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The South African Department of Health has put the Johnson & Johnson (J&J) Covid-19 vaccine on hold temporarily, while it investigates a possible link between the jab and a rare blood clot disorder.
Johnson & Johnson vaccine
This follows the Food and Drug Administration's (FDA's) decision to suspend the J&J vaccine after an unusual blood clot condition with a low platelet count was reported in six women between the ages of 18 and 48, even though over 6.6 million J&J shots have been administrated in the United States. The clots manifested in six to 13 days after the patients had the vaccine.
No similar side effects in SA
South African health minister, Dr Zweli Mkhize, was at pains to point out that 289,787 healthcare workers have been inoculated with the J&J vaccine under the Sisonke Protocol, without any similar side effects being reported.
“Based on their advice, we have determined to voluntarily suspend our roll-out until the causal relationship between the development of clots and the Johnson & Johnson vaccine is sufficiently interrogated,” Mkhize said.
He is optimistic that the suspension would only last 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 & Johnson vaccine from the vaccination armament."
“We also wish to assure citizens that these kinds of reports are expected to emerge as part of a robust post-market surveillance system. This should provide comfort that medical authorities keep a vigilant watch on all new products that are deployed into the market to ensure they remain safe and effective for human consumption. It is for this reason that we implemented the Sisonke Protocol and will also implement a similar post-market surveillance study for Pfizer when we roll out the first batch of doses to healthcare workers.”
He said the South African Health Products Regulatory Authority (Sahpra) will collate information from Johnson & Johnson, the FDA and other regulatory bodies to make a thorough assessment of the situation and provide further guidance. Sahpra has approved the Johnson & Johnson vaccine for use in South Africa.
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