ArticleVaccine2021
The critical role of background rates of possible adverse events in the assessment of COVID-19 vaccine safety.
Article in Vaccine, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 38 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
38 citing papers in PubMed.
- Posterior Circulation Ischemic Stroke Occurring After ChAdOx1 nCoV-19/AZD1222 Vaccination Without Evidence of Vaccine-Induced Immune Thrombotic Thrombocytopenia: A Case Report and Focused Narrative Review.Journal of clinical medicine · 2026Review
- Publicly Available Clinical Trial Safety Data: Review and a Call for Standardization and Improved Reporting Practices.Pharmaceutical medicine · 2026Review
- Background rates of medical events of interest before and during the COVID-19 pandemic: a longitudinal cohort study using claims data.BMJ open · 2025Article
- Article
- Reflux-Related Abnormalities at Distal oesophagus, Gastric Pouch and Anastomotic Site 4 Years After OAGB: Diagnostic Accuracies of Endoscopy Compared to Biopsy and of Symptoms Compared to Both.Obesity surgery · 2025Article
- Active vaccine safety surveillance: Experience from a prospective cohort event monitoring study of COVID-19 vaccines in Kenya.PLOS global public health · 2025Article
- The use of observed-to-expected analyses as a signal detection tool in COVID-19 vaccine safety surveillance: lessons learned from an industry perspective.Frontiers in drug safety and regulation · 2025Review
- Background incidence rates from electronic healthcare databases for vaccine safety monitoring: review of challenges from the COVID-19 vaccination campaign and proposal for best practices.Frontiers in drug safety and regulation · 2025Article
- Observational
- Article
- System and facility readiness assessment for conducting active surveillance of adverse events following immunization in Addis Ababa, Ethiopia.International health · 2023Article
- Safety of Streptococcus pyogenes Vaccines: Anticipating and Overcoming Challenges for Clinical Trials and Post-Marketing Monitoring.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2023Article
- Myocarditis and Pericarditis Post-mRNA COVID-19 Vaccination: Insights from a Pharmacovigilance Perspective.Journal of clinical medicine · 2023Article
- Background incidence rates of selected adverse events of special interest (AESI) to monitor the safety of COVID-19 vaccines.Vaccine · 2023Article
- Value and Implementation of the Aggregate Safety Assessment Plan.Pharmaceutical medicine · 2023Article
- Reports of Guillain-Barré Syndrome After COVID-19 Vaccination in the United States.JAMA network open · 2023Article
- Article
- Background rates of adverse events of special interest for COVID-19 vaccine safety monitoring in the United States, 2019-2020.Vaccine · 2023Article
- Article
- Active surveillance of adverse events following COVID-19 vaccines in a tertiary care hospital.Therapeutic advances in vaccines and immunotherapy · 2023Article
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Beginning in December of 2019, a novel coronavirus, SARS-CoV-2, emerged in China and is now a global pandemic with extensive morbidity and mortality. With the emergence of this threat, an unprecedented effort to develop vaccines against this virus began. As vaccines are now being introduced globally, we face the prospect of millions of people being vaccinated with multiple types of vaccines many of which use new vaccine platforms. Since medical events happen without vaccines, it will be important to know at what rate events occur in the background so that when adverse events are identified one has a frame of reference with which to compare the rates of these events so as to make an initial assessment as to whether there is a potential safety concern or not. Background rates vary over time, by geography, by sex, socioeconomic status and by age group. Here we describe two key steps for post-introduction safety evaluation of COVID-19 vaccines: Defining a dynamic list of Adverse Events of Special Interest (AESI) and establishing background rates for these AESI. We use multiple examples to illustrate use of rates and caveats for their use. In addition we discuss tools available from the Brighton Collaboration that facilitate case evaluation and understanding of AESI.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.