Post-Marketing Safety Study of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) mRNA-1273 COVID-19 Vaccine in the United States

Moderna

Status: Completed

Conditions: SARS-CoV-2

Study type: Observational

Funder types: Industry

Identifiers

NCT04958954

mRNA-1273-P903

EUPAS41392 (Other Identifier)

Details and patient eligibility

About

The goal of this study is to add to the ongoing active and passive safety signal detection through signal refinement and, if needed, evaluation of potential safety signals related to taking the SARS-CoV-2 mRNA-1273 vaccine.

Full description

This retrospective observational cohort study will use secondary, de-identified individual-level medical and pharmacy claims data provided by HealthVerity.

Enrollment: 50,000,000 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Included in a health plan covered by HealthVerity database
• Covered by a health plan during at least 1 period of interest (pre-COVID-19, active-COVID-19, and post-EUA periods), but not necessarily the full period.
• Demonstrate an AESI specified clean period of continuous baseline enrollment or activity before the period of interest (pre-COVID-19, active-COVID-19, and post-EUA periods) during which the participant is covered.

Exclusion criteria

None

Trial design

50,000,000 participants in 4 patient groups

Cohort 1a: Pre-COVID

Description:

All participants meeting eligibility criteria in the Pre-COVID-19 period (immediately preceding the emergence of COVID-19) (Time Period 1) from 01 December 2018 to 30 November 2019

Cohort 1b: Pre-COVID

Description:

All participants with evidence of an influenza vaccination and meeting eligibility criteria in the Pre-COVID-19 period (immediately preceding the emergence of COVID-19) (Time Period 1) from 01 December 2018 to 30 November 2019

Cohort 2: Active-COVID

Description:

All participants meeting eligibility criteria in the Active-COVID-19 period, Pre-Emergency Use Authorization (EUA) period (following the emergence of COVID-19 but before the first COVID-19 vaccine EUA) (Time Period 2) from 01 December 2019 to 10 December 2020 (1 day prior to first United States SARS-CoV-2 vaccine EUA)

Cohort 3: Post-EUA

Description:

All mRNA-1273 vaccinated participants meeting eligibility criteria in the Post-EUA period (Time Period 3) from date of first United States SARS-CoV-2 vaccine EUA to 31 December 2022