U.S. CDC Advisory Committee on Immunization Practices Recommends Booster Vaccination with Moderna’s COVID-19 Vaccine
October 21 2021 - 5:49PM
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 65 and older; people aged
18 to 64 who are at high risk of severe COVID-19; and people aged
18 to 64 with frequent institutional or occupational exposure to
SARS-CoV-2 under the Emergency Use Authorization (EUA) issued
yesterday by the U.S. Food and Drug Administration (FDA). The
positive vote was unanimous with 15 ACIP members recommending the
booster.
“Since we began this journey in January of 2020, our goal has
been to protect as many people as possible from COVID-19. The ACIP
recommendation is another step forward in our quest to address this
devastating pandemic with a vaccine,” said Stéphane Bancel, Chief
Executive Officer of Moderna. “We are grateful for the opportunity
to provide individuals with another layer of protection against
COVID-19.”
The ACIP is comprised of independent health experts. Today’s
ACIP recommendation follows the FDA’s emergency use authorization
for a booster dose, which was granted yesterday. 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. The Committee
based its recommendation on the totality of scientific evidence
shared by the company and reviewed by the FDA’s Vaccines and
Related Biological Products Advisory Committee (VRBPAC).
Moderna estimates that the authorization of a booster dose of
mRNA-1273 at the 50 µg dose level and subsequent approval could
result in up to 1 billion extra doses being available for
distribution in 2022.
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 six 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 approval of mRNA-1273
for use as a booster dose; the potential recommendation by the CDC
of booster doses of mRNA-1273 at the 50 µg dose level; and the
Company’s potential vaccine production in 2022. 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20211021006097/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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