INFORMATION AND GUIDANCE ON APPLICATION FOR REGISTRATION OF CANDIDATE COVID-19 VACCINE

Coronavirus disease (COVID-19) is an infectious disease caused by a newly discovered coronavirus, SARS- CoV-2. The rapid spread of this virus has resulted in the COVID-19 pandemic that has led to a dramatic loss of human life worldwide and presents an unprecedented challenge to public health, food systems and the world of work. The economic and social disruption caused by the pandemic is devastating. In an attempt to tackle this novel virus, many pharmaceutical companies are busy manufacturing and investigating possible candidate vaccines that can be used to limit the spread of Covid-19 virus.

SAHPRA in readiness for the possible registration of Covid-19 vaccines has adopted approaches, which seeks to expedite access to quality, safe and efficacious vaccine to the South African public.

SAHPRA routinely processes the applications for registration of various vaccines, and it may be naturally assumed that the evaluation process for Covid-19 candidate vaccines would follow the same pathway. However, due to the global impact of the Covid-19, the anticipated applications for registration of Covid-19 vaccines need to be expedited and some of the applications received may not fully comply with ZA-CTD requirements, this may present some challenges in terms of how to approach the assessments and what modalities are  available to facilitate such assessments.

To that end, SAHPRA’s intention with this document is to provide guidance to applicants who wish to submit the applications for registration of Covid-19 vaccine.

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