Moderna Announces European Medicines Agency Authorizes Third Dose of COVID-19 Vaccine for Immunocompromised Individuals Aged 12 Years and Older
October 05 2021 - 9:21AM
Business Wire
Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering
messenger RNA (mRNA) therapeutics and vaccines today announced that
the European Medicines Agency (EMA) has authorized a third dose of
the Moderna COVID-19 vaccine (Spikevax) given at least 28 days
after the second dose to severely immunocompromised individuals 12
years of age or older.
“We recognize the need to protect immunocompromised individuals
who are at the highest risk of severe COVID-19 disease. It is
promising to see recent trials demonstrating that a third dose of
the Moderna COVID-19 vaccine may enhance immune response in this
important population,” said Stéphane Bancel, Chief Executive
Officer of Moderna. “We remain committed to helping to end the
COVID-19 pandemic with our mRNA vaccine.”
A growing number of studies have shown the benefit of a third
dose of COVID-19 vaccine in immunocompromised subjects. In
particular, a recent double-blind, randomized controlled trial of
120 individuals who had undergone solid organ transplant procedures
(heart, kidney, kidney-pancreas, liver, lung, pancreas)
demonstrated that a third dose of the Moderna COVID-19 vaccine
improved immune response compared to placebo1. In the study, the
third dose was generally well tolerated.
About Spikevax (COVID-19 Vaccine Moderna)
Spikevax (formerly known as 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 autoimmune 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 THE EU
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
- 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 of Spikevax during mass vaccination outside of
clinical trials:
- Severe allergic reactions, including anaphylaxis
- Myocarditis and pericarditis
- 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 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.
- The black equilateral triangle denotes that additional
monitoring is required to capture any adverse reactions. This will
allow quick identification of new safety information. Individuals
can help by reporting any side effects they may get. Side effects
can be reported to EudraVigilance (https://www.adrreports.eu/) or
directly to Moderna using email EMEAMedinfo@modernatx.com.
For complete information on the safety of Spikevax, always make
reference to the approved Summary of Product Characteristics and
Package Leaflet available in all the languages of the European
Union on the EMA website.
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 ability of a third dose
of mRNA-1273 to enhance immune response against COVID-19 in
immunocompromised populations; and the safety profile for mRNA-1273
in immunocompromised 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 Hall et al., N Engl J Med 385;13
September 23, 2021
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version on businesswire.com: https://www.businesswire.com/news/home/20211005005772/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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