a) When new information is shared with SAHPRA either by the applicants or by reports shared from other regulators and/or also published journal information it is reviewed considering existing approval. Therefore, the report received in respect of the Pfizer vaccine is being reviewed to establish whether changes will be required in the current approved status. If there are changes required, these will be communicated to the applicant to provide details of the findings and recommendations. Following the applicant’s inputs/response, SAHPRA will then pronounce on changes to be effected and if it severely impacts on the safety and efficacy and affects the risk benefit of the vaccine, this will then be given conditions under which it can be used and if so deemed it may be withdrawn from market and for use.
b) Yes, SAHPRA still holds the view that vaccines are safe to be rolled out. This is based on the outcome of the safety reports which indicated that the benefit-risk ratio of these vaccines remains positive.
END.