Vaccination pause should be lifted, says Health Products Regulatory Authority

THE South African Health Products Regulatory Authority (Sahpra) has recommended that the pause in the Sisonke Implementation Study be lifted, provided that specific conditions are met.

This after Health Minister Dr Zweli Mkhize said the country would be temporarily suspending the administration of the Johnson & Johnson (J&J) vaccine, a part of the study, following the discovery of six cases of blood clotting disorders in the US.

The US Food and Drug Administration and the Centers for Disease Control and Prevention have since temporarily suspended their roll-out, pending further investigation.

During a media briefing on Tuesday, Dr Mhize said he did not believe the suspension would result in the complete withdrawal of the J&J vaccine from the country’s roll-out.

On Saturday, Sahpra released a statement following discussions with the Sisonke Phase 3B Implementation Study team and Jannsen Pharmaceutica on the safety data and adverse events reported in the US. The recommendation that the pause be lifted was made based on a review of the data, provided that specific conditions are met.

“These conditions include, but are not limited to, strengthened screening and monitoring of participants who are at a high risk of 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. The participant information sheets and informed consent forms will be updated to include the newly identified adverse events,” read the statement.

“Participants in the Sisonke study will 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 count.

“The study team will submit the required updated documents, procedures and study arrangements to Sahpra for approval.”

South Africa has secured about 30 million doses of the J&J vaccine, along with 30 million doses of the Pfizer vaccine, for the financial year.