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.

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