On Tuesday, 13 April 2021, the Minister of Health Dr Zweli Mkhize announced the temporary pause of the Johnson & Johnson Sisonke study in South Africa. The announcement follows a decision by the United States Food and Drug Administration (US FDA) and the Centres for Disease Control (CDC) to halt the rollout of the J&J vaccine in the USA after six female patients presented a rare clotting disorder.
Healthcare workers who have received the J&J vaccine are assured that no cases of clotting associated with low platelet counts, central venous thrombosis or disseminated intravascular coagulation (DIC) have been reported amongst the nearly 290 000 healthcare workers who have been administered the J&J vaccine.
Healthcare workers who have been vaccinated against COVID-19 more than three weeks ago are not at an increased risk of developing a thromboembolic event. And those who have been vaccinated less than three week ago are advised to seek care hastily if they present any of the following symptoms: breathlessness; pain in the chest or stomach; swelling or coldness in a leg, severe headache or blurred vision; persistent bleeding; multiple small bruises; reddish or purplish spots, or blood blisters under the skin. It is important to advice your doctor or occupational nurse that you have recently been vaccinated, and for them to report the incident to the Sisonke Desk on 0800 014 956.
It is essential to monitor the safety and efficacy of COVID-19 vaccines and the next steps will see the South African Health Products Regulatory Authority collating information in order to make a thorough recommendation. Hopes are high to resume the Sisonke study soon and citizens are encouraged to take the COVID-19 vaccine once they are eligible.