Short-Term Adverse Events and Antibody Response to the BNT162b2 SARS-CoV-2 Vaccine in 4156 Health Care Professionals.

Elena Azzolini,Antonio Desai,Massimo Turato,Carlo Selmi,Maria Rescigno,Luca Germagnoli,Antonio Voza,Maria De Santis,Salvatore Badalamenti,Angela Ceribelli,Jack Pepys,Chiara Pozzi,Alberto Mantovani,Lorenzo Maria Canziani

doi:10.3390/vaccines10030439

Abstract

Short-term adverse events are common following the BNT162b2 vaccine for SARS-Cov-2 and have been possibly associated with IgG response. We aimed to determine the incidence of adverse reactions to the vaccine and the impact on IgG response. Our study included 4156 health-care professionals who received two doses of the BNT162b2 vaccine 21 days apart and obtained 6113 online questionnaires inquiring about adverse events. The serum response was tested in 2765 subjects 10 days after the second dose. Adverse events, most frequently a local reaction at the site of injection, were reported by 39% of subjects. Multivariate analysis showed that female sex (odds ratio—OR—1.95; 95% confidence interval—CI—1.74–2.19; p < 0.001), younger age (OR 0.98 per year, p < 0.001), second dose of vaccine (OR 1.36, p < 0.001), and previous COVID-19 infection (OR 1.41, p < 0.001) were independently associated with adverse events. IgG response was significantly higher in subjects with adverse events (1110 AU/mL—IQR 345-1630 vs. 386 AU/mL, IQR 261-1350, p < 0.0001), and the association was more pronounced in subjects experiencing myalgia, fever, and lymphadenopathy. We demonstrate that a more pronounced IgG response is associated with specific adverse events, and these are commonly reported by health care professionals after the BNT162b2 vaccine for SARS-Cov-2.

Highlights

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and the resulting coronavirus disease 2019 (COVID-19) affected nearly 200 million people with over 5 million deaths as of December 2021, according to the World Health Organization (WHO)
We report the incidence of adverse events and the serological response 10 days after two doses of BNT162b2 vaccine in a cohort of 4156 health care professionals from a COVID-19 high-impacted hospital
A multivariable analysis using a logistic regression model for adverse events occurrence (Table 2) led to BMI being discarded because of missing values while female sex, age, second dose of vaccine, and previous COVID-19 infection reached statistical significance

Summary

Introduction

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection and the resulting coronavirus disease 2019 (COVID-19) affected nearly 200 million people with over 5 million deaths as of December 2021, according to the World Health Organization (WHO). Short-term adverse events are common following each dose of the BNT162b2 vaccine, as evident from the reports on self-reporting apps [6] with a proposed impact on the IgG response [7]. We report the incidence of adverse events and the serological response 10 days after two doses of BNT162b2 vaccine in a cohort of 4156 health care professionals from a COVID-19 high-impacted hospital. Previous SARS-Cov-2 infection, and the occurrence of minor adverse events following vaccination are independently associated with a more pronounced IgG response to vaccination

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