Immunogenicity and safety of the BNT162b2 mRNA COVID-19 vaccine in healthcare workers

Osszefoglalo. Bevezetes: A SARS-CoV-2 koronavirus okozta COVID-19 altalanos egeszsegugyi es gazdasagi krizist idezett elő. Celkitűzes: A megfigyeleses vizsgalat celja a BNT162b2 mRNS-Pfizer-BioNTech-vakcina hatasossaganak, biztonsagossaganak es immunogenitasanak igazolasa a Budai Irgalmasrendi Korhaz dolgozoin. Modszer: A vakcina adasa utan elemeztuk a COVID-19-fertőzes előfordulasat, az oltasok utani reakciokat, valamint a "spike" (S-) protein es a nukleokapszid (N)-protein elleni ellenanyag szintjenek valtozasat. Eredmenyek: A felmeresben reszt vevő 295 dolgozo kozul az oltast megelőzően 36 dolgozo esett at COVID-19-fertőzesen (COVID-19-pozitiv csoport). A masodik oltas utan a megfigyelesi időszak harom honapjaban COVID-19-fertőzes nem alakult ki a felmeresben reszt vevő oltott dolgozok koreben. Az oltasi reakciok enyhek voltak. A COVID-19-pozitiv csoportban az N-antitestek median kuszobertekindexe az első vakcina utan 4 hettel merve szignifikansan magasabb volt (28,37), mint a COVID-19-negativ (0,085) csoportban (p<0,0001). Az első vakcina utan 4 hettel az S-antitestek median erteke (8015 U/ml) a COVID-19-pozitiv csoportban szignifikansan magasabb volt (p<0,0001), mint a COVID-19-negativ csoportban (23,18 U/ml). A COVID-19-negativ csoport S-antitest-kozeperteke a masodik vakcina utan szignifikans (p<0,0001), mintegy 500×-os emelkedest mutatott (23,18 U/ml ről 1173 U/ml-re). Egy vakcina hatasossagat a fertőzesek terjedesenek megakadalyozasa igazolja. Kovetkeztetesek: A masodik vakcina utani megfigyelesi időszakban uj COVID-19-fertőzes nem volt az oltott dolgozok koreben. A fertőzesen at nem esett COVID-19-negativ egyenek eseten az S-antitest emelkedese mersekelt az első oltas utan, mig a masodik oltas utan lenyegesen emelkedik. A COVID-19-fertőzesen atesett egyenek csoportjaban mar az első vakcina is jelentős S-antitest-termelődest valt ki. Orv Hetil. 2021; 162(39): 1551-1557. SUMMARY 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.