The study was temporarily paused two weeks ago after six American women suffered an extremely rare blood clotting disorder after receiving the J&J vaccine.
SA HEALTH care workers have been urged to register for the Johnson & Johnson Sisonke Programme to vaccinate health workers, as the study resumed on Wednesday.
With almost 300,000 health care workers vaccinated so far, the study was temporarily paused two weeks ago after six American women suffered an extremely rare clotting disorder after receiving the J&J vaccine.
“We are two weeks behind and we urge all our health care workers not yet registered to please register and this now includes their personnel like secretaries, like the staff working in surgeries so that phase 1B also can commence as quickly as possible,” said Dr Angelique Coetzee, chairperson of South African Medical Association (Sama).
As a condition for resuming the Covid-19 vaccination trial programme, the South African Health Products Regulatory Authority (Sahpra) 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 participate.
Additional recommendations also include that pregnant and breast-feeding women should be excluded from the trial at this stage.
Professor Glenda Gray, co-principal investigator of the Sisonke implementation study, says they have also introduced enhanced screening processes.
“Vaccine recipients will be sent two additional SMS reminders 1 and 2 weeks after their vaccination prompting them to seek care if they develop any symptoms including new-onset severe headache, weakness on one side, difficulty speaking, severe abdominal pain, swelling or pain in one leg, shortness of breath or chest pain, or blood spots around the site of injection,” she said.
Meanwhile, Professor Barry Schoub, who chairs the Ministerial Advisory Committee on Covid-19 Vaccines, said “The aim is to finish before the 17 of May with the phase of the health care workers.”
– African News Agency (ANA)
