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While several studies have been conducted on HLA and Covid-19 infection, few investigated the role of HLA polymorphism on vaccination response. We previously analyzed the HLA allele and haplotype frequencies in a hundred weak responders (antibody levels <5th percentile) after mRNA anti-Covid vaccine and found some suggestions about specific alleles and one haplotype. We moved on typing individuals enrolled in the same cohort study ("RENAISSANCE") with antibody titers above the 95th percentile at six months after vaccination, in order to search for any alleles predictive of strong humoral response. Individuals with clinical history of COVID-19 or positive anti-nucleocapsid antibodies were excluded. Allelic frequencies were compared with those of weak responders and of the general population, taken from the national bone marrow donor registry, IBMDR. N = 123 evaluable individuals presented with >95th percentile antibody titers at six months after BNT162b2 vaccine. One-third of them had >2080 BAU/mL, lowest value was 1261 BAU/mL. Comparison of allelic frequencies with weak responders showed a significant different proportion of individuals carrying A*03:01, A*24:02 and DRB1*16:01 (21.5% vs. 3.6%, 7.7% vs. 14.9% and 3.2% vs. 8.1% respectively). Moreover, when looking at alleles of the ancestral haplotype A3-B35-C4-DR1, we observed frequencies of 4.47%, 0.84% and 0% in the present cohort, IBMDR and weak responders, respectively. After adjusting for age, gender and BMI, the presence of A*03:01 confirmed to be statistically significant (p<0.0001) and was predictive of high antibody titers at six months with an odds ratio of 12.5 with respect to weak antibody levels. Age was the only other significant variable, with an odds ratio of 0.96. Clinical collection data is underway to correlate Covid-19 infection rates in both cohorts, in an attempt to find a definite correlation between HLA and vaccine protection.
ABSTRACT
Objective: Numerous national and international publications highlight an increase in enquiries for exposures to disinfectants and antiseptics related to the COVID-19 pandemic. The data published in the literature, however, are limited to analyzing the months corresponding to the first period of confinement, while data relating to the second and third pandemic waves are lacking. Our aim was to analyse these exposures in the months following the wave of the pandemic. Methods: We used descriptive statistics to analyse toxicology consultation volumes to hypochlorite bleaches, disinfectants and antiseptic products for the period 1 February 2020-3 May 2020 (first lockdown), 1 October 2020-31 December 2020 (second lockdown) and we compared these data with that relating to the same periods of 2019 and the period 1 February 2021-3 May 2021. Results: Compared to 2019, accidental exposures to all the products considered in the study showed an increase of 67.9% in the period February-May 2020, an increase of 26.3% in the period October-December 2020 and an increase of 16.9% in the period February-May 2021. (Table 1). During the period February-May 2020 the respective increases compared to the same period of 2019 were: bleaches (+45.7%), antiseptics (+61.7%), disinfectants (+140.2%);for the period October-December 2020 the respective increases compared to the same period of 2019 were: bleaches (+0.3%), antiseptics (+43.2%), disinfectants (+113%). During the period from February to May 2021 compared to 2019 changes were as follows: bleaches (-9.7%), antiseptics (+44.3%), disinfectants (+59%). Respiratory symptoms were present in the majority of cases, followed by gastrointestinal, oropharyngeal, ocular and other routes. Conclusion: The data highlight how the effect of the COVID-19 pandemic on exposures to antiseptic and disinfectant products in Italy did not end with the first wave, but persists, although with smaller numbers, even in the period of the second wave and in early 2021. (Table Presented).
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OBJECTIVE: This study aimed to improve the post-marketing surveillance on mRNA anti-SARS- CoV-2 vaccines, characterizing the adverse events (AEs) after the first dose of mRNA BNT162b vaccine. The associations between the AEs and individuals' characteristics were explored. PATIENTS AND METHODS: All adult healthcare workers at Niguarda Hospital ( Milan, Italy) who were referred for the first dose of vaccine were offered to participate in a cross-sectional survey during the second-dose administration, between 18 January and 7 February 2021. All participants completed a questionnaire about age, gender, weight, height, medical history, concurrent therapies, employment status, previous diagnosis/testing for SARS- CoV-2 infection, and a list of 24 AEs (solicited AEs). The development of at least one solicited AEs was the main outcome. AEs were stratified by the presence of injection-site symptoms, systemic symptoms or both, and the differences between strata were assessed as a secondary outcome. Biometric data and reports of a previous diagnosis of SARS-CoV-2 infection were also explored, as predictors of the main outcome. RESULTS: 7,014 healthcare workers were included. An incidence of 3 per 10.000 persons for serious AEs following the first administration of the mRNA BNT162b vaccine was found. An association between the development of non-serious AEs with young age, female gender, low body mass index, and previous history of SARS-CoV-2 was described. CONCLUSIONS: This real-life study supported data on the safety profile of the BNT162b2 mRNA vaccine. Our findings on the associations between the development of non-serious AEs with some individual characteristics may help physicians and patients make educated and informed medical decisions towards anti-COVID-19 vaccination.
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OBJECTIVE: Anti-COVID-19 vaccines were mainly associated with non-serious adverse events (AEs), whose prevalence was reported to be up to 70% in healthcare workers (HCWs). This may lead to sick leave requests, but this impact has never been quantified. This study aimed to investigate the absence from work among HCWs following anti-COVID-19 vaccination. Its association with age and previous COVID-19 infection was also assessed. PATIENTS AND METHODS: This is a retrospective observational cross-sectional study on administrative data about sick leave requests after anti-COVID-19 vaccination. All the HCWs employed at the Niguarda Hospital (Milan, Italy) who received the vaccine from December 27, 2020 to February 28, 2021 were included. RESULTS: In total, 4,088 HCWs received the first dose of the vaccine and 4,043 completed the vaccination cycle. After the first injection, 1.6% of HCWs requested sick leave, while after the second injection, the number of requests significantly increased (+6.1%, p<0.001). A significant increase in sick leave was detected for those who have had SARS-CoV-2 infection after the first injection (+2.3%, p<0.001). After the second dose, a significant increase in sick leave was observed in the 20-30-year-old group compared to >30 years (+3.6%, p=0.017), if HCWs without a history of SARS-CoV-2 infection were considered. CONCLUSIONS: The requests for sick leave among HCWs following the anti-COVID-19 vaccine were limited and higher after the second injection. This may help the management of the human resources when the large-scale administration of the anti-COVID-19 vaccines will involve other categories of workers.
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Background: Antithrombotic treatment, including low molecular weight heparin (LMWH), has been proposed as a potential therapy for Coronavirus disease 2019 (COVID-19), to counteract diffuse intravascular clotting activation. However, it is unclear whether prophylactic or therapeutic doses are similarly effective in reducing mortality. Methods: We performed a systematic review and meta-analysis of clinical studies to evaluate the efficacy of heparin (either, LMWH or fondaparinux) compared to no anticoagulation in reducing overall mortality. A subgroup analysis comparing prophylactic or therapeutic regimen was performed. Secondary endpoints were major bleeding and length of hospital stay (LOS). Results: 12 studies were included, 2 prospective and 10 retrospective with 15,704 patients. Of these, 11,251 (71.6%) were on heparins. Ten studies reported data on all-cause mortality (figure), showing that both prophylactic and full dose reduced mortality (pooled Hazard Ratio [HR] 0.55, 95% confidence interval [CI] 0.48-0.63 and HR 0.49, 95% CI 0.41-0.59, respectively). The prophylactic dose was associated with a lower risk of major bleeding (Odds Ratio [OR] 0.60, 95% CI 0.41-0.87), while a nonsignificant trend towards an increased risk of bleeding for the therapeutic dose was noted (OR 1.55, 95% CI 0.98-2.43). Finally, LOS was evaluated in 3 studies;the mean difference for prophylactic heparin treatment was -2.38 (-3.14, -1.61) days. Discussion: Heparin is effective in reducing mortality in COVID-19 patients, with therapeutic and prophylactic regimens showing a similar reduction in the mortality rate. Prophylactic dose may be considered as the first choice in all patients with COVID-19 requiring hospital admission.
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Objective: During the COVID-19 pandemic, public health messaging emphasized the use of hand sanitizer products to reduce SARS-CoV-2 exposure, the agent responsible for COVID-19. Our aim was to analyse these exposures and compare to the same period in 2019. Methods: We used descriptive statistics to analyse Milan Poison Center exposures to alcohol-based hand sanitizers for the period 1 January 2019 to 30 September 2019 to the same period in 2020. Results: During the 2020 study period a total of 474 exposures were collected and in the same period in 2019 there were 211 exposures. During the COVID-19 pandemic in 2020 an increase in exposures of 124.6% compared to 2019 was observed. In relation to the year 2020, the age group distribution was: < 1 year 5.5% (n=26), ≥ 1<5 years 49.6% (n=235), ≥ 5<18 years 6.5% (n=31);≥ 18 years 50.4% (n=239) and age unknown 7% (n=33). The circumstance of exposure was unintentional for 77.2% (366 cases), intentional 2.1% (n=10), transfer from original container 5.9% (n=28), other 13.3% (n=63), and therapeutic error instead of medicament 1.5% (n=7). In one of the therapeutic error cases, the hand sanitizer was mistaken for vitamins and was administered to a baby of one week and in a second case a man of 78 years mistook the hand sanitizer for ophthalmic gel and presented pain and ocular inflammation. The oral route was involved in 79% of cases, ocular in 4.9%, skin in 3.8%, and multiple routes in 12.3%. Most exposures were managed at home (86.5%) and 13.5% in hospital. The most frequently reported clinical effects were nausea, vomiting, diarrhea, heartburn, pharyngodynia, ocular pain and inflammation. Overall, 377 patients (79.5%) had no effects, 79 had minor effects (16.7%) and 18 (3.8%) had moderate effects. Conclusion: The public health messaging advocating the use of these products was necessary to mitigate COVID-19 health effects. Messaging should also emphasize proper use of these products. The increased availability at home was temporally associated with an increase in exposures. The analysis of data reveals the role of poison control centers in the identification of risk factors for prevention and for reducing unnecessary emergency medical attention.