[16 MARKS]The South African Health Products Regulatory Autho…
The South African Health Products Regulatory Authority recently received multiple post-marketing spontaneous reports from a global biopharmaceutical company marketing a new mRNA-based vaccine against a respiratory viral infection. The reports are for rare but severe cases of myocarditis following vaccination, particularly in young adults. The Pharmacovigilance Unit manager has requested you to lead the safety communication process.Discuss the key considerations and practical application of safety communication in pharmacovigilance and safety surveillance, using this scenario as context. (16 marks)