J&J vaccine benefits outweigh risks: SA Health Products Regulatory Authority
Four cases of thrombosis with thrombocytopenia syndrome in the country
The SA Health Products Regulatory Authority (Sahpra) says out of the more than 8.5-million people who received the Johnson & Johnson (J&J) Covid-19 vaccine in SA, only four had presented with thrombosis with thrombocytopenia syndrome (TTS).
“Sahpra has been informed of four cases of TTS in SA following 8,589,109 vaccinations with the Covid-19 vaccine , including Sisonke study doses. Two cases reported from the Sisonke cohort were confirmed to be TTS and have fully recovered.
“The remaining two cases are under investigation. Sahpra will share further information with the public as soon as the investigations are completed, and causality is assessed,” it said.
The authority was responding to restrictions imposed in the US on the use of the vaccine. There have been 60 confirmed cases of a rare but life-threatening syndrome of blood clots in combination with low levels of platelets, referred to as TTS, in the US.
“Sahpra, in line with the World Health Organisation and the European Medicines Agency has determined the known benefits of Janssen vaccine for the prevention of Covid-19 greatly outweigh the known and potential risks of receiving the vaccine.
“The authority continues to monitor closely the efficacy against variants of concern and the safety profile of the vaccine as determined in the approved risk management plan. The Janssen vaccine remains effective in reducing disease severity and hospitalisation.”
In the US and SA, the J&J vaccine was approved as a single primary vaccination dose, with a single booster dose at least two months after the primary vaccination dose, and as a heterologous booster dose after completion of primary vaccination with a different Covid-19 vaccine.
“On May 5 2022, the US Food and Drug Administration (FDA) revised the approval of the Janssen Covid-19 vaccine for use in that country with specific restrictions. In the US, the vaccine may only be administered to individuals 18 years of age and older for whom other FDA-authorised or approved Covid-19 vaccines are not accessible or clinically appropriate, and to individuals 18 years of age and older who elect to receive this vaccine because they would otherwise not receive a Covid-19 vaccine.
“The FDA had noted 60 confirmed cases of a rare but life-threatening syndrome of blood clots in combination with low levels of platelets, referred to as TTS. The onset of symptoms occurred approximately one to two weeks following administration of the Janssen Covid-19 vaccine. It must be noted this is not a new signal, as it was reported in 2021,” said Sahpra.
On March 31 last year, Sahpra approved the use of the J&J vaccine in individuals 18 and older.
“The Sahpra-approved professional information (PI) notes that the safety and efficacy of the Janssen Covid-19 vaccine have not yet been established in children and adolescents (younger than 18 years of age). Sahpra approved the Janssen Covid-19 vaccine booster dose on December 22 for individuals 18 and older.
“The risk of TTS is addressed in the approved PI and patient information leaflet (Pil) for the Janssen Covid-19 vaccine. The PI and Pil contraindicates the use of this vaccine in individuals with a history of TTS. Furthermore, TTS is included in the PI and Pil as a special warning and is listed as an undesirable effect.”
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