South Africa has joined the US in suspending its rollout of the Johnson & Johnson COVID-19 vaccine, following reports that six women who received the immunisation doses had developed unusual blood clots with low platelet count. After this advisory came to my attention, I held urgent consultations with our scientists, who have advised that we cannot take the decision made by the US Food and Drug Administration (FDA) lightly.
Based on their advice, we have determined to voluntarily suspend our rollout until the causal relationship between the development of clots and the Johnson and Johnson vaccine is sufficiently interrogated, Health Minister Zweli Mkhize said in a statement on Tuesday evening. Mkhize emphasised that there had not been any reports of clots that have formed after vaccinations in South Africa, despite 289,787 health care workers already having received the vaccine. All the cases of blood colt-related complications have arisen from the US.
The South African Health Products Regulatory Authority will collate information from Johnson & Johnson, the FDA and other regulatory bodies to make a thorough assessment of the situation and advise us as a regulatory body that has exercised its authoritative powers on the approval of the vaccine in their own right, Mkhize said.
The minister called for patience, saying that the discussion around the suspension might only take a few days. 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 vaccination armament, he said.
We are confident that the rollout of Johnson & Johnson will resume and so, with 30 million doses of Johnson & Johnson and 30 million doses of Pfizer secured we now have enough doses to exceed the 40 million we were targeting this year. This is in line with our commitment to vaccinate as many people as possible in this financial year- in the ideal scenario we would vaccinate every single adult found in South Africa, the minister said.
The minister added that the additional Pfizer vaccines would also not impede the government’s vaccine roll-out plan. This also reassures us that, in the extremely unlikely event that the Johnson and Johnson rollout is completely halted, we will not have any impediment to proceed with phase two of the rollout with Pfizer, he said.
South Africa has so far lost 53,498 lives to COVID-19, along with 1,561,559 confirmed cases, according to Johns Hopkins University.
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