Moderna Highlights New Clinical Data on its COVID-19 Vaccine
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
“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
Real-World Effectiveness: Prospective Cohort Study at Kaiser Permanente Southern California (follow-up through
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.
Recent data published by the
Analysis of Open-Label Part of Phase 3 COVE Study (July-
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
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
In 10 years since its inception,
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 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 Preventionguidelines (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
whohave 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.
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
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
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
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