Submission based on Phase 2/3 study of SPIKEVAX
in children ages 6 to 11
Moderna Inc. (Nasdaq: MRNA), a biotechnology company pioneering
messenger RNA (mRNA) therapeutics and vaccines, today announced
that it has submitted for authorization with Health Canada for the
evaluation of a 50 µg two-dose series of SPIKEVAX™ (elasomeran mRNA
vaccine)1 in children ages 6 to 11 years.
“We are pleased to announce that we have submitted for
authorization of a 50 µg two-dose series of our COVID-19 vaccine
for use in children 6 to 11 years old with Health Canada,” said
Stéphane Bancel, Chief Executive Officer of Moderna. “We are
encouraged that the Moderna COVID-19 vaccine at the 50 µg dose
level helped prevent SARS-CoV-2 infection in children. We plan to
submit these data to other regulatory agencies around the world to
protect this important younger age population with our COVID-19
vaccine.”
The Phase 2/3 “KidCOVE” study of SPIKEVAX in pediatric
population ages 6 months to under 12 years is ongoing. Moderna
recently shared new data from the KidCOVE study in children ages 6
years to 11 years. Vaccine efficacy of 100% using the Phase 3 COVE
study primary case definition for COVID-19 was observed two weeks
after the first dose of SPIKEVAX at the 50 µg dose level.
Additionally, for asymptomatic infection two weeks after the first
dose, vaccine efficacy was 65% (95% CI: .16, .85). For SARS-CoV-2
infection regardless of symptoms, vaccine efficacy was 80% (95%
CI: .62, .90) two weeks after the first dose. On October 24, the
Company announced positive top line data in children 6 to 11 years
of age. The geometric mean ratio (GMR) comparing the response in
children to the response in young adults from the Phase 3 COVE
study was 1.5 (95% CI: 1.3, 1.8), with a seroresponse rate of
99.3%. Two 50 μg doses of SPIKEVAX were generally well
tolerated2.
The KidCOVE study3 is a randomized, observer-blind,
placebo-controlled expansion study to evaluate the safety,
tolerability, reactogenicity and effectiveness of two 50 µg doses
of mRNA-1273 given to healthy children 28 days apart. The study
population is divided into 3 age groups (6 to <12 years, 2 to
<6 years, and 6 months to <2 years).
On September 16, 2021, Health Canada approved the New Drug
Submission (NDS-CV) for SPIKEVAX for active immunization to prevent
COVID-19 in individuals 12 years of age and older. More recently,
on November 12, 2021 Health Canada authorized the use of a 50 µg
booster dose for individuals aged 18 and older administered at
least six months after completion of the primary series.
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 seven 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 .
• Post-marketing 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/health-canada/services/drugs-health-products/drug-products/drug-product-database.html)
and send it to the local Health Unit.
The full product monograph is available at the Health Canada
website:
https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/drug-product-database.html
and https://www.modernacovid19global.com/ca/.
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 COVID-19 (mRNA-1273); the Company’s application
for, and potential authorization of, the administration of
mRNA-1273 in children ages 6 to 11 years old in Canada; the
effectiveness of mRNA-1273 at preventing infection with COVID-19
and the safety and tolerability of mRNA-1273 in pediatric
populations; and the conduct of clinical trials for mRNA-1273 in
pediatric populations. 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.
2
https://investors.modernatx.com/news-releases/news-release-details/moderna-announces-positive-top-line-data-phase-23-study-covid-19
3
The study is being conducted in
collaboration with the National Institute of Allergy and Infectious
Diseases (NIAID), part of the National Institutes of Health (NIH)
and the Biomedical Advanced Research and Development Authority
(BARDA), part of the Office of the Assistant Secretary for
Preparedness and Response at the U.S. Department of Health and
Human Services (HHS). The ClinicalTrials.gov identifier is
NCT04796896.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20211117005865/en/
Moderna Contacts
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
Moderna (NASDAQ:MRNA)
Historical Stock Chart
From Feb 2024 to Mar 2024
Moderna (NASDAQ:MRNA)
Historical Stock Chart
From Mar 2023 to Mar 2024