Swiss Federal Government has secured 7.5
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 Swissmedic, the Swiss Agency for Therapeutic Products, has
authorized the COVID-19 Moderna Vaccine in Switzerland.
The authorization is given according to the ordinary approvals
procedure and is based on a rolling submission of data and the
totality of scientific evidence shared by the Company, including a
data analysis from the pivotal Phase 3 clinical study announced on
November 30.
“Having our COVID-19 Vaccine Moderna authorized in Switzerland
is an important milestone for us,” said Stéphane Bancel, Chief
Executive Officer of Moderna. “Switzerland has played a critical
role in Moderna’s history since our early days and it means a lot
to us that we can now provide a highly effective vaccine to help
protect the citizens of Switzerland.”
The Swiss Federal Government has secured 7.5 million doses of
the COVID-19 Vaccine Moderna. Following today’s authorization, the
first deliveries are expected to begin in Switzerland in the next
week.
Moderna has also received authorization for its COVID-19 vaccine
from regulatory authorities in the United States, Canada, Israel,
the European Union and the United Kingdom. Additional
authorizations are currently under review in other countries and by
the World Health Organization.
To learn more about Moderna’s work on 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 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 granted temporary approval
by Swissmedic, the Swiss Agency for Therapeutic Products, based
upon the recommendation of the Human Medicines Expert Committee
(HMEC), 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
In 10 years since its inception, Moderna has transformed from a
science research-stage company advancing programs in the
promising-but-still-unproven field of messenger RNA (mRNA), to an
enterprise with its first medicine having treated millions of
people, a diverse clinical portfolio of vaccines and therapeutics
across six modalities, a broad intellectual property portfolio in
areas including mRNA and lipid nanoparticle formulation, and an
integrated manufacturing plant that allows for both clinical and
commercial production at scale and at unprecedented speed. Moderna
maintains alliances with a broad range of domestic and overseas
government and commercial collaborators, which has allowed for the
pursuit of both groundbreaking science and rapid scaling of
manufacturing. Most recently, Moderna’s capabilities have come
together to allow the authorized use of one of the earliest and
most-effective vaccines against the COVID-19 pandemic.
Moderna’s mRNA platform builds on continuous advances in basic
and applied mRNA science, delivery technology and manufacturing,
and has allowed the development of therapeutics and vaccines for
infectious diseases, immuno-oncology, rare diseases, cardiovascular
diseases and auto-immune diseases. Today, 24 development programs
are underway across these therapeutic areas, with 13 programs
having entered the clinic. 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 Switzerland,
and the timing of deliveries of the vaccine. 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/20210112005612/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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