SAHPRA: Benefits of J&J vaccine in preventing Covid-19 far outweigh the risks

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 have fully recovered.

Meanwhile, the other two cases are still under investigation.

SAHPRA said out of more than 8.5 million people who did receive the vaccine, only four cases of TTS were reported in South Africa.

“The risk of TTS is addressed in the approved professional information (PI) and patient information leaflet (PIL), said SAHPRA in a statement.

The PI and PIL state that the J&J vaccine should not be given to patients 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,” SAHPRA added.

Still, the health product 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 J&J shot had been approved in both the United States and South Africa as a primary single dose or a booster for people older than 18.

But on 5 May 2022, the United States Food and Drug Administration (FDA) revised the approval of the J&J jab with specific restrictions, which include an age limit (18 years and older) or ‘clinically appropriate individuals.’

“The FDA had noted 60 confirmed cases of a rare but life-threatening syndrome of blood clots in combination with low levels of platelets.

“The onset of symptoms occurred approximately one to two weeks following administration of the Covid-19 Vaccine Janssen. It must be noted that this is not a new signal as it was already reported in 2021,” said SAHPRA in a statement.

SAHPRA approved the J&J shot for patients older than 18 in March last year. The safety and efficacy of J&J shots for children and adolescents (younger than 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 line with the World Health Organization (WHO), and the European Medicines Agency (EMA), determined the known benefits of the Covid-19 vaccine Janssen for the prevention of Covid-19 greatly outweigh the known and potential risks of receiving the vaccine.”

SAHPRA said it is monitoring the vaccine’s efficacy against variants of concern and the safety profile of the J&J jab.

“The Covid-19 Vaccine Janssen (J&J) remains effective in reducing disease severity and hospitalisation,” it 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 through the Google Play or App Store. For more information on reporting adverse events following immunisation, please visit the SAHPRA website.

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