Dataset Information

Near real-time surveillance of safety outcomes in US COVID-19 vaccine recipients aged 12 to 64 years.

ABSTRACT:

Background

Active monitoring of safety outcomes following COVID-19 vaccination is critical to understand vaccine safety and can provide early detection of rare outcomes not identified in pre-licensure trials. We present findings from an early warning rapid surveillance system in three large commercial insurance databases including more than 16 million vaccinated individuals.

Methods

We evaluated 17 outcomes of interest following COVID-19 vaccination among individuals aged 12-64 years in Optum, HealthCore, and CVS Health databases from December 11, 2020, through January 22, 2022, January 7, 2022, and December 31, 2021, respectively. We conducted biweekly or monthly sequential testing and generated rate ratios (RR) of observed outcome rates compared to historical (or expected) rates prior to COVID-19 vaccination.

Findings

Among 17 outcomes evaluated, 15 did not meet the threshold for statistical signal in any of the three databases. Myocarditis/pericarditis met the statistical threshold for a signal following BNT162b2 in two of three databases (RRs: 1.83-2.47). Anaphylaxis met the statistical threshold for a signal in all three databases following BNT162b2 vaccination (RRs: 4.48-10.86) and mRNA-1273 vaccination (RRs: 7.64-12.40).

Discussion

Consistent with published literature, our near-real time monitoring of 17 adverse outcomes following COVID-19 vaccinations identified signals for myocarditis/pericarditis and anaphylaxis following mRNA COVID-19 vaccinations. The method is intended for early detection of safety signals, and results do not imply a causal effect. Results of this study should be interpreted in the context of the method's utility and limitations, and the validity of detected signals must be evaluated in fully adjusted epidemiologic studies.

SUBMITTER: Lloyd PC

PROVIDER: S-EPMC9513329 | biostudies-literature | 2022 Oct

REPOSITORIES: biostudies-literature

ACCESS DATA

Publications

Near real-time surveillance of safety outcomes in US COVID-19 vaccine recipients aged 12 to 64 years.

Lloyd Patricia C PC Hu Mao M Wong Hui-Lee HL Shoaibi Azadeh A Ke Zhou Cindy C Lo An-Chi AC Amend Kandace K Beachler Daniel C DC McMahill-Walraven Cheryl N CN Smith Elizabeth R ER Seeger John J Secora Alex A Audrey Djibo Djeneba D Obidi Joyce J Feng Yuhui Y Song Jennifer J Reich Christian C Harris Charalynn C Akhtar Sandia S Clifford Robin R Selvam Nandini N Pigoga Jennifer L JL Jiao Yixin Y Chillarige Yoganand Y MaCurdy Thomas T Forshee Richard R Anderson Steven A SA

Vaccine 20220927 45

<h4>Background</h4>Active monitoring of safety outcomes following COVID-19 vaccination is critical to understand vaccine safety and can provide early detection of rare outcomes not identified in pre-licensure trials. We present findings from an early warning rapid surveillance system in three large commercial insurance databases including more than 16 million vaccinated individuals.<h4>Methods</h4>We evaluated 17 outcomes of interest following COVID-19 vaccination among individuals aged 12-64 ye ...[more]

PMID: 36195472

Similar Datasets

Project description:BackgroundMonitoring safety outcomes following COVID-19 vaccination is critical for understanding vaccine safety especially when used in key populations such as elderly persons age 65 years and older who can benefit greatly from vaccination. We present new findings from a nationally representative early warning system that may expand the safety knowledge base to further public trust and inform decision making on vaccine safety by government agencies, healthcare providers, interested stakeholders, and the public.MethodsWe evaluated 14 outcomes of interest following COVID-19 vaccination using the US Centers for Medicare & Medicaid Services (CMS) data covering 30,712,101 elderly persons. The CMS data from December 11, 2020 through Jan 15, 2022 included 17,411,342 COVID-19 vaccinees who received a total of 34,639,937 doses. We conducted weekly sequential testing and generated rate ratios (RR) of observed outcome rates compared to historical (or expected) rates prior to COVID-19 vaccination.FindingsFour outcomes met the threshold for a statistical signal following BNT162b2 vaccination including pulmonary embolism (PE; RR = 1.54), acute myocardial infarction (AMI; RR = 1.42), disseminated intravascular coagulation (DIC; RR = 1.91), and immune thrombocytopenia (ITP; RR = 1.44). After further evaluation, only the RR for PE still met the statistical threshold for a signal; however, the RRs for AMI, DIC, and ITP no longer did. No statistical signals were identified following vaccination with either the mRNA-1273 or Ad26 COV2.S vaccines.InterpretationThis early warning system is the first to identify temporal associations for PE, AMI, DIC, and ITP following BNT162b2 vaccination in the elderly. Because an early warning system does not prove that the vaccines cause these outcomes, more robust epidemiologic studies with adjustment for confounding, including age and nursing home residency, are underway to further evaluate these signals. FDA strongly believes the potential benefits of COVID-19 vaccination outweigh the potential risks of COVID-19 infection.

Dataset Information

Near real-time surveillance of safety outcomes in US COVID-19 vaccine recipients aged 12 to 64 years.

Background

Methods

Findings

Discussion

Publications

Near real-time surveillance of safety outcomes in US COVID-19 vaccine recipients aged 12 to 64 years.

Similar Datasets

OmicsDI is part of the ELIXIR infrastructure

Tweets