SA pauses J&J vaccine rollout over clot fears

SA will suspend the rollout of the Johnson & Johnson Covid-19 vaccine over blood clot fears.

This was announced by health minister Dr Zweli Mkhize on Tuesday evening.

The move comes after a decision by the US Food and Drug Administration (FDA) to advise the temporary suspension of the vaccine rollout in America.

Mkhize said: “This has occurred due to reports of six females who developed unusual blood clots with low platelets.

“These incidents occurred between six and 13 days after vaccination in women between the ages of 18 and 48.

“It must be noted that more than 6.6-million citizens have been inoculated with the Johnson & Johnson vaccine in the US.”

Mkhize stressed that in SA there had not been any reports of clots that had formed after vaccination, “and this is after having inoculated 289,787 health-care workers under the Sisonke Protocol”.

He said that after the US advisory came to his attention, he had held urgent consultations with SA scientists, who had advised that the decision taken by the FDA could not be taken 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 & Johnson vaccine is sufficiently interrogated.

“Sahpra [SA 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 its own right.”

The minister hoped  that the deliberations would 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 & 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.”

Meanwhile, the government has successfully negotiated for a further 10-million vaccine doses from Pfizer.

Of these, just under two-million are expected to be delivered in May.

“This, therefore, means we have secured 30-million doses of the Pfizer vaccine for this financial year.

“This also reassures us that, in the extremely unlikely event that the Johnson & Johnson rollout is completely halted, we will not have any impediment to proceed with phase two of the rollout with Pfizer,” Mkhize 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.”

Aspen Pharmacare’s sterile facility in Gqeberha is “filling and packing” the J&J vaccine before its distribution.

The raw materials for the doses come from the US and the Netherlands.- HeraldLIVE