Moderna Announces FDA Authorization of Booster Dose of COVID-19 Vaccine in the U.S. for Adults 18 Years and Older
November 19 2021 - 8:07AM
Business Wire
Authorization includes the use of Moderna’s
booster dose following primary vaccination with other authorized or
approved COVID-19 vaccines
Moderna, Inc. (Nasdaq:MRNA), a biotechnology company pioneering
messenger RNA (mRNA) therapeutics and vaccines, today announced
that the U.S. Food and Drug Administration (FDA) has extended the
emergency use authorization of a booster dose of the Moderna
COVID-19 vaccine at the 50 µg dose level to all adults aged 18 and
older. This booster can be used in all individuals 18 years and
older who have completed a primary vaccination with any other
authorized or approved COVID-19 vaccine.
“This emergency use authorization comes at a critical time as we
enter the winter months and face increasing COVID-19 case counts
and hospitalizations across the country,” said Stéphane Bancel,
Chief Executive Officer of Moderna. “We thank the FDA for their
review, and are confident in the robust clinical evidence that a 50
µg booster dose of mRNA-1273 induces a strong immune response
against COVID-19.”
The booster dose is to be administered at least six months after
completion of any primary series COVID-19 vaccination. On October
20th, the FDA authorized for emergency use a booster dose of the
Moderna COVID-19 vaccine at the 50 µg dose level for people aged 65
and older as well as adults 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. The Moderna
COVID-19 booster vaccine is authorized for adults ages 18 and above
regardless of occupational risk factors in many international
markets. This follows the earlier approval of the 100 µg mRNA 1273
third dose in immunocompromised individuals.
The FDA based this EUA on the totality of scientific evidence
shared by the company including a data analysis from the Phase 2
clinical study of mRNA-1273, which was amended to offer a booster
dose of mRNA-1273 at the 50 µg dose level to interested
participants 6-8 months following their second dose (n=344).
Neutralizing antibody titers had waned prior to boosting,
particularly against variants of concern, at approximately 6
months. Notably, a booster dose of mRNA-1273 at the 50 µg dose
level boosted neutralizing titers significantly above the Phase 3
benchmark. The safety profile following the booster dose was
similar to that observed previously for dose 2 of mRNA-1273.
As a next step, the U.S. Centers for Disease Control and
Prevention’s (CDC) Advisory Committee on Immunization Practices
(ACIP) will meet to discuss a potential recommendation for rollout
of COVID-19 boosters to Americans.
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; the ability of
mRNA-1273 booster at the 50 µg dose to trigger an immune response,
and the safety profile for that booster. 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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Moderna Contacts
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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