Moderna, Inc. (Nasdaq: MRNA), a biotechnology
company pioneering messenger RNA (mRNA) therapeutics and vaccines,
today announced Health Canada has approved the New Drug Submission
(NDS-CV) for SPIKEVAX™ (elasomeran mRNA vaccine), which has been
known as COVID-19 Vaccine Moderna, for active immunization to
prevent COVID-19 in individuals 12 years of age and older.
“Health Canada’s approval of our COVID-19 vaccine is an
important milestone as it is our first full approval for Spikevax.
I would like to thank Health Canada for their hard work throughout
the process,” said Stéphane Bancel, Chief Executive Officer of
Moderna. “I would also like to thank the Government of Canada for
the partnership they have built with us and for their confidence in
our mRNA platform in addressing the COVID-19 pandemic.”
Health Canada approved the New Drug Submission for SPIKEVAX
based on clinical data from the Phase 3 COVE study of the Moderna
COVID-19 vaccine, which enrolled more than 30,000 participants in
the U.S. In final analysis of Phase 3 COVE study data, SPIKEVAX
showed 93% efficacy, with the efficacy remaining durable through
six months after administration of the second dose. The safety
profile based on extended safety follow-up was consistent with the
Phase 3 COVE study primary results.
The Moderna COVID-19 vaccine was originally authorized in Canada
under an Interim Order for individuals 18 years of age and older
granted by Health Canada on December 23, 2020. On August 27, 2021,
Health Canada expanded the Interim Order authorization for the
Moderna COVID-19 vaccine to include adolescents 12 years of age and
older.
About SPIKEVAX
The Moderna COVID-19 vaccine, brand name SPIKEVAX, is an mRNA
vaccine against COVID-19 encoding for a prefusion stabilized form
of the Spike (S) protein. 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 received
emergency (or other conditional, interim or provisional)
authorization for use of its COVID-19 vaccine in adults from health
agencies in more than 50 countries and an Emergency Use Listing
(EUL) from the World Health Organization (WHO).1
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. Moderna has been named a top
biopharmaceutical employer by Science for the past six years. To
learn more, visit www.modernatx.com.
AUTHORIZED USE IN CANADA
SPIKEVAX (elasomeran mRNA vaccine) has been granted approval by
Health Canada and is indicated for active immunization against
coronavirus disease 2019 (COVID-19) caused by the severe acute
respiratory syndrome coronavirus 2 (SARS-CoV-2) virus in
individuals 12 years of age and older.
IMPORTANT SAFETY INFORMATION
• Do not administer SPIKEVAX to individuals with a known history
of severe allergic reaction (e.g., anaphylaxis) to any component of
SPIKEVAX
• Appropriate medical treatment to manage immediate allergic
reactions must be immediately available in the event an acute
anaphylactic reaction occurs following administration of SPIKEVAX.
Monitor SPIKEVAX recipients for the occurrence of immediate adverse
reactions according to the Centers for Disease Control and
Prevention guidelines
(https://www.cdc.gov/vaccines/covid-19/clinical-considerations/managing-anaphylaxis.html).
• Postmarketing data demonstrate increased risks of myocarditis
and pericarditis, particularly within 7 days following the second
dose.
• Syncope (fainting) may occur in association with
administration of injectable vaccines. Procedures should be in
place to avoid injury from fainting.
• Immunocompromised persons, including individuals receiving
immunosuppressive therapy, may have a diminished response to
SPIKEVAX.
• SPIKEVAX may not protect all vaccine recipients.
• Adverse reactions reported in clinical trials following
administration of SPIKEVAX include pain at the injection site,
fatigue, headache, myalgia, arthralgia, chills, nausea/vomiting,
axillary swelling/tenderness, fever, swelling at the injection
site, and erythema at the injection site.
• The following adverse reactions have been reported following
administration SPIKEVAX during mass vaccination outside of clinical
trials:
o Severe allergic reactions, including
anaphylaxis o Myocarditis and pericarditis o Syncope
• Available data on SPIKEVAX administered to pregnant women are
insufficient to inform vaccine-associated risks in pregnancy. Data
are not available to assess the effects of SPIKEVAX on the
breastfed infant or on milk production/excretion.
• There are no data available on the interchangeability of
SPIKEVAX with other COVID-19 vaccines to complete the vaccination
series. Individuals who have received one dose of SPIKEVAX should
receive a second dose of SPIKEVAX to complete the vaccination
series.
• Additional adverse reactions, some of which may be serious,
may become apparent with more widespread use of SPIKEVAX.
• If a patient experiences a side effect following immunization,
healthcare professionals should complete the Adverse Events
Following Immunization (AEFI) Form appropriate for the
province/territory
(https://www.canada.ca/en/public-health/services/immunization/reporting-adverse-events-following-immunization/form.html)
and send it to the local Health Unit.
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 effectiveness and safety
of the Company’s vaccine against COVID-19 (mRNA-1273), brand name
SPIKEVAX. 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 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.
1 BARDA, part of ASPR within the U.S. HHS is supporting the
continued research and development of the Company’s COVID-19
vaccine development efforts with federal funding under contract no.
75A50120C00034 BARDA is reimbursing Moderna for 100 percent of the
allowable costs incurred by the Company for conducting the program
described in the BARDA contract. The U.S. government has agreed to
purchase supply of mRNA-1273 under U.S. Department of Defense
contract no. W911QY-20-C-0100.
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version on businesswire.com: https://www.businesswire.com/news/home/20210916005677/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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