The Study on Side Effects Caused by Pfizer/BioNTech COVID-19 Vaccine: Focus on IgG Antibodies, and Serological Biomarkers

Abstract

Abstract Background A SARS-CoV-2 pandemic that spread swiftly is now a major global public health issue. Vaccines are currently being distributed in an effort to limit the viral transmission and mortality. Objectives monitoring of both safety and efficacy in determining the overall effectiveness of the vaccine and identifying any potential safety concerns. Methods A retrospective, cross-sectional study employing a validated 13-item structured questionnaire divided into two sections between March 2022 and September 2022. Different post-vaccination side effects SE according to symptoms severity in terms of age and sex for participants were reported. Additionally, some pertinent serological assays for participant’s post-vaccinations were investigated. Results A total of 502 participants (male: 262: female: 240) with comorbidity (healthy: 258: morbid: 244) who received two Pfizer/BioNTech mRNA vaccine doses were included. Importantly, second dose D2 SE experienced a significant more SE than single dose D1 vaccination (P < 0.0001). Hence, in D1 vaccination the injection site pain ISP (45%), followed by equal proportion of headache and fever (40%) were the most common vaccine’s SE, while in D2 vaccination, the ISP (66%), nausea (57%) reported respectively. 97% (P < 0.0001) of participants reported a positive IgG antibody within D2 vaccination. Similarly, serum CR-Protein level was elevated significantly (P < 0.0001) corresponding to the severity of SE between D1 and D2. Significant differences are reported between M, F and ages between both D1 and D2 vaccination(P < 0.0001). Conclusions In light of the extensive data from this study, it is evident that mRNA vaccines, particularly the Pfizer/BioNTech vaccine, have proven highly safe and effective in mitigating the impact of the SARS-CoV-2 pandemic.