The study – called the 3B open-label Sisonke study – was launched after government’s official rollout of the AstraZeneca vaccines was paused on 9 February, over efficacy concerns.
Presenting to parliament on Wednesday (24 March), Gray said that following the pause of the official rollout, something needed to be done to ensure that healthcare workers were inoculated.
“We moved rapidly to start the phase 3B open-label study to replace the national rollout. The reason that we did this is because healthcare workers are three to four times more likely to develop Covid.”
“To transition to the Johnson & Johnson study was almost a ‘no-brainer’ because its a single-dose vaccine that can protect against severe disease.”
Government has faced criticism or the slow rolling out of vaccines, with just over 200,000 healthcare workers inoculated 36 days after the Sisonke study began – averaging 5,700 doses daily. At this rate, it would take over 16 years to vaccinate 67% of the population.
However, Gray said that the country has only received approximately 80,000 doses every two weeks – as part of the study. An additional 80,000 doses are expected next week, while a shipment of around 200,000 vaccines is expected within two weeks.
More than 486 million doses have been administered across 137 countries, according to data collected by Bloomberg. The latest rate was roughly 11.9 million doses a day.
In the US, more Americans have received at least one dose than have tested positive for the virus since the pandemic began. So far, 130 million doses have been given. In the last week, an average of 2.49 million doses per day were administered, Bloomberg said.
Government has reportedly secured a total of 43 million doses through deals with pharmaceutical companies Johnson & Johnson, Pfizer and the Covax group, having halted the rollout of the AstraZeneca vaccine.
However, just a fraction of these vaccines has been sent to the country, with the manufacturers operating on a quarterly basis for deliveries.
Worse still, a new study by Israeli scientists suggested that the Pfizer-BioNTech vaccine is less effective against the local 501Y.V2 variant.
The South African Health Products Regulatory Authority (Sahpra) approved a section 21 emergency-use application for the Covid-19 vaccine developed by Pfizer and BioNTech, earlier this month.
Sahpra said in a statement that the approval was subject to further efficacy and safety surveillance of the vaccine in the country, including against the dominant local coronavirus variant.
The initial target for South Africa was for 1.5 million people to be inoculated by the end of March (phase 1), when AstraZeneca was still part of government’s plan. The broader goal was for 40 million South Africans to receive the jab by year-end (phase 3).
However, with the official rollout paused and a shift to the Sisonke study, progress as stalled. According to Gray, it is anticipated that the study will be completed by the end of April, with 500,000 healthcare workers vaccinated.
Medical experts and government advisors have also tempered expectations around initial targets, saying they will likely be missed.
Ministerial Advisory Committee chair Barry Schoub said that the target of vaccinating most of the population by the end of the year is “ambitious” and an enormous challenge.
“We need to be realistic, we are not going to get to that level. But if we can immunise all of our healthcare workers, and everybody that is at risk – the elderly people and people with comorbidities – if we can do that by the end of winter, going into spring, we would have achieved a tremendous amount,” he said.
Health minister Zweli Mkhize, meanwhile, said that the targets are constantly being reviewed based on the available information and available vaccines.
Vaccine availability is expected to ramp up as the year progresses. However, there has been no indication from the health department when the official rollout programme will start again.
Study vs rollout
Gray explained that an open-label study is conducted after the efficacy of a drug or vaccine has been established. This was confirmed in a study at the end of January, she said.
She added that the Johnson & Johnson vaccine is not experimental – it is known to work – and no placebo control arm is in place. Instead, what is being tested is the field effectiveness of the vaccine and building the safety profile of the drug.
“It basically brings an effective vaccine to populations in an accelerated fashion while registration is ongoing at a global level. These trials are always executed under regulatory and ethical oversight.”
Responding to questions from MPs about the transparency of the vaccine rollout, Gray said that there is no ‘covering up’ and that televised press conferences have been held explaining the Sisonke study.
She added that the Electronic Vaccine Date System and associated consent forms makes it clear that this a study.
As of Wednesday (24 March) there have been 1,048 new cases in South Africa, taking the total reported to 1,540,009.
Deaths have reached 52,372 (a daily increase of 121), while recoveries have climbed to 1,466,595, leaving the country with a balance of 21,042 active cases. The total number of vaccines administered is 207,808.