Health Minister Zweli Mkhize has announced that South Africa will temporarily suspend its Johnson & Johnson COVID-19 vaccine rollout.
This followed a recommendation from U.S. health officials to pause the use of Johnson & Johnson’s COVID-19 vaccine based on concerns about rare and severe blood clotting side effects.
A type of brain blood clot called cerebral venous sinus thrombosis was seen in combination with low levels of blood platelets in six women between the ages of 18 and 48.
The U.S. Centers for Disease Control and Prevention (DCP) and Food and Drug Administration (FDA) said more than 6.8 million doses of the vaccine have been administered.
The recommended pause may further complicate efforts to vaccinate the world, just weeks after a vaccine relying on a similar approach and developed by AstraZeneca and the University of Oxford raised similar concerns in Europe.
South Africa has already backed out of its AstraZeneca vaccine plans because of its low efficacy against the 501Y.V2 variant, which is dominant in South Africa.
Mkhize has now said South Africa will temporarily suspend its Johnson & Johnson vaccine rollout until the causal relationship between the vaccine and blood clots is sufficiently interrogated.
Although South Africa has not had any reports of blood clots that have formed following vaccination, he said they do not take the FDA caution lightly.
“It’s important to be aware that with any vaccine it is essential to closely monitor its safety and efficacy. If a problem is reported following a vaccination, a thorough investigation should take place,” 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 thoroughly assessment of the situation.
SAHPRA will then advise the Department of Health as a regulatory body that has exercised its authoritative powers on the approval of the vaccine in their own right.
Mkhize said he hoped the deliberations will only take a few days and he expect it will not result in the complete withdrawal of the Johnson & Johnson vaccine.
Statement by the Minister of Health, Dr Zwelini Mkhize, on the FDA’s Temporary Suspension of Johnson and Johnson vaccine rollout in the United States. pic.twitter.com/DTnUK0a2li
— Dr Zweli Mkhize (@DrZweliMkhize) April 13, 2021