Abstract
mRNA vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), such as BNT162b2 (Comirnaty®), have proven to be highly immunogenic and efficient but also show marked reactogenicity, leading to adverse effects (AEs). Here, we analyzed whether the severity of AEs predicts the antibody response against the SARS-CoV-2 spike protein. Healthcare workers without prior SARS-CoV-2 infection, who received a prime-boost vaccination with BNT162b2, completed a standardized electronic questionnaire on the duration and severity of AEs. Serum specimens were collected two to four weeks after the boost vaccination and tested with the COVID-19 ELISA IgG (Vircell-IgG), the LIAISON® SARS-CoV-2 S1/S2 IgG CLIA (DiaSorin-IgG) and the iFlash-2019-nCoV NAb surrogate neutralization assay (Yhlo-NAb). A penalized linear regression model fitted by machine learning was used to correlate AEs with antibody levels. Eighty subjects were enrolled in the study. Systemic, but not local, AEs occurred more frequently after the boost vaccination. Elevated SARS-CoV-2 IgG antibody levels were measured in 92.5% of subjects with Vircell-IgG and in all subjects with DiaSorin-IgG and Yhlo-NAb. Gender, age and BMI showed no association with the antibody levels or with the AEs. The linear regression model identified headache, malaise and nausea as AEs with the greatest variable importance for higher antibody levels (Vircell-IgG and DiaSorin-IgG). However, the model performance for predicting antibody levels from AEs was very low for Vircell-IgG (squared correlation coefficient r2 = 0.04) and DiaSorin-IgG (r2 = 0.06). AEs did not predict the surrogate neutralization (Yhlo-NAb) results. In conclusion, AEs correlate only weakly with the SARS-CoV-2 spike protein antibody levels after COVID-19 vaccination with BNT162b2 mRNA.
Highlights
A penalized linear regression model fitted by machine learning was used to correlate adverse effects (AEs) with antibody levels
Coronavirus disease 2019 (COVID-19) is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which was first described in December 2019 in Wuhan, China [1,2]
All employees of the Institute for Clinical Microbiology, Immunology and Hygiene of the University Hospital Erlangen, Germany who received a prime-boost vaccination with BNT162b2 in March and April 2021 and gave their informed consent were eligible for the study
Summary
Coronavirus disease 2019 (COVID-19) is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), which was first described in December 2019 in Wuhan, China [1,2] Since it has become a pandemic, infecting over 226 million people and resulting in approximately 4.6 million deaths worldwide [3]. The authorization of new vaccines depends on their immunogenicity, clinical efficacy and safety [5] The latter is usually assumed when the level of reactogenicity (i.e., transient signs of inflammation at the injection site (e.g., pain, redness, swelling and induration) or systemically (e.g., increase of body temperature, chills, fatigue, cephalgia or arthralgia)) is acceptable and severe AEs were not observed. Neutralizing antibodies, which are a surrogate for clinical efficacy, were three times higher than in convalescent individuals and were detected in approximately 97% of patients after the second injection of BNT162b2 [8,9,10,11]
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