The South African Health Products Regulatory Authority (SAHPRA) has responded to the United States Food and Drug Administration's (FDA) decision to revise the approval of the COVID-19 Vaccine Janssen.
The decision was made after the FDA noted 60 confirmed cases of a rare but life-threatening syndrome of blood clots in combination with low levels of platelets, referred to as thrombosis with thrombocytopenia syndrome (TTS).
The onset of symptoms occurred approximately one to two weeks following the administration of the vaccine.
SAHPRA spokesperson Dr Boitumelo Semete-Makokotlela says of the 8 589 109 J&J vaccines administered in South Africa four cases of TTS were reported of which two patients completely recovered.
She says the J&J booster dose was approved on 22 December 2021, for individuals 18 years and older and the risk of TTS is addressed in the approved professional information (PI) and patient information leaflet.
Dr Semete-Makokotlela says the known benefits of the Vaccine Janssen for the prevention of COVID-19 greatly outweigh the known and potential risks of receiving the vaccine.
She says the J&J vaccine remains effective in reducing disease severity and hospitalisation.
