Moderna Announces FDA Advisory Committee Unanimously Votes in Support of Emergency Use for a Booster Dose of Moderna’s COVID-19 Vaccine in the U.S.
October 14 2021 - 04:47PM
Business Wire
Positive unanimous vote for mRNA-1273 booster
at the 50 µg dose level for individuals aged 65 and older as well
as individuals aged 18 through 64 at high risk of contracting
COVID-19 at least 6 months after completion of the primary
series
Company estimates that booster at the 50 µg
dose level could result in up to 1 billion additional doses
Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering
messenger RNA (mRNA) therapeutics and vaccines, today confirmed
that the U.S. Food and Drug Administration’s (FDA) Vaccines and
Related Biological Products Advisory Committee (VRBPAC) recommended
that the FDA grant an Emergency Use Authorization (EUA) for 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
whose exposure to COVID-19 puts them at risk for COVID-19
complications or severe illness. The positive vote was unanimous
with 19 VRBPAC members recommending EUA. The booster dose is to be
administered at least six months after completion of the primary
series.
“We are grateful for the opportunity to present the clinical
data package for our COVID-19 booster vaccine to the FDA’s advisory
committee today. We thank the committee for their review and for
their positive recommendation in support of Emergency Use
Authorization. This positive recommendation is supported by data on
the 50 µg booster dose of our COVID-19 vaccine, which shows robust
antibody responses against the original virus, but also against the
Delta variant,” said Stéphane Bancel, Chief Executive Officer of
Moderna. “We remain committed to staying ahead of the virus and
following the evolving epidemiology of SARS-CoV-2. We look forward
to making our booster available to people in the U.S. to help
protect themselves against this ongoing public health
emergency.”
The VRBPAC based its recommendation on the totality of
scientific evidence, 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, notably 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.
Moderna estimates that the positive vote in support 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.
FDA advisory committees provide non-binding recommendations. The
FDA will take the VRBPAC’s recommendation into consideration in
making a final decision on authorization. Under an EUA, the FDA has
the authority to allow unapproved medical products or unapproved
uses of approved medical products to be used in an emergency to
diagnose, treat, or prevent serious or life-threatening diseases or
conditions during a declared public health emergency when there are
no adequate, approved, and available alternatives. Next, the U.S.
Centers for Disease Control and Prevention’s (CDC) Advisory
Committee on Immunization Practices (ACIP) will meet to discuss
their recommendation for the use of COVID-19 boosters.
Separately, on August 13, Moderna announced that the U.S. FDA
approved an update to the emergency use authorization for the
Moderna COVID-19 vaccine to include a third dose at the 100 µg dose
level for immunocompromised individuals 18 years of age or older in
the United States who have undergone solid organ transplantation,
or who are diagnosed with conditions that are considered to have an
equivalent level of immunocompromise.
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.
- The following adverse reactions have been reported following
administration of the Moderna COVID-19 Vaccine during mass
vaccination outside of clinical trials:
- Severe allergic reactions, including anaphylaxis
- Myocarditis and pericarditis
- Syncope
- 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.
- There are no data available on the interchangeability of the
Moderna COVID-19 Vaccine with other COVID-19 vaccines to complete
the vaccination series. Individuals who have received one dose of
the Moderna COVID-19 Vaccine should receive a second dose of the
Moderna COVID-19 Vaccine to complete the vaccination series.
- 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 potential for FDA
approval of boosters at the 50 µg dose level for mRNA-1273, and the
impact on the Company’s vaccine production capacity for 2022; the
potential for 50 µg booster doses to trigger an antibody response
across different age groups; and the safety profile for the 50 µg
booster doses of mRNA-1273. 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/20211014006104/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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