Safety of mRNA BNT162b2 COVID-19 (Pfizer-BioNtech) vaccine in children aged 5-11 years: Results from an active pharmacovigilance study in central Italy.

This survey investigated on adverse events after vaccination with mRNA BNT162b2 (Comirnaty, Pfizer-BioNTech) vaccine in children aged 5-11 years in central Italy through active surveillance reporting. During December 2021-January 2022, parents of children who undergone vaccination were interviewed using a structured questionnaire. 197 out of 208 contacted parents participated (94.7% response rate), of whom 166 (84.3%) had one child. Of the 229 children, the mean age was 8.9 years, 50.7% were female. 193 (84.3%) had at least one adverse event after the first dose (mean age 9.1 years; 54.4% female), and 146 (73.4%) of 199 after the second (mean age 8.9 years; 54.8% female), which was not administered to 30 children due to previous COVID-19 history. Local symptoms after the first and second dose occurred in 183 (94.8%) and 141 (96.6%) recipients (p = .435), respectively, while systemic reactions in 62 (32.1%) and 34 (23.3%) (p = .074). Mild events were reported by 81.7% and 69.8% children after the first and second dose, followed by moderate (3.9% and 10.6%) and severe (1.3% and 0.5%). After each dose, injection site reactions (79.5% and 68.8%) were the most frequent, followed by headache (13.1%) and lymphadenopathy (8.5%) after the first and second dose, respectively. The adverse events were reported to pediatricians only for 5.7% and 3.9% of children and treated for 17.6% and 15.8%. This is the first report about safety profile through active surveillance of mRNA BNT162b2 among children in Italy, revealing temporary and mild-to-moderate symptoms with no serious events after each vaccine dose.

Biosimilar epoetin α is as effective as originator epoetin-α plus liposomal iron (Sideral®), vitamin B12 and folates in patients with refractory anemia: A retrospective real-life approach.

Several biosimilar versions of recombinant human erythropoietin are currently approved for use in Europe, including a biosimilar epoetin-α. The aim of this the study was to verify that biosimilar epoetin-α is similar in terms of efficacy, safety and cost to originator epoetin-α for the treatment of refractory anemia in patients with myelodysplastic syndrome. A total of 92 patients with myelodysplasia and refractory anemia were investigated. The patients received either originator (group A) or biosimilar (group B) epoetin-α. In addition, they received liposomal iron (Sideral®), calcium levofolinate and vitamin B12. Moreover, the median monthly overall costs were calculated for each group. The results demonstrated that hemoglobin (Hb) levels increased by 1 g/dl after a median time of 5 weeks in group A and 4 weeks in group B. In group A, a Hb level of >12 g/dl was achieved after 12 weeks, while in group B after 10.5 weeks. The median cost of therapy was 1,536 euros/month in group A and 1,354 euros/month in group B. A total of 5 patients required transfusion support in group A and 7 in group B. In conclusion, biosimilar epoetin-α appears to be comparable to originator epoetin-α in terms of efficacy and safety for the treatment of refractory anemia.