Short term adverse event profile of COVID-19 mRNA vaccines in children aged 5-15 years in Australia.
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ABSTRACT:
SUBMITTER: Wood N
PROVIDER: S-EPMC9854254 | biostudies-literature | 2023 Feb
REPOSITORIES: biostudies-literature
Publications
Short term adverse event profile of COVID-19 mRNA vaccines in children aged 5-15 years in Australia.
Wood Nicholas N Lopez Laura K LK Glover Catherine C Leeb Alan A Cashman Patrick P Deng Lucy L Macartney Kristine K
The Lancet regional health. Western Pacific 20230120
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Project description:Corneal thickness (CT) maps of the central (2-mm diameter), para-central (2 to 5-mm diameter), peripheral (5 to 6-mm diameter), and minimum (5-mm diameter) cornea were measured in normal Chinese school children aged 7 to 15 years old using Fourier-domain optical coherence tomography. Multiple regression analyses were performed to explore the effect of associated factors [age, gender, refraction, axial length and corneal curvature radius (CCR)] on CT and the relationship between central corneal thickness (CCT) and intraocular pressure (IOP). A total of 1228 eyes from 614 children were analyzed. The average CCT was 532.96 ± 28.33 μm for right eyes and 532.70 ±28.45 μm for left eyes. With a 10 μm increase in CCT, the IOP was elevated by 0.37 mm Hg, as measured by noncontact tonometry. The CT increased gradually from the center to the periphery. The superior and superior nasal regions had the thickest CTs, while the thinnest points were primarily located in the inferior temporal cornea. The CCT was associated with CCR (p = 0.008) but not with gender (p = 0.075), age (p = 0.286), axial length (p = 0.405), or refraction (p = 0.985). In the para-central region and the peripheral cornea, increased CT was associated with younger age, male gender, and a flatter cornea.
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Project description:To examine trends in colorectal cancer (CRC) incidence and colonoscopy history in adolescents and young adults (AYAs) aged 15-39 years in Western Australia (WA) from 1982 to 2007.Descriptive cohort study using population-based linked hospital and cancer registry data.Five-year age-standardized and age-specific incidence rates of CRC were calculated for all AYAs and by sex. Temporal trends in CRC incidence were investigated using Joinpoint regression analysis. The annual percentage change (APC) in CRC incidence was calculated to identify significant time trends. Colonoscopy history relative to incident CRC diagnosis was examined and age and tumor grade at diagnosis compared for AYAs with and without pre-diagnosis colonoscopy. CRC-related mortality within 5 and 10 years of incident diagnosis were compared for AYAs with and without pre-diagnosis colonoscopy using mortality rate ratios (MRRs) derived from negative binomial regression.Age-standardized CRC incidence among AYAs significantly increased in WA between 1982 and 2007, APC = 3.0 (95% CI 0.7-5.5). Pre-diagnosis colonoscopy was uncommon among AYAs (6.0%, 33/483) and 71% of AYAs were diagnosed after index (first ever) colonoscopy. AYAs with pre-diagnosis colonoscopy were older at CRC diagnosis (mean 36.7 ± 0.7 years) compared to those with no prior colonoscopy (32.6 ± 0.2 years), p < 0.001. At CRC diagnosis, a significantly greater proportion of AYAs with pre-diagnosis colonoscopy had well-differentiated tumors (21.2%) compared to those without (5.6%), p = 0.001. CRC-related mortality was significantly lower for AYAs with pre-diagnosis colonoscopy compared to those without, for both 5-year [MRR = 0.44 (95% CI 0.27-0.75), p = 0.045] and 10-year morality [MRR = 0.43 (95% CI 0.24-0.83), p = 0.043].CRC incidence among AYAs in WA has significantly increased over the 25-year study period. Pre-diagnosis colonoscopy is associated with lower tumor grade at CRC diagnosis as well as significant reduction in both 5- and 10-year CRC-related mortality rates. These findings warrant further research into the balance in benefits and harms of targeted screening for AYA at highest risk.
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Project description:Background Adverse pregnancy outcomes (APOs) (hypertensive disorders of pregnancy [HDP], preterm delivery [PTD], or low birth weight [LBW]) are associated adverse maternal and offspring cardiovascular outcomes. Therefore, we sought to describe nationwide temporal trends in the burden of each APO (HDP, PTD, LBW) from 2007 to 2019 to inform strategies to optimize maternal and offspring health outcomes. Methods and Results We performed a serial cross-sectional analysis of APO subtypes (HDP, PTD, LBW) from 2007 to 2019. We included maternal data from all live births that occurred in the United States using the National Center for Health Statistics Natality Files. We quantified age-standardized and age-specific rates of APOs per 1000 live births and their respective mean annual percentage change. All analyses were stratified by self-report of maternal race and ethnicity. Among 51 685 525 live births included, 15% were to non-Hispanic Black individuals, 24% Hispanic individuals, and 6% Asian individuals. Between 2007 and 2019, age standardized HDP rates approximately doubled, from 38.4 (38.2-38.6) to 77.8 (77.5-78.1) per 1000 live births. A significant inflection point was observed in 2014, with an acceleration in the rate of increase of HDP from 2007 to 2014 (+4.1% per year [3.6-4.7]) to 2014 to 2019 (+9.1% per year [8.1-10.1]). Rates of PTD and LBW increased significantly when co-occurring in the same pregnancy with HDP. Absolute rates of APOs were higher in non-Hispanic Black individuals and in older age groups. However, similar relative increases were seen across all age,racial and ethnic groups. Conclusions In aggregate, APOs now complicate nearly 1 in 5 live births. Incidence of HDP has increased significantly between 2007 and 2019 and contributed to the reversal of favorable trends in PTD and LBW. Similar patterns were observed in all age groups, suggesting that increasing maternal age at pregnancy does not account for these trends. Black-White disparities persisted throughout the study period.
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Project description:We aimed to investigate the type and frequency of adverse events over 7 days following the first and second BNT162b2 vaccination. This observational and historical cohort study included patients aged 5-11 years who received two doses of BNT162b2 and provided consent along with their guardians. We collected data on sex, age, height, weight, blood type, history of Bacille Calmette-Guerin vaccination, allergic disease, medication, history of coronavirus disease 2019 (COVID-19), and adverse reactions 7 days following the first and second BNT162b2 vaccination using a questionnaire. Our results were compared with previously reported results for individuals aged 12-15 years. A total of 421 participants were eligible for this study. Among the 216 patients with allergic disease, 48 (22.2%) had experienced worsening of their chronic diseases, and the frequency of fatigue and dizziness after the second dose was higher than that of healthy individuals. The experience of systemic adverse reactions was associated with asthma. The frequency of headache, diarrhea, fatigue, muscle/joint pain, and fever after the second BNT162b2 vaccination was lower in individuals aged 5-11 years than in those aged 12-15 years. Fever was the only systemic adverse reaction that lasted longer than 5 days (1.0% of participants).ConclusionsIndividuals with allergic diseases, who are potentially susceptible to COVID-19, may experience worsening of their chronic diseases and more frequent adverse reactions after BNT162b2 vaccination than healthy individuals. To ensure that children with allergic diseases receive the vaccine safely, further information needs to be collected.What is known• Adverse reactions after BNT162b2 vaccination among individuals aged 5-11 years are generally nonserious, more common after second vaccination, and substantially less common compared to those observed among individuals aged 12-15 years.What is new• Individuals with allergic diseases experienced worsening of their chronic diseases and more frequent adverse reactions after BNT162b2 vaccination than healthy individuals. • Systemic adverse reactions were associated with asthma. Fever was the only systemic adverse reaction that lasted longer than 5 days.
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Project description:IntroductionThe BNT162b2 and mRNA-1273 COVID-19 vaccines are the main vaccines that have been used for mass vaccination in Japan. Information on adverse reactions to COVID-19 vaccines in the Japanese population is limited.MethodsWe conducted an online survey on self-reported adverse reactions in individuals who had received two doses of the BNT162b2 or mRNA-1273 vaccine. The incidence of adverse events after each dose of vaccine was investigated. Propensity score matching was used to compare the incidence of adverse reactions after the second dose of the BNT162b2 and mRNA-1273 vaccines.ResultsAfter the first and second doses of the BNT162b2 vaccine, and the first and second doses of the mRNA-1273 vaccine, 890, 853, 6401, and 3965 individuals, respectively, provided complete responses. Systemic reactions, including fever, fatigue, headache, muscle/joint pain, and nausea were significantly more common in females, individuals aged <50 years, and after the second dose. The incidence of injection site pain did not differ significantly according to the dose. The incidence of delayed injection site reactions after the first dose of mRNA-1273 vaccine was 3.9% and 0.8% among females and males, respectively, and 10.6% among females aged 40-69 years. Local and systemic reactions after the second dose, including fever, fatigue, headache, muscle/joint pain, nausea, and skin rash were more common in individuals who had received the mRNA-1273 vaccine.ConclusionsAdverse reactions were more frequently reported in females, younger individuals, and after the mRNA-1273 vaccine.
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Project description:IntroductionChildhood immunization schedules often involve multiple vaccinations per visit. When increased risk of an adverse event is observed after simultaneous (same-day) vaccinations, it can be difficult to ascertain which triggered the adverse event. This methods paper discusses a systematic process to determine which of the simultaneously administered vaccine(s) are most likely to have caused an observed increase in risk of an adverse event.MethodsWe use an example from the literature where excess risk of seizure was observed 1 day after vaccination, but same-day vaccination patterns made it difficult to discern which vaccine(s) may trigger the adverse event. We illustrate the systematic identification process using a simulation that retained the observed pattern of simultaneous vaccination in an empirical cohort of vaccinated children. We simulated "true" effects for diphtheria-tetanus-acellular pertussis (DTaP) and pneumococcal conjugate (PCV) on risk of seizure the day after vaccination. We varied the independent and interactive effects of vaccines (on the multiplicative scale). After applying the process to simulated data, we evaluated risk of seizure 1 day after vaccination in the empirical cohort.ResultsIn all simulations, we were able to determine which vaccines contributed to excess risk. In the empirical data, we narrowed the association with seizure from all vaccines in the schedule to three likely candidates, DTaP, PCV, and/or Haemophilus influenzae type B (HiB) (p < 0.01, attributable risk when all three were administered together: five per 100,000). Disentangling their associations with seizure would require a larger sample or more variation in the combinations administered. When none of these three were administered, no excess risk was observed.ConclusionThe process outlined could provide valuable information on the magnitude of potential risk from individual and simultaneousvaccinations. Associations should be further investigated with independent data as well as biologically based, statistically independent hypotheses.
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Project description:Dermatologic adverse events (dAEs) are common with the use of epidermal growth factor receptor-tyrosine kinase inhibitor (EGFR-TKI) therapy. First- and second-generation agents (erlotinib, gefitinib, and afatinib) are frequently associated with acneiform rash, pruritus, xerosis, and paronychia; the incidence and characterization of these dAEs have been well described. However, there is evidence that the dAE profile is different with third-generation EGFR-TKIs. Herein, we describe the dAEs associated with third-generation EGFR-TKIs and our clinical experience with osimertinib, a third-generation EGFR-TKI approved by the U.S. Food and Drug Administration for the treatment of metastatic, EGFR T790M mutation-positive non-small cell lung cancer in patients whose disease has progressed on or after EGFR-TKI therapy. Case summaries of patients from two of our institutions who received osimertinib and were referred to a dermatologist for dAEs are also presented. Overall, the evidence suggests that osimertinib is associated with less severe and less frequent dAEs than first- and second-generation EGFR-TKIs and that therefore a different approach is warranted. Finally, we outline dAE management approaches for osimertinib in the context of those typically employed with first- and second-generation EGFR-TKIs.Implications for practiceAppropriate prevention and management of dermatologic adverse events (dAEs) associated with the use of epidermal growth factor receptor-tyrosine kinase inhibitors (EGFR-TKIs) may help patients to continue therapy and lessen any negative impact on their quality of life. EGFR-TKIs are frequently associated with acneiform rash, pruritus, xerosis, and paronychia; however, dAEs associated with third-generation EGFR-TKIs are lower in frequency and severity. Before therapy, health care providers should discuss the potential osimertinib-associated dAEs and encourage patients to report their dAEs. Patients should also be educated on prophylactic measures to minimize the severity of dAEs and the importance of adherence to the treatment regimen.
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