The health department’s hopes of having dozens of politicians receive early Covid-19 vaccinations to shore up public confidence in the jab have been dealt a blow after the medicines regulator turned down its request to include them in the first phase of the rollout aimed at health-care workers.
The government launched its national Covid-19 vaccination drive on Wednesday, offering health-care workers the Johnson & Johnson (J&J) shot in a tightly controlled research setting in order to get around the fact that the product is not yet commercially available.
The government suspended its planned rollout of the AstraZeneca shot last week, after preliminary findings from a small clinical trial showed it offered minimal protection against mild to moderate illness caused by the 501Y.V2 variant dominating transmission in SA.
It pivoted to the US company’s shot, but because the product has yet to be licensed by regulators it is administering the vaccine in a phase 3b clinical trial, with a strict protocol that limits participation to health-care workers.
The first 80,000 doses of J&J clinical trial stock arrived in SA on Tuesday night, and the rollout began on Wednesday afternoon at 18 public hospitals in all nine provinces.
A document seen by Business Day shows the health department sought permission from the SA Health Products Regulatory Authority (Sahpra) to provide the J&J jab to a list of senior leaders, including ministers, premiers, MECs and health sector unions as part of its efforts to manage vaccine hesitancy, but was turned down.
“Unfortunately, we could not get protocol deviation for those who do not have a health background,” says the document.
A recent survey by the University of Johannesburg and the Human Sciences Research Council found a third of respondents would either not get a Covid-19 vaccine or were undecided.
The only politicians who have so far received J&J’s vaccine are health minister Zweli Mkhize, who is a doctor, and President Cyril Ramaphosa. Both publicly received their vaccinations at Cape Town’s Khayelitsha District Hospital shortly after SA’s first recipient, nurse Zoliswa Gidi-Dyosi.
Mkhize’s spokesperson, Lwazi Manzi, said the issue had been debated extensively. “In the end it was decided that a few, most importantly the head of state, should lead by example to build confidence in the vaccine,” she said.
Trial co-principal investigator Linda-Gail Bekker said permission was granted for only two people who are not health-care workers to get the shot: Ramaphosa and Deputy President David Mabuza.
“We got a special dispensation from Sahpra for the president and deputy president. It was felt by all the team that this very positive leading from the front is an important message for [vaccine] hesitancy.
“We had agreement from all the regulators and ethical boards,” she said.
Sahpra spokesperson Yuven Gounden confirmed that the regulator had approved a request to amend the trial protocol to include the president and deputy president.
Medical Research Council president Glenda Gray, who is also a co-principal investigator on the trial, said it might be worth considering further amendments to the trial protocol, because each consignment from J&J was accompanied by a buffer stock of several hundred doses in case vials were accidentally broken or damaged. If some of this stock was still available when the next 80,000-dose consignment arrived in a fortnight, it could potentially be used to vaccinate influential figures without compromising access for health-care workers, she said.
Addressing the media after receiving his shot, Mkhize said most of the cabinet and influential figures such as religious leaders, musicians and traditional leaders would be vaccinated in phase 2 of the rollout.
The details of phase 2 have yet to be finalised, but the government has said it plans to cover essential workers, people over the age of 60, younger people with underlying health conditions that increase their risk of severe Covid-19, and people living in crowded settings such as care homes and prisons.
The government had enough vaccines in the pipeline to inoculate the 40-million people who need to be immunised to reach herd immunity, said Mkhize.
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