Submission based on Phase 2/3 study of
mRNA-1273 in adolescents ages 12 to less than 18 in the U.S.
Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering
messenger RNA (mRNA) therapeutics and vaccines, today announced
that it has submitted an authorization application to Swissmedic
for use of its COVID-19 vaccine in adolescents.
“We are pleased to announce that we have submitted an
authorization application for our COVID-19 vaccine with Swissmedic
for use in adolescents in Switzerland,” said Stéphane Bancel, Chief
Executive Officer of Moderna. “We are encouraged that the Moderna
COVID-19 vaccine was highly effective at preventing COVID-19 and
SARS-CoV-2 infection in adolescents. We have already filed for
authorization with the U.S. FDA, Health Canada and the European
Medicines Agency and we will continue to file with regulatory
agencies around the world for this important younger age
population. We remain focused on helping to end the COVID-19
pandemic.”
In May, the Company announced that the Phase 2/3 TeenCOVE study
of Moderna’s COVID-19 vaccine in adolescents met its primary
immunogenicity endpoint, successfully bridging immune responses to
the adult vaccination. In the study, no cases of COVID-19 were
observed in participants who had received two doses of the Moderna
COVID-19 vaccine using the primary definition. The vaccine efficacy
in the nearly 2,500 adolescents who received the Moderna COVID-19
vaccine was observed to be 100% when using the same case definition
as in the Phase 3 COVE study in adults. In addition, a vaccine
efficacy of 93% in seronegative participants was observed starting
14 days after the first dose using the secondary Centers for
Disease Control and Prevention (CDC) case definition of COVID-19,
which tested for milder disease. The study enrolled 3,732
participants ages 12 to less than 18 years in the U.S.
The Moderna COVID-19 vaccine was generally well tolerated with a
safety and tolerability profile generally consistent with the Phase
3 COVE study in adults. No significant safety concerns have been
identified to date. The majority of adverse events were mild or
moderate in severity. The most common solicited local adverse event
was injection site pain. The most common solicited systemic adverse
events after the second dose of mRNA-1273 were headache, fatigue,
myalgia and chills. Safety data continues to accrue, and the study
continues to be monitored by an independent safety monitoring
committee. All participants will be monitored for 12 months after
their second injection to assess long-term protection and safety.
These data are subject to change based on ongoing data
collection.
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 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 received
emergency (or other conditional, interim or provisional)
authorization for use of its COVID-19 vaccine in adults from health
agencies in Canada, Israel, the European Union, the United Kingdom,
Switzerland, Singapore, Qatar, Taiwan, the Philippines, Thailand,
Brunei, Paraguay, Japan, South Korea, Botswana and an Emergency Use
Listing (EUL) from the World Health Organization (WHO).
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
was submitted as a preprint to medRxiv and will be submitted for
peer-reviewed publication upon completion of the multivalent
mRNA-1273.211 booster arm.
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 14 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 to protect against the SARS-CoV-2 virus (mRNA-1273, also
referred to as the Moderna COVID-19 Vaccine); the Company’s plans
to file for authorization with Swissmedic for the use of the
vaccine by adolescents; the efficacy of the vaccine, its safety
profile and ongoing clinical trials. 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210614005371/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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