Herpes zoster and simplex reactivation following COVID-19 vaccination: new insights from a vaccine adverse event reporting system (VAERS) database analysis.

BACKGROUND: A few cases of Herpes Zoster and Simplex reactivation following COVID-19 immunization have been recently described, but the real extent of this suspected adverse event has not been elucidated yet. METHODS: We performed a nested case/control study by using the U.S. Vaccine Adverse Event Reporting System database. We carried out a case-level clinical review of all Herpes reactivation cases following the administration of COVID-19 vaccines. For cases and controls, significance was set at P = 0.05, differential risk of reporting was assessed for each vaccine as reporting odds ratio and incidence was estimated based on the total number of vaccine doses administered. RESULTS: Of 6,195 cases included in the analysis (5,934 and 273 reporting Herpes Zoster and Herpes Simplex, respectively) over 90% were non-serious. We found a slightly higher risk of reporting both for Zoster (ROR = 1.49) and Simplex (ROR = 1.51) infections following the Pfizer-BioNTech vaccine. The estimated incidence was approximately 0.7/100,000 and 0.03/100,000 for Zoster and Simplex, respectively. CONCLUSIONS: The paucity of cases (almost all of non-serious nature) makes the potential occurrence of this adverse effect negligible from clinical standpoints, thus supporting the good safety profile of the COVID-19 vaccination, which remains strongly recommended.

The use of biological agents in pregnant women affected by autoimmune disorders: Why we need more research of this neglected area.

Women of childbearing age are largely affected by several autoimmune disorders (the estimates range between 1.5 and 10 per 10,000). The increasing number of effective biological agents has dramatically revolutionized the treatment of these clinical conditions, ameliorating the patient's quality of life. The use of these agents by women during pregnancy is growing to ensure the disease activity control and avoid adverse health outcomes. However, for many newer biological agents, the degree of information concerning their use in pregnancy is often incomplete to perform a conclusive risk assessment on fetal and maternal health given the exclusion of this specific population from pharmacological clinical trials. More recently, the COVID-19 pandemic has confirmed the unacceptable inequities of pharmacological research and medical treatment for pregnant and lactating women, exacerbating the need for filling the gaps of quantitative and qualitative pharmacology data in this sensitive population. ere we summarize (i) what is already known about safety and effectiveness of biological agents in this understudied population (with specific focus on pregnancy-related health outcomes), and what we are going to learn from the on-going studies among pregnant women treated with biological agents; (ii) the methodological and ethical considerations that characterize the pharmacological research in pregnancy, also discussing emerging evidence on the use of therapeutic drug monitoring (TDM) in this clinical setting.

Preliminary evidence on the safety profile of BNT162b2 (Comirnaty): new insights from data analysis in EudraVigilance and adverse reaction reports from an Italian health facility.

The first vaccine against SARS-CoV-2 made available in Italy has been BNT162b2, the two-dose mRNA-based vaccine developed by Pfizer-BioNTech. The ASST Fatebenefratelli-Sacco hospital is located in one of the areas most affected by the pandemic, and to date over 2000 healthcare professionals have been injected with both vaccine doses. We have collected all spontaneous safety reports in which BNT162b2 was designated as the possible cause. We also have carried out a descriptive analysis of reports submitted in EudraVigilance in the same time-frame and compared our findings with those observed in clinical trials. We have identified several new and unexpected adverse reactions that will be helpful for reviewing the safety profile defined in the Summary of Product Characteristics for this vaccine.