The resumption of the Johnson & Johnson (J&J) vaccine programme awaits approval of its updated protocol by the SA Health Products Regulatory Authority (Sahpra) and a group of university research ethics committees before the stalled programme can restart.
“Once we have received the formal documentation, we will be able to critically evaluate it and turn it around very quickly,” said Prof Marc Blockman, chair of the human research ethics committee at the University of Cape Town’s faculty of health.
This could see the first phase of the country’s vaccine programme restarting in a matter of days. It is referred to as the Sisonke 3B implementation study and aims to vaccinate half a million of the country’s front-line health-care workers using the J&J vaccine.
The programme was suspended last week as scientists evaluated the possible link between the vaccine and a rare type of blood clot in the brain. So far, 292,623 health-care workers have had the vaccine, with just over 200,000 outstanding under the first phase.
The programme is being sponsored by the SA Medical Research Council (SAMRC) in conjunction with J&J and the department of health. The rollout involves a group of universities in each province that are working with the respective provincial departments of health.
The first step in lifting the suspension came at the weekend when Sahpra recommended that the suspension be lifted, subject to specific conditions being met.
These include enhanced screening and monitoring of participants who are at a higher risk of being prone to blood clotting disorders, as well as heightened safety measures for dealing with participants who develop thrombosis (blood clots).
Dr Glenda Gray, president of the SAMRC and co-principal investigator and sponsor of the programme, told Business Day on Sunday that she has already submitted an amendment with the necessary documentation (comprising the updated protocol and management plan) to Sahpra for approval.
Sahpra and the ethics committees of the various universities (led by Blockman) will now separately approve the amendments before the programme can restart.
Sahpra had not responded to questions on when its own approval process would be completed at the time of publication.
There is enough inventory for the programme to restart quickly, said Stavros Nicolaou, representing Business for SA (B4SA), indicating that sites should still have doses of the vaccine to dispense once the go-ahead is given.
Inventory
“Not all of the 200,000 remaining doses are in the country, but we should be on track to complete the rollout by May 16,” said Nicolaou.
Under the current plan, another 500,000-700,000 units of commercial J&J stock will arrive in SA from April 24, with the first batches of Pfizer stock arriving in early May.
Phase 2 of the country’s vaccine programme is due to begin on May 17, when 5-million citizens over 60 years old and a further 12-million essential workers and those who have co-morbidities will begin being vaccinated. The phase is expected to be concluded by the middle of November.
Phase 3, which will dispense 22.5-million vaccines, is expected to start in the middle of November and run until the middle of February 2022.
According to the National Institute for Communicable Diseases, 1,089 cases of Covid-19 were reported on Sunday, with 25 recorded deaths.
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