Sisonke programme recommences today
RE-CONSENT is necessary as the Johnson & Johnson (J&J) Sisonke Programme aiming to vaccinate health-care workers – as part of the first phase of the Covid19 vaccine roll-out – resumes today, the health department confirmed.
It was paused temporarily after a small percentage (eight out of more than six million people) of participants in the US vaccination programme suffered a rare clotting disorder. The South African Medical Research Council (SAMRC) confirmed that no cases had been described in South Africa yet.
“As a condition for resuming the Covid-19 vaccination trial programme, Sahpra (South African Health Products Regulatory Authority) has added a requirement that all Sisonke participants need to be informed of the potential risk of the rare clotting disorder and therefore re-consent to participating.
The revisions also pertain to the additional Sahpra recommendation that pregnant and breastfeeding women be excluded from the trial at this stage,” the provincial health department said.
This condition, now known as vaccine-induced thrombotic thrombocytopenia, or VITT (referring to clots and low platelets), has been recognised as an extremely rare complication of both the AstraZeneca-Oxford and J&J vaccines, the SAMRC said. “VITT typically presents with new onset severe and unrelenting headache four to 20 days post-vaccination. In these people, it can be rapidly diagnosed using a widely available blood test. Treatment differs from the usual therapies for clotting problems and should be undertaken in consultation with a specialist haematologist with experience managing a similar disorder that sometimes occurs following a commonly used blood thinner called heparin.”
Meanwhile South African infectious disease epidemiologist Professor Salim Abdool Karim has been appointed as a member of the Science Council of the World Health Organization (WHO). The Science Council, comprising nine of the world's leading health researchers and chaired by Nobel Laureate Dr Harold Varmus, was inaugurated yesterday by the WHO's director-general.
Abdool Karim previously served as the chairperson of the South African ministerial advisory committee on Covid-19. He is the director of the Centre for the Aids Programme of Research in South Africa (Caprisa) – and Caprisa professor of global health at Columbia University in the US. On his appointment, Abdool Karim said: “Pandemics such as Aids and Covid-19 have highlighted the important role of science in global health. I am looking forward to participating in this council, providing scientific advice to WHO on future developments in health that the world needs to be better prepared for.”