SAHPRA UPDATE ON VACCINE APPROVALS
21 June 2021
SAHPRA as an independent health products regulatory authority focuses on the three pillars of quality, safety and efficacy. These core elements of its mandate also apply to COVID-19 vaccines as well.
The normal process for the evaluation of a vaccine, necessitates that all the required information regarding product safety, efficacy and quality be provided at the time of submission. In other words, all the clinical trial data for safety and efficacy from phase one to three should be provided together with manufacturing information of the product quality. The assessment is then conducted considering all information provided.
In an effort to respond to the pandemic, SAHPRA introduced another mechanism to facilitate review of COVID-19 applications, which is the rolling review process. The rolling review is a mechanism that facilitates the submission of data as it becomes available. Whilst reviews can commence earlier with a rolling submission, it is important to note that some very important efficacy, quality and safety information is sometimes outstanding and would require review for consideration of such products for public use. Therefore, Pharmaceutical companies can submit applications indicating a plan of when they will be submitting their data, i.e outline when the next rolling submission sequence is available for review.
When an applicant submits their respective dossiers, SAHPRA works closely with the applicant in evaluating the data. Technical, subject matter experts within SAHPRA and external members that are appointed by the CEO, comprise the team that evaluates these applications. SAHPRA also works closely with other regulators across the world as well as with the World Health Organisation (WHO) in assessing the quality, safety and efficacy of health products, and in this case, COVID-19 vaccines.