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1.
Drug Safety ; JOUR:1311-1312, 45(10).
Article in English | EMBASE | ID: covidwho-2085647

ABSTRACT

Introduction: Marketed COVID-19 vaccines showed an overall favourable safety profile in pivotal trials. However, those trials did not include high risk/fragile patient categories;hence, close monitoring of COVID-19 vaccine safety in those special cohorts in real-world setting is needed. The European Medicines Agency-funded "Covid- Vaccine-Monitor" project was set up to prospectively measure the incidence of solicited/unsolicited adverse events following COVID- 19 vaccination in several European Countries as reported by vaccinees through web-based questionnaires. Italy is one of the Countries participating in the project as a large network named "ilmiovaccinocovid19 collaborating group". Objective(s): To measure the incidence of vaccinee-reported adverse events following immunization (AEFIs) with marketed COVID-19 vaccines in pregnant and lactating women, pediatrics, immunocompromised, people with history of allergy and people with prior SARSCoV- 2 infection in Italy. Method(s): We performed a prospective cohort study of the abovementioned categories of vaccinees, who were recruited at multiple vaccination centers within 48 hours from either the first or booster COVID-19 vaccine dose administration. After providing informed consent and get registered into the web-app, vaccinees were asked to fill in an electronic baseline questionnaire and 6 follow-up questionnaires at different time points, within 6-month from vaccine administration, in which information on potential vaccine-related AEFIs were collected. We explored and compared the frequency of local and systemic solicited adverse events following first or booster dose for each special cohort and vaccine brands. Result(s): Overall, 1,331 vaccinees (40.4% first dose and 59.6% booster dose) were included in the analysis. Of these, 8.4% were immunocompromised, 32.0% had history of allergy, 25.5% had prior SARS-CoV-2 infection, 23.4% were children/adolescents, 6.2% were pregnant and 4.6% were lactating women (non-mutually exclusive cohorts). Of subjects belonging to at least one cohort, 52.3% reported at least one AEFI following either the first or booster dose. Among all special cohorts, injection site pain was the most frequently reported solicited local AEFI, after both the first (37.5%) and booster (39.5%) dose. As solicited systemic AEFIs, headache (19.0%) was the most frequently reported after the first dose, while malaise (23.7%) and fatigue (23.7%) after the booster dose. The frequency of severe AEFIs was very low following both first dose (0.8%) and booster dose (0.6%). Conclusion(s): Overall, this study confirmed the favourable safety profile of COVID-19 vaccines also in the above-mentioned special categories who have not (or marginally) been included in pivotal trials.

2.
Drug Safety ; 45(10):1311-1312, 2022.
Article in English | ProQuest Central | ID: covidwho-2045217

ABSTRACT

Introduction: Marketed COVID-19 vaccines showed an overall favourable safety profile in pivotal trials. However, those trials did not include high risk/fragile patient categories;hence, close monitoring of COVID-19 vaccine safety in those special cohorts in real-world setting is needed. The European Medicines Agency-funded "Covid-Vaccine-Monitor" project was set up to prospectively measure the incidence of solicited/unsolicited adverse events following COVID-19 vaccination in several European Countries as reported by vaccinees through web-based questionnaires. Italy is one of the Countries participating in the project as a large network named "ilmiovaccinocovid19 collaborating group". Objective: To measure the incidence of vaccinee-reported adverse events following immunization (AEFIs) with marketed COVID-19 vaccines in pregnant and lactating women, pediatrics, immunocompromised, people with history of allergy and people with prior SARS-CoV- 2 infection in Italy. Methods: We performed a prospective cohort study of the abovementioned categories of vaccinees, who were recruited at multiple vaccination centers within 48 hours from either the first or booster COVID-19 vaccine dose administration. After providing informed consent and get registered into the web-app, vaccinees were asked to fill in an electronic baseline questionnaire and 6 follow-up questionnaires at different time points, within 6-month from vaccine administration, in which information on potential vaccine-related AEFIs were collected. We explored and compared the frequency of local and systemic solicited adverse events following first or booster dose for each special cohort and vaccine brands. Results: Overall, 1,331 vaccinees (40.4% first dose and 59.6% booster dose) were included in the analysis. Of these, 8.4% were immunocompromised, 32.0% had history of allergy, 25.5% had prior SARS-CoV-2 infection, 23.4% were children/adolescents, 6.2% were pregnant and 4.6% were lactating women (non-mutually exclusive cohorts). Of subjects belonging to at least one cohort, 52.3% reported at least one AEFI following either the first or booster dose. Among all special cohorts, injection site pain was the most frequently reported solicited local AEFI, after both the first (37.5%) and booster (39.5%) dose. As solicited systemic AEFIs, headache (19.0%) was the most frequently reported after the first dose, while malaise (23.7%) and fatigue (23.7%) after the booster dose. The frequency of severe AEFIs was very low following both first dose (0.8%) and booster dose (0.6%). Conclusion: Overall, this study confirmed the favourable safety profile of COVID-19 vaccines also in the above-mentioned special categories who have not (or marginally) been included in pivotal trials.

3.
J Hosp Infect ; 115: 51-58, 2021 Sep.
Article in English | MEDLINE | ID: covidwho-1379144

ABSTRACT

BACKGROUND: Occurrence of hepatitis C virus (HCV) infection is reduced by effective risk management procedures, but patient-to-patient transmission continues to be reported in healthcare settings. AIM: To report the use of phylogenetic analysis in the clinical risk management of an HCV outbreak among 128 thalassaemia outpatients followed at a thalassaemia centre of an Italian hospital. METHODS: Epidemiological investigation and root-cause analysis were performed. All patients with acute hepatitis and known chronic infection were tested for HCV RNA, HCV genotyping, and NS3, NS5A, and NS5B HCV genomic region sequencing. To identify transmission clusters, phylogenetic trees were built for each gene employing Bayesian methods. FINDINGS: All patients with acute hepatitis were infected with HCV genotype 1b. Root-cause analysis, including a lookback procedure, excluded blood donors as the source of HCV transmission. The phylogenetic analysis, conducted on seven patients with acute infection and eight patients with chronic infection, highlighted four transmission clusters including at least one patient with chronic and one patient with acute HCV infection. All patients in the same cluster received a blood transfusion during the same day. Two patients with acute hepatitis spontaneously cleared HCV within four weeks and nine patients received ledipasvir plus sofosbuvir for six weeks, all achieving a sustained virological response. CONCLUSION: Combined use of root-cause analysis and molecular epidemiology was effective in ascertaining the origin of the HCV outbreak. Antiviral therapy avoided the chronic progression of the infection and further spread in care units and in the family environment.


Subject(s)
Hepatitis C , Thalassemia , Antiviral Agents/therapeutic use , Bayes Theorem , Disease Outbreaks , Genotype , Hepacivirus/genetics , Hepatitis C/epidemiology , Humans , Italy/epidemiology , Phylogeny , Risk Management , Thalassemia/complications , Thalassemia/epidemiology , Thalassemia/therapy
4.
27th International DMS Conference on Visualization and Visual Languages, DMSVIVA 2021 ; : 55-62, 2021.
Article in English | Scopus | ID: covidwho-1368079

ABSTRACT

The COVID-19 pandemic has caused disruption across the globe and put pressure on healthcare systems. In order to limit the use of hospital resources, the use of home care and telehealth has been very important to minimize direct human intervention in monitoring patients. The purpose of this work is to present YouCare: a multiplatform application that allows the collection of medical data on the health status of the user in order to allow physicians to efficiently monitor the status of the patient. As an important feature, it includes functions to monitor the general situation through statistics and interactions with the other users of the application. This might make the isolation period less stressful while exchanging current COVID experiences. The use of the application has been experimented with a usability test, obtaining positive feedback from the users. We also report other similar applications that have been developed and used in different parts of the world. © DMSVIVA 2021.All right reserved.

5.
EuroMediterranean Biomedical Journal ; 16(19):80-84, 2021.
Article in English | Scopus | ID: covidwho-1280734

ABSTRACT

In Italy, vaccination against COVID-19 began on December 27, 2020. To date, 13,713,224 people in Italy are fully vaccinated, which accounts for 25.3 % of the general population, and 44.8% received at least one vaccination dose. The present study aim to investigate willingness to receive COVID-19 vaccination in costumers accessing a sample of community pharmacies in the Province of Palermo, Italy. A self-administered and anonymous questionnaire was carried out among costumers older than 18 years old between December 2020 and March 2021. Three hundred and sixty-three subjects were enrolled in the study, 259 (71.3%) expressed their willingness to receive COVID-19 vaccination. The main determinants associated with vaccination acceptance resulted “trust in safety and effectiveness of vaccinations” and the absence of any previous negative vaccination experience. Unfavourable information on COVID-19 vaccination obtained through internet/media/social media and lack of confidence in COVID-19 vaccines and in the Italian national healthcare system are the main determinants associated with vaccine refusal. Male gender, younger age classes and influenza vaccination acceptance due to the impact of COVID pandemic were significantly associated with willingness to be vaccinated against COVID-19. In order to promote COVID-19 vaccination campaign accurate, informative and communicative campaign dedicated to subjects that are more hesitant regarding COVID-19 vaccination (e.g. female sex, adults, people that usually do not adhere to influenza vaccination campaign) should be implemented. © EuroMediterranean Biomedical Journal 2021.

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