Safety profile of recombinant adjuvanted anti-herpes zoster vaccine (RZV) in high-risk groups: Data from active surveillance program. Puglia (Italy), 2021-23.

BACKGROUND: Since 2021 a recombinant adjuvanted anti-Herpes Zoster vaccine(Recombinant Zoster Vaccine, RZV) is offered in Italy to high-risk patients. Few real-life data about RZV safety are available in target populations. OBJECTIVES: This study investigates Adverse Events Following Immunization(AEFIs), baseline disease flare-ups, and Herpes Zoster (HZ) episodes occurring after RZV administration in a heterogeneous population of fragile patients to design its safety profile. METHODS: This is a retrospective population-based study. RZV-vaccinated patients at Bari Policlinico General Hospital vaccination clinic from October 1st, 2021, to March 31st, 2023, were enrolled. Subjects were screened for reason of RZV eligibility and baseline chronic pathologies. AEFIs occurred in the first 7-days post-vaccination period were collected, and baseline disease flare-ups and post-vaccination HZ episodes were assessed via a 3-month follow-up. RESULTS: Five-hundred-thirty-eight patients were included and total of 1,031 doses were administered. Most patients were vaccinated due to ongoing immunosuppressive therapy(54.65 %); onco-hematological and cardiovascular conditions were the most common chronic baseline pathologies. Out of 1,031 follow-ups, 441 AEFI cases were reported(42.7/100). The most common symptoms were injection site pain/itching(35.60/100), asthenia/malaise(11.44/100), and fever (10.09/100). Four serious AEFIs occurred(0.38/100). Older age, male sex, and history of cardiovascular diseases(OR:0.71; 95CI:0.52-0.98; p-value <0.05) were found to decrease AEFIs risk, while endocrine-metabolic illnesses(OR:1.61; 95CI:1.15-2.26; p-value <0.05) increased it. Twelve patients(2.23 %) reported a flare-up/worsening of their baseline chronic condition within the first three months after vaccination(mean interval 31.75 days, range 0-68 days). Patients with rheumatological illnesses had a higher risk of relapse(OR:16.56; 95CI:3.58-76.56; p-value <0.001), while male sex behaved as a protective factor. Twelve patients who completed the vaccination cycle(2.43%) had at least one HZ episode by the long-term follow-up. CONCLUSIONS: The study demonstrates RZV safety in a significant number of high-risk patients. Hence, RZV should be actively offered as part of tailored vaccination programs to decrease the burden of HZ in fragile populations.

COVID-19 Vaccine Knowledge, Attitude, Acceptance and Hesitancy among Pregnancy and Breastfeeding: Systematic Review of Hospital-Based Studies.

The risk of unfavourable outcomes for SARS-CoV-2 infection is significant during pregnancy and breastfeeding. Vaccination is a safe and effective measure to lower this risk. This study aims at reviewing the literature concerning the anti-SARS-CoV-2 vaccine's acceptance/hesitancy among pregnant and breastfeeding women attending hospital facilities. A systematic review of literature was carried out. Hospital-based observational studies related to vaccination acceptance, hesitancy, knowledge and attitude among pregnant and breastfeeding women were included. Determinants of acceptance and hesitancy were investigated in detail. Quality assessment was done via the Johann Briggs Institute quality assessment tools. After literature search, 43 studies were included, 30 of which only focused on pregnant women (total sample 25,862 subjects). Sample size ranged from 109 to 7017 people. Acceptance of the SARS-CoV-2 vaccine ranged from 16% to 78.52%; vaccine hesitancy ranged between 91.4% and 24.5%. Fear of adverse events for either the woman, the child, or both, was the main driver for hesitancy. Other determinants of hesitancy included religious concerns, socioeconomic factors, inadequate information regarding the vaccine and lack of trust towards institutions. SARS-CoV-2 vaccine hesitancy in hospitalized pregnant women appears to be significant, and efforts for a more effective communication to these subjects are required.

Adverse events following immunization (AEFIs) with anti-meningococcus type B vaccine (4CMenB): Data of post-marketing active surveillance program. Apulia Region (Italy), 2019-2023.

The four-component recombinant-DNA anti-meningococcus B vaccine (4CMenB) has been approved by the European Medicines Agency in 2013. In Italy, 4CMenB is recommended since 2017 for use in infants under one year of age. Due to the strong evidence of increased risk of fever after administration, surveillance of adverse events following immunization (AEFIs) is a priority for 4CMenB. This cross-sectional prospective study aims at investigating 4CMenB's safety profile. The study population is represented by infants under twelve months of age vaccinated with 4CMenB in selected ambulatories in Apulia, a region in South-Eastern Italy, from October 1st, 2020, to March 31st, 2023. Parents were provided with a post-vaccination diary covering up to seven days after immunization and were contacted one week after the vaccination day. Information about AEFIs was collected, and reactions were classified following World Health Organization guidelines. For serious AEFIs, causality assessment was carried out. AEFI risk determinants were investigated via logistic regression. A total of 4,773 diaries were completed, with 78.13 % of them (3,729/4,773) containing one or more AEFI reports. Systemic reactions such as malaise, drowsiness/insomnia and fatigue were the most common ones, followed by fever and local pain, tenderness, redness and swelling. Twenty-three cases of serious AEFIs were reported. Following causality assessment, 78.26 % of serious adverse events (18/23) were deemed to have a consistent causal association with the administration of 4CMenB (reporting rate: 0.38 %). Three infants were hospitalized following vaccination, but no cases of death or permanent/severe impairment were reported. Prophylactic paracetamol administration showed a significant protective effect against the risk of manifesting fever within the first 24 h after administration (OR: 0.75; p < 0.005). Our data confirms existing evidence regarding the safety of 4CMenB vaccination in babies under 2 years of age, but also highlight a significant risk of fever after vaccination. Prophylactic paracetamol administration could represent a protective factor against fever, especially during the first 24 h after vaccination.

Determinants of compliance to influenza and COVID-19 vaccination in a cohort of solid organ transplant patients in Puglia, Southern Italy (2017-2022).

Influenza and Coronavirus Disease 2019 (COVID-19) vaccination are recommended in both solid organ transplant (SOT) candidates and recipients. In Puglia, Southern Italy, an active vaccination offer program has been activated targeting these patients. This study aims at investigating vaccination coverage (VC) for both vaccines in a SOT patients' cohort, as well as at identifying the vaccination compliance determinant. This is a retrospective, population-based study. The study population consists of the SOT patients who accessed Bari's "Policlinico" General Hospital during 2017-2022. Patients were contacted and, after providing their consent, asked their immunization status regarding influenza and COVID-19 and whether they had already undergone transplant or were waiting to do so. Regression models were fitted to investigate the determinants of VCs for influenza vaccination (2021/22 and 2022/23 seasons) and for COVID-19 vaccination (three-dose base cycle, first and second booster doses). Three-hundred and ten SOT patients were identified; 85.2% (264/310) had already undergone SOT. VCs were suboptimal, especially for constant yearly influenza vaccination (17.7%) and COVID-19 vaccination's second booster (1.94%). Logistic regression highlighted that influenza VCs are higher for SOT recipients than SOT candidates, as well as for older patients, although when considering both vaccination seasons only age significantly impact the vaccination uptake. Older age was the only influential variable for COVID-19 VC. VCs for SOT patients seem to be unsatisfying. Stronger interventions are required.

A Systematic Review of Population-Based Studies Assessing Knowledge, Attitudes, Acceptance, and Hesitancy of Pregnant and Breastfeeding Women towards the COVID-19 Vaccine.

The anti-SARS-CoV-2 vaccination is recommended for pregnant women due to the high risk of complications. However, pregnancy has been associated with vaccine hesitancy. Our review aims at summarizing the existing literature about anti-SARS-CoV-2 vaccine hesitancy in pregnant and lactating women. The research was conducted on PubMed/MEDLINE, ExcerptaMedica Database (EMBASE), and Scopus, according to PRISMA guidelines. Articles regarding the COVID-19 vaccine's acceptance and/or refusal by pregnant and lactating women were selected. Only observational, population-based studies were included. The Joanna Briggs Institute quality assessment tools were employed. A total of 496 articles were retrieved, and after the selection process, 21 papers were included in the current analysis. All the included studies were cross-sectional, mostly from Europe and North America. The sample sizes ranged between 72 and 25,111 subjects. All of them included pregnant subjects, except one that focused on breastfeeding women only. Vaccine hesitancy rates ranged from 26% to 57% among different studies. Fear of adverse events and lack of knowledge were shown to be the main drivers of hesitancy. Approximately half of the studies (11/21) were classified as low quality, the remaining (9/21) were classified as moderate, and only one study was classified as high quality. Primigravidae were also shown to be more likely to accept anti-SARS-CoV-2 vaccination. Our findings confirm significant anti-SARS-CoV-2 vaccine hesitancy among pregnant women. Information gaps should be addressed to contain concerns related to adverse events.

The Effects of the COVID-19 Pandemic on Vaccination Hesitancy: A Viewpoint.

Vaccination hesitancy is considered by the World Health Organization as a danger to global health. In recent years, vaccine hesitancy rates to COVID-19 have been studied worldwide. In our study, we aim to provide an overview of the concept of vaccine hesitancy, with regard to the post-COVID era, and to provide prevention and management strategies. A search of the international literature until March 2023 was conducted in the PubMed database. The 5723 papers found were divided into two groups: prior to the COVID-19 era and from 2021 onward. Papers about the vaccine hesitation phenomenon are becoming more common during the SARS-CoV-2 pandemic and following the marketing that the vaccine companies have carried out on the different types of COVID-19 vaccines. It is advisable that healthcare authorities, at the national and international level, as well as healthcare professionals, at the local level, should promote a series of activities to reduce the vaccine hesitancy rate.

Allergic adverse events following immunization: Data from post-marketing surveillance in Apulia region (South of Italy).

Introduction: Among adverse events following immunization (AEFIs), allergic reactions elicit the most concern, as they are often unpredictable and can be life-threatening. Their estimates range from one in 1,000,000 to one in 50,000 vaccine doses. This report describes allergic events following immunization reported from 2020 to 2021 in Puglia, a region in the South-East of Italy with around 4 million inhabitants. Its main objective is to describe the allergic safety profile of currently employed vaccines. Materials and methods: This is a retrospective observational study. The study period spanned from January 2020 to December 2021, and the whole Apulian population was included in the study. Information regarding AEFIs reported in Puglia during the study period was gathered from the Italian Drug Authority's pharmacovigilance database (National Pharmacovigilance Network, RNF). The overall number of vaccine doses administered was extrapolated by the Apulian online immunization database (GIAVA). Reporting rates were calculated as AEFIs reported during a certain time span/number of vaccine doses administered during the same period. Results: 10,834,913 vaccine doses were administered during the study period and 95 reports of allergic AEFIs were submitted to the RNF (reporting rate 0.88/100,000 doses). 27.4% of the reported events (26/95) were classified as serious (reporting rate 0.24/100,000 doses). 68 out of 95 (71.6%) adverse events were at least partially resolved by the time of reporting and none of them resulted in the subject's death. Conclusions: Allergic reactions following vaccination were rare events, thus confirming the favourable risks/benefits ratio for currently marketed vaccines.

Immunogenicity and safety of BNT162b2 mRNA COVID-19 vaccine in a subject affected by Shapiro's syndrome: A case report.

Shapiro's syndrome (SS) is a rare neurological disorder characterized by spontaneous periodic hypothermia and hyperhidrosis without identifiable systemic causes or brain injuries. We present the case of F. a young patient, without agenesis of the corpus callosum and with episodes of recurrent hypothermia, who was successfully immunized against SARS-CoV-2 via vaccination. F. was born on 2012 and started suffering from episodes of hypothermia at the age of three, with body temperature reaching as low as 32.8°C Hypothermia episodes were initially associated with ibuprofen intake, but were later defined as symptoms of SS. No SARS-CoV-2 infections had been reported before vaccination. The subject received the first dose of pediatric formulation anti-SARS-CoV-2 Comirnaty vaccine on 11 January 2022 and the second dose on 5 February 2022. A one-week follow-up for adverse events was performed via telephone contact after both administrations. Further contact occurred one month after immunization. Anti-SARS-CoV-2 IgG titers were evaluated fifteen days after administration of the second dose. Following vaccination, slight fluctuations in body temperature and local adverse events were noted. These adverse events were not worrying; the vaccine's safety profile is therefore confirmed. The child also developed an excellent antibody titer (>28x103 AU/ml), thus suggesting a good immune response.