Therapy Areas: Cardiovascular
Moderna Highlights Data Showing COVID-19 Vaccine "Highly Effective" Against Circulating Variants
16 September 2021 - - US-based biotechnology company Moderna, Inc. (NASDAQ: MRNA) has 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 California healthcare provider Kaiser Permanente Southern California and in a separate recent publication by the US Centers for Disease Control and Prevention, the company said.

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, Moderna said.

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, 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 hospitalization.

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 US 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.

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.

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 US 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 from the World Health Organization.

In 10 years since its inception, Moderna has transformed from a science research-stage company advancing programs in the field of messenger RNA, 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 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.

Moderna COVID-19 Vaccine is authorized for use under an Emergency Use Authorization 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.
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