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SA is weighing up whether to pause administration of Johnson & Johnson’s (J&J) Covid-19 vaccine while its safety is investigated, as reports emerge in the US and Europe of rare blood-clotting events that may be associated with the shot.

The government’s national vaccination strategy hinges on two vaccines: J&J’s single-dose shot, and Pfizer-BioNTech’s double-dose jabs, both of which it has planned to roll out at scale within the next few weeks.

The US Food and Drug Agency has recommended pausing J&J’s vaccine out of an “abundance of caution” after six reported cases of a severe type of blood clot in people who had received the shot. It emphasised these events were extremely rare, noting that 6.8-million doses of the vaccine have been administered in the US so far. The European Medicines Agency is also reviewing reports of blood clots, after four cases were recorded.

SA Medical Research Council president Glenda Gray said on Tuesday that discussions are underway between SA’s medicines regulator, the health minister, and researchers about whether to pause administering the shots until there is greater clarity on the possible link between the vaccine and the blood-clotting events reported in the US and Europe. SA is administering J&J’s vaccine in the Sisonke implementation study that was designed to provide the shot to health workers, pending licensure.

The rare blood-clotting events involve an unusual combination of blood clots and low platelet count. None has been reported among recipients of J&J’s vaccine in SA, said Gray. As of Monday, the Sisonke study had administered 289,787 doses of the vaccine. It aims to reach 500,000.

The SA Health Products Regulatory Authority and health minister Zweli Mhize’s spokesperson Lwazi Manzi were not immediately available for comment.



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