Moderna Announces Submission of Data to European Medicines Agency for its COVID-19 Vaccine Booster
September 03 2021 - 4:01PM
Business Wire
mRNA-1273 at 50 µg dose level induced robust
antibody responses of more than 40 times against the Delta variant
(B.1.617.2)
Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering
messenger RNA (mRNA) therapeutics and vaccines, today announced it
has submitted for a conditional marketing approval (CMA) with the
European Medicines Agency (EMA) for the evaluation of a booster
dose of the Moderna COVID-19 vaccine (mRNA-1273) at the 50 µg dose
level.
“We are pleased to submit for a conditional marketing approval
with the EMA for our booster candidate at the 50 µg dose level. The
amended Phase 2 study and additional analyses shows that a 50 µg
booster dose of our COVID-19 vaccine induces robust antibody
responses against the Delta variant,” said Stéphane Bancel, Chief
Executive Officer of Moderna. “We remain committed to staying ahead
of the virus and following the evolving epidemiology of
SARS-CoV-2.”
The Phase 2 study of mRNA-1273 was amended to offer a booster
dose of mRNA-1273 at the 50 µg dose level to interested
participants 6 months following their second dose (n=344).
Neutralizing antibody titers had waned significantly prior to
boosting at approximately 6 months. A booster dose of mRNA-1273 at
the 50 µg dose level boosted neutralizing titers significantly
above the Phase 3 benchmark. After a third dose, a similar level of
neutralizing titers was achieved across age groups, notably in
older adults (ages 65 and above). The safety profile following dose
3 was similar to that observed previously for dose 2 of mRNA-1273.
These data will be submitted to a peer-reviewed publication.
An additional analysis showed that a booster dose of mRNA-1273
at the 50 µg dose level induced robust antibody responses and
significantly increased geometric mean titers (GMT) for all
variants of concern including Beta (B.1.351) by 32- fold, Gamma
(P.1) by 43.6-fold and Delta (B.1.617.2) by 42.3-fold.
About Spikevax (COVID-19 Vaccine Moderna)
COVID-19 Vaccine Moderna 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).
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, 23 development programs
are underway across these therapeutic areas, with 15 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.
AUTHORIZED USE
Spikevax (COVID-19 Vaccine Moderna) has been granted conditional
marketing authorisation by the European Commission for active
immunisation to prevent COVID-19 caused by SARS-CoV-2 in
individuals 12 years of age and older.
IMPORTANT SAFETY INFORMATION FROM U.S. FDA EMERGENCY USE
AUTHORIZATION PRESCRIBING INFORMATION
- Do not administer the Moderna COVID-19 Vaccine to individuals
with a known history of severe allergic reaction (e.g.,
anaphylaxis) to any component of the Moderna COVID-19 Vaccine.
- Appropriate medical treatment to manage immediate allergic
reactions must be immediately available in the event an acute
anaphylactic reaction occurs following administration of the
Moderna COVID-19 Vaccine. Monitor Moderna COVID-19 Vaccine
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 the
Moderna COVID-19 Vaccine.
- The Moderna COVID-19 Vaccine may not protect all vaccine
recipients.
- Adverse reactions reported in a clinical trial following
administration of the Moderna COVID-19 Vaccine 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 of the Moderna COVID-19 Vaccine during mass
vaccination outside of clinical trials:
- Severe allergic reactions, including anaphylaxis
- Myocarditis and pericarditis
- Available data on Moderna COVID-19 Vaccine administered to
pregnant women are insufficient to inform vaccine-associated risks
in pregnancy. Data are not available to assess the effects of
Moderna COVID-19 Vaccine on the breastfed infant or on milk
production/excretion.
- There are no data available on the interchangeability of the
Moderna COVID-19 Vaccine with other COVID-19 vaccines to complete
the vaccination series. Individuals who have received one dose of
Moderna COVID-19 Vaccine should receive a second dose of Moderna
COVID-19 Vaccine to complete the vaccination series.
- Additional adverse reactions, some of which may be serious, may
become apparent with more widespread use of the Moderna COVID-19
Vaccine.
- Vaccination providers must complete and submit reports to VAERS
online at https://vaers.hhs.gov/reportevent.html. For further
assistance with reporting to VAERS, call 1-800-822-7967. The
reports should include the words “Moderna COVID- 19 Vaccine EUA” in
the description section of the report.
Click for Fact Sheet for Healthcare Providers Administering
Vaccine (Vaccination Providers) and Full EUA Prescribing
Information for more information.
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 submission to
the European Medicines Agency for authorization to administer a
third dose of mRNA-1273 at the 50 µg dose level; the ability of a
third dose of mRNA-1273 at the 50 µg dose level to boost
neutralizing antibody titers and to induce antibody responses
against wildtype SARS-CoV-2 and variants of concern; and the safety
profile for a third booster dose. 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/20210903005439/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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