In August 2022, Italy launched a vaccination campaign to combat the spread of the monkeypox virus, which the WHO has designated as a public health emergency. Priority targets for the campaign included laboratory personnel and men who have sex with men with specific risk criteria. Primary immunization involved two doses of the Imvanex/Jynneos vaccine, followed by a single booster dose. We conducted a study in two Italian towns, Bologna and Forl ì, in October and November 2022 to investigate adverse events following immunization (AEFIs) of the monkeypox vaccine through participant-based active surveillance. Participants who received the vaccine and were aged 18 and over were invited to complete an e-questionnaire by scanning a QR code during their second vaccine appointment or by email one month after the booster dose. A descriptive analysis of AEFI incidences was conducted, with the results stratified by type and severity of symptoms. A total of 135 first-dose, 50 second-dose, and 6 single-dose recipients were included, with a mean age of 36.4 & PLUSMN; 8.7 years. Systemic reactions after the first and second doses were reported by 39.3% and 26.0% of participants, respectively, with asthenia being the most common symptom. Local site reactions were reported by 97.0% and 100.0% of participants, respectively, with redness, swelling, and itching being the most common local AEFIs. Grade 3 or 4 AEFIs were reported for local AEFIs only by 16.8% and 14.0% of participants after the first and second doses, respectively. Our findings suggest that the monkeypox vaccine has a high tolerability profile in terms of short-term common systemic AEFIs. However, the high incidence and severity of local AEFIs highlight the need to monitor their persistence following intradermal administration of the vaccine.

Safety of Monkeypox Vaccine Using Active Surveillance, Two-Center Observational Study in Italy / Montalti, Marco; Di Valerio, Zeno; Angelini, Raffaella; Bovolenta, Elena; Castellazzi, Federica; Cleva, Marta; Pandolfi, Paolo; Reali, Chiara; Resi, Davide; Todeschini, Renato; Gori, Davide. - In: VACCINES. - ISSN 2076-393X. - ELETTRONICO. - 11:7(2023), pp. 1163.1-1163.11. [10.3390/vaccines11071163]

Safety of Monkeypox Vaccine Using Active Surveillance, Two-Center Observational Study in Italy

Montalti, Marco;Di Valerio, Zeno
;
Cleva, Marta;Reali, Chiara;Gori, Davide
2023

Abstract

In August 2022, Italy launched a vaccination campaign to combat the spread of the monkeypox virus, which the WHO has designated as a public health emergency. Priority targets for the campaign included laboratory personnel and men who have sex with men with specific risk criteria. Primary immunization involved two doses of the Imvanex/Jynneos vaccine, followed by a single booster dose. We conducted a study in two Italian towns, Bologna and Forl ì, in October and November 2022 to investigate adverse events following immunization (AEFIs) of the monkeypox vaccine through participant-based active surveillance. Participants who received the vaccine and were aged 18 and over were invited to complete an e-questionnaire by scanning a QR code during their second vaccine appointment or by email one month after the booster dose. A descriptive analysis of AEFI incidences was conducted, with the results stratified by type and severity of symptoms. A total of 135 first-dose, 50 second-dose, and 6 single-dose recipients were included, with a mean age of 36.4 & PLUSMN; 8.7 years. Systemic reactions after the first and second doses were reported by 39.3% and 26.0% of participants, respectively, with asthenia being the most common symptom. Local site reactions were reported by 97.0% and 100.0% of participants, respectively, with redness, swelling, and itching being the most common local AEFIs. Grade 3 or 4 AEFIs were reported for local AEFIs only by 16.8% and 14.0% of participants after the first and second doses, respectively. Our findings suggest that the monkeypox vaccine has a high tolerability profile in terms of short-term common systemic AEFIs. However, the high incidence and severity of local AEFIs highlight the need to monitor their persistence following intradermal administration of the vaccine.
2023
Safety of Monkeypox Vaccine Using Active Surveillance, Two-Center Observational Study in Italy / Montalti, Marco; Di Valerio, Zeno; Angelini, Raffaella; Bovolenta, Elena; Castellazzi, Federica; Cleva, Marta; Pandolfi, Paolo; Reali, Chiara; Resi, Davide; Todeschini, Renato; Gori, Davide. - In: VACCINES. - ISSN 2076-393X. - ELETTRONICO. - 11:7(2023), pp. 1163.1-1163.11. [10.3390/vaccines11071163]
Montalti, Marco; Di Valerio, Zeno; Angelini, Raffaella; Bovolenta, Elena; Castellazzi, Federica; Cleva, Marta; Pandolfi, Paolo; Reali, Chiara; Resi, Davide; Todeschini, Renato; Gori, Davide
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/11585/962616
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