South Africa suspends roll-out of the Johnson and Johnson vaccine- 13 April 2021

Office of the Premier 2021/04/12 - 22:00



Qaqambile Mdledle

Health Minister, Zweli Mkhize on Tuesday, 13 April announced the immediate suspension of the Johnson and Johnson vaccine which the country has been using since the beginning of the national COVID-19 vaccination programme.

This follows a meeting with the country's health experts to discuss the implications of the United State's decision to pause the administering of the Johnson and Johnson (J&J) following reported cases of rare blood clots  

"This has occurred to due reports of 6 females who developed unusual blood clots with low platelets. These incidents occurred between 6 and 13 days after vaccination in women between the ages of 18 and 48 years old," said Mkhize.

He did however reassure South Africans that there have not had any reports of clots that have formed after vaccination, and this is after having inoculated 289 787 health care workers under the Sisonke Protocol.

The Minister had an urgent consultation with scientists following the Food and Drug Administration in the United States of America advising the temporary suspension of the Johnson and Johnson vaccine rollout in the US.

"We have been advised that we cannot take the decision made by the FDA lightly. 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.

The South African Health Products Authority (SAHPRA) will collate information from Johnson and 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.

The Minister also said so far there is no cause for alarm and the public should know that such reports are expected to emerge as part of a robust post market surveillance system.

Even though the coronavirus vaccines were developed more quickly than other vaccines in the past, they have been carefully tested and continue to be monitored.

According to department of health, all vaccines need to go through the three phases of a clinical trial and will only be licensed for use by the national regulatory authority in the country where it is manufactured after adequate clinical studies have been conducted to confirm that the vaccine is effective and safe for use.

He also reassured the public that if the J&J rollout is completely halted, there will be no impediment to proceed with phase two of the rollout with Pfizer.

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