(350) Transverse Myelitis Associated with Tozinameran Use: Adverse Events- Signal

Background: Tozinameran (COVID-19 Vaccine, mRNA) is indicated for active immunization to prevent coronavirus disease 2019 (COVID-19) caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in individuals five years of age and older. Transverse myelitis is a rare neurological condition. It's caused by inflammation of the spinal cord. The swelling damages the nerves and can leave permanent scars or lesions. A signal of Tozinameran and transverse myelitis was found. Saudi Food and Drug Authority (SFDA) has conducted this safety review based on that.

Objectives: The purpose of this review is to evaluate the risk of transverse myelitis in association with Tozinameran use and, if necessary, make regulatory recommendations.

Methods: We carried out a thorough analysis and causality evaluation of local and global cases of Tozinameran-associated transverse myelitis using the Saudi NPC database and the WHO worldwide database, Vigibase. To find supporting evidence, literature was also searched, and disproportionality analysis was performed. Information Component (IC) was used to calculate the reporting ratio.

Results: Cases Review: A search in the World Health Organization (WHO) database (Vigibase) was conducted to retrieve all reported cases via the signal detection tool (Vigilyze). The search resulted in 733 Individualized Case Safety Reports (ICSRs). The authors applied WHO-UMC causality on 30 cases with the highest completeness score. The assessment resulted in 28 cases with possible association, and two cases were unassessable due to lack of information. Data mining: Information Component (IC) value was measured using the method for disproportionality analysis developed by the Uppsala Monitoring Center (UMC). (1.4) value for spontaneous reporting suggests that the reported cases of myelitis transverse have been observed more with Tozinameran when compared to other medications in the WHO database. Literature: Upon conducting a literature search, a case report of a 26-year-old female presented with anesthesia, numbness, and allodynia was found. The symptoms appeared three days after receiving BNT162B2 SARS-CoV-2 (Pfizer-BioNTech) vaccine. Her clinical picture was suggestive of incomplete subacute transverse myelitis.

Conclusions: The weighted cumulative evidence identified from the causality assessment of the reported cases, and literature are sufficient to support a causal association between Tozinameran and the risk of transverse myelitis. Health regulators and health care professionals must be aware of this potential risk and it is advisable to monitor any signs or symptoms in treated patients.