Adherence to and early adverse events of COVID-19 vaccine in a cohort of 600 Italian breastfeeding and pregnant physicians.

Pregnant and breastfeeding women (PBW) have been excluded from COVID-19 vaccine registry and the majority of post-marketing trials, despite the recognized increased risk of severe infections and complications. The lack of efficacy and safety data prevented the formulation of specific indications/guidelines for vaccination and could have also contributed to increased vaccine hesitancy (VH) in PBW. The aim of this cross-sectional study is to assess the rate and predictors of VH, and early adverse events (AEFI) following COVID-19 vaccine in PBW with a cross-sectional study. In January 2021, a purposely designed questionnaire was administered to 600 PBW part of a Facebook group of physicians, immunized with two doses of Comirnaty®. Thirty-eight (29%) pregnant women and 13 (2.8%) breastfeeders were hesitant. The only statistically significant negative predictor of COVID-19 VH appeared to be having had the flu shot in 2020/2021 (OR: 0.35; 95% CI: 0.13-0.97; p = .044). Approximately 27% of PBW reported hesitancy toward the 2020/2021 season influenza vaccine. Among the vaccinated subjects, 51.6% of pregnant and 75.2% of breastfeeding women reported at least one symptom after the first, and 82.4% and 81.6%, respectively, after the second dose. Nausea/vomiting, fatigue, headache and arthralgia/myalgia were the most common symptoms; dizziness, shivering, syncope and limb paresthesia were rarely reported. Among infants of breastfeeding mothers, six experienced fever, five rash and four moderate and self-limiting diarrhea. Preliminary data on mRNA COVID-19 vaccine in PBW and in their infants are reassuring since AEFI, although frequent, are typically mild and similar to those occurring in the general population, and in PBW after other vaccines. Larger studies with longer follow-up after vaccination are strongly recommended to develop recommendations in these patients.

Sars-CoV2 vaccine hesitancy in Italy: A survey on subjects with diabetes.

BACKGROUND AND AIMS: Vaccine Hesitancy (VH) is a relevant obstacle for the COVID-19 vaccination campaign. The aim of this study is to assess the proportion of subjects unwilling to vaccinate among patients with type 1 (T1DM) and 2 (T2DM) diabetes, exploring factors associated with VH. METHODS AND RESULTS: A purposely created interview was delivered from physicians to a consecutive series of adult (>18 years) subjects with diabetes referring to the Diabetes Outpatient Clinic of Careggi Hospital, Florence, from January 1st to April 30th 2021. Out of 502 subjects enrolled, 92 were vaccine hesitant respondents (18.3%); the corresponding figure for T1DM and T2DM was 13.0% (N = 14), and 19.9% (N = 78), respectively. After adjusting for age, higher HbA1c (1.07 [1.02-1.13], p = 0.008) and triglycerides levels (1.03 [1.01-1.06], p = 0.011) were positively associated with VH, among patients with T1DM. At multivariate analysis, after adjusting for age, creatinine, and statin use, patients with T2DM affected by obesity (9.98 [4.89-9.59], p < 0.01) and with lower levels of creatinine (0.36 [0.21-0.54], p = 0.029) were more likely to refuse COVID vaccination. CONCLUSIONS: Hesitancy toward COVID-19 vaccination among subjects with diabetes is not negligible and seems to be more prevalent in individuals with lower adherence to medical prescriptions and/or reduced concerns over their health. This suggests the need for specific interventions to increase awareness and counter prejudices on vaccines.

Glucose control in diabetes during home confinement for the first pandemic wave of COVID-19: a meta-analysis of observational studies.

AIM: To assess the effect on glycaemic control of confinement due to lockdown measures, during COVID-19 pandemic, in people with type 1 (T1DM) and type 2 (T2DM) diabetes. METHODS: Meta-analysis of observational studies reporting measures of glucose control and variability before and during and/or after periods of confinement caused by COVID-19 in 2020 and/or 2021. RESULTS: We included 27 studies on T1DM. No significant change in Hba1c was observed after lockdown (WMD - 1.474 [- 3.26; 0.31] mmol/mol, I2 = 93.9). TIR significantly increased during and after lockdown (WMD: 2.73 1.47; 4.23 %, I2 = 81% and 3.73 [1.13; 5.33] %, I2 = 85%, respectively).We retrieved nine studies on T2DM patients. No significant variation in HbA1c was detected (WMD - 1.257 - 3.91; 1.39 mmol/mol, I2 = 98.3%). HbA1c had a more favourable trend in studies performed in Asia than in Europe (p = 0.022 between groups). CONCLUSION: Lockdown showed no significant detrimental effect on HbA1c in either T1DM or T2DM. Conversely, home confinement led to a reduction in mean glucose and glucose variability in T1DM, although with a high heterogeneity of results.

Rate and Predictors of Hesitancy toward SARS-CoV-2 Vaccine among Type 2 Diabetic Patients: Results from an Italian Survey.

Vaccine hesitancy (VH) has been identified as one of the major health concerns of our time by the World Health Organization. It may prove especially detrimental in the light of the ongoing SARS-CoV-2 pandemic, as vaccination campaigns still represent the primary strategy against the detrimental consequences of the pandemic. Among patients suffering from type 2 diabetes mellitus (DB), who are particularly vulnerable to COVID-19, VH might represent an even more serious threat. Therefore, our study focuses on identifying potential determinants of VH among patients with type 2 diabetes. Study participants (n = 1176) filled in a two-section online self-administered questionnaire, answering questions regarding demographic and anamnestic data, as well as their intention to accept any vaccination against COVID-19. Some possible reasons underlying VH were investigated as well. An overall hesitancy rate of 14.2% was registered. Data showed how older age, male gender, higher education level, and having been vaccinated for seasonal influenza in 2020-2021 were associated with a significantly higher propensity to receive the COVID-19 vaccine. On the contrary, having experienced adverse effects following past vaccinations was a negative predictor. In addition to confirming an array of predictors of VH, we found a worryingly high prevalence of VH among diabetics, who have been shown to be particularly exposed to severe COVID-19 and death. These findings may be useful in planning targeted action toward acceptance improvement and enhancing the efficacy of vaccination campaigns.

Association between different screening strategies for SARS-CoV-2 and deaths and severe disease in Italy.

BACKGROUND: The WHO recommends testing any suspected person with Severe Acute Respiratory Syndrome CoronaVirus-2 (SARS-CoV-2), in order to limit the spread of the epidemic. In Italy, some Regions opted for extensive testing, whereas others limited tests to selected subjects. To assess the influence of different strategies, we examined the incidence of death and severe cases in Italy. METHODS: Data on new cases of SARS-CoV-2, number of tests, deaths and admissions to Intensive Care Units (ICU) were retrieved in each Italian Region, from 24 February to 18 March 2020. As an index of different screening strategies, the number of tests/positive test results (P/T) ratio as of 7 March 2020, was considered. The cumulative number of deaths and of new severe cases, between March 23 and 25 was recorded. The association of those two outcomes with the number of P/T ratio was assessed using linear regression models. RESULTS: In the interval between March 23 and 25, recorded deaths (*million inhabitants) were 14 (3-54), whereas severe cases were 31 (10-112). Both the number of deaths and that of severe cases showed a significant correlation (R2 .57 and .41, with P < .01) with the P/T ratio. Deaths and severe cases were associated with higher mean personal income and lower density of General Practioners (GPs). The association of P/T with severe cases and deaths retained statistical significance after adjusting for mean personal income (R2 .30 and .41, respectively; both P = .04) and GPs density (R2 .21 and .19, respectively; both P = .03). CONCLUSIONS: A more aggressive screening strategy for SARS-Cov-2, was associated with lower rates of death and severe disease in Regions of Italy.

Are diabetes and its medications risk factors for the development of COVID-19? Data from a population-based study in Sicily.

BACKGROUND AND AIMS: Diabetes mellitus (DM) has been associated with higher incidence of severe cases of COVID-19 in hospitalized patients, but it is unknown whether DM is a risk factor for the overall COVID-19 incidence. The aim of present study was to investigate whether there is an association of DM with COVID-19 prevalence and case fatality, and between different DM medications and risk for COVID-19 infection and death. METHODS AND RESULTS: retrospective observational study on all SARS-CoV-2 positive (SARS-CoV-2+) cases and deaths in Sicily up to 2020, May 14th. No difference in COVID-19 prevalence was found between people with and without DM (RR 0.92 [0.79-1.09]). Case fatality was significantly higher in SARS-CoV-2+ with DM (RR 4.5 [3.55-5.71]). No diabetes medication was associated with differences in risk for SARS-Cov2 infection. CONCLUSIONS: in Sicily, DM was not a risk factor for COVID-19 infection, whereas it was associated with a higher case fatality.

Factors associated with increased all-cause mortality during the COVID-19 pandemic in Italy.

BACKGROUND: The number of excess deaths during February-March 2020 in Italy, in comparison with previous years, was considerably higher than the recorded COVID19-related deaths. The present study aimed to explore the association of excess mortality with some indices related to the COVID-19 pandemic and its management. METHODS: Data on all-cause mortality from 20 February-31 March in the years 2015-2020, and demographic, socioeconomic and healthcare organisation data of each Italian region were obtained from the Italian Institute of Statistics. Non-COVID-19-Imputed Excess Mortality (NCIEM) was calculated as the difference between the excess 2020 mortality and reported COVID-19 mortality. The association of NCIEM with the rate of COVID-19 cases, COVID-19 mortality and other potential moderators was assessed using linear regression models. RESULTS: The nationwide number of excess deaths and COVID-19 deaths was 26,701 and 13,710, respectively, with a difference of 12,991. The NCIEM in different regions showed a direct correlation with COVID-19 mortality (r2 = 0.61, p < 0.001) and total cases (r2 = 0.30, p = 0.012), and an inverse correlation with cases/total tests ratio (r2 = 0.49, p = 0.001). Direct correlations were also found with the proportion of institutionalised elderly, whereas inverse correlations were observed with prevalence of diabetes, cardiovascular mortality and density of general practitioners. CONCLUSIONS: The impact of the COVID-19 pandemic on all-cause mortality was considerably greater than that indicated by official counts of victims. Limited testing capacity and causes of death other than COVID-19 could have contributed to the increase in overall mortality rates.