Sahpra reviews side effects associated with Johnson & Johnson’s Covid-19 vaccine.



The South African Health Products Regulatory Authority (SAHPRA) has not yet clarified the details related to the side effects associated with the Johnson and Johnson Covid-19 vaccine.

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

This leads to rare but potentially life-threatening blood clots one to two weeks after vaccination, according to the FDA.

With several vaccines available, the FDA has decided to keep the J&J vaccine for use only when no other options are available.

Peter Marks, director of the FDA’s Center for Biological Evaluation and Research, said the institution recognizes that the Janssen Covid-19 vaccine still plays a role in the current pandemic response in the United States and around the world.

“Our actions reflect our updated TTS risk analysis following the introduction of this vaccine and restrict the use of the vaccine to certain individuals. We have closely monitored the Janssen Covid-19 vaccine and the occurrence of TTS following its introduction and have used updated information from our safety surveillance systems to review the EUA.”

“The agency will continue to monitor the safety of Janssen’s COVID-19 vaccine and all other vaccines and, as it has done throughout the pandemic, will carefully evaluate new safety information,” Mark said.

In an effort to gain clarity on the severity of side effects, Citizen contacted the Ministry of Health and Sahpra regarding exposure and who may be potentially at risk.

While the health ministry did not respond to the request, Sahpra spokesman Juven Gunden said they were investigating.

“Sahpra is in the process of reviewing the information provided by the FDA, along with reports of AEFI received locally, and will soon release a media statement to advise on further action. More than 18.7 million doses of the J&J vaccine have been administered in the US since it was first approved for emergency use, according to the Centers for Disease Control and Prevention. Of these, 60 cases of TTS were confirmed, including nine deaths.

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