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<dc:title>Effectiveness of Comirnaty® Vaccine and Correlates of Immunogenicity and Adverse Reactions: A Single-Center Prospective Case Series Study</dc:title>
<dc:creator>Fernández-Lázaro, Diego</dc:creator>
<dc:creator>Garrosa, Manuel</dc:creator>
<dc:creator>Sánchez-Serrano, Nerea</dc:creator>
<dc:creator>Garrosa, Evalina</dc:creator>
<dc:creator>Jiménez-Callejo, Elena</dc:creator>
<dc:creator>Pardo Yanguas, María Dolores</dc:creator>
<dc:creator>Mielgo Ayuso, Juan</dc:creator>
<dc:creator>Seco-Calvo, Jesús</dc:creator>
<dc:subject>Elderly</dc:subject>
<dc:subject>Healthcare workers</dc:subject>
<dc:subject>BNT162b2</dc:subject>
<dc:subject>SARS-CoV-2</dc:subject>
<dc:subject>Humoral response</dc:subject>
<dc:subject>Adverse effects</dc:subject>
<dc:subject>Inmunogenicity</dc:subject>
<dc:subject>Case report</dc:subject>
<dc:description>The literature suggests that real-world data on the effectiveness and safety of the BNT162b2&#xd;
vaccine depend on the characteristics of the vaccinated volunteers. The purpose of this study was to&#xd;
evaluate antibody responses and kinetics, established association with sociodemographic and clinical characteristics, and adverse reactions after complete vaccination with the BNT162b2 vaccine. A&#xd;
single-center prospective case series study was conducted with 112 eligible volunteers who were&#xd;
institutionalized elderly and health care workers with had a negative anti-SARS-CoV-2 IgG test prior&#xd;
to receiving the first dose of vaccine. At least one serological antibody test after each dose of vaccine&#xd;
was performed. Volunteers with a positive SARS-CoV-2 PCR test before vaccination were excluded.&#xd;
A chemiluminescent immunoassay anti-S1 antibody assay performed a serological evaluation. Both&#xd;
vaccine doses elicited positive IgG antibodies 3799.0 ± 2503.0 AU/mL and 8212.0 ± 4731.0 AU/mL&#xd;
after 20 days of the first and second doses of BNT162b2, respectively. Comirnaty® vaccine induced&#xd;
an 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,&#xd;
p-value = 0.640), blood group first dose (p-value for Kruskal–Wallis test = 0.093) and second dose&#xd;
(p-value for Kruskal–Wallis test = 0. 268), number of drugs (Spearman rho = −0.07, p-value = 0.490),&#xd;
and number of chronic diseases first dose (p-value for Kruskal–Wallis test = 0.632) and second dose&#xd;
(p-value for Kruskal–Wallis test = 0.510). IgG antibodies to SARS-CoV-2 were intensely elevated after&#xd;
the second administration of the BNT162b2 vaccine. The higher the titer of anti-peptide IgG antibodies&#xd;
generated after the first dose of vaccine, the higher the titer generated by the second dose of vaccine&#xd;
(Spearman rho = 0.86, p-value &lt; 0.001) and the total antibody titer (Spearman rho = 0.93, p-value &lt; 0.001).&#xd;
Furthermore, no serious adverse effects were reported among participants, although mild to moderate&#xd;
adverse effects (local or systemic) were reported after both doses of the BNT162b2 vaccine, being more&#xd;
frequent after the first dose of the vaccine. No participants showed a positive PCR. The BNT162b2&#xd;
vaccine 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 the&#xd;
possible temporal distancing of the interval between doses. In general, the vaccines were well tolerated.</dc:description>
<dc:date>2023-03-24T07:50:29Z</dc:date>
<dc:date>2023-03-24T07:50:29Z</dc:date>
<dc:date>2022-07</dc:date>
<dc:type>info:eu-repo/semantics/article</dc:type>
<dc:identifier>http://hdl.handle.net/10259/7592</dc:identifier>
<dc:identifier>10.3390/vaccines10081170</dc:identifier>
<dc:identifier>2076-393X</dc:identifier>
<dc:language>eng</dc:language>
<dc:relation>Vaccines. 2022, V. 10, n. 8, 1170</dc:relation>
<dc:relation>https://doi.org/10.3390/vaccines10081170</dc:relation>
<dc:relation>info:eu-repo/grantAgreement/UVA//SO-2-2020/ES/</dc:relation>
<dc:relation>info:eu-repo/grantAgreement/Junta de Castilla y León/FONDO-COVID19/07.04.467804.74011.0/</dc:relation>
<dc:rights>http://creativecommons.org/licenses/by/4.0/</dc:rights>
<dc:rights>info:eu-repo/semantics/openAccess</dc:rights>
<dc:rights>Atribución 4.0 Internacional</dc:rights>
<dc:publisher>MDPI</dc:publisher>
</ow:Publication>
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