Sahpra recommends pause on Johnson & Johnson vaccine study be lifted, 'provided conditions are met'

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A healthcare worker receives a dose of the Johnson & Johnson vaccine against Covid-19.
A healthcare worker receives a dose of the Johnson & Johnson vaccine against Covid-19.
PHOTO: Phill Magakoe/AFP
  • Sahpra has called for the pause in the J&J implementation study to be lifted. 
  • The study was stopped after six patients in the US developed blood clot disorders after vaccination. 
  • A local J&J research team has to submit updated documents to Sahpra for approval. 

The SA Health Products Regulatory Authority (Sahpra) has recommended that the pause on the Johnson & Johnson (J&J) Sisonke study be lifted.

The implementation study, which rolls out Covid-19 vaccines to healthcare workers, was placed on ice four days ago after the US Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) recommended a pause because of "an abundance of caution". 

This, after six women in the US developed blood clot disorders. More than 6.6 million people in the US have received the J&J jab. 

Health Minister Zweli Mkhize said while there were no cases of blood clot disorders in the more than 290 000 vaccinated people locally, the study would be paused as a precautionary measure. 

He added a decision on the J&J vaccine would be made in a few days. 

In a statement on Saturday evening, Sahpra said "based on a review of available data", it recommended the pause on the Sisonke study be lifted, "provided that specific conditions are met".

WATCH | Covid-19: Mkhize suspends rollout of J&J vaccine as a 'precautionary measure'

The conditions for the lift include strengthening, screening, and monitoring participants who are at high risk of a blood clotting disorder. 

The regulator also recommended measures be implemented to ensure the safe management of any participants who develop vaccine-induced thrombosis and thrombocytopenia.

The statement said:

Participant information sheets and informed consent forms will be updated to include the newly identified adverse events.

Sahpra added that participants in the Sisonke study should be informed about the possible risks of developing a blood clotting disorder after vaccination.

"They will also be advised to seek immediate medical assistance if they develop early signs and symptoms associated with blood clots or low platelet counts."

Before the study can resume, the J&J study team has to submit updated documents, procedures and study arrangements to Sahpra for approval. Research ethics committees will also have to approve the resumption.

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