Sahpra lifts suspension on J&J vaccines with 'conditions'
The SA Health Products Regulatory Authority (Sahpra) has recommended that the temporary pause on the rollout of the Johnson & Johnson vaccine be lifted “provided that specific conditions are met”, the organisation said in a statement on Saturday evening.
“These conditions include, but are not limited to, strengthened screening and monitoring of participants who are at high risk of a blood clotting disorder.
“Measures are to be implemented to ensure the safe management of any participants who develop vaccine-induced thrombosis and thrombocytopenia (VITT),” Sahpra said.
SA placed a temporary suspension on the J&J vaccination rollout last week while scientists probe the possible link between the vaccine and a rare type of blood clot in the brain.
This is after the US’ Food and Drug Administration reportedly took a decision to pause the use of the vaccination pending a review, after reports that six women in the US developed rare cerebral venous thrombosis, which are blood clots in combination with low blood levels of blood platelets.
A total of 6.6 million people have been vaccinated with J&J in the US.
Sahpra said it had engaged with the J&J’s Sisonke phase 3B implementation study team and Janssen Pharmaceutica to discuss the safety of the vaccines as well as the adverse findings reported in the US.
“Based on their review of the available data, Sahpra has recommended that the pause in the Sisonke study be lifted, provided that specific conditions are met.”
The information sheets as well as the informed consent forms of those who will be vaccinated will be updated to include the newly identified adverse events.
“The participant information sheets and informed consent forms will be updated to include the newly identified adverse events.”
Health-care workers participating in the Sisonke study will also be informed about the possible risks of developing a blood clotting disorder after vaccination.
“They will also be advised to seek immediate medical assistance if they develop early signs and symptoms associated with blood clots or low platelet counts. The study team will submit the required updated documents, procedures and study arrangements to Sahpra for approval.”
While Sahpra recommended the lift, the resumption of the Sisonke phase 3B implementation study still requires the approval from relevant ethics committees.