SA’s regulators have given Johnson and Johnson’s (J&J) Covid-19 vaccine the green light for a phase 3b trial in health-care workers, paving the way for the government to begin dispensing shots on Wednesday.
Last week, the government suspended its planned rollout of AstraZeneca’s vaccine, after preliminary findings from a small clinical trial found it offered minimal protection against mild to moderate Covid-19 caused by the new variant, 501Y.V2, which now dominates transmission in SA.
SA has yet to decide what to do with the AstraZeneca vaccines it has already procured, but it has quickly pivoted to J&J’s vaccine, which it plans to administer in a study with the Medical Research Council (MRC) to get around the fact that it is not yet commercially available.
Preliminary data from the Ensemble trial, which J&J is using to seek emergency use authorisation from the US Food and Drug Administration, showed its vaccine was 57% effective at preventing mild to moderate illness in SA and 85% effective in preventing severe Covid-19.
The first 80,000 doses of J&J’s vaccine, drawn from stock manufactured for clinical trials, are expected to arrive in SA from Belgium on Tuesday.
They will then be transported under police and military guard to 17 large public hospitals designated as vaccination centres, with the first doses slated to be dispensed on Wednesday, according to MRC president Glenda Gray, who is co-principal investigator on the study.
The SA Health Products Regulatory Authority, the registrar of genetically modified organisms and the MRC’s ethics committee have all approved the study, which will investigate breakthrough infections and adverse reactions among vaccine recipients.
Vaccines will be offered to health-care personnel employed at the 17 hospitals and at nearby public and private health-care facilities, said Gray. “We are working hand in hand with the private sector, and the private sector will be beneficiaries from day one,” she said. “We want to vaccinate for 10 hours a day, seven days a week.”
Each province has been allocated two vaccination sites with the exception of Northern Cape, which has just one. The initial allocations to each site will be based on the number of health-care workers and the burden of disease in each province.
J&J has committed up to 500,000 doses for the study. They will arrive at 14-day intervals. The study will cost an estimated R400m, with the government expected to be the biggest contributor. The vaccines have been supplied at no cost by J&J, and discussions are under way with potential donors, said Gray.
Right to Care CEO Ian Sanne, who is working on the rollout at Kimberley hospital, appealed to health-care practitioners to register on the electronic vaccine data system as soon as possible.
“The more demand we have the better we can plan for the next shipment,” he said.
“The study team has worked incredibly hard in the last 10 days to make this possible.
“Once established, I believe we have laid the groundwork for multiple phase 3b studies of various vaccine candidates that will come to SA,” said Sanne, who is also a member of health minister Zweli Mkhize’s advisory committee on Covid-19.
The ministerial advisory committee on vaccines has yet to finalise its recommendations on the AstraZeneca vaccine, said chair Barry Schoub.
One option under consideration is to provide the vaccine in a research setting, similar to the one devised for the J&J shots.
The World Health Organisation said last week that AstraZeneca’s vaccine should be widely deployed even in countries where the 501Y.V2 variant might reduce its efficacy. And the head of the local phase 2 trial of AstraZeneca’s vaccine, Wits dean of health sciences Shabir Madhi, said it would be a mistake to reject the shots entirely.
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