Association between IgG antibody levels and adverse events after first and second Bnt162b2 mRNA vaccine doses

Braun, Eyal; Horowitz, Netanel A.; Leiba, Ronit; Weissman, Avi; Mekel, Michal; Shachor-Meyouhas, Yael; Hussein, Khetam; Halberthal, Michael; Azzam, Zaher S.; Berger, Gidon

doi:10.1016/j.cmi.2022.07.002

Cited by 6 publications

(5 citation statements)

References 17 publications

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“…Necrotizing pancreatitis necessitating drainage or surgery, was only reported from one patient after the second vaccination, whereas the first vaccination was well tolerated as in our patient [ 5 ]. This is in accordance with findings from a cohort study which found that adverse events, except local pain, were more common after the second Pfizer/BioNTech vaccine dose compared with the first vaccine dose [ 22 ].…”

Section: Discussionsupporting

confidence: 92%

Necrotizing pancreatitis, microangiopathic hemolytic anemia and thrombocytopenia following the second dose of Pfizer/BioNTech COVID-19 mRNA vaccine

Stöllberger,

Kastrati,

Dejaco

et al. 2023

Wien Klin Wochenschr

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Implementing vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a major asset in slowing down the coronavirus disease 2019 (COVID-19) pandemic. For mRNA vaccines, the main severe adverse events reported in pharmacovigilance systems and post-authorization studies were anaphylaxis and myocarditis. Pancreatitis after Pfizer/BioNTech COVID-19 vaccination has been reported only in 10 patients. We report a 31-year-old female with a history of borderline personality disorder, intravenous drug abuse, allergic asthma, eating disorder, psoriatic arthritis treated with tofacitinib, neurogenic bladder disturbance, cholecystectomy, recurrent thoracic herpes zoster, vaginal candida infections and urinary tract infections, who developed pancreatitis associated with thrombotic microangiopathy and hemolytic-uremic syndrome 10 days after the second vaccination, whereas the first has been well tolerated. She was treated by plasma exchange, and eventually by transgastric drainage with implantation of a plastic stent to remove fluid abdominal retentions. She was discharged after 19 days. Since then her condition has improved continuously. Computed tomography after 12 months did not reveal retentions anymore. As other causes of pancreatitis have been excluded, this case of acute pancreatitis, microangiopathic hemolytic anemia and thrombocytopenia, temporally associated with the Pfizer-BioNTech COVID-19 vaccine, suggests a causal link.

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Section: Discussionsupporting

confidence: 92%

Necrotizing pancreatitis, microangiopathic hemolytic anemia and thrombocytopenia following the second dose of Pfizer/BioNTech COVID-19 mRNA vaccine

Stöllberger,

Kastrati,

Dejaco

et al. 2023

Wien Klin Wochenschr

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“…Notably, studies report an increase in AE after the second and third dose of COVID-19 vaccination as compared to the first dose (15, 20). We had limited data on injection site and systemic AE after the first dose and therefore we could not validly study this.…”

Section: Discussionmentioning

confidence: 99%

“…Time point of blood sample measurement also differed across studies. Oyebanji et al (2021), Uwamino et al (2022) and Braun et al (2022) collected blood samples at approximately two weeks, three weeks and one month after the second dose respectively, whereas we included blood samples taken between three to eight weeks after vaccination (8, 20, 23). In addition, many studies were performed in HCP populations as opposed to the general population, but HCP were found to have higher IgG peak levels after vaccination compared to non-HCP, potentially due to the healthy worker effect (21).…”

Section: Discussionmentioning

confidence: 99%

Association between common adverse events after COVID-19 vaccination and anti-SARS-CoV-2 antibody concentrations in a population-based prospective cohort study in the Netherlands

Holwerda,

Hoeve,

Huiberts

et al. 2023

Preprint

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INTRODUCTION: Adverse events (AE) such as pain at injection site or fever are common after COVID-19 vaccination. We aimed to describe determinants of AE after COVID-19 vaccination and investigate the association between AE and pre- and post-vaccination antibody concentrations. METHODS: Participants of an ongoing prospective cohort study (VASCO) completed a questionnaire on AE within two months after COVID-19 vaccination and provided 6-monthly serum samples. Data from May 2021 to November 2022 were included. Logistic regression analyses were performed to investigate determinants of AE after mRNA vaccination, including pre-vaccination Ig antibody concentrations against the receptor binding domain. Multivariable linear regression was performed in SARS-CoV-2 naive participants to assess the association between AE and log-transformed antibody concentrations 3-8 weeks after mRNA vaccination. RESULTS: 47,947 AE questionnaires were completed by 28,032 participants. In 42% and 34% of questionnaires, injection site and systemic AE were reported, respectively. In 2.2% of questionnaires, participants sought medical attention due to AE. AE were reported significantly more frequently by women, younger participants (<60 years), participants with medical risk conditions and Spikevax recipients (versus Comirnaty). Higher pre-vaccination antibody concentrations were associated with higher incidence of systemic AE after the second and third dose, but not with injection site AE or AE for which medical attention was sought. Any AE after the third dose was associated with higher post-vaccination antibody concentrations (geometric mean concentration ratio: 1.38, 95%CI 1.23-1.54). CONCLUSION: Our study suggests that high pre-vaccination antibody levels induce AE, and that experiencing AE may be a marker for a good antibody response to vaccination.

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“…Systemic adverse reactions have been found to be associated with a higher antibody response in mostly healthy younger [ 16 , 17 ] and diseased populations [ 18 , 19 ]. We observed this association across all age groups, health conditions, and genders, but only with respect to short-term effects of vaccination.…”

Section: Discussionmentioning

confidence: 99%

The Incidence and Effect of Adverse Events Due to COVID-19 Vaccines on Breakthrough Infections: Decentralized Observational Study With Underrepresented Groups

Gabashvili¹

2022

JMIR Form Res

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Background Despite continuing efforts to improve the inclusion of underserved groups in clinical research, gaps in diversity remain. Participation of special populations is especially important when facing problems of unprecedented complexity such as the COVID-19 pandemic. A better understanding of factors associated with the immune response in diverse populations would advance future preventive and curative approaches. Objective The objective of this study was to investigate the factors potentially responsible for adverse events following COVID-19 immunization. The study population included adults from rural areas, transitional countries, and those with medically understudied conditions, across a broad age range. Methods The study evolved from peer support networks developed during the COVID-19 pandemic. Participants were recruited digitally through online neighborhood and health communities. Some of the participants volunteered as study investigators assisting with offline recruitment and safety monitoring. Individuals who consented to participate were asked to share their vaccination experiences either using constantly evolving web-based surveys or via one-on-one communication. Inferential statistical analysis to estimate differences between study groups was performed using parametric and nonparametric tests. Results Of 1430 participants who shared their vaccination experiences, 648 had outcome measures at their 1.5-year follow-up. Significant differences were found between age groups, types of vaccine adverse events (VAEs), incidences of breakthrough infections, and health conditions linked to the microbiome. Pairwise comparisons showed that VAEs interfering with daily activities were significantly higher in both younger (18-59 years) and older age groups (80-100 years, P<.001) than in the 60-79–year age group. Short-term VAEs were associated with lower incidence of breakthrough COVID-19 infections relative to those who reported either minimal or long-term adverse events (P<.001). A genetic origin was suggested for some adverse reactions. Conclusions The findings of this study demonstrate that vaccine adverse reactions in older individuals are being overlooked, and the incidence of VAEs impairing immunity may be higher than previously perceived. Better preventive measures are needed for all those at risk for life-threatening and long-term adverse events due to vaccination. Supportive community-based studies focusing on these populations could add important data to the current body of knowledge. Further and more comprehensive studies should follow. Trial Registration ClinicalTrials.gov NCT04832932; https://clinicaltrials.gov/ct2/show/NCT04832932 International Registered Report Identifier (IRRID) RR2-10.1101/2021.06.28.21256779

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Association between IgG antibody levels and adverse events after first and second Bnt162b2 mRNA vaccine doses

Cited by 6 publications

References 17 publications

Necrotizing pancreatitis, microangiopathic hemolytic anemia and thrombocytopenia following the second dose of Pfizer/BioNTech COVID-19 mRNA vaccine

Necrotizing pancreatitis, microangiopathic hemolytic anemia and thrombocytopenia following the second dose of Pfizer/BioNTech COVID-19 mRNA vaccine

Association between common adverse events after COVID-19 vaccination and anti-SARS-CoV-2 antibody concentrations in a population-based prospective cohort study in the Netherlands

The Incidence and Effect of Adverse Events Due to COVID-19 Vaccines on Breakthrough Infections: Decentralized Observational Study With Underrepresented Groups

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