The South African Health Products Regulatory Authority reports that two patients who developed thrombosis or thrombocytopenia syndrome (TTS) after receiving the J&J Covid-19 vaccine have made a full recovery.
Meanwhile, two other cases are still under investigation.
SAHPRA said that of more than 8.5 million people who received the vaccine, only four cases of TTS have been reported in South Africa.
“TTS risk is addressed in the Approved Professional Information (PI) and Patient Information Leaflet (PIL),” SAHPRA said in a statement.
PI and PIL state that the J&J vaccine should not be given to patients with a history of TTS.
“In addition, TTS is included in PI and PIL as a special warning and is listed as an undesirable effect,” added SAHPRA.
However, the health products regulatory authority said the benefits of getting vaccinated in terms of preventing the spread of Covid-19 far outweigh the risks.
The single-dose J&J vaccine has been approved in both the United States and South Africa as a single-dose primary or booster dose for people over 18 years of age.
But on May 5, 2022, the U.S. Food and Drug Administration (FDA) revised the approval of the J&J vaccine with specific restrictions, including an age limit (18 years or older) or “clinically eligible individuals.”
The FDA has noted 60 confirmed cases of a rare but life-threatening thrombus syndrome associated with low platelets.
“The onset of symptoms occurred about one to two weeks after the administration of the Janssen Covid-19 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 vaccine for patients over 18 in March last year. The safety and efficacy of J&J injections in children and adolescents (under 18 years of age) have not yet been established.
SAHPRA then approved the use of the J&J shot for boosters in December 2021.
SAHPRA, in conjunction 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 preventing Covid-19 far outweigh the known and potential risks of receiving the vaccine. vaccine”.
SAHPRA said it is monitoring the efficacy of the vaccine against the variants of concern and the safety profile of the J&J vaccine.
“The Janssen (J&J) Covid-19 vaccine continues to be effective in reducing disease severity and hospitalization rates,” the report said.
Healthcare professionals and the public must report all adverse events following vaccination through the Med Safety app.
The app can be downloaded from Google Play or the App Store. For more information on reports of adverse events following immunization, visit the SAHPRA website. Web site.