[COVID-19 infections and effectiveness of the vaccination among healthcare workers]. / A COVID­19-fertozés és a védooltások hatásosságának vizsgálata egészségügyi dolgozókon.

INTRODUCTION: New variants of the SARS-CoV-2 coronavirus are constantly appearing, causing the COVID-19 pandemic. From November 2021, most infections were caused by the Omicron coronavirus variant. OBJECTIVE: The aim of this prospective observational cohort study was to estimate the incidence of COVID-19 infections in the high-risk healthcare workers after two BNT162b2 mRNA Pfizer-BioNTech vaccines and the subsequent booster vaccine, as well as the effectiveness, the safety and the humoral immune response of the vaccines. METHOD: We started the two Pfizer-BioNTech ((BNT162b29) vaccinations of healthcare workers of the Polyclinic of the Hospitaller Brothers of St. John between January 07 and March 08, 2021. The choice of the type and timing of the third booster vaccination was voluntary. The workers were followed up between January 07, 2021 and June 29, 2022. The infection rate, adverse events of the vaccination, risk factors to infection and the kinetics of anti-spike (S) antibody and anti-nucleocapsid (N) antibody serum level were evaluated. RESULTS: The data of 294 healthcare workers - 96 medical doctors, 127 nurses and 71 workers in hospital - who had at least three antibody level measurements were analyzed. The third booster vaccine was given to 280 workers, the distribution of the vaccines was the following: Pfizer-BioNTech (BNT162b29) vaccine (n = 210), Moderna COVID-19 (mRNA-1273) vaccine (n = 37), Sinopharm COVID-19 vaccine (n = 21), Janssen COVID-19 (n = 10), AstraZeneca (ChAdOx1 nCoV-19) vaccine (n = 2). Infection occurred in 121 cases (41%) during the observation period. The course of the COVID-19 infections was mostly mild (97%) and recovered within a week. During the observational period, 2 workers died: a 56-year-old woman died after two vaccinations for reason unrelated to COVID-19 infection, and a 58-year-old man died after the booster vaccination, following COVID-19 infection. The incidence of infection did not correlate with age, sex, comorbidities, smoking, occupation and BMI. The median titre of anti-S antibody serum level increased one month after the second vaccination of the basic immunization (1173.0 U/ml) and decreased slowly until the 8th month (678.5-625.8-538.0 U/ml) after the basic vaccination. One month after the booster vaccination, the median titre of anti-S antibody serum level increased significantly (16 535 U/ml), and showed a decreasing trend in the 3rd month after the booster vaccination (9697.7 U/ml). An exceptionally high S antibody serum level increasing after the basic (>10 000 U/mL) and booster (>60 000 U/m) vaccination showed a correlation with prior COVID-19 infection. The median cut-off index (COI) of anti-N antibody was not affected by vaccination, the increasing of the titre is related to the infection. CONCLUSION: The booster vaccination had less effect on the infection caused by Omicron variant, but the course of the infection was milder. Compared to the basic immunisation, the booster vaccination caused a significant increase in the S antibody level. An exceptionally high S antibody level correlated with prior COVID-19 infection. Orv Hetil. 2023; 164(5): 163-171.

Immunogenicity and safety of the BNT162b2 mRNA COVID-19 vaccine in healthcare workers / A BNT162b2 mRNS-Pfizer-BioNTech-védooltás hatásosságának és immunogenitásának monitorozása egészségügyben dolgozókon.

Összefoglaló. Bevezetés: A SARS-CoV-2 koronavírus okozta COVID-19 általános egészségügyi és gazdasági krízist idézett elo. Célkituzés: A megfigyeléses vizsgálat célja a BNT162b2 mRNS-Pfizer-BioNTech-vakcina hatásosságának, biztonságosságának és immunogenitásának igazolása a Budai Irgalmasrendi Kórház dolgozóin. Módszer: A vakcina adása után elemeztük a COVID-19-fertozés elofordulását, az oltások utáni reakciókat, valamint a "spike" (S-) protein és a nukleokapszid (N)-protein elleni ellenanyag szintjének változását. Eredmények: A felmérésben részt vevo 295 dolgozó közül az oltást megelozoen 36 dolgozó esett át COVID-19-fertozésen (COVID-19-pozitív csoport). A második oltás után a megfigyelési idoszak három hónapjában COVID-19-fertozés nem alakult ki a felmérésben részt vevo oltott dolgozók körében. Az oltási reakciók enyhék voltak. A COVID-19-pozitív csoportban az N-antitestek medián küszöbértékindexe az elso vakcina után 4 héttel mérve szignifikánsan magasabb volt (28,37), mint a COVID-19-negatív (0,085) csoportban (p<0,0001). Az elso vakcina után 4 héttel az S-antitestek medián értéke (8015 U/ml) a COVID-19-pozitív csoportban szignifikánsan magasabb volt (p<0,0001), mint a COVID-19-negatív csoportban (23,18 U/ml). A COVID-19-negatív csoport S-antitest-középértéke a második vakcina után szignifikáns (p<0,0001), mintegy 500×-os emelkedést mutatott (23,18 U/ml rol 1173 U/ml-re). Egy vakcina hatásosságát a fertozések terjedésének megakadályozása igazolja. Következtetések: A második vakcina utáni megfigyelési idoszakban új COVID-19-fertozés nem volt az oltott dolgozók körében. A fertozésen át nem esett COVID-19-negatív egyének esetén az S-antitest emelkedése mérsékelt az elso oltás után, míg a második oltás után lényegesen emelkedik. A COVID-19-fertozésen átesett egyének csoportjában már az elso vakcina is jelentos S-antitest-termelodést vált ki. Orv Hetil. 2021; 162(39): 1551-1557. INTRODUCTION: The coronavirus disease 2019 (COVID-19) pandemic caused global public health and economic crises. OBJECTIVE: The aim of this observation study was to estimate the effectiveness, safety and elicited immune response of the BNT162b2 mRNA Pfizer-BioNTech vaccine in healthcare workers of the Buda Hospital of the Hospitaller Order of St. John of God. METHOD: After vaccination, the infection rate, adverse events and the kinetics of anti-SARS-CoV-2 spike (S) protein and anti-SARS-CoV-2 nucleocapsid (N) protein antibodies were evaluated. RESULTS: Before vaccination, from the 295 healthcare workers 36 recovered from prior COVID-19 infection (COVID-19-positive group). After the second vaccination, there was no COVID-19 infection during the three-month follow-up period. The adverse events were mild. In the COVID-19-positive group, the median cut-off index of anti-N antibodies measured at 4 weeks after the first vaccination were significantly (p<0.0001) higher (28.37) than in the COVID-19-negative group (0.085). After the first vaccine, the median titer of anti-S antibodies was significantly higher (p<0.0001) in the COVID-19-positive group (8015 U/ml) compared to the COVID-19-negative group (23.18 U/ml). In the COVID-19-negative group, the median titer of anti-S antibodies increased significantly (p<0.0001) after the second vaccine (from 23.18 U/ml to 1173 U/ml), showing an increase of 500×. CONCLUSIONS: After the second vaccination, there was no COVID-19 infection during the follow-up. In the COVID-19-negative group, the anti-S antibody titer is moderate after the first vaccination and increases significantly after the second vaccine. In the COVID-19-positive group, the first vaccine induces significant anti-S antibody production. Orv Hetil. 2021; 162(39): 1551-1557.