potential for the
Moderna COVID-19 Vaccine to prevent COVID-19 disease and slow the
spread of SARS-CoV-2 and plans for the supply and distribution of
the Moderna COVID-19 Vaccine to the Israeli Government. 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
mRNA-1273 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 mRNA-1273; 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/20210104005849/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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