RT info:eu-repo/semantics/article T1 Effectiveness of Comirnaty® Vaccine and Correlates of Immunogenicity and Adverse Reactions: A Single-Center Prospective Case Series Study A1 Fernández-Lázaro, Diego A1 Garrosa, Manuel A1 Sánchez-Serrano, Nerea A1 Garrosa, Evalina A1 Jiménez-Callejo, Elena A1 Pardo Yanguas, María Dolores A1 Mielgo Ayuso, Juan A1 Seco-Calvo, Jesús K1 Elderly K1 Healthcare workers K1 BNT162b2 K1 SARS-CoV-2 K1 Humoral response K1 Adverse effects K1 Inmunogenicity K1 Case report K1 Fisiología K1 Physiology K1 Enfermedades infecciosas K1 Communicable diseases K1 Salud K1 Health AB The literature suggests that real-world data on the effectiveness and safety of the BNT162b2vaccine depend on the characteristics of the vaccinated volunteers. The purpose of this study was toevaluate antibody responses and kinetics, established association with sociodemographic and clinical characteristics, and adverse reactions after complete vaccination with the BNT162b2 vaccine. Asingle-center prospective case series study was conducted with 112 eligible volunteers who wereinstitutionalized elderly and health care workers with had a negative anti-SARS-CoV-2 IgG test priorto receiving the first dose of vaccine. At least one serological antibody test after each dose of vaccinewas performed. Volunteers with a positive SARS-CoV-2 PCR test before vaccination were excluded.A chemiluminescent immunoassay anti-S1 antibody assay performed a serological evaluation. Bothvaccine doses elicited positive IgG antibodies 3799.0 ± 2503.0 AU/mL and 8212.0 ± 4731.0 AU/mLafter 20 days of the first and second doses of BNT162b2, respectively. Comirnaty® vaccine inducedan immune response with antibody production against SARS-CoV-2 in 100% of participants, regardless of age (Spearman rho = −0.10, p-value = 0.312), body mass index (Spearman rho = 0.05,p-value = 0.640), blood group first dose (p-value for Kruskal–Wallis test = 0.093) and second dose(p-value for Kruskal–Wallis test = 0. 268), number of drugs (Spearman rho = −0.07, p-value = 0.490),and number of chronic diseases first dose (p-value for Kruskal–Wallis test = 0.632) and second dose(p-value for Kruskal–Wallis test = 0.510). IgG antibodies to SARS-CoV-2 were intensely elevated afterthe second administration of the BNT162b2 vaccine. The higher the titer of anti-peptide IgG antibodiesgenerated after the first dose of vaccine, the higher the titer generated by the second dose of vaccine(Spearman rho = 0.86, p-value < 0.001) and the total antibody titer (Spearman rho = 0.93, p-value < 0.001).Furthermore, no serious adverse effects were reported among participants, although mild to moderateadverse effects (local or systemic) were reported after both doses of the BNT162b2 vaccine, being morefrequent after the first dose of the vaccine. No participants showed a positive PCR. The BNT162b2vaccine induces a robust and rapid antibody response regardless of participant characteristics. The second dose might be especially important because of the increased immunogenicity it produces and thepossible temporal distancing of the interval between doses. In general, the vaccines were well tolerated. PB MDPI YR 2022 FD 2022-07 LK http://hdl.handle.net/10259/7592 UL http://hdl.handle.net/10259/7592 LA eng NO This research was funded by (i) Chair of Knowledge and Innovation “Caja Rural de Soria” (Spain) in the call for funding research projects related to the COVID-19 pandemic. With project number SO-2-2020; (ii) Call for expressions of interest for the funding of research projects on SARS-CoV-2 and COVID-19 disease by the FONDO-COVID-19 n 07.04.467804.74011.0 within the framework of Royal Decree Law 8/2020 of 17 March on extraordinary urgent measures to deal with the economic and social impact of COVID-19. Financed by the FEDER and the Junta of Castilla-Leon, Spain. DS Repositorio Institucional de la Universidad de Burgos RD 29-mar-2024