Moderna Announces FDA Authorization of a Booster Dose of Moderna’s COVID-19 Vaccine in the U.S.
October 20 2021 - 5:37PM
Business Wire
Emergency Use Authorization (EUA) granted for
individuals 65 years of age and older, and individuals ages 18
through 64 within certain high-risk groups
FDA also authorized 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 authorized for
emergency use a booster dose of the Moderna COVID-19 vaccine
(mRNA-1273) 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. The booster dose is to be administered at
least six months after completion of the primary series. The FDA
also authorized a single booster dose of the Moderna COVID-19
Vaccine for individuals who have completed a primary vaccination
with other authorized or approved COVID-19 vaccines.
“This emergency use authorization is supported by robust
clinical evidence that a 50 µg booster dose induces a strong immune
response against COVID-19. We thank the FDA for their review and
for this EUA including for those people who have completed a
primary vaccination with a different COVID-19 vaccine,” said
Stéphane Bancel, Chief Executive Officer of Moderna. “We believe
that mRNA vaccines are uniquely positioned to adapt to the evolving
epidemiology of SARS-CoV-2. We’re grateful for the opportunity to
provide individuals with another layer of protection.”
The FDA based this EUA on the totality of scientific evidence
shared by the company and reviewed by the FDA’s Vaccines and
Related Biological Products Advisory Committee (VRBPAC), 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. After a booster dose, a similar level of
neutralizing titers was achieved across age groups including in
older adults (ages 65 and above). The safety profile following the
booster dose was similar to that observed previously for dose 2 of
mRNA-1273. The positive vote was unanimous with 19 VRBPAC members
recommending EUA.
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 the use
and 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 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 ability of mRNA-1273 boosters at the
50 µg dose to trigger an immune response, and the safety profile
for those boosters. 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/20211020006110/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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