Background. The Coronavirus Disease 2019 (COVID-19) pandemic, caused by a new severe acute respiratory syndrome induced by Coronavirus 2, was first recognized in December 2019, affecting more than 200 countries around the world to date. On 21 December 2020 the European Commission, according to the positive opinion of the European Medicines Agency (EMA), granted conditional marketing authorization in the European Union for the anti-COVID-19 mRNA vaccine Bnt162b2 (Comirnaty®/Pfizer-Biontech). The management, storage, preparation and administration of the Comirnaty® vaccine presents numerous critical points due by the new development platform and the pandemic emergency. These factors, if not well considered, can compromise the quality, efficacy and safety of the vaccine. The present study highlights the decisive role of the hospital pharmacist in the technical-logistical management of the vaccine in the current pandemic situation, from preparation to pharmacovigilance. Materials and methods. The detection of adverse reactions manifested by all employees of the IRCCS Sacro Cuore Don Calabria in Negrar di Valpolicella (VR) vaccinated between 01/01/2021-28/02/2021, are described. A prospective observational study, approved by the Ethics Committee of the hospital, was conducted through the compilation of a short questionnaire for the detection of adverse events after the administration of the first and second dose of vaccine. Results. From the pharmacovigilance analysis of 2030 subjects included in this observational study, only 1 serious adverse event was reported (equal to 0,05% incidence). Differently, the 99,95% of the reports refer to non-serious adverse events, mainly: pain at the injection site, fever, asthenia/fatigue, headache, muscle pain, joint pain, chills and skin rashes. The number of symptomatic subjects is statistically greater after the second vaccine administration and the reported events occur mainly immediately after vaccination, resolving within 48 hours after onset. Conclusions. In the context of the current health emergency, this work demonstrates how the professional supervision implemented by the pharmacist, in the current phase of mass immunization, guarantees the maintenance of the quality, efficacy and safety of the vaccine, respectively through the correct use of asepsis techniques, respect for the cold chain (fundamental element especially for Pfizer vaccine) and post-vaccination surveillance through active vaccinovigilance.
Il ruolo del farmacista ospedaliero dall’allestimento del vaccino a mRNA Bnt162b2 (Comirnaty®/Pfizer-Biontech) alla relativa vaccinovigilanza
Nicola Realdon;
2021-01-01
Abstract
Background. The Coronavirus Disease 2019 (COVID-19) pandemic, caused by a new severe acute respiratory syndrome induced by Coronavirus 2, was first recognized in December 2019, affecting more than 200 countries around the world to date. On 21 December 2020 the European Commission, according to the positive opinion of the European Medicines Agency (EMA), granted conditional marketing authorization in the European Union for the anti-COVID-19 mRNA vaccine Bnt162b2 (Comirnaty®/Pfizer-Biontech). The management, storage, preparation and administration of the Comirnaty® vaccine presents numerous critical points due by the new development platform and the pandemic emergency. These factors, if not well considered, can compromise the quality, efficacy and safety of the vaccine. The present study highlights the decisive role of the hospital pharmacist in the technical-logistical management of the vaccine in the current pandemic situation, from preparation to pharmacovigilance. Materials and methods. The detection of adverse reactions manifested by all employees of the IRCCS Sacro Cuore Don Calabria in Negrar di Valpolicella (VR) vaccinated between 01/01/2021-28/02/2021, are described. A prospective observational study, approved by the Ethics Committee of the hospital, was conducted through the compilation of a short questionnaire for the detection of adverse events after the administration of the first and second dose of vaccine. Results. From the pharmacovigilance analysis of 2030 subjects included in this observational study, only 1 serious adverse event was reported (equal to 0,05% incidence). Differently, the 99,95% of the reports refer to non-serious adverse events, mainly: pain at the injection site, fever, asthenia/fatigue, headache, muscle pain, joint pain, chills and skin rashes. The number of symptomatic subjects is statistically greater after the second vaccine administration and the reported events occur mainly immediately after vaccination, resolving within 48 hours after onset. Conclusions. In the context of the current health emergency, this work demonstrates how the professional supervision implemented by the pharmacist, in the current phase of mass immunization, guarantees the maintenance of the quality, efficacy and safety of the vaccine, respectively through the correct use of asepsis techniques, respect for the cold chain (fundamental element especially for Pfizer vaccine) and post-vaccination surveillance through active vaccinovigilance.
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