mRNA-1273 remains highly effective against
COVID-19 in real-world effectiveness study during surge in Delta
cases
New analysis of open-label portion of Phase 3
COVE study shows lower risk of breakthrough infection in
participants vaccinated more recently (median 8 months after first
dose) than participants vaccinated last year (median 13 months
after first dose)
Company believes data support benefit of an
mRNA-1273 booster dose
Company to host conference call today at 4:30
pm ET
Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering
messenger RNA (mRNA) therapeutics and vaccines, today highlighted a
new analysis suggesting that the Moderna COVID-19 vaccine is highly
effective against circulating variants of concern, including in a
vaccine effectiveness study conducted in partnership with Kaiser
Permanente Southern California (KPSC) and in a separate recent
publication by the U.S. Centers for Disease Control and Prevention
(CDC). Additionally, the Company shared a new analysis of follow-up
through 1 year in the Phase 3 COVE study suggesting a lower risk of
breakthrough infection in participants vaccinated more recently
(median 8 months after first dose) compared to participants
vaccinated last year (median 13 months after first dose).
Manuscripts summarizing both findings have been posted to preprint
servers and will be submitted for peer-reviewed publication.
“It is promising to see clinical and real-world evidence adding
to the growing body of data on the effectiveness of the Moderna
COVID-19 vaccine,” said Stéphane Bancel, Chief Executive Officer of
Moderna. “The increased risk of breakthrough infections in COVE
study participants who were vaccinated last year compared to more
recently illustrates the impact of waning immunity and supports the
need for a booster to maintain high levels of protection. We hope
these findings are helpful as health authorities and regulators
continue to assess strategies for ending this pandemic.”
Real-World Effectiveness: Prospective Cohort Study at Kaiser
Permanente Southern California (follow-up through June 30,
2021)
In a prospective cohort study at Kaiser Permanente Southern
California (KPSC), an analysis of 352,878 recipients of 2 doses of
mRNA-1273 matched to 352,878 unvaccinated individuals found a
vaccine effectiveness of 87% (99.3% CI: 85-90%) against COVID-19
diagnosis and 96% (99.3% CI: 91-98%) against COVID-19
hospitalization1. The study was conducted during the emergence of
the Delta variant, which was identified in 47% of cases in fully
vaccinated individuals. These data have been posted to a preprint
server and submitted for peer review.
CDC Interim Estimates of COVID-19 Vaccine Effectiveness
(June-August 2021)
Recent data published by the U.S. CDC2 examined vaccine efficacy
across nine states based on 32,867 medical encounters including
14,636 hospitalizations between June and August 2021, during the
time when the Delta variant became predominant in the United
States. In the analysis, the Moderna COVID-19 vaccine efficacy
against COVID-19 urgent care or emergency visit was 92% (95% CI:
89-93%) and against hospitalization was 95% (95% CI: 92-97%) at a
median of 96 and 106 days respectively after vaccination. Across
all age groups, vaccine efficacy was reported to be significantly
higher among Moderna vaccine recipients than other COVID-19
vaccines.
Analysis of Open-Label Part of Phase 3 COVE Study
(July-August 2021)
Today, Moderna is sharing a new analysis of the incidence of
breakthrough COVID-19 cases among vaccinated participants in the
open-label portion of the Phase 3 COVE study between July 1, 2021
and August 27, 2021. The goal of the analysis is to quantify the
impact of waning immunity in the face of the Delta surge in the
United States. The analysis compared participants initially
randomized to mRNA-1273 (vaccinated from July-October 2020;
n=14,746; median follow-up of 13 months since first dose) against
participants initially randomized to placebo who were crossed over
and vaccinated following Emergency Use Authorization (vaccinated
from December 2020-March 2021; n=11,431; median follow-up of 8
months since first dose).
In the analysis, 88 breakthrough cases of COVID-19 occurred in
the more recently vaccinated group (49.0 cases per 1000
person-years) compared to 162 cases in the group vaccinated last
year (77.1 cases per 1000 person-years). The reduction in incidence
rates for participants vaccinated more recently compared to
participants vaccinated last year was 36% (95% CI: 17-52%). A Cox
proportional hazards model showed similar results after adjusting
for age and risk factors for severe COVID-19. Fortunately, only 19
severe cases were observed. While not significant, there was a
numerical trend towards a lower rate of severe cases in the group
vaccinated more recently (3.3 per 1000 person-years) compared to
the group vaccinated last year (6.2 per 1000 person-years).
The increased risk of breakthrough in this analysis quantifies
the impact of waning immunity in the COVE study between the median
follow-up time of 8 months and 13 months since first dose. The
Company believes this adds to evidence of potential benefit of a
booster dose of mRNA-1273. A manuscript has been submitted as a
preprint to medRxiv and will be submitted for peer-reviewed
publication.
Investor Call and Webcast Information
Moderna will host a live conference call and webcast at 4:30 pm
ET today, Wednesday, September 15, 2021. To access the live
conference call, please dial 866-922-5184 (domestic) or
409-937-8950 (international) and refer to conference ID 7998623. A
webcast of the call will also be available under “Events and
Presentations” in the Investors section of the Moderna website at
investors.modernatx.com. The archived webcast will be available on
Moderna’s website approximately two hours after the conference call
and will be available for one year following the call.
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.
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 received emergency (or other conditional,
interim or provisional) authorization for use of its COVID-19
vaccine in adults from health agencies in more than 50 countries
and an Emergency Use Listing (EUL) from the World Health
Organization (WHO).3
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
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).
- 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 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.
- 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
- 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 regarding: the Company’s development of
a vaccine against COVID-19 (mRNA-1273); the effectiveness and
duration of protection against COVID-19 provided by mRNA-1273,
including against the Delta variant; the safety profile for
mRNA-1273; and whether booster doses of mRNA-1273 may be advisable
to provide ongoing protection against COVID-19. 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.
_________________________________
1 Bruxvoort K, Sy L, Qian L, et al.
Real-World Effectiveness of the mRNA-1273 Vaccine Against COVID-19:
Interim Results from a Prospective Observational Cohort Study.
Preprints with The Lancet on SSRN.
https://ssrn.com/abstract=3916094
2 Grannis SJ, Rowley EA, Ong TC, et al.
Interim Estimates of COVID-19 Vaccine Effectiveness Against
COVID-19–Associated Emergency Department or Urgent Care Clinic
Encounters and Hospitalizations Among Adults During SARS-CoV-2
B.1.617.2 (Delta) Variant Predominance — Nine States, June–August
2021. MMWR Morb Mortal Wkly Rep.
https://www.cdc.gov/mmwr/volumes/70/wr/mm7037e2.htm
3 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210915006076/en/
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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