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April 7, 2021
CAMBRIDGE, Mass.--(BUSINESS WIRE)--Moderna, Inc. (Nasdaq: MRNA), a biotechnology company
pioneering messenger RNA (mRNA) therapeutics and vaccines, today
highlighted the publication of antibody persistence data out to 6
months following the second dose of the Moderna COVID-19 Vaccine in The New
England Journal of Medicine.
"We are pleased
that this new data shows antibody persistence through 6 months following
the second dose of our COVID-19 vaccine," said Stéphane Bancel, Chief
Executive Officer of Moderna. "This gives us further confidence in the
protection afforded by our COVID-19 vaccine. We remain committed to
continuing to address the COVID-19 pandemic."
This study analyzed
33 healthy adult participants in the NIH-led Phase 1 study of Moderna's
COVID-19 Vaccine at 6 months following the second 100 μg dose (day 209). As
detected by three distinct serologic assays, antibodies elicited by the
Moderna COVID-19 vaccine persisted through 6 months after the second dose.
Antibody decay was estimated using two approaches and was consistent with
published observations of convalescent patients with COVID-19 through 8
months after symptom onset.
Studies monitoring
immune responses beyond 6 months are ongoing. Out of an abundance of
caution, Moderna is also pursuing a clinical development strategy against emerging
variants. Additionally, NIAID, part of the National Institutes of Health
(NIH), will conduct a Phase 1 clinical trial to assess the monovalent and
multivalent modified mRNA-1273 vaccines as a primary series in naïve
individuals and as a booster vaccine in those previously vaccine with
mRNA-1273.
About the Moderna
COVID-19 Vaccine
The Moderna COVID-19
Vaccine is an mRNA vaccine against COVID-19 encoding for a prefusion
stabilized form of the Spike (S) protein, which was co-developed by Moderna
and investigators from the National Institute of Allergy and Infectious
Diseases' (NIAID) Vaccine Research Center. The first clinical batch, which
was funded by the Coalition for Epidemic Preparedness Innovations, was
completed on February 7, 2020 and underwent analytical testing; it was
shipped to the National Institutes of Health (NIH) on February 24, 2020, 42
days from sequence selection. The first participant in the NIAID-led Phase
1 study of the Moderna COVID-19 Vaccine was dosed on March 16, 2020, 63
days from sequence selection to Phase 1 study dosing. On May 12, 2020, the
U.S. FDA granted the Moderna COVID-19 Vaccine Fast Track designation. On
May 29, 2020, the first participants in each age cohort were dosed in the
Phase 2 study of the vaccine. On July 8, 2020, the Phase 2 study completed
enrollment.
Results from the
second interim analysis of the NIH-led Phase 1 study of the Moderna
COVID-19 Vaccine in the 56-70 and 71+ age groups were published on
September 29, 2020 in The New England Journal of Medicine. On
November 30, 2020, Moderna announced the primary efficacy analysis of the
Phase 3 study of the vaccine conducted on 196 cases. On November 30, 2020,
the Company also announced that it filed for Emergency Use Authorization
with the U.S. FDA and a Conditional Marketing Authorization (CMA) application
with the European Medicines Agency. On December 18, 2020, the U.S. FDA
authorized the emergency use of the Moderna COVID-19 Vaccine in individuals
18 years of age or older. Moderna has also received authorization for its
COVID-19 vaccine from health agencies in Canada, Israel, the European
Union, the United Kingdom, Switzerland, Singapore and Qatar. Additional
authorizations are currently under review in other countries and by the
World Health Organization.
The Biomedical
Advanced Research and Development Authority (BARDA), part of the Office of
the Assistant Secretary for Preparedness and Response (ASPR) within the
U.S. Department of Health and Human Services (HHS) is supporting the
continued research and development of the Company’s COVID-19 vaccine development
efforts with federal funding under contract no. 75A50120C00034. BARDA is
reimbursing Moderna for 100 percent of the allowable costs incurred by the
Company for conducting the program described in the BARDA contract. The
U.S. government has agreed to purchase supply of mRNA-1273 under U.S.
Department of Defense contract no. W911QY-20-C-0100.
AUTHORIZED USE
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 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).
·
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 a clinical trial 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.
·
Severe
allergic reactions, including anaphylaxis, have been reported following
administration of the Moderna COVID-19 Vaccine during mass vaccination
outside of clinical trials.
·
Available
data on 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 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 Moderna COVID-19 Vaccine should
receive a second dose of 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 statements
regarding: the Company’s development of a vaccine (mRNA-1273) to protect
against the SARS-CoV-2 virus, which causes COVID-19, the duration of such
protection, and the Company’s strategy for developing vaccines in response
to variants of the SARS-CoV-2 virus. In some cases, forward-looking
statements can be identified by terminology such as “will,” “may,”
“should,” “could,” “expects,” “intends,” “plans,” “aims,” “anticipates,”
“believes,” “estimates,” “predicts,” “potential,” “continue,” or the
negative of these terms or other comparable terminology, although not all
forward-looking statements contain these words. 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, among others: the fact that there has never been a commercial
product utilizing mRNA technology approved for use; the fact that the rapid
response technology in use by Moderna is still being developed and
implemented; the safety, tolerability and efficacy profile of the Moderna
COVID-19 Vaccine observed to date may change adversely in ongoing analyses
of trial data or subsequent to commercialization; the Moderna COVID-19
Vaccine may prove less effective against variants of the SARS-CoV-2 virus,
or the Company may be unsuccessful in developing future versions of its
vaccine against these variants; despite having ongoing interactions with
the FDA or other regulatory agencies, the FDA or such other regulatory
agencies may not agree with the Company’s regulatory approval strategies,
components of our filings, such as clinical trial designs, conduct and
methodologies, or the sufficiency of data submitted; Moderna may encounter
delays in meeting manufacturing or supply timelines or disruptions in its
distribution plans for the Moderna COVID-19 Vaccine; whether and when any
biologics license applications and/or additional emergency use
authorization applications may be filed in various jurisdictions and
ultimately approved by regulatory authorities; potential adverse impacts
due to the global COVID-19 pandemic such as delays in regulatory review,
manufacturing and clinical trials, supply chain interruptions, adverse
effects on healthcare systems and disruption of the global economy; and
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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