- Sahpra says that it has found four rare blood clot cases in people after taking the J&J vaccine.
- Two of the patients have fully recovered, while the remaining two cases are still under investigation.
- The body will continue to monitor the effects of all Covid-19 vaccines.
The South African Health Products Regulatory Authority (Sahpra) has found four cases of thrombocytopenia syndrome (TTS), a rare but life-threatening syndrome involving blood clots, following the J&J Covid-19 vaccine.
The organisation looked at more than 8.5 million J&J vaccinations, and found that only four people reported blood clots.
“Two cases reported from the Sisonke cohort were confirmed to have TTS and have fully recovered. The remaining two are still under investigation. Sahpra will share further information with the public as soon as the investigations are completed and causality is assessed,” the body said on Thursday evening.
Risk of TTS not new
The United States Food and Drug Administration restricted the use of the J&J vaccines to people above 18 after finding 60 TTS cases. In South Africa, the vaccine has only been approved for people above 18.
“On 31 March 2021, SAHPRA approved the use of the Covid-19 Vaccine Janssen in individuals 18 years of age and older. The SAHPRA-approved professional information (PI) notes that the safety and efficacy of Covid-19 Vaccine Janssen have not yet been established in children and adolescents (younger than 18 years of age),” the statement reads.
Sahpra says that the risk of TTS is not new. It was first reported in 2021.
J&J vaccine remains safe
Sahpra says that the J&J vaccine remains safe and effectively reduces the risk of severe Covid-19 and Covid-19-related deaths.
“Sahpra, in line with the World Health Organization (WHO), as well as the European Medicines Agency (EMA), has determined that the known benefits of the J&J Janssen Covid-19 vaccine for the prevention of Covid-19 greatly outweigh the known and potential risks of receiving the vaccine,” the regulator said.
The organisation said it would continue to monitor the vaccine side effects and encourage healthcare workers and the public to report all adverse events following vaccination with Covid-19 vaccines, including the J&J vaccine, through the Med Safety App.