The Sisonke trial, that was paused earlier this month because of the US government’s regulator the Food and Drug Administration’s investigation into rare blood clotting disorders associated with the Johnson & Johnson jab, resumed on Wednesday, April 28th. Pregnant and breastfeeding women will now be included too, subject to new documents that need to be approved. Find out more from our summary and Twitter thread and access the full press releases.
- The Sisonke COVID-19 vaccine trial resumed on Wednesday. There will be a total of 95 vaccination sites countrywide. These sites will also be used to vaccinate the rest of the country’s health workers who aren’t part of the Sisonke trial. The study uses the Johnson & Johnson (J&J) jab.
- The trial was paused for two weeks in April after the United States’ Food and Drug Administration temporarily paused the country’s J&J roll-out because of blood clotting disorders occurring in eight out of about seven million vaccinated people in the United States.
- Initially, SA’s medicines regulator, the South African Health Products Regulatory Authority (Sahpra) stipulated that pregnant and lactating women in South Africa wouldn’t be allowed to receive the J&J jab. But on Thursday, April 29, it announced that these groups could be included in the trial, subject to the Sisonke researchers submitting new documents for approval, so that study’s protocol could be adjusted.
- Researchers of the Sisonke trial will have to do intensified screening to establish if someone is at risk of blood clotting, they will have to inform study participants of the risk and also have to conduct post vaccination monitoring.
Read our Mia Malan’s Twitter thread explaining what this means for you. And here Mia tweeted about the reversal of Sahpra’s decision to exclude pregnant and breastfeeding women from the Sisonke trial.
Sahpra’s April 29th press release in which the regulator explains it new decision to include pregnant and breastfeeding women in the Sisonke trial:
[30 April 2021 7:20 am This article was updated to reflect Sahpra’s new guidance, announced on the evening of April 29, to include pregnant and breastfeeding women in the Sisonke trial.]