Sahpra reviewing side-effects related to Johnson & Johnson’s Covid-19 vaccine



The South African Health Products Regulatory Authority (SAHPRA) is yet to clarify details surrounding side-effects related to the Johnson and Johnson Covid-19 vaccine.

Researchers with the Food and Drug Administration (FDA) and Centers for Disease Control and Prevention in the US found that the vaccine resulted in 60 confirmed cases of thrombosis with thrombocytopenia syndrome.

This leads to rare but potentially life-threatening blood clots, the FDA said, one to two weeks after receiving the shot.

With multiple vaccines available, the FDA decided to bench the J&J vaccine, only to be used when other options are unavailable.

Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research said the institution recognize that the Janssen Covid-19 Vaccine still has a role in the current pandemic response in the United States and across the global community.

“Our action reflects our updated analysis of the risk of TTS following administration of this vaccine and limits the use of the vaccine to certain individuals. We’ve been closely monitoring the Janssen Covid-19 Vaccine and occurrence of TTS following its administration and have used updated information from our safety surveillance systems to revise the EUA.” 

“The agency will continue to monitor the safety of the Janssen COVID-19 Vaccine and all other vaccines, and as has been the case throughout the pandemic, will thoroughly evaluate new safety information,” Mark said.

Seeking to get clarity on the severity of the side effects, The Citizen reached out to the National Health Department and Sahpra with regards to the impact and who may be potentially at risk.

While the Health Department did not respond to the query, Sahpra spokesperson Yuven Gounden said they are investigating.

“Sahpra is in the process of reviewing the information as reported by the FDA together with the AEFI reports received locally, and will be issuing a media statement shortly to advise on the way forward. More than 18.7 million doses of the J&J vaccine have been administered in the U.S. since it was first approved for emergency use, the Centers for Disease Control and Prevention reported. Of which, a total of 60 cases of TTS have been confirmed, including nine deaths.

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