South Africa: Does Government Have a Moral Obligation to Roll Out the Astrazeneca Vaccine?

analysis

South Africa is likely headed for a third wave of COVID-19 infections, experts warn. With no windfall of vaccines in sight, many people at high risk of COVID-19 will remain unvaccinated. Now some doctors and medical ethicists are asking: Is a safe vaccine that could possibly protect them better than nothing?

This week, a peer-reviewed article in the New England Medical Journal confirmed what South African researchers announced to the world in February: Although the AstraZeneca vaccine was found to be safe, it only reduced a person's risk of developing mild-to-moderate COVID-19 caused by the B.1.351 variant in South Africa by about 10% - too little to be deemed effective. Prior to the variant's rise, the vaccine had been shown to reduce this risk by about 75%

The findings, however, come with wide confidence intervals - a commonly used measure to describe uncertainty in most studies -- and if conducted again, might return different results, explains Clare Cutland, one of the study's researchers and scientific coordinator at the University of the Witwatersrand's African Leadership in Vaccinology Expertise (Alive) initiative.

The study also wasn't large enough, nor did it include a diverse enough group of people, to tell us whether the vaccine works to prevent serious COVID-19, hospitalisations or deaths caused by the variant.

Why the WHO is not willing to give up on AstraZeneca... yet

South Africa ultimately scrapped its planned AstraZeneca vaccine rollout based on the disappointing findings regarding the new variant, despite having a million doses already in the country. Instead, the country opted to use the Johnson & Johnson (J&J) vaccine, which has been shown to be about 64% effective at preventing moderate to severe COVID-19 caused by the variant about a month after vaccination, according to data provided to the United States regulator, the Food and Drug Administration.

Some stocks of the Pfizer vaccine are also expected to arrive soon, Health Minister Zweli Mkhize said earlier this month. In laboratory tests described in a March New England Medical Journal study the jab - like the J&J vaccine - worked less well against the new variant in South Africa, but scientists are confident it will still offer people some protection against infection and disease. The Pfizer vaccine has not been tested against the variant in human trials.

As of 5 March, the health department was in advanced stages of negotiating to sell its stock of the AstraZeneca jab to the African Union, Deputy Health Minister Joseph Phaahla told Parliament.

The World Health Organisation's (WHO) expert vaccine committee, however, continues to recommend AstraZeneca for use in countries with variants such as South Africa. The global body says AstraZeneca's two-dose jab may still protect against serious COVID-19 based on the fact that most COVID-19 vaccines work better to protect against serious COVID-19 as compared to milder forms. Plus, the WHO says that the vaccine was able to trigger certain immune system responses that may -- according to some research -- play a bigger role in warding off severe COVID-19 than antibodies alone.

In the face of clear gaps in data, the WHO's decision was also framed by a scarcity of vaccines amid mounting deaths.

"Waiting for more information, when we have enough to make a recommendation, I think, would not be appropriate," said WHO vaccine committee chair Alejandro Cravioto in February. "We have thousands of people dying from infection. Anything we can do to use a product that might reduce that is totally justified - even if the information is not as complete as we would like."

Countries are not required to follow WHO guidance.

Mkhize admits South Africa faces shortages of J&J and Pfizer vaccines in the second quarter of the year as a third wave of infections is expected. With few other vaccine options, some experts argue that, ethically, people at a high-risk of COVID-19 should be offered the AstraZeneca vaccine. After all, they say, it may give them some protection -- or it may give them no protection but otherwise do them no harm.

Chair of the Ministerial Advisory Committee (MAC) on COVID-19 vaccines Barry Schoub remains firm that without actual data from human clinical trials, it's inappropriate to use the vaccine. Meanwhile, some are calling for more transparency about how the final decision regarding AstraZeneca's use was made.

'It would seem ethically justified to give patients whatever protection you can'

Steve Biko Centre for Bioethics at Wits University director Kevin Behrens says whether the government might be ethically bound to offer the AstraZeneca jab to high-risk patients comes down to a discussion of harm.

"It all really revolves around harm and whether or not giving the vaccines to patients is in any way harming them. Are we harming them directly by putting them at risk, for instance, of some sort of severe reaction?" he asks. "The scientists are telling us.. that this vaccine is not going to cause those kinds of harms."

Several European countries recently suspended their AstraZeneca vaccine rollouts over concerns it could be linked to a heightened blood clot risk. On Thursday, the European Medicines Agency confirmed that the vaccine was not shown to increase a person's overall risk of blood clots after reviewing less than 30 reported cases of clots among 20 million vaccinated people. However, the regulator says the jab may be associated with very rare cases of specific types of blood clots, but further research is needed.

If the vaccine has been proven safe, Behrens explains, then giving it to - let's say - an elderly person isn't likely to harm them. But it could give them protection against becoming seriously ill and even dying of COVID-19.

"The most ethically justified thing, in that case, would be that [high-risk people] are given whatever protection you can give them," he says.

But Behren says this calculus changes suddenly if large amounts of a vaccine with better data -- such as the J&J jab -- were suddenly to become available.

The MAC did consider a targetted rollout of AstraZeneca

Dr Francois Venter is the director of the HIV research organisation Ezintsha and a deputy director at the Wits Reproductive Health Institute. A longtime HIV treatment advocate, Venter has been vocal about his support for a AstraZeneca rollout focused on high-risk groups using the country's existing stocks.

Venter says that as a doctor he would happily recommend AstraZeneca's vaccine to high-risk patients, family and friends.

"The absolute worst - and totally implausible - case scenario is that people get a vaccine that doesn't work," he argues. "The best-case scenario, which every piece of data seems to suggest, is that it's every bit as good as other vaccines and stops you totally getting very sick."

The health department did not respond to requests for comment.

Schoub says that the MAC discussed the WHO's AstraZeneca recommendations but ultimately did not adopt them. He also adds that the MAC did consider a limited rollout of the AstraZeneca jab among, for instance, the elderly when it looked like the vaccines might expire before South Africa could sell the jabs onward. The vaccine makers, the Serum Institute, ultimately said it was safe to extend the immunisations' shelf-life past original expiration dates.

Schoub remains firm: The responsible decision is to forgo offering the AstraZeneca vaccine to the elderly and vulnerable, who he adds might then stop social distancing or wearing masks believing themselves to be fully protected against COVID-19.

He also worries that rolling out a jab that may not work to prevent deaths and hospitalisations, may fuel vaccine hesitancy. And rolling out an additional vaccine also comes with added costs, Schoub says. "You're going to invest quite a significant amount of human and monetary resources in something where there's evidence, admittedly not conclusive evidence, that it's not going to work," Schoub tells Spotlight.

"The bottom line is this: It [AstraZeneca vaccine] may... be fairly effective against preventing severe disease," he explains. "The critical word is 'may'... we just don't know. And because we don't know we've got to try and go rather for vaccines where there is evidence."

'If this was a scientifically-based decision... I would love to see the calculus'

Ciara Staunton is a senior lecturer in law at London's Middlesex University who focuses on health governance and has worked in South Africa. The science of whether a treatment or a vaccine works is often not the only factor that governments consider when making healthcare decisions, she explains.

Instead, politics, economics, cost and even individual rights all play a role in how healthcare, including vaccines, are delivered in the face of scarce resources.

With so many competing interests, policymakers' transparency and accountability about how decisions are made are crucial for retaining trust, she warns.

"The old adage that justice must not only be done but must be seen to be done is so important," she says. "The responsibility falls on the government to explain to the public why it is making these decisions."

"Trust is key and it's something that's hard to get but very easy to lose," she says. "Once it's gone - it's incredibly difficult to get it back."

As part of the government's advisory body, workstreams of experts and some civil society representatives prepare summary recommendations on issues, which are then discussed at the larger MAC. Schoub confirms that no, non-medical representatives from civil society or patients' rights groups sit on the MAC.

The MAC ultimately provides the minister of health with brief advisories, which become the property of the health minister and are his to accept or reject, Schoub explains.

Some but not all of these advisories are posted to a dedicated section on the government's COVID-19 website. This section has not been updated since 11 January 2021 - about a month before the government halted the AstraZeneca rollout. And although these advisories summarise the MAC's recommendations, they do not outline the discussions that led up to them.

Spotlight has asked Health Minister Zweli Mkhize's spokesperson Lwazi Manzi for the MAC advisory regarding the decision to shelve the vaccine as well as a copy of the non-disclosure agreements (NDAs) that MAC and workstream members have signed.

Schoub says these NDAs are to protect confidential research shared with experts for decision-making. Schoub -- who, like many MAC members does sometimes several media interviews a day - says these NDAs do not prohibit MAC members from discussing the nature of deliberations.

But given the contested data and uncertainty around whether AstraZeneca's vaccine could protect against serious COVID-19 -- and what is an uncharacteristic departure from WHO guidance for South Africa - some say there needs to be more transparency around how the decision to forgo a targeted rollout was made.

"If this was [a scientifically-based decision], I don't understand it," Venter says. "I would love to see the calculus explained openly."

He continues: "There has been a lack of transparency around the vaccines, much like so many COVID-19 decisions."

Should people most affected by COVID-19 sit on the MAC?

Vicki Pinkey-Atkinson heads the Non-communicable Diseases (NCD) Alliance and lives with several underlying health conditions that put her at a high-risk of serious COVID-19.

People with NCDs including high blood pressure, diabetes and obesity are more likely to be hospitalised and die from severe COVID-19, a review of almost 42 000 hospital records in South Africa shows. These findings have not yet been peer-reviewed.

Pinkey-Atkinson admits she has been privileged to be able to reduce her risk of developing serious COVID-19 by staying at home during the epidemic. She says she's already planned to spend another year largely at home and so isn't sure she would take an AstraZeneca vaccine if it was offered to her.

"I suppose I [might] take it if I knew I wasn't going to get vaccinated for another six months," she says. "There is a hesitancy to take this vaccine when there's been such a big show made of giving it away and it not working already."

Still, she says whether people living with NCDs should be offered the jab ahead of the third wave has to be a discussion that is much more inclusive and transparent than what has happened in the MAC: "There is no way for people living with NCDs to be involved."

Pinkey-Atkinson says after fighting to be included in ongoing discussions, she was asked in early March to join one of the MAC's workstreams but says she hasn't been part of any discussions.

When asked if the MAC should include representatives from the NCD sector, Schoub said he believed it wasn't appropriate. "The MAC is a body of experts of scientific and medical experts, who look at the scientific aspects, and not the sociological and anthropological and those kinds of issues," he explains. "There aren't any lay people on the committee at all. I don't think it's really appropriate."

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