SAHPRA recommends that government resumes the J&J vaccine rollout
The South African Health Products Regulatory Authority (SAHPRA) recommended that the pause on the Johnson & Johnson (J&J) vaccine Sisonke study should be lifted, on Saturday, 17 April.
Health Minister Dr Zweli Mkhize suspended the study on Tuesday, 13 April, following a caution issued by the United States Food and Drug Administration (FDA) after six women, out of approximately 6.6 million citizens that received the J&J vaccine, reportedly developed “unusual” blood clots with low platelets. The blood clotting incidents in the US reportedly occurred between 6 and 13 days after vaccination.
NO BLOOD CLOT INCIDENTS IN SOUTH AFRICA AFTER NEARLY 300K J&J JABS
“In South Africa, we have not had any reports of clots that have formed after vaccination and this is after having inoculated 289 787 health care workers under the Sisonke Protocol,” said Mkhize in a statement on 13 April.
Mkhize, however, added that the decision to suspend South Africa’s rollout of the J&J vaccine was based on urgent consultations with scientists.
“We hope that the deliberations will only take a few days. Given the preliminary literature on hand, our scientists are confident that the FDA’s decision is on a precautionary basis and we expect that this will not result in the complete withdrawal of the Johnson and Johnson vaccine from the vaccine armament,” said Mkhize.
SAHPRA GIVES J&J ROLLOUT THE GREENLIGHT
In the statement issued on Saturday, SAHPRA said that based on their review of the available data, the pause on the Sisonke study can be lifted “provided that specific conditions are met.”
According to the regulator, the conditions include, but are not limited to, improved screening and keeping an eye on participants who have a high risk of a blood clotting disorder.
“In addition, measures are to be implemented to ensure the safe management of any participants who develop vaccine-induced thrombosis and thrombocytopenia (VITT),” said SAHPRA.
The documents participants have to complete, including participant information sheets and informed consent forms, will be updated to include the newly identified adverse potential effects of the vaccine.
“Participants in the Sisonke study will be informed about the possible risks of developing a blood clotting disorder after vaccination,” added the regulator. “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 resumption of Phase 3B of the Sisonke Study is dependent on the J&J study team submitting updated documents, procedures and study arrangements to SAHPRA and the approval from the relevant Research Ethics Committees.
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