U.S. CDC Advisory Committee on Immunization Practices Recommends Booster Vaccination with Moderna’s COVID-19 Vaccine
November 19 2021 - 3:13PM
Business Wire
Recommendation follows U.S. FDA authorization
for emergency use of a booster dose of the Moderna COVID-19
vaccine
Moderna, Inc., (Nasdaq: MRNA) a biotechnology company pioneering
messenger RNA (mRNA) therapeutics and vaccines today announced that
the U.S. Centers for Disease Control and Prevention’s (CDC)
Advisory Committee on Immunization Practices (ACIP) voted today to
recommend the use of a booster dose of the Moderna COVID-19 vaccine
at the 50 µg dose level for people aged 18 and older under the
Emergency Use Authorization (EUA) issued by the U.S. Food and Drug
Administration (FDA). The positive vote was unanimous with 11 ACIP
members recommending the booster.
“We thank the ACIP for this recommendation, which will provide
individuals with another layer of protection against COVID-19 as we
enter the winter months and as cases of COVID-19 and
hospitalizations are increasing across the country,” said Stéphane
Bancel, Chief Executive Officer of Moderna. “This is another
important step in our quest to address this pandemic with our mRNA
vaccine.”
The ACIP is comprised of independent health experts. Today’s
ACIP recommendation follows the FDA’s emergency use authorization
of a booster dose. This ACIP recommendation will be forwarded to
the Director of the CDC and the U.S. Department of Health and Human
Services (HHS) for review and adoption. The ACIP advises the CDC on
the populations and circumstances for which vaccines should be
used.
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 THE US
Moderna COVID-19 Vaccine is authorized for use under an
Emergency Use Authorization (EUA) for active immunization to
prevent coronavirus disease 2019 (COVID-19) caused by severe acute
respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals 18
years of age and older.
IMPORTANT SAFETY 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 the 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 clinical trials 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, and
rash.
- Anaphylaxis and other severe allergic reactions, myocarditis,
pericarditis, and syncope have been reported following
administration of the Moderna COVID-19 Vaccine during mass
vaccination outside of clinical trials.
- Available data on the 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 the
Moderna COVID-19 Vaccine on the breastfed infant or on milk
production/excretion.
- 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 authorization of
mRNA-1273 for use as a booster dose by the U.S. FDA and the related
recommendation of the CDC’s Advisory Committee on Immunization
Practices (ACIP); and potential future action by the CDC with
respect to the review and adoption of the ACIP’s recommendation.
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/20211119005733/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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