NEURO-COVAX: An Italian Population-Based Study of Neurological Complications after COVID-19 Vaccinations.

OBJECTIVE: In this Italian population-based study, we aimed to evaluate the neurological complications after the first and/or second dose of COVID-19 vaccines and factors potentially associated with these adverse effects. METHODS: Our study included adults aged 18 years and older who received two vaccine doses in the vaccination hub of Novegro (Milan, Lombardy) between 7 and 16 July 2021. The NEURO-COVAX questionnaire was able to capture the neurological events, onset and duration. That data that were digitized centrally by the Lombardy region were used to match the demographic/clinical characteristics and identify a vulnerability profile. Associations between vaccine lines and the development of complications were assessed. Digital healthcare system matching was also performed to evaluate severe neurological complications (Guillain-Barrè syndrome, Bell's palsy, transverse myelitis, encephalitis) and the incidence of hospital admissions and/or the mortality rate after two doses of the vaccines. RESULTS: The NEURO-COVAX-cohort included 19.108 vaccinated people: 15.368 with BNT162b2, 2077 with mRNA-1273, 1651 with ChAdOx1nCov-19, and 12 with Ad26.COV2.S who were subsequently excluded. Approximately 31.2% of our sample developed post-vaccination neurological complications, particularly with ChAdOx1nCov-19. A vulnerable clinical profile emerged, where over 40% of the symptomatic people showed comorbidities in their clinical histories. Defining the neurological risk profile, we found an increased risk for ChAdOx1nCov-19 of tremors (vs. BNT162b2, OR: 5.12, 95% CI: 3.51-7.48); insomnia (vs. mRNA-1273, OR: 1.87, 95% CI: 1.02-3.39); muscle spasms (vs. BNT162b2, OR: 1.62, 95% CI: 1.08-2.46); and headaches (vs. BNT162b2, OR: 1.49, 95% CI: 0.96-1.57). For mRNA-1273, there were increased risks of parethesia (vs. ChAdOx1nCov-19, OR: 2.37, 95% CI: 1.48-3.79); vertigo (vs. ChAdOx1nCov-19, OR: 1.68, 95% CI: 1.20-2.35); diplopia (vs. ChAdOx1nCov-19, OR: 1.55, 95% CI: 0.67-3.57); and sleepiness (vs. ChAdOx1nCov-19, OR: 1.28, 95% CI: 0.98-1.67). In the period that ranged from March to August 2021, no one was hospitalized and/or died of severe complications related to COVID-19 vaccinations. DISCUSSION: This study estimates the prevalence and risk for neurological complications potentially associated with COVID-19 vaccines, thus improving the vaccination guidelines and loading in future personalized preventive medicine.

Genesis and prospects of the shortage of specialist physicians in Italy and indicators of the 39 schools of hygiene and preventive medicine.

BACKGROUND AND AIM: In Italy, the number of physicians decreased in recent years due to retirements not being replaced by young specialists. To address this shortage of medical personnel, proper planning is needed, taking into consideration the number of accesses in medical schools and residency contracts. The main objective of this study is to deepen the data on the number of physicians, provide a prospective picture and make some suggestions for future planning.  Materials and Methods: Estimates of the number of physicians, contracts, assignments, and abandonments for specialist schools are based on data from the General Medical Council, the Ministry of University and Research, Eurostat and the "Associazione Liberi Specializzandi".    Results: Estimates of the number of physicians for the period 2023-2032 predict the minimum availability of active doctors between 2028 and 2029. While there has been an increase in the number of contracts for residents in recent years, there are concurrently high dropout rates and non-assignment of contracts, varying across Schools of Specialization. An examination of the available data for the 39 Schools of Specialization in Hygiene and Preventive Medicine shows lower than-average abundance rates.  Conclusions: In recent decades, poor planning and early retirement have led to a shortage of doctors, particularly specialists, that will not be resolved until after 2030. Proposed solutions to this 'health emergency' include importing doctors from abroad, delaying the retirement age, recruiting junior doctors to the National Health Service and changing the distribution of junior doctor contracts.

Immediate adverse events following COVID-19 immunization. A cross-sectional study of 314,664 Italian subjects.

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.

Safety surveillance after BNT162b2 mRNA COVID-19 vaccination: results from a cross-sectional survey among staff of a large Italian teaching hospital.

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).

Challenges and Opportunities of Mass Vaccination Centers in COVID-19 Times: A Rapid Review of Literature.

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.

The Gender Impact Assessment among Healthcare Workers in the SARS-CoV-2 Vaccination-An Analysis of Serological Response and Side Effects.

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.