Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering
messenger RNA (mRNA) therapeutics and vaccines today announced that
interim safety and primary efficacy results from the Phase 3 trial
of the Moderna COVID-19 Vaccine (mRNA-1273) were published in the
New England Journal of Medicine. The 100 μg two-dose regime of the
Moderna COVID-19 Vaccine given 28 days apart was well-tolerated and
demonstrated vaccine efficacy of 94.1% against COVID-19. The Phase
3 study, known as the COVE study, enrolled more than 30,000
participants in the U.S. and is being conducted in collaboration
with the National Institute of Allergy and Infectious Diseases
(NIAID), part of the National Institutes of Health (NIH), and the
Biomedical Advanced Research and Development Authority (BARDA),
part of the Office of the Assistant Secretary for Preparedness and
Response at the U.S. Department of Health and Human Services.
The primary endpoint of the Phase 3 COVE study was based on the
analysis of COVID-19 cases confirmed and adjudicated starting two
weeks following the second dose of vaccine. This final analysis was
based on 196 cases, of which 185 cases of COVID-19 were observed in
the placebo group versus 11 cases observed in the Moderna COVID-19
Vaccine group, corresponding to a 94.1% vaccine efficacy (95% CI
89.3-96.8%; p<0.0001).
A secondary endpoint analyzed severe cases of COVID-19 and
included 30 severe cases (as defined in the study protocol) in this
analysis. All 30 cases occurred in the placebo group and none in
the mRNA-1273 vaccinated group. There was one COVID-19-related
death in the study to date, which occurred in the placebo
group.
The Moderna COVID-19 Vaccine exhibited a favorable tolerability
and safety profile. Based on a data cut-off date of November 25,
2020, the study had a median of 9 weeks of safety data available
after the second dose and contributed to the main safety dataset.
Baseline demographic characteristics were generally balanced
between the placebo and vaccine groups. Among these participants,
the mean age was 51.4 years, 47.3% were female, 24.8% were older
than 65 years, and 16.7% were under the age of 65 but have
high-risk chronic diseases that put them at increased risk of
severe COVID-19, such as diabetes, severe obesity and cardiac
disease. Participants from communities of color represented 37% of
the study population, similar to the diversity of the U.S. at
large. This included 20.5% participants who identify as Hispanic or
LatinX, and 10.2% participants who identify as Black or African
American.
The most common solicited adverse reactions (ARs) after the
two-dose series was injection site pain (86.0%). Solicited systemic
adverse events occurred more often in the Moderna COVID-19 vaccine
group (54.9% and 79.4%) than in the placebo (42.2% and 36.5%) group
after both the first dose and the second dose respectively and were
most commonly headache, fatigue and myalgia. While the majority of
these ARs were mild (grade 1) or moderate (grade 2), there was a
higher occurrence of severe (grade 3) reactions in the Moderna
COVID-19 Vaccine group after the first (2.9%) and second (15.8%)
injections. The majority of local solicited ARs occurred within the
first one to two days after injection and generally persisted for a
median of one to two days. Safety data continues to accrue, and the
study continues to be monitored by an independent Data Safety
Monitoring Board (DSMB) appointed by the NIH. All participants in
the COVE study will be monitored for two years after their second
dose to assess long-term protection and safety.
The Phase 3 COVE study is ongoing and will continue to follow
participants for two years. Additional data to be collected will
include longer term safety follow-up, duration of protection
against COVID-19, and efficacy against asymptomatic SARS-CoV-2
infection. Moderna is also conducting a Phase 2/3 study of the
Moderna COVID-19 vaccine in adolescents 12 to under 18 years of
age. Additional studies are planned to evaluate the Moderna
COVID-19 Vaccine in pregnant women, children younger than 12 years,
and those in special risk groups, such as the
immunocompromised.
About the Moderna COVID-19 Vaccine
The Moderna COVID-19 Vaccine (previously referred to as
mRNA-1273) 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 NIAID’s 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 NIH on February 24, 42 days from sequence selection. The
first participant in the NIAID-led Phase 1 study of the vaccine was
dosed on March 16, 63 days from sequence selection to Phase 1 study
dosing. On May 12, the FDA granted the Moderna COVID-19 Vaccine
Fast Track designation. On May 29, the first participants in each
age cohort: adults ages 18-55 years (n=300) and older adults ages
55 years and above (n=300) were dosed in the Phase 2 study of
mRNA-1273. On July 8, 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 in The New England Journal of
Medicine. On July 28, results from a non-human primate preclinical
viral challenge study evaluating the vaccine were published in The
New England Journal of Medicine. On July 14, an interim analysis of
the original cohorts in the NIH-led Phase 1 study of the vaccine
was published in The New England Journal of Medicine. On November
30, Moderna announced the primary efficacy analysis of the Phase 3
study of the vaccine conducted on 196 cases. On November 30, the
Company also announced that it filed for Emergency Use
Authorization with the U.S. FDA and a Conditional Marketing
Authorization (CMA) with the European Medicines Agency. On December
3, a letter to the editor was published in The New England Journal
of Medicine reporting that participants in the Phase 1 study of the
Moderna COVID-19 Vaccine retained high levels of neutralizing
antibodies through 119 days following first vaccination (90 days
following second vaccination). On December 18, 2020, the FDA
authorized the emergency use of the Moderna COVID-19 Vaccine in
individuals 18 years of age or older.
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 Moderna COVID-19 Vaccine with $955
million in 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 the Moderna COVID-19 Vaccine under U.S. Department of Defense
contract no. W911QY-20-C-0100.
A summary of the company’s work to date on COVID-19 can be found
here.
AUTHORIZED USE:
The Moderna COVID-19 Vaccine has been authorized for emergency
use by the U.S. Food and Drug Administration (FDA) 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 and has been authorized by
Health Canada for the immunization of Canadians 18 years of age and
older under an Interim Order. Moderna has submitted the final
Conditional Marketing Authorization Application (CA) following
rolling submissions with the European Medicines Agency (EMA) and
several other regulatory agencies around the world.
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/).
- 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.
- 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.
About Moderna
Moderna is advancing messenger RNA (mRNA) science to create a
new class of transformative medicines for patients. mRNA medicines
are designed to direct the body’s cells to produce intracellular,
membrane or secreted proteins that can have a therapeutic or
preventive benefit and have the potential to address a broad
spectrum of diseases. The company’s platform builds on continuous
advances in basic and applied mRNA science, delivery technology and
manufacturing, providing Moderna the capability to pursue in
parallel a robust pipeline of new development candidates. Moderna
is developing therapeutics and vaccines for infectious diseases,
immuno-oncology, rare diseases and cardiovascular diseases,
independently and with strategic collaborators.
Headquartered in Cambridge, Mass., Moderna currently has
strategic alliances for development programs with AstraZeneca PLC
and Merck & Co., Inc., as well as the Defense Advanced Research
Projects Agency (DARPA), an agency of the U.S. Department of
Defense, and BARDA. Moderna has been named a top biopharmaceutical
employer by Science for the past six years. To learn more, visit
www.modernatx.com.
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 against the novel coronavirus, the
potential for the Moderna COVID-19 Vaccine to prevent COVID-19
disease and slow the spread of SARS-CoV-2, and the safety profile
for the Moderna COVID-19 Vaccine. 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; 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 Quarterly Report on Form 10-Q 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20201231005159/en/
Moderna Media: Colleen Hussey Director, Corporate
Communications 617-335-1374 Colleen.Hussey@modernatx.com Investors:
Lavina Talukdar Head of Investor Relations 617-209-5834
Lavina.Talukdar@modernatx.com
Moderna (NASDAQ:MRNA)
Historical Stock Chart
From Mar 2024 to Apr 2024
Moderna (NASDAQ:MRNA)
Historical Stock Chart
From Apr 2023 to Apr 2024