PMID- 34696171 OWN - NLM STAT- PubMed-not-MEDLINE LR - 20211029 IS - 2076-393X (Print) IS - 2076-393X (Electronic) IS - 2076-393X (Linking) VI - 9 IP - 10 DP - 2021 Sep 24 TI - Reactogenicity Correlates Only Weakly with Humoral Immunogenicity after COVID-19 Vaccination with BNT162b2 mRNA (Comirnaty((R))). LID - 10.3390/vaccines9101063 [doi] LID - 1063 AB - mRNA vaccines against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), such as BNT162b2 (Comirnaty((R))), 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((R)) 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 r(2) = 0.04) and DiaSorin-IgG (r(2) = 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. FAU - Held, Jurgen AU - Held J AUID- ORCID: 0000-0003-1130-9727 AD - Mikrobiologisches Institut-Klinische Mikrobiologie, Immunologie und Hygiene, Universitatsklinikum Erlangen und Friedrich-Alexander-Universitat (FAU) Erlangen-Nurnberg, Wasserturmstr. 3/5, 91054 Erlangen, Germany. FAU - Esse, Jan AU - Esse J AUID- ORCID: 0000-0003-0601-8837 AD - Mikrobiologisches Institut-Klinische Mikrobiologie, Immunologie und Hygiene, Universitatsklinikum Erlangen und Friedrich-Alexander-Universitat (FAU) Erlangen-Nurnberg, Wasserturmstr. 3/5, 91054 Erlangen, Germany. FAU - Tascilar, Koray AU - Tascilar K AUID- ORCID: 0000-0002-8109-826X AD - Medizinische Klinik 3-Rheumatologie und Immunologie & Deutsches Zentrum fur Immuntherapie, Universitatsklinikum Erlangen und Friedrich-Alexander-Universitat (FAU) Erlangen-Nurnberg, Ulmenweg 18, 91054 Erlangen, Germany. FAU - Steininger, Philipp AU - Steininger P AD - Virologisches Institut-Klinische und Molekulare Virologie, Universitatsklinikum Erlangen und Friedrich-Alexander-Universitat (FAU) Erlangen-Nurnberg, Schlossgarten 4, 91054 Erlangen, Germany. FAU - Schober, Kilian AU - Schober K AUID- ORCID: 0000-0001-9323-9472 AD - Mikrobiologisches Institut-Klinische Mikrobiologie, Immunologie und Hygiene, Universitatsklinikum Erlangen und Friedrich-Alexander-Universitat (FAU) Erlangen-Nurnberg, Wasserturmstr. 3/5, 91054 Erlangen, Germany. FAU - Irrgang, Pascal AU - Irrgang P AD - Virologisches Institut-Klinische und Molekulare Virologie, Universitatsklinikum Erlangen und Friedrich-Alexander-Universitat (FAU) Erlangen-Nurnberg, Schlossgarten 4, 91054 Erlangen, Germany. FAU - Alsalameh, Rayya AU - Alsalameh R AD - Mikrobiologisches Institut-Klinische Mikrobiologie, Immunologie und Hygiene, Universitatsklinikum Erlangen und Friedrich-Alexander-Universitat (FAU) Erlangen-Nurnberg, Wasserturmstr. 3/5, 91054 Erlangen, Germany. FAU - Tenbusch, Matthias AU - Tenbusch M AD - Virologisches Institut-Klinische und Molekulare Virologie, Universitatsklinikum Erlangen und Friedrich-Alexander-Universitat (FAU) Erlangen-Nurnberg, Schlossgarten 4, 91054 Erlangen, Germany. FAU - Seggewies, Christof AU - Seggewies C AD - Center for Medical Information and Communication Technology, Universitatsklinikum Erlangen, Krankenhausstrasse 12, 91054 Erlangen, Germany. FAU - Bogdan, Christian AU - Bogdan C AD - Mikrobiologisches Institut-Klinische Mikrobiologie, Immunologie und Hygiene, Universitatsklinikum Erlangen und Friedrich-Alexander-Universitat (FAU) Erlangen-Nurnberg, Wasserturmstr. 3/5, 91054 Erlangen, Germany. LA - eng GR - BO996/7-1/Deutsche Forschungsgemeinschaft/ PT - Journal Article DEP - 20210924 PL - Switzerland TA - Vaccines (Basel) JT - Vaccines JID - 101629355 PMC - PMC8539109 OTO - NOTNLM OT - BioNTech OT - Pfizer OT - SARS-CoV-2 OT - adverse effects OT - adverse reactions OT - antibody OT - mRNA vaccine OT - machine learning OT - side effects COIS- J.H. received test kits for other studies free of charge from Vircell S.L. (Granada, Spain). All other authors declare that they have no potential financial or ethical conflicts of interest regarding the contents of the publication. EDAT- 2021/10/27 06:00 MHDA- 2021/10/27 06:01 PMCR- 2021/09/24 CRDT- 2021/10/26 01:02 PHST- 2021/08/27 00:00 [received] PHST- 2021/09/18 00:00 [revised] PHST- 2021/09/20 00:00 [accepted] PHST- 2021/10/26 01:02 [entrez] PHST- 2021/10/27 06:00 [pubmed] PHST- 2021/10/27 06:01 [medline] PHST- 2021/09/24 00:00 [pmc-release] AID - vaccines9101063 [pii] AID - vaccines-09-01063 [pii] AID - 10.3390/vaccines9101063 [doi] PST - epublish SO - Vaccines (Basel). 2021 Sep 24;9(10):1063. doi: 10.3390/vaccines9101063.