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2.
Acta Biomed ; 92(S6): e2021487, 2021 10 19.
Article in English | MEDLINE | ID: covidwho-1503980

ABSTRACT

BACKGROUND AND AIM: The urgency of having rapidly safe and efficient COVID-19 vaccines called for the need to shorten trial phases, reduce sample sizes, and speed-up the approval process by the regulatory Agencies. In light of this, monitoring adverse effects (AEFI) (both immediate and at medium-long term) become of great importance. Aim of this cross-sectional study was to explore the associations between several factors and risk of immediate AEFI. METHODS: Data come from the electronic dataset developed ad hoc to record demographic data, anamnesis and data related to immunization, set-up in the mass vaccination site in Novegro (Milan). Novegro mass vaccination site was one of the mass vaccinations sites with the highest flow in Lombardy Region, with a maximum capacity of 5,000 vaccinations/day. The center opened in April 2021 and closed the 1st of August 2021. A multivariable logistic regression model was used. Odds ratios adjusted (aOR) for age and sex are presented. Statistical significance was set at p<0.05. Analyses were conducting using STATA. RESULTS: Among the total of 314,671 subjects vaccinated, 0.5% developed an immediate AEFI, on average 17.0 ± 0.43 minutes after the administration. The three most frequent AEFI recorded were vagal response (30%), anxiety reaction (24%) and dizziness (21%). AEFI were more frequently observed among women [aOR= 2.24 (95%CI= 2.00 - 2.50)], and those with at least one previous disease [aOR= 1.47 (95%CI= 1.22-1.76)]. CONCLUSIONS: In conclusion, AEFI were less likely to occur for increasing age and after the second dose. Results from this large, complete and representative sample population regarding enrich the interesting scientific debate on potential adverse events following COVID-19 immunization.


Subject(s)
COVID-19 Vaccines/adverse effects , COVID-19 , Vaccination , Adverse Drug Reaction Reporting Systems , COVID-19/prevention & control , Cross-Sectional Studies , Female , Humans , Immunization , Italy/epidemiology , Male , Vaccination/adverse effects
3.
Acta Biomed ; 92(S6): e2021450, 2021 10 01.
Article in English | MEDLINE | ID: covidwho-1472541

ABSTRACT

BACKGROUND AND AIM: Comirnaty® was the first COVID-19 vaccine available for the vaccination campaign of healthcare workers in Italy. With the aim of assessing vaccine safety, we conducted a cross-sectional survey administrating a voluntary-based questionnaire on adverse events following immunisation (AEFIs) in San Raffaele Hospital, Milano, Italy. METHODS: From 4th January 2021 to 27th April 2021, we collected 2,659 questionnaires (response rate: 24,5%). We analyzed data, reporting AEFIs by gender, age, self-reported severity, type, time of insurgence and duration, and estimating relative-risk ratios (RRR) and corresponding 95% confidence intervals (CI). RESULTS: The most reported symptoms were injection site pain, fatigue, headache, myalgia, chills, fever, and arthralgia. Severe systemic reactions were more frequent after receiving the second dose (RRR 6.25, 95% CI 4.57-8.55), in women (RRR 3.33, 95% CI 2.30-4.82), and less frequent in individuals aged 60 or more (RRR 0.26, 95% CI 0.14-0.49). In addition, we noted a wide range of adverse events of special interest (AESIs). CONCLUSIONS: Consistently with clinical trials and pharmacovigilance surveillance, AEFIs were frequent, but severe ones were uncommon, supporting the massive implementation of the COVID-19 vaccination campaign and providing valuable data for a risk profiling of vaccinees. (www.actabiomedica.it).


Subject(s)
COVID-19 Vaccines , COVID-19 , Vaccination , COVID-19/prevention & control , COVID-19 Vaccines/adverse effects , Cross-Sectional Studies , Female , Hospitals, Teaching , Humans , Italy/epidemiology , Male , RNA, Messenger , Vaccination/adverse effects
4.
Vaccines (Basel) ; 9(6)2021 Jun 01.
Article in English | MEDLINE | ID: covidwho-1259629

ABSTRACT

A mass vaccination center is a location, normally used for nonhealthcare activities, set up for high-volume and high-speed vaccinations during infectious disease emergencies. The high contagiousness and mortality of COVID-19 and the complete lack of population immunity posed an extraordinary threat for global health. The aim of our research was to collect and review previous experiences on mass vaccination centers. On 4 April 2021, we developed a rapid review searching four electronic databases: PubMed/Medline, Scopus, EMBASE, Google Scholar and medRxiv. From a total of 2312 papers, 15 of them were included in the current review. Among them, only one article described a COVID-19 vaccination center; all of the others referred to other vaccinations, in particular influenza. The majority were conducted in the United States, and were simulations or single-day experiences to practice a mass vaccination after bioterrorist attacks. Indeed, all of them were published after September 11 attacks. Regarding staff, timing and performance, the data were highly heterogenous. Several studies used as a model the Center for Disease Control and Prevention guidelines. Results highlighted the differences around the definition, layout and management of a mass vaccination center, but some aspects can be considered as a core aspect. In light of this, we suggested a potential definition. The current review answers to the urgency of organizing a mass vaccination center during the COVID-19 pandemic, highlighting the most important organizational aspects that should be considered in the planning.

5.
Vaccines (Basel) ; 9(5)2021 May 18.
Article in English | MEDLINE | ID: covidwho-1234846

ABSTRACT

Healthcare professionals are considered to be at high risk of exposure and spread of SARS-CoV-2, and have therefore been considered a priority group in COVID-19 vaccination campaign strategies. However, it must be assumed that the immune response is influenced by numerous factors, including sex and gender. The analysis of these factors is an impact element for stratifying the population and targeting the vaccination strategy. Therefore, a large cohort of healthcare workers participating in the Italian vaccination campaign against SARS-CoV-2 has been studied to establish the impact of sex and gender on vaccination coverage using the Gender Impact Assessment approach. This study shows a significant difference in the antibody titers among different age and sex groups, with a clear decreasing trend in antibody titers in the older age groups. Overall, the serological values were significantly higher in females; the reported side effects are more frequent in females than in males. Therefore, disaggregated data point out how the evaluation of gender factors could be essential in COVID-19 vaccination strategies. On this biomedical and social basis, suggestions are provided to improve the SARS-CoV-2 vaccination campaign in healthcare professionals. Still, they could be adapted to other categories and contexts.

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