Question NW1178 to the Minister of Health
21 April 2022 - NW1178
Chirwa, Ms NN to ask the Minister of Health
How does (a) the newly released report on the Pfizer vaccine impact the decision of the SA Health Products Regulatory Authority (SAHPRA) to authorise the vaccine in the Republic and (b) SAHPRA still hold the view that the vaccine is safe to be rolled out, following the recently publicised report regarding the vaccine and its adverse effects?
Reply:
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risk benefit of the vaccine, this will then be given conditions under which it can be used and if so deemed it may be withdrawn from market and for use.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.