PB0067 - Safety of Sinopharm covid-19 Vaccine in Iranian Patients with congenital bleeding disorders: A Preliminary Report

Background: There are limited data regarding safety of Sinopharm vaccine in patients with congenital bleeding disorders (CBD). The guidance published by World federation of hemophilia mainly recommends prophylaxis therapy in hemophilia patients with factor activity below 10% before getting vaccinated.

Aims: To evaluate side effects of Sinopharm vaccine in patients with CBD.

Methods: A total of 93 patients including 75 males and 18 females who filled the consent form, participated in this historical cohort study. A questionnaire was designed to report any experienced side effects. In case of continuing feel of discomfort at the injection site, it was recommended to administration of coagulation factor concentrate.

Results: The mean age of the patients was 37 ±12.8 (18-78) years. The type of bleeding disorders is shown on table 1. The disease severity was mild in 41.9%, moderate in 8.9%, and severe in 41.9% of the patients. About 65% of patients had coagulation factor activity less than 10%. Comorbidities were seen in 7 patients. The most common reported side effects were headache (6.6%), feeling weakness (5.5%) and body pain (4.4%). Two patients (2.1%) experienced hematoma following vaccination in injection site, one severe hemophilia A patient who recovered without any treatment. Another one was a severe hemophilia B who received Factor concentrate resulted in disappearing hematoma.

Conclusion(s): No safety concerns were detected in patients who received two doses of Sinopharm vaccine. Moreover, our results showed that it seems vaccination is safe in patients with factor activity less than 10% without giving prophylaxis. This issue is important due to the limited access to coagulation factors in developing countries.