The Sisonke vaccine trial of health workers will start again on Wednesday, health minister Zweli Mkhize has announced, and the sites offering vaccinations will be expanded to 95 from 18.
Mkhize said in a statement, “It has since been established there is a one-in-a-million chance of getting a clot after the Johnson & Johnson (J&J) vaccine, and it appears that women between the ages of 18 and 48 are at risk.”
He said there were far more cases of blood clots related to Covid-19 itself and urged people to get vaccinated.
Regulators around the world have paused vaccine rollouts and investigated clots linked to the J&J vaccine and the AstraZeneca-Oxford one that uses a similar technology.
The blood clot condition, known as vaccine-induced thrombotic thrombocytopenia (VITT), caused both a blood clot in the brain and abdomen, as well as a low platelet count. Eight people in the US developed this after 6.8-million J&J vaccinations.
The SA Health Products Regulatory Authority (Sahpra) has declared the J&J vaccine safe and given the go ahead to start using it again after a temporary pause in the trial, adding new conditions to the rollout. In the US, the Food and Drug Administration lifted its pause on the J&J vaccine on Saturday.
Sahpra now requires health workers to be informed of the risk of blood clots and to be screened for a previous history of clots. Almost 300,000 health workers received the vaccine before the pause but no cases of VITT have been recorded.
Sahpra has said pregnant and breastfeeding women are not permitted to be given the vaccine, which the Medical Research Council (MRC) said it would discuss further with the regulator.
Doctors, nurses and traditional healers registered for the vaccine have to sign new consent forms, even if they have signed older consent forms on the electronic vaccination registration system.
Health workers receiving the shot will also receive SMSs in the first and second week after vaccination warning them to seek treatment should they develop any of the following symptoms: severe headaches, 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.
A help desk is open seven days a week, 24 hours a day to answer queries from doctors worried about any side-effects that may develop. A doctor and a haematology expert will be provided to guide the treatment of any health worker should they develop the rare blood clots.
The vaccination of some other citizens is set to start in the middle of May. Half a million people over 60 have already registered on the electronic database to receive vaccines.
Mkhize said on Monday he was “thrilled” to announce that the first 1.1-million doses of the J&J vaccines are ready for dispatch from the Aspen Gqeberha (formerly Port Elizabeth) plant where they are being packaged.
After regulations of the no-fault compensation scheme were gazetted on Thursday by minister of co-operative governance and traditional affairs Nkosazana Dlamini-Zuma, J&J said it was ready to release the vaccines within days. The compensation scheme will allow anyone severely injured by the vaccine to claim money from a state-run fund and ensures the drug companies will not be held liable for any vaccine-related harm.
The first vaccines for the general population will be flown from Gqebherha to Johannesburg, then will be transported to a central storage warehouse.
Once quality assurance processes are completed by the SA National Control Laboratory for Biological Products, the vaccines will be dispatched to 900 distribution sites across SA. Some of these sites may be vaccination centres, while some are only storage hubs.
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