The government has paused the use of Johnson (J&J)’s Covid-19 vaccine, pending a safety review by SA’s medicines regulator, health minister Zweli Mkhize announced on Tuesday night.
The development came just hours after the US Food and Drug Administration (FDA) and the US Centers for Disease Control (CDC) jointly recommended pausing administration of J&J’s vaccine after six cases of a severe type of blood clot were reported in women aged between 18 and 48, who all developed symptoms within two weeks of receiving the shot.
The FDA emphasised these events were extremely rare, as 6.8-million doses of the vaccine have been administered in the US. The European Medicines Agency announced last week that it would probe reports of rare clotting disorders, after four cases were recorded among J&J vaccine recipients in Europe.
Mkhize said he had held urgent meetings with scientists on Tuesday following the FDA’s announcement. “Based on their advice, we have (decided) to voluntarily suspend our rollout until the causal relationship between the development of clots and the J&J vaccine is sufficiently interrogated,” he said.
The SA Health Products Regulatory Authority (Sahpra) was expected to discuss the matter on Tuesday evening, and an urgent meeting of his ministerial advisory committee on Covid-19 had been scheduled for Wednesday morning, he said.
Mkhize said the pause was a precautionary measure, and he hoped vaccination would resume within a matter of 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 J&J vaccine from the vaccination armament,” he said in a national address.
SA was the first country in the world to begin administering J&J’s vaccine, via the Sisonke implementation study. The study has provided vaccines to 290,000 health-care workers, and aims to reach 500,000 people. No blood clotting events have been reported among vaccine recipients in SA, said the minister.
The US developments prompted J&J to delay the rollout of its vaccine in Europe, and could complicate SA’s vaccination plans, as the easy to store jab is central to its strategy.
It has ordered 31-million doses of J&J’s single-shot vaccine, enough to inoculate three quarters of its target of 40-million people, and said last week that it intended these shots to be provided to people in harder to reach settings such as rural areas. Mkhize said the government had since then secured an extra 10-million doses of Pfizer/BioNTech’s double-shot vaccine, taking its total number of Pfizer jabs to 30-million doses, enough to protect 15-million people.
“In the extremely unlikely event that J&J rollout is completely halted, we will not have any impediment to proceed with phase two of the rollout with Pfizer’s vaccine,” he said, referring to the government’s plans to expand vaccination beyond health-care workers in May.
The US J&J vaccine recipients developed clots in the veins that drain blood from the brain, and had low platelets, an extremely rare combination that requires specialised treatment, said Peter Marks, director of the FDA centre for biologics evaluation and research. Part of the reason for pausing the administration of the vaccine in the US was to allow time to alert health-care workers to the condition so they could diagnose, treat and report it. Standard treatment for blood clots, using heparin, could make the condition worse, he said.
Sahpra chair Helen Rees said if a causal link between these events and the J&J vaccine was established, the regulator would need to weigh up the risks versus the benefits of the jab.
Scientists from the FDA and CDC will jointly consider possible links between the clotting disorder and the vaccine, and determine whether its use should continue for all adults, or be limited.
There have been no significant safety concerns reported with the Pfizer/BioNTech shot in the US, said FDA officials. The vaccines developed by J&J and AstraZeneca use adenovirus vectors, while the Pfizer jab uses mRNA technology.
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