Comparative assessment of allergic reactions to COVID-19 vaccines in Europe and the United States.
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ABSTRACT:
SUBMITTER: Hatziantoniou S
PROVIDER: S-EPMC9111347 | biostudies-literature | 2022 May
REPOSITORIES: biostudies-literature
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Comparative assessment of allergic reactions to COVID-19 vaccines in Europe and the United States.
Hatziantoniou Sophia S Anastassopoulou Cleo C Lampropoulou Vicky V Maltezou Helena C HC Andreakos Evangelos E Poland Gregory A GA Tsakris Athanasios A
Allergy 20220224 5
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Project description: Not available
| S-EPMC7941251 | biostudies-literature
Project description:BackgroundData on allergic reactions after the administration of coronavirus disease (COVID-19) vaccines are limited. Our aim is to analyze reports of allergic reactions after COVID-19 vaccine administration.MethodsThe Vaccine Adverse Event Reporting System database was searched for reported allergic reactions after the administration of any of the COVID-19 vaccines from December 2020 to June 2021. After data mapping, the demographic and clinical characteristics of the reported cases were analyzed. Potential factors associated with anaphylaxis were evaluated using multivariable logistic regression models.ResultsIn total, 14,611 cases were reported. Most cases of allergic reactions comprised women (84.6%) and occurred after the first dose of the vaccine (63.6%). Patients who experienced anaphylaxis were younger (mean age 45.11 ± 5.6 vs. 47.01 ± 6.3 years, P < 0.001) and had a higher prevalence of a history of allergies, allergic rhinitis, asthma, and anaphylaxis than those who did not (P < 0.05). A history of allergies (odds ratio (OR) 1.632, 95% confidence interval (CI) 1.467-1.816, P < 0.001), asthma (OR 1.908, 95%CI 1.677-2.172, P < 0.001), and anaphylaxis (OR 7.164, 95%CI 3.504-14.646, P < 0.001) were potential risk factors for anaphylaxis. Among the 8,232 patients with reported outcomes, 16 died.ConclusionsFemale predominance in allergic reaction cases after the receipt of COVID-19 vaccines was observed. Previous histories of allergies, asthma, or anaphylaxis were risk factors for anaphylaxis post-vaccination. People with these risk factors should be monitored more strictly after COVID-19 vaccination.
| S-EPMC9152252 | biostudies-literature
Project description:ImportanceAs of May 2021, more than 32 million cases of COVID-19 have been confirmed in the United States, resulting in more than 615 000 deaths. Anaphylactic reactions associated with the Food and Drug Administration (FDA)-authorized mRNA COVID-19 vaccines have been reported.ObjectiveTo characterize the immunologic mechanisms underlying allergic reactions to these vaccines.Design, setting, and participantsThis case series included 22 patients with suspected allergic reactions to mRNA COVID-19 vaccines between December 18, 2020, and January 27, 2021, at a large regional health care network. Participants were individuals who received at least 1 of the following International Statistical Classification of Diseases and Related Health Problems, Tenth Revision anaphylaxis codes: T78.2XXA, T80.52XA, T78.2XXD, or E949.9, with documentation of COVID-19 vaccination. Suspected allergy cases were identified and invited for follow-up allergy testing.ExposuresFDA-authorized mRNA COVID-19 vaccines.Main outcomes and measuresAllergic reactions were graded using standard definitions, including Brighton criteria. Skin prick testing was conducted to polyethylene glycol (PEG) and polysorbate 80 (P80). Histamine (1 mg/mL) and filtered saline (negative control) were used for internal validation. Basophil activation testing after stimulation for 30 minutes at 37 °C was also conducted. Concentrations of immunoglobulin (Ig) G and IgE antibodies to PEG were obtained to determine possible mechanisms.ResultsOf 22 patients (20 [91%] women; mean [SD] age, 40.9 [10.3] years; 15 [68%] with clinical allergy history), 17 (77%) met Brighton anaphylaxis criteria. All reactions fully resolved. Of patients who underwent skin prick tests, 0 of 11 tested positive to PEG, 0 of 11 tested positive to P80, and 1 of 10 (10%) tested positive to the same brand of mRNA vaccine used to vaccinate that individual. Among these same participants, 10 of 11 (91%) had positive basophil activation test results to PEG and 11 of 11 (100%) had positive basophil activation test results to their administered mRNA vaccine. No PEG IgE was detected; instead, PEG IgG was found in tested individuals who had an allergy to the vaccine.Conclusions and relevanceBased on this case series, women and those with a history of allergic reactions appear at have an elevated risk of mRNA vaccine allergy. Immunological testing suggests non-IgE-mediated immune responses to PEG may be responsible in most individuals.
| S-EPMC8449279 | biostudies-literature
Project description:The Food and Drug Administration (FDA) has recently authorized the two messenger RNA (mRNA) vaccines BNT162b2 and mRNA-1273 for emergency use against the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) causing the COVID-19 coronavirus disease. BNT162b2 and mRNA-1273 vaccines were developed by Pfizer-BioNTech and Moderna, respectively, in 2020. The United Kingdom, Bahrain, Canada, Mexico, United States, Singapore, Oman, Saudi Arabia, Kuwait, and European Union began their vaccination programs with the BNT162b2 vaccine, while the United States and Canada also started the mRNA-1273 vaccination program in mid December 2020. On 28th December 2020, studies reported severe allergic reactions in people who received the BNT162b2, and few people who received the mRNA-1273 vaccine. Authors of the letter thus attempt to explore possible causes of anaphylaxis following COVID-19 vaccination.
| S-EPMC8140554 | biostudies-literature
Project description:IntroductionThis study aims to provide a risk assessment of the adverse reactions related to the COVID-19 vaccines manufactured by AstraZeneca, Janssen, Moderna, and Pfizer-BioNTech which have been in use in the European Union and the United States between December 2020 and October 2021.MethodsData from the European Database of Suspected Adverse Drug Reaction (EudraVigilance) and the Vaccine Adverse Events Reporting System (VAERS) from 2020 to October 2021 are analysed. More than 7.8 million adverse reactions of about 1.6 million persons are included. The adverse reactions are classified with the Common Toxicity Criteria (CTC) categories. COVID-19 vaccine exposures and adverse reactions reported between December 2020 and October 2021 are compared to influenza vaccine exposures and adverse reactions reported between 2020 and 2021. The population-level vaccine exposures to COVID-19 and influenza vaccines comprised about 451 million and 437 million exposures, respectively. Absolute and relative risk estimates are calculated by CTC categories and COVID-19 vaccines for the EU and US populations aged 18 years and older.ResultsA higher risk of reporting serious adverse reactions was observed for the COVID-19 vaccines in comparison to the influenza vaccines. Individuals age 65 and older were associated with a higher frequency of death, hospitalisations, and life-threatening reactions than younger individuals (relative risk estimates between 1.49 99% CI [1.44-1.55] and 8.61 99% CI [8.02-9.23]). Outcome onset of serious adverse reactions occurred within the first 7 days after vaccination in about 77.6-89.1% of cases. The largest absolute risks were observed for allergic, constitutional reactions, dermatological, gastrointestinal, neurological reactions, and localised and non-localised pain. The largest relative risks between COVID-19 vs. influenza vaccines were observed for allergic reactions, arrhythmia, general cardiovascular events, coagulation, haemorrhages, gastrointestinal, ocular, sexual organs reactions, and thrombosis.ConclusionThe present study provides an overview of adverse reactions frequently reported to the pharmacovigilance systems following COVID-19 vaccination in the EU and US populations. Despite the limitations of passive reporting systems, these results may inform further clinical research investigating in more detail the pathophysiological mechanisms potentially associated with the COVID-19 vaccines.
| S-EPMC8850379 | biostudies-literature
Project description:Determining whether SARS-CoV-2 exhibits seasonality like other respiratory viruses is critical for public health planning. We evaluated whether COVID-19 rates follow a seasonal pattern using time series models. We used time series decomposition to extract the annual seasonal component of COVID-19 case, hospitalization, and mortality rates from March 2020 through December 2022 for the United States and Europe. Models were adjusted for a country-specific stringency index to account for confounding by various interventions. Despite year-round disease activity, we identified seasonal spikes in COVID-19 from approximately November through April for all outcomes and in all countries. Our results support employing annual preventative measures against SARS-CoV-2, such as administering seasonal booster vaccines in a similar timeframe as those in place for influenza. Whether certain high-risk individuals may need more than one COVID-19 vaccine booster dose each year will depend on factors like vaccine durability against severe illness and levels of year-round disease activity.
| S-EPMC9994397 | biostudies-literature
Project description:2017-2020 data from Medical Examiner Offices of 19 large U.S. counties are collected to study how suicides evolved during the early stage of the COVID-19 pandemic. I use these data to obtain three key findings. First, I document that the total number of suicides per month was increasing during the early months of the pandemic but was below previous years' levels. Second, using a monthly event study design to account for seasonal trends and county-level differences in suicides, I find that during April through August 2020, monthly suicides were between 11.2 and 20.5% lower than previous years. Third, I explore whether school closures during the start of the pandemic might be associated with suicides among school-age individuals, and I find that monthly suicides increased relative to previous years for this age group, with the highest increases during the summer.Supplementary informationThe online version contains supplementary material available at 10.1007/s43546-022-00235-0.
| S-EPMC9205144 | biostudies-literature
Project description:Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a novel coronavirus causing a global pandemic. Coronaviruses are a large family of single-stranded ribonucleic acid (RNA) viruses. The virus has four essential structural proteins which include the spike (S) glycoprotein, matrix (M) protein, nucleocapsid (N) protein and small envelope (E) protein. Different technologies are being used for vaccine development to battle the pandemic. There are messenger ribonucleic acid (mRNA)-based vaccines, deoxyribonucleic acid (DNA) vaccines, inactivated viral vaccines, live attenuated vaccines, protein subunit-based vaccines, viral vector-based vaccines and virus-like particle-based vaccines. Vaccine development has five stages. In the clinical developmental stage, vaccine development can be sped up by combining phase 1 and 2. The vaccines can also be approved more swiftly on an emergent basis and released sooner for usage. The United States Food and Drug Administration (USFDA) has approved Pfizer-BioNTech, Moderna and Janssen coronavirus disease 2019 (COVID-19) vaccines for emergency use. There are other vaccines that have been approved around the world. The mRNA vaccines have been created using a novel technology and they contain a synthetically created RNA sequence of virus fragments encoding the S-protein which is injected. These vaccines have a relatively low cost of production and faster manufacturing time but can have comparatively lower immunogenicity and more than one dose of vaccine may be required. In the case of viral vector-based vaccines, genes encoding the SARS-CoV-2 S protein are isolated and following gene sequencings are introduced into the adenovirus vector. These vaccines have a relatively fast manufacturing time but the efficacy of the vaccine is variable based on the host's immune response to the viral vector. At the time of this paper, there were 81 vaccines in clinical development stage and 182 vaccines in preclinical development stage. Vaccines are an essential tool in our battle against COVID-19. Some of the COVID-19 vaccines have completed their phase III trials while many other potential vaccines are still in developmental stages. It used to take close to a decade for a vaccine to be developed and undergo rigorous testing until its production and availability to the public, but over the past year, we have seen multiple vaccines in different phases of testing against SARS-CoV-2 virus.
| S-EPMC8110223 | biostudies-literature
Project description: Not available
| S-BSST1493 | biostudies-other
Project description:IntroductionTo compare the mortality of hospitalized patients with COVID-19 between those that required supplemental oxygen and received dexamethasone with a comparable set of patients who did not receive dexamethasone.MethodsWe utilized the Premier Health Database to identify hospitalized adult patients with COVID-19 from July 1, 2020-January 31, 2021. Index date was when patients first initiated oxygen therapy. The primary endpoint was in-hospital mortality for patients receiving dexamethasone versus those not receiving dexamethasone 1-day pre- to 1-day post-index period. Secondary endpoints included 28-day mortality, time to in-hospital mortality, progression to invasive mechanical ventilation or death, time to discharge, and proportion discharged alive by day 28. Twenty-three models using weighting, matching, stratification, and regression were deployed through the concept of frequentist model average (FMA) to estimate the effect of dexamethasone on all-cause mortality up to the 28-day hospitalization period.ResultsA total of 1,208,881 patients with COVID-19 were screened; as an inpatient 255,216 used oxygen, and 251,536 were included in the analysis. In the dexamethasone group, odds of in-hospital mortality were higher than those of the comparator (FMA: odds ratio [OR] 1.15, 95% CI 1.08, 1.22). Using a best fit model, OR for in-hospital mortality was non-significant for the dexamethasone group compared with the comparator (OR 1.02, 95% CI 0.92, 1.14). Dexamethasone treatment was associated with poorer outcomes versus the comparator group across the majority of secondary endpoints, except for number of days in hospital, which was lower in the dexamethasone group versus the comparator group (mean difference - 2.14, 95% CI - 2.43, - 1.47).ConclusionsHospitalized adult patients with COVID-19 who required supplemental oxygen and received dexamethasone did not have a survival benefit versus similar patients not receiving dexamethasone. The dexamethasone group was not associated with favorable responses for outcomes such as progression to death or mechanical ventilation and time to in-hospital death.
| S-EPMC9374287 | biostudies-literature