This work describes the Adverse Events Monitoring study caused by vaccines against Covid-19 (MEA-VAX19), an observational, perspective, follow-up study about the Covid-19 vaccine-vigilance, promoted and conducted by the European Institute of Oncology in Milan in coordination with the Monzino Cardiology Center. The study was proposed to the employees, who joined the vaccination campaign, which began on 7/01/21. The project aims to contribute to post-marketing surveillance studies of anti-COVID-19 vaccines that obtained a conditional marketing authorization. This study examines the Comirnaty vaccine by Pfizer and BioNTech and the Vaxzevria vaccine by AstraZeneca. The study endpoints are: - Primary: to determine treatment’s effects in terms of safety and tolerability in short, medium and long term by COVID-19 vaccines during the observational period of twenty-four months since the immunization of the subject (the date of presumed immunization of the subject is established on the basis of the data in the RCP of the administered vaccine). - Secondary: to quantify the cases of post-vaccination reinfection Covid-19 (treatment failure) compared to the total number of subjects involved in the study. The involvement is voluntary and included employees aged ≥18 years old, who joined the vaccination campaign signing informed agreement to the vaccination. Furthermore, data of vaccinated subjects, who signed the MEA-Vax19 study agreement, were collected. The variable used for the primary endpoint consists in the suspected adverse reactions (ADRs) number, following the vaccine administration of the COVID-19 vaccine (first and second dose, according to the administration schedule reported in the RCP). The ADRs collected were analyzed from a quantitative and descriptive point of view, stratifying them according to the parameters indicated by the current legislation on pharmacovigilance. This thesis focuses on the primary endpoint for time-related reasons. The study involves periodic follow-ups in the following time frames: at T0 (first dose), T14, T21(second dose), T35,60,90 days and at T6,12,24 months. For the collection of the first four follow-ups it was required the completion of a report containing personal information with suspected adverse reactions checklist which may arise after the vaccination. For the next follow-ups, it will be used a report that include the notification of any re-infection by COVID-19 after vaccination; the date of any re-infection by COVID-19 after vaccination; the development of any worsening/exacerbation pathology, of pre-existing pathology and if so, which ones. Besides, other documents were used for data collection: informed consent to vaccination for anamnestic data of involved subjects and the vaccinated subjects’s list. Of a total of 2082 vaccinated subjects, 1921 joined the study with an adhesion of 92.23%. 2094 adverse event reports were collected, of which the largest number occurred in female subjects aged from 35 to 60 years old. Most were non-serious reactions that completely cleared up in two days. There were no cases of hospitalization. Serious reactions were fever ≥ 39°C, facial paralysis, syncope, and febrile sweating, all of which were solved in a few days. The most common reactions were injection site pain, fatigue, drowsiness, shivers, muscle aches, headache, and nausea. The obtained results are in line with the national trend of reports and with what was expected. The project will develop over the next two years, it will investigate the secondary endpoint and perhaps it will link vaccine administration and the occurrence of late adverse events or events concerning fertility/teratogenicity.
Il seguente lavoro di tesi descrive lo studio di Monitoraggio di Eventi Avversi ai vaccini contro Covid-19 (MEA-VAX19), uno studio osservazionale, prospettico, di follow-up sulla vaccinovigilanza dei vaccini Covid-19, promosso e condotto dall’Istituto Europeo di Oncologia di Milano in coordinazione con il Centro Cardiologico Monzino. Lo studio è stato proposto ai dipendenti che hanno aderito alla campagna vaccinale, iniziata il 7/01/21. Il progetto ha lo scopo di contribuire agli studi di sorveglianza post-marketing dei vaccini anti-COVID-19 che hanno ottenuto un’autorizzazione all’immissione in commercio condizionale. In questo studio si prendono in considerazione il vaccino Comirnaty di Pfizer e BioNTech e il vaccino Vaxzevria di AstraZeneca. Gli endpoint dello studio sono: - Primario: determinare gli effetti in termini di sicurezza e tollerabilità a breve, medio e lungo termine del trattamento con i vaccini contro COVID-19 nel corso del periodo osservazionale della durata di ventiquattro mesi dall’immunizzazione del soggetto. - Secondario: quantificare i casi di reinfezione da COVID-19 post-vaccinazione (treatment failure) rispetto al totale dei soggetti arruolati allo studio. L’arruolamento è stato su base volontaria, ha incluso i dipendenti di età ≥ 18 anni che hanno aderito alla campagna vaccinale firmando il consenso informato alla vaccinazione. Sono stati raccolti i dati dei soggetti vaccinati che hanno firmato il consenso allo studio MEA-Vax19. La variabile utilizzata per l’endpoint primario è costituita dal numero di sospette reazioni avverse (ADRs) in seguito alla somministrazione del vaccino contro COVID-19 (prima e seconda dose, secondo lo schema di somministrazione riportato nell’RCP). Le ADRs raccolte sono state analizzate dal punto di vista quantitativo e descrittivo stratificandole secondo i parametri indicati dalla normativa vigente in materia di farmacovigilanza. Il lavoro di tesi presentato si concentra sull’endpoint primario per ragioni tempo-correlate. Lo studio prevede dei follow-up periodici nelle seguenti tempistiche: a T0 (prima dose), T14, T21(seconda dose), T35,60,90 giorni e a T6,12,24 mesi. Per la raccolta dei primi quattro follow-up è stata richiesta la compilazione di una scheda contenente le informazioni anagrafiche insieme ad una check-list di sospette reazioni avverse che possono insorgere in seguito alla vaccinazione. Per i successivi follow-up verrà utilizzata una scheda riportante la notifica di un’eventuale re-infezione da COVID-19 dopo la vaccinazione; la data di un’eventuale re-infezione da COVID-19 dopo la vaccinazione; lo sviluppo di eventuali patologie peggioramento/esacerbazione di patologie pre-esistenti e se sì, quali. Inoltre per la raccolta dati sono stati utilizzati altri documenti: il consenso informato alla vaccinazione per i dati anamnestici dei soggetti arruolati e l’elenco dei vaccinati. Su un totale di 2082 soggetti vaccinati, 1921 hanno aderito allo studio con un’adesione del 92.23%. Sono state elaborate 2094 schede di eventi avversi dei quali il numero maggiore si è verificato nei soggetti donne tra i 35 e i 60 anni. La maggior parte sono state reazioni non gravi risolte completamente nel giro di due giorni. Non c’è stato nessun caso di ospedalizzazione o ricovero. Le reazioni gravi sono state febbre ≥ 39°C, paralisi facciale, sincope e sudorazione febbrile, tutte risolte in pochi giorni. Le reazioni più comuni sono state dolore nel sito di iniezione, stanchezza, sonnolenza, brividi, dolori muscolari, mal di testa e nausea. I risultati ottenuti sono in linea con l’andamento nazionale delle segnalazioni e con quanto atteso. Il progetto si svilupperà nel corso dei prossimi due anni, indagherà l’endpoint secondario ed eventualmente correlerà la somministrazione del vaccino con l’insorgenza di eventi avversi a lungo termine o eventi riguardanti la fertilità/teratogenicità.
Monitoraggio degli Eventi Avversi a Vaccino contro COVID-19 (MEA-VAX19): dati preliminari dello studio sviluppato e condotto all’Istituto Europeo di Oncologia
GIAMMANCO, NADIA
2019/2020
Abstract
This work describes the Adverse Events Monitoring study caused by vaccines against Covid-19 (MEA-VAX19), an observational, perspective, follow-up study about the Covid-19 vaccine-vigilance, promoted and conducted by the European Institute of Oncology in Milan in coordination with the Monzino Cardiology Center. The study was proposed to the employees, who joined the vaccination campaign, which began on 7/01/21. The project aims to contribute to post-marketing surveillance studies of anti-COVID-19 vaccines that obtained a conditional marketing authorization. This study examines the Comirnaty vaccine by Pfizer and BioNTech and the Vaxzevria vaccine by AstraZeneca. The study endpoints are: - Primary: to determine treatment’s effects in terms of safety and tolerability in short, medium and long term by COVID-19 vaccines during the observational period of twenty-four months since the immunization of the subject (the date of presumed immunization of the subject is established on the basis of the data in the RCP of the administered vaccine). - Secondary: to quantify the cases of post-vaccination reinfection Covid-19 (treatment failure) compared to the total number of subjects involved in the study. The involvement is voluntary and included employees aged ≥18 years old, who joined the vaccination campaign signing informed agreement to the vaccination. Furthermore, data of vaccinated subjects, who signed the MEA-Vax19 study agreement, were collected. The variable used for the primary endpoint consists in the suspected adverse reactions (ADRs) number, following the vaccine administration of the COVID-19 vaccine (first and second dose, according to the administration schedule reported in the RCP). The ADRs collected were analyzed from a quantitative and descriptive point of view, stratifying them according to the parameters indicated by the current legislation on pharmacovigilance. This thesis focuses on the primary endpoint for time-related reasons. The study involves periodic follow-ups in the following time frames: at T0 (first dose), T14, T21(second dose), T35,60,90 days and at T6,12,24 months. For the collection of the first four follow-ups it was required the completion of a report containing personal information with suspected adverse reactions checklist which may arise after the vaccination. For the next follow-ups, it will be used a report that include the notification of any re-infection by COVID-19 after vaccination; the date of any re-infection by COVID-19 after vaccination; the development of any worsening/exacerbation pathology, of pre-existing pathology and if so, which ones. Besides, other documents were used for data collection: informed consent to vaccination for anamnestic data of involved subjects and the vaccinated subjects’s list. Of a total of 2082 vaccinated subjects, 1921 joined the study with an adhesion of 92.23%. 2094 adverse event reports were collected, of which the largest number occurred in female subjects aged from 35 to 60 years old. Most were non-serious reactions that completely cleared up in two days. There were no cases of hospitalization. Serious reactions were fever ≥ 39°C, facial paralysis, syncope, and febrile sweating, all of which were solved in a few days. The most common reactions were injection site pain, fatigue, drowsiness, shivers, muscle aches, headache, and nausea. The obtained results are in line with the national trend of reports and with what was expected. The project will develop over the next two years, it will investigate the secondary endpoint and perhaps it will link vaccine administration and the occurrence of late adverse events or events concerning fertility/teratogenicity.È consentito all'utente scaricare e condividere i documenti disponibili a testo pieno in UNITESI UNIPV nel rispetto della licenza Creative Commons del tipo CC BY NC ND.
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https://hdl.handle.net/20.500.14239/13230