Expected Rates of Select Adverse Events following Immunization for COVID-19 Vaccine Safety Monitoring.
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ABSTRACT:
SUBMITTER: Abara WE
PROVIDER: S-EPMC8755334 | biostudies-literature | 2021 Dec
REPOSITORIES: biostudies-literature
Publications
Expected Rates of Select Adverse Events After Immunization for Coronavirus Disease 2019 Vaccine Safety Monitoring.
Abara Winston E WE Gee Julianne J Delorey Mark M Tun Ye Y Mu Yi Y Shay David K DK Shimabukuro Tom T
The Journal of infectious diseases 20220501 9
Using meta-analytic methods, we calculated expected rates of 20 potential adverse events of special interest (AESI) that would occur after coronavirus disease 2019 (COVID-19) vaccination within 1-, 7-, and 42-day intervals without causal associations. Based on these expected rates, if 10 000 000 persons are vaccinated, (1) 0.5, 3.7, and 22.5 Guillain-Barre syndrome cases, (2) 0.3, 2.4, and 14.3 myopericarditis cases, (3) and 236.5, 1655.5, and 9932.8 all-cause deaths would occur coincidentally w ...[more]
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Project description:BackgroundVaccination against coronavirus disease 2019 (COVID-19) is underway globally to prevent the infection caused by the severe acute respiratory syndrome coronavirus 2. We aimed to investigate the adverse events following immunization (AEFIs) for COVID-19 among healthcare workers (HCWs).MethodsThis was a retrospective study of the AEFIs associated with the first dose of the ChAdOx1 nCoV-19 vaccine at the Kosin University Gospel Hospital from March 3 to March 22, 2021. We investigated the systemic and local adverse events during the 7 days following the vaccination using the Mobile Vaccine Adverse Events Reporting System (MVAERS) developed by our hospital.ResultsA total of 1,503 HCWs were vaccinated, and the data of 994 HCWs were reported in the MVAERS. The most commonly reported AEFIs were tenderness at the injection site (94.5%), fatigue (92.9%), pain at the injection site (88.0%), and malaise (83.8%). The severity of most AEFIs was mild-to-moderate, and the severity and number of AEFIs were less in the older age group. There were no serious events requiring hospitalization, and most AEFIs improved within a few days.ConclusionThe AEFIs associated with the ChAdOx1 nCoV-19 vaccine were tolerable, and the use of the MVAERS was helpful in monitoring the AEFIs. The use of MVAERS will help in sharing accurate and ample information about vaccination against COVID-19.
| S-EPMC8093606 | biostudies-literature
Project description:BackgroundThe U.S. Food and Drug Administration (FDA) Biologics Effectiveness and Safety (BEST) Initiative conducts active surveillance of adverse events of special interest (AESI) after COVID-19 vaccination. Historical incidence rates (IRs) of AESI are comparators to evaluate safety.MethodsWe estimated IRs of 17 AESI in six administrative claims databases from January 1, 2019, to December 11, 2020: Medicare claims for adults ≥ 65 years and commercial claims (Blue Health Intelligence®, CVS Health, HealthCore Integrated Research Database, IBM® MarketScan® Commercial Database, Optum pre-adjudicated claims) for adults < 65 years. IRs were estimated by sex, age, race/ethnicity (Medicare), and nursing home residency (Medicare) in 2019 and for specific periods in 2020.ResultsThe study included >100 million enrollees annually. In 2019, rates of most AESI increased with age. However, compared with commercially insured adults, Medicare enrollees had lower IRs of anaphylaxis (11 vs 12-19 per 100,000 person-years), appendicitis (80 vs 117-155), and narcolepsy (38 vs 41-53). Rates were higher in males than females for most AESI across databases and varied by race/ethnicity and nursing home status (Medicare). Acute myocardial infarction (Medicare) and anaphylaxis (all databases) IRs varied by season. IRs of most AESI were lower during March-May 2020 compared with March-May 2019 but returned to pre-pandemic levels after May 2020. However, rates of Bell's palsy, Guillain-Barré syndrome, narcolepsy, and hemorrhagic/non-hemorrhagic stroke remained lower in multiple databases after May 2020, whereas some AESI (e.g., disseminated intravascular coagulation) exhibited higher rates after May 2020 compared with 2019.ConclusionAESI background rates varied by database and demographics and fluctuated in March-December 2020, but most returned to pre-pandemic levels after May 2020. It is critical to standardize demographics and consider seasonal and other trends when comparing historical rates with post-vaccination AESI rates in the same database to evaluate COVID-19 vaccine safety.
| S-EPMC9640387 | biostudies-literature
Project description:BackgroundWith over 80% of children worldwide vaccinated, concerns about vaccine safety continues to be a public health issue. Ghana's Adverse Events Following Immunization surveillance started in 1978 with the objective to promptly detect and manage AEFI cases either real or perceived. Periodic evaluation of the surveillance system is critical for optimal performance; hence we evaluated the system to assess its attributes, usefulness and system's performance in meeting its objectives.MethodsA case of AEFI was defined as any untoward medical event occurring within 28 days after vaccination and may not necessarily have causal relationship with the vaccine use. We reviewed surveillance data and procedures for the period 2014 to 2018 and interviewed key stakeholders. Adapting the CDC's Updated Guidelines for Evaluating Public Health Surveillance Systems, we assessed the system's attributes and usefulness. We performed summary descriptive statistics on quantitative data and directed content analysis on information gathered from interviews.ResultsIn all, 2,282 AEFI cases including 476 (21%) serious cases (life threatening events) were reported for the period. The highest case detection rates of 61.45 AEFIs per 100,000 surviving infants was recorded in 2018. Reporting forms were modified to accommodate new indicators without any disruption in the function of the system. At the national level, completeness of 100 randomly sampled reporting forms (100%) and was higher than the region (27%) but timeliness (50%) was lower than the region (83%). All (16/16) Community Health Nurses interviewed indicated "fear of being victimized" as the reason for underreporting, nonetheless, the system was useful as it made them cautious when vaccinating children to prevent reactions. Data on AEFI surveillance was also useful in guiding training needs and provision of vaccination logistics.ConclusionThe AEFI surveillance system is useful at all levels but partially meeting its objective due to underreporting. We recommend training and supportive supervision to improve timeliness of reporting, data completeness and acceptability.
| S-EPMC8887767 | biostudies-literature
Project description:Post licensure surveillance of adverse events following immunization (AEFI) is a fundamental activity to improve safety and maintain public confidence in vaccines. Since 2011, the Liguria Region has been involved in the inter-regional project of post-marketing surveillance of AEFI, coordinated by the Italian Medicine Agency and the Veneto region. The main objectives of the project are: (1) to coordinate the surveillance activities in the 8 Italian Regions included in the project; (2) to encourage the signal of AEFI by healthcare workers and patients; (3) to organize education activities addressed to health care workers, and, finally; (4) to establish vaccination counseling services in each Region. In particular, the Ligurian multidisciplinary team, composed by physicians expert in the field of vaccination and pharmacists, is involved in the causality assessment between vaccines and all adverse events signaled within the Liguria Region and in the analysis of all adverse events signaled in Italy as possibly related to influenza vaccines. During 2013, the team has organized 4 courses, addressed to healthcare personnel of vaccination outpatient clinics, focused on European and Italian legislation on pharmaco-vigilance and vaccine-vigilance and aimed at promoting signal of AEFI. Since October 2013, the Liguria Region has been participating to the inter-regional project of active surveillance of adverse events aimed at promoting the signal of AEFI by parents of vaccinated infants. After two years of implementation of the project both the number of reported AEFI and the reporting rate per 100 000 administered doses of vaccine increased. The activities need to be consolidated in the next years in order to guarantee high standard of vaccine safety, maintain the confidence in current immunization programs and reach optimal vaccination coverage rate.
| S-EPMC4514437 | biostudies-other
Project description:BackgroundDespite their effectiveness, coronavirus disease 2019 (COVID-19) vaccines have been associated with adverse effects, underscoring the importance of continuous surveillance to ensure vaccine safety and effective management of public health. Herein, the characteristics and risk factors of vaccine-related adverse events (AEs) were identified to gain an in-depth understanding of vaccine safety by investigating the impact of the vaccination dose on changes in post-vaccination AEs.MethodsHerein, a linked database of COVID-19 vaccination records from the Korea Disease Control and Prevention Agency, AE reports from the COVID-19 Vaccination Management System, and healthcare claims from the National Health Insurance Service, targeting ≥ 5-year-old individuals, was utilized (study duration = February 26, 2021, to January 31, 2023). The frequency and severity of reported post-vaccination AEs were evaluated. Furthermore, we specifically explored AEs in relation to the cumulative dosage of vaccines administered while evaluating associated risk factors.ResultsDuring the observation period, 42,804,523 individuals completed the COVID-19 vaccination series, with 365,900 reporting AEs, with headache, muscle pain, and fever being the most frequently reported. Notably, the AE reports were approximately twice as high for women than for men, which was further exacerbated following both doses. Analysis by age group revealed that AE reports were lower among children, adolescents, and older adults than in the middle-aged cohort (age = 50-64 years), with higher reports observed for 18-49-year-old individuals. Additionally, a higher risk of reporting was identified among individuals with lower socioeconomic status compared with those of middle socioeconomic status. Excluding dementia, the risk of reporting AEs was high in individuals with underlying diseases compared with those without, for instance, the risk of reporting AEs following two-dose vaccinations was approximately twice as high in individuals with chronic obstructive pulmonary disease and asthma.ConclusionThese findings indicate that women, younger people, those with a lower socioeconomic status, and those with underlying health conditions reported a higher incidence of AEs following COVID-19 vaccinations. This emphasizes the need for continued monitoring to ensure safe vaccination and address vaccine-related anxiety and fear, especially within the aforementioned groups.
| S-EPMC11538574 | biostudies-literature
Project description:BackgroundOwing to limited experience with the new vaccine platforms, discussion of vaccine safety is inevitable. However, media coverage of adverse events of special interest could influence the vaccination rate; thus, evaluating the outcomes of adverse events of special interest influencing vaccine administration is crucial.MethodsWe conducted regression discontinuity in time analysis to calculate the local average treatment effect (LATE) using datasets from Our World in Data and Johns Hopkins University Center for Systems Science and Engineering. For the United States, the United Kingdom, and Europe, the cutoff points were April 23rd and June 23rd, April 7th, and the 14th week of 2021, respectively.ResultsThe LATE of the Advisory Committee on Immunization Practices (ACIP) meeting held on April 23rd was -0.249 for all vaccines, -0.133 (-0.189 to -0.076) for Pfizer, -0.064 (-0.115 to -0.012) for Moderna, and -0.038 (-0.047 to -0.030) for Johnson & Johnson. Discontinuities were observed for all three types of vaccines in the United States. The June 23rd meeting of the ACIP (mRNA vaccines and myocarditis) did not convene any discontinuities. Furthermore, there was no significant drop in the weekly average vaccination rates in Europe following the European Medicines Agency (EMA) statement on April 7th. Conversely, there was a significant drop in the first-dose vaccination rates in the United Kingdom related to the EMA report. The first-dose vaccination rate for all vaccines changed by -0.104 (-0.176 to -0.032).ConclusionAlthough monitoring and reporting of adverse events of special interest are important, a careful approach towards public announcements is warranted.
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Project description:Pakistan is facing the world's largest outbreak of extensively drug-resistant (XDR) Typhoid. Vaccination campaign for children aged 6 months to 10 years old with Typhoid Conjugate Vaccine (Typbar-TCV®) was conducted in high-risk areas of Hyderabad during 2018. About 207,000 children were vaccinated. Here we report the adverse events following immunization (AEFI) during the campaign. The campaign was carried out using outreach and fixed centre strategy. Community mobilizers visited each household to perform line listing and mobilize parents with age-eligible children. Children were observed for 30 min post-vaccination. Two-pronged strategy was used for ascertainment of AEFI. A 24/7 hotline number was provided to all parents/caretakers (n = 199,861) to report AEFI during 14 days following immunization. An age-stratified (n = 7139 children) were actively followed at days 7 and 14 for the ascertainment of AEFI. All AEFI were examined by three trained medical officers. A structured questionnaire using Brighton collaboration criteria with level 3 diagnostic certainty was used for the recording of AEFI. Data were analysed using Microsoft Excel Office 365. Overall, 499 AEFI (433 in the subset actively followed and 66 self-reported through hotline) were observed. The rate of AEFI was significantly higher among very young children (age group 6 to 12 months) as compared to 2 to 3 years old children (0.54% vs. 0.33% respectively; p-value < 0.001). Fever was the most common AEFI self-reported through the hotline (38/199,861 = 0.02%) and among the subset followed actively for 14 days (206/7139 = 2.89%). Fever was followed by local reactogenicity 10/199,861(0.01%), and 134/7139 (1.88%) through self-reported hotline and active follow-up, respectively. No serious AEFI was observed. Administration of a single dose of Typbar-TCV among children aged 6 months to 10 years old during an outbreak setting of Hyderabad Pakistan was safe.
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Project description:The Vaccine Adverse Event Reporting System (VAERS) is a passive reporting system, used for monitoring the safety of all US licensed vaccines. In March 2008, ACAM2000(®) replaced Dryvax(®) as the only licensed smallpox vaccine and is administered to all persons entering military service and certain civilian researchers. In 2011, routine data mining of VAERS identified a vaccine safety concern resulting in acute ischemic cardiac events (ICE) following ACAM2000(®).During March 1, 2008 through June 30, 2013, we reviewed all serious reports received following ACAM2000(®)and classified them by diagnostic category. We identified possible ICE cases by searching the Medical Dictionary for Regulatory Affairs (MedDRA(®)) terms for "myocardial ischaemia," "acute myocardial infarction," "myocardial infarction," and "ischaemia," and applied standardized surveillance case definitions.VAERS received 1149 reports following ACAM2000(®) administration; 169 (14.7%) were serious (resulting in permanent disability, hospitalization or prolongation of hospitalization, life-threatening illness or death), including one death. The two most frequent diagnostic categories for serious reports were cardiovascular and other infectious conditions. The MedDRA(®) search found 31 reports of possible ICE after receipt of ACAM2000(®) vaccine. Of a total 30 possible ICE cases with demographic information, all but one was male; the age range was 20-45 years (median 32) and median interval to onset of symptoms was 12 days. On clinical review there were 16 cases of myocarditis/pericarditis and 15 ICE cases.Our review of the data mining signal did not substantiate the concerns about ICE after ACAM2000(®). Our study also suggests that with current pre-vaccination screening, cardiac morbidity in generally healthy vaccinated populations remains uncommon.
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Project description:In 2019, there were multiple outbreaks of measles in the United States. In the context of the public awareness of these outbreaks, we performed an intervention with the intent to improve the rate of measles immunization in our pediatric population. Pediatric patients that were lacking adequate measles immunization were identified by electronic medical record (EMR) survey. Charts were reviewed and updated if records were found to be incomplete. Parents of the remaining children were sent a letter, personally signed by the child's primary care provider, encouraging measles immunization. A measles fact sheet, produced by the United States Center for Disease Control, was also included with the letter. There were 44 patients in the study group whose parents received a letter and measles fact sheet. As a result, 5 of these children were brought in for a measles, mumps, and rubella (MMR) immunization. The 44 patients whose parents received a letter included 20 patients whose parents had previously expressed intent to not vaccinate their children as documented in the EMR. None of these children received an MMR immunization. Although small in scope, this project provides a glimpse into the importance of personal provider guidance to parents who are inclined to immunize their children. Unfortunately, it also demonstrated that provider advice did not change the opinions of parents who had already taken a stance against vaccination, even in the context of an urgent public health situation that had garnered widespread coverage in the lay press and social media.
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Project description:It is critical to distinguish events that are temporarily associated with, but not caused by, vaccination from those caused by vaccination during mass immunization. We performed a literature search in China National Knowledge Infrastructure and Pubmed databases. The number of coincident events was calculated based on its incidence rate and periods after receipt of a dose of hypothesized vaccine. We included background incidences of Guillain-Barré syndrome, anaphylaxis, seizure, sudden adult death syndrome, sudden cardiac death, spontaneous abortion, and preterm labour or delivery. In a cohort of 10 million individuals, 7.71 cases of Guillain-Barré syndrome would be expected to occur within six weeks of vaccination as coincident background cases. Even for rare events, a large number of events can be expected in a short period because of the large population targeted for immunization. These findings may encourage health authorities to screen the safety of vaccines against unpredictable pathogens.
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