Professor Shabir Madhi, Dean of the Faculty of Health Sciences at Witwatersrand University and principal researcher of the AstraZeneca vaccine in the country, is calling on South Africa to use the consignment on vaccines that were found last month on delivery to have an April expiry date to offset the slow inflow of the currently-used Johnson & Johnson vaccine.
He is backed by Professor Francois Venter, deputy executive director of the Wits Reproductive Health Institute and HIV/Aids research and treatment veteran, who asks, “Why are we sending away 1,5 million [AstraZeneca] vaccines, and on what basis – the bottom line is we could have vaccinated one million vulnerable people? All the rest is just nonsense. There are enough vulnerable people to have rolled this out urgently.”
The irony is that Health Minister Dr Zweli Mkhize based his decision to scrap the AstraZeneca rollout (and the current sale to the African Union), on Madhi’s research into the efficacy of the vaccine against the local virus variant (N501.V2). Based on a small cohort of people aged on average 30, and testing its efficacy only against mild to moderate disease, it was found to be effective in only 10% of people. The Johnson & Johnson vaccine, however, reduces infection by up to 85%, more especially in moderate to severe disease with a wider age range. Both efficacy percentages are against the more infectious local variant.
Daily Maverick learnt from a top government source that South African regulatory issues have been delaying the finalisation of the 1,5-million Astra-Zeneca doses via international sale – which is at the high price the government paid for it. “It’s a demand issue – when there’s a shortage in the market, people take it at whatever price they can get it for,” the source explained.
All 1,5-million doses were to be sold (no longer keeping back 100,000 vials for local research), probably by Friday, 19 March. Another impeccable source said MTN had offered to buy the entire consignment on behalf of the AU, but this could not be confirmed at the time of going to press.
“It’s not about money or political will, it’s about contractual terms and negotiating the best deal for the country. It seems we’re damned if we do [sell] and damned don’t [use it],” the source added.
WHO approves AstraZeneca vax
Mahdi’s contention is that with other broader trials of AstraZeneca elsewhere in the world showing vastly greater efficacy against moderate to severe disease (other variants) and the World Health Organisation, now rolling it out across Africa via the Covax initiative, it’s reasonable to depart from a hard and fast local, evidence-based approach. He says the vaccine is completely safe and can be topped up with a second, different vaccine without causing any harm. Existing South African data on healthcare worker infection and mortality from Covid-19 from between March and November last year show that 6.8% of all public healthcare workers were infected (35,145), and 340 died.
These figures are probably nearly double that now, given the far higher prevalence of hospitalisation and death from the more infectious second variant-driven wave in late December.
Madhi emphasises that the two-shot AstraZeneca vaccine would initially only be targeted at frontline healthcare workers rendered vulnerable by their co-morbidities – in the absence of sufficiently available but proven, Johnson & Johnson doses. The government source said while sufficient J&J supplies were “locked in”, scheduling difficulties were causing the slow inflow.
On Saturday, 13 March, a second consignment of the J&J vaccine landed in South Africa, with the third batch expected later this week.
Madhi believes the probability of the AstraZeneca vaccine saving the lives of co-morbid healthcare workers would be very high, given the WHO endorsing its use and neighbouring countries like Lesotho and Swaziland rolling it out.
He adds that the N501.V2 variant first identified in South Africa has spread throughout the continent. His team has begun urgent larger AstraZeneca vaccine trials in Botswana, with another trial about to begin in another SADC country, while awaiting an infection resurgence to enable hospitalised patients to be enrolled. He said one small study in Zambia showed 90% of infections there were being caused by the N501.V2 variant.
Professor Glenda Gray, CEO of the Medical Research Council (and lead Johnson & Johnson vaccine researcher), whose research into the J&J alternative led to its roll-out in February, says she is implementing “Plan B” to the best of her ability.
In scientific circles however, debate around Madhi and Venter’s urgent plea has sprung up, with strong views about the global scientific data, the local variant and healthcare ethics.
‘Use it or lose it’
The abandonment and sale of the R75-million AstraZeneca consignment in the face of what several see as a slow government vaccine procurement response includes comments like; “failing to give vulnerable healthcare workers a fighting chance”, “premature sell-off”, and “scientifically incomprehensible”.
Gray told Daily Maverick that so far, 20% of SA’s healthcare workers have received the single-shot J&J jab (145,544 of a StatsSA-estimated 603,958 healthcare workers in both sectors), in an occupational risk-prioritised roll-out. Gray said the tempo had been stepped up to 10,192 inoculated nationally on Tuesday last week.
Madhi stressed, “The WHO recommends that the AstraZeneca vaccine be used in countries where the ‘SA’ variant circulates, because of the likelihood of it being able to protect against severe disease. That’s based on the body’s natural killer cells being largely spared in terms of the response, even with the mutation [variant]. This is what will probably protect you against severe disease.”
He believed the South African government was “naïve” to think the AU would purchase the AstraZeneca consignment from South Africa at anywhere near the four times higher price it paid – compared to what Covax was offering them, which probably explains the reported philanthropic intervention of MTN.
“The bottom line is that it’s a toss-up between leaving high-risk groups unvaccinated and some of the population benefitting from a vaccine that even the WHO believes is protective. I have no idea what goes into the thinking in keeping so many people unvaccinated and unprotected as against taking a chance with AstraZeneca, which is perfectly safe and can be topped up with another vaccine later to get greater efficacy.”
He stressed, “If you can get the J&J dose, I’d certainly take it – it’s a no- brainer. My point is that we can’t test another million doses of J&J – we don’t have them – but we do have the AZ doses.”
AZ best for healthcare workers
Madhi emphasised that he was not proposing the use of the AstraZeneca vaccine in healthy healthcare workers as it would probably offer little protection. The vaccine was also likely to protect older people, (according to research on other variants in the United Kingdom), he said.
Professor Helen Rees, CEO of the South African Health Products Regulatory Authority (Sahpra) and founder of the Wits Reproductive Health and HIV Institute, said the issue was not about safety but about whether the AstraZeneca vaccine worked.
“The question is can we generate better data [on the vaccine], or will the public not feel confident in any sort of study where we generate this going forward?”
She confirmed that there was UK evidence of the AstraZeneca vaccine being highly effective against a different variant there, adding, “but we don’t have data here [on the local variant]”.
Government ‘tardy’ in vax procurement
Venter said the government’s initial “stubborn” insistence on procuring vaccines only from the Covax initiative and sudden change to AstraZeneca procurement from India’s Serum Institute meant South Africa was now, “way behind the curve”.
He cited Rwanda, where 70,000 people were recently vaccinated in one day and accused Ministerial Advisory Committee chief Professor Salim Abdool Karim and Professor Barry Schoub, chairperson of the committee on vaccines, of promoting a “fatuous” narrative on vaccine nationalism while initially talking about only securing vaccine supplies via Covax.
“The government has been asleep at the wheel in securing other vaccine supplies and now we have this incoherent scientific argument about shelving and selling off the AZ consignment,” Venter said.
Clock ticking on AstraZeneca use or sell-off
A Treasury source said that the government had signed for 11-million J&J doses, with an option for another 20-million by the end of March.
“I think people are worried about securing enough doses for April, May and June before winter and a potential [third-wave] surge – I know the private sector would love more flow earlier on,” he observed.
Gray said the probe into initial abuse of the electronic vaccine data system by private healthcare professionals and members of the public was ongoing. She said the system had been substantially improved, making fraudulent procurement of healthcare worker vaccination vouchers harder. She appealed to anyone with information to come forward to facilitate the criminal prosecution of offenders.
Karim did not respond to several queries about Madhi’s appeal.
Popo Maja, spokesperson for the Department of Health, did not respond to a request for comment by the time of publication.
We published a version of this story on Friday 12 March, but have since updated it with new information from a Health Department source as well as the unconfirmed information on MTN offering to buy the consignment on behalf of the AU.
Chris Bateman is a freelance journalist.
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