Health minister Dr Zweli Mkhize has announced the voluntary suspension of the Johnson & Johnson Covid-19 vaccine rollout in South Africa.
In a media briefing on Tuesday evening (13 April), Mkhize said that the decision was taken following the Food and Drug Administration’s recommendation to temporarily pause the J&J vaccine programme in the USA.
In taking the decision, Mkhize said that the FDA recommendation ‘should 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,” he said.
“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.
Mkhize that the South African Health Products Regulatory Authority will collate all the information on the vaccine’s use in order to do a thorough assessment.
South Africa is using the J&J vaccine as part of its Sisonke trial rollout which is targeting healthcare workers. Mkhize said he was hopeful that the temporary suspension would not impact the country’s long-term vaccine plans.
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
A type of brain blood clot called cerebral venous sinus thrombosis was seen with low levels of blood platelets in the women, who were all between the ages of 18 and 48, the US Centre for Disease Control and Prevention and Food and Drug Administration said on Tuesday in a joint statement.
“We are recommending a pause in the use of this vaccine out of an abundance of caution,” the CDC and the FDA said in the statement.
“This is important, in part, to ensure that the health care provider community is aware of the potential for these adverse events and can plan for proper recognition and management due to the unique treatment required with this type of blood clot.”
More than 6.8 million doses of the J&J vaccine have been administered in the US through Monday, the agencies said.
The recommended pause may also further complicate the global vaccination push, coming just weeks after a vaccine relying on a similar approach and developed by AstraZeneca and the University of Oxford raised similar concerns in Europe.
Clotting fears have prompted many countries to impose age restrictions on use of the Astra vaccine, which was co-developed with the University of Oxford.
Johnson & Johnson has also said it will also delay the rollout of its Covid-19 vaccine in Europe. The company said it is reviewing the cases of blood clotting with European health authorities in a statement on Tuesday.