New Switzerland agreement and option is in
additional to earlier agreements for 13.5 million doses
Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering
messenger RNA (mRNA) therapeutics and vaccines, today announced a
new supply agreement with the Swiss Federal Government for 7
million doses of booster vaccine in 2022, with an additional option
for another 7 million doses for delivery during the second half of
2022 or first quarter of 2023. Purchase under this agreement is
subject to regulatory approval of the booster vaccine candidate.
Today’s announcement follows two earlier agreements between
Switzerland and Moderna to supply a total of 13.5 million doses of
the COVID-19 Vaccine Moderna. Swissmedic, the Swiss Agency for
Therapeutic Products, authorized the COVID-19 Vaccine Moderna in
Switzerland on January 12, 2021.
“We appreciate the partnership of the Swiss Federal Government,
and their continued support demonstrated by this new supply
agreement for doses of Moderna variant booster candidates,” said
Stéphane Bancel, Chief Executive Officer of Moderna. “We are
encouraged by the new data, which reinforce our confidence that our
booster strategy should be protective against these newly detected
variants and we will continue to make as many updates to our
COVID-19 vaccine as necessary to control the pandemic.”
Initial data from Moderna’s Phase 2 study in the U.S. showed
that a single 50 µg dose of mRNA-1273 or mRNA-1273.351 given as a
booster to previously vaccinated individuals increased neutralizing
antibody titer responses against SARS-CoV-2 and two variants of
concern, B.1.351 (first identified in South Africa) and P.1 (first
identified in Brazil). A booster dose of mRNA-1273.351, the
Company’s strain-matched booster, achieved higher neutralizing
antibody titers against the B.1.351 variant of concern than a
booster dose of mRNA-1273. Safety and tolerability profiles
following third dose booster injections of 50 µg of mRNA-1273 or
mRNA-1273.351 were generally comparable to those observed after the
second dose of mRNA-1273 in the previously reported Phase 2 and
Phase 3 studies. A manuscript describing these preliminary results
has been submitted as a preprint to bioRxiv and will be submitted
for peer-reviewed publication upon completion of the multivalent
mRNA-1273.211 booster arm.
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 the
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 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 November 30, 2020, Moderna announced the primary
efficacy analysis of the Phase 3 study of the vaccine conducted on
196 cases. On November 30, 2020, 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 18, 2020, the U.S. FDA
authorized the emergency use of the Moderna COVID-19 Vaccine in
individuals 18 years of age or older. Moderna has also received
authorization for its COVID-19 vaccine from health agencies in
Canada, Israel, the European Union, the United Kingdom,
Switzerland, Singapore, Qatar, Taiwan, the Philippines and from the
World Health Organization. Additional authorizations are currently
under review in other countries.
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 field of
messenger RNA (mRNA), to an enterprise with 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; plans for the supply and
distribution of the COVID-19 Vaccine Moderna to Switzerland and the
timing for such supply; the Company’s development of booster
vaccines to protect against specific variants of the SARS-CoV-2
virus, and the protection provided by those boosters, and the
safety and tolerability profile of those boosters. 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
Annual Report on Form 10-K 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/20210506005563/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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