The South African Health Products Regulatory Authority says the two patients who presented with thrombosis or thrombocytopenia syndrome (TTS) after receiving the J&J Covid-19 vaccine made a full recovery.
Meanwhile, the other two cases are still under investigation.
SAHPRA said that out of more than 8.5 million people who have received the vaccine, only four cases of TTS have been reported in South Africa.
“The risk of TTS is addressed in the Approved Professional Information (PI) and Patient Information Sheet (PIL), SAHPRA said in a statement.
The PI and GDP state that the J&J vaccine should not be given to patients with a history of TTS.
“Additionally, TTS is included in the PI and GDP as a special warning and is listed as an undesirable effect,” added SAHPRA.
However, the health products regulatory body said the benefits of receiving the jab in terms of preventing the spread of Covid-19 far outweigh the risks.
The single dose of J&J has been approved in both the United States and South Africa as a single primary dose or as a booster for people over 18 years of age.
But on May 5, 2022, the US Food and Drug Administration (FDA) revised the approval of the J&J jab with specific restrictions, which include an age limit (18 years and above) or “clinically appropriate individuals.”
“The FDA had noted 60 confirmed cases of a rare but life-threatening syndrome of blood clots combined with low platelet levels.
“The onset of symptoms occurred approximately one to two weeks after the administration of the Covid-19 Janssen vaccine. It should be noted that this is not a new signal as it was already reported in 2021, “SAHPRA said in a statement.
SAHPRA approved the J&J injection for patients over the age of 18 in March last year. The safety and effectiveness of J&J shots for children and adolescents (under the age of 18) have not yet been established.
SAHPRA then approved the use of the J&J shot for boosters in December 2021.
“SAHPRA, in line with the World Health Organization (WHO) and the European Medicines Agency (EMA), has determined that the known benefits of the Janssen Covid-19 vaccine for the prevention of Covid-19 far outweigh the known and potential risks of receiving the vaccine “.
SAHPRA said it is monitoring the vaccine’s effectiveness against variants of concern and the safety profile of the J&J vaccine.
“The Covid-19 Janssen (J&J) vaccine remains effective in reducing disease severity and hospitalization,” he said.
Healthcare professionals and the public must report all adverse events after receiving their shots, via the Med Safety app.
The App can be downloaded via Google Play or the App Store. For more information on reporting adverse events after immunization, visit the SAHPRA place.