Question NW1177 to the Minister of Health
21 April 2022 - NW1177
Chirwa, Ms NN to ask the Minister of Health
In light of the fact that the SA Health Products Regulatory Authority (SAHPRA) is said to not have known about the report that the Food and Drug Administration received from Pfizer and used to authorise the vaccines, (a) which report and evidence was utilised by SAHPRA to determine the safety of Pfizer, (b) was it inclusive of the recently publicised report on the adverse effects of the vaccine and (c) was SAHPRA aware of the possible side effects and adverse effects of the Pfizer vaccine?
Reply:
a) SAHPRA has considered all Clinical Trials and clinical data submitted in the application for emergency access and registration, as well as all periodic safety update reports received; Adverse Drug Reaction (ADRs) received as well as reports and information shared by other Regulators that SAHPRA aligns with such as EMA European Medicines Agency (EMA); USFDA (USA); PMDA(Japan); Health Canada; TGA (Australia); Swissmedic. Therefore, at the time of approval these are considered and that on an ongoing basis SAHPRA continuously receives and reviews safety updates as these are reported and hence the agency is constantly monitoring for safety and will update its report on any product based on these reviews.
b) SAHPRA is constantly reviewing safety updates and where there is a need for update and communicate such changes accordingly. SAHPRA approvals are based on clinical data submitted and these are done on risk benefit basis. The reports available at the time of review are considered. Note that SAHPRA approval of the Comirnaty vaccine for patients 12 years and older was done and communicated on 16 September 2021 and reviews and approvals were based on data available at the time. The date of registration is 25 January 2022 and is prior to the recently published reports. Thus, at the point of initial approval this report was not considered. This report now and based on the current PV data which is continuously monitored by SAHPRA there is still benefit exceeding risk in the populations this vaccine has been approved for and for the population the review was based on.
c) Yes, SAHPRA has received the clinical trial information as well as adverse events reported including those of trials and as published. All information regarding the side effects and adverse drug reactions as reported in various studies and as are adequately documented and validated are considered and SAHPRA is therefore of the view that as current information becomes available it is reviewed and the outcome of the regulatory decision would then be updated accordingly, however if there is no change in this decision it would mean that following assessment the risk benefit has not changed. SAHPRA convened webinars to educate the public on the side effects and adverse events of vaccines.
END.