Covid-19 vaccine trial in SA: Will we have access to treatment if it is a success, and approved?

Covid-19 vaccine, Covid-19 vaccine development, how far are we from a vaccine
Covid-19 vaccine, Covid-19 vaccine development, how far are we from a vaccine
  • The UK has already ordered billions of doses of the vaccine currently being trialled
  • This is because of an agreement between Oxford University and AstraZeneca
  • Should SA's trial be successful, our best opportunity to secure vaccine is through COVAX

Oxford University’s Covid-19 vaccine candidate, AZD-1222, proved to be safe and effective with few side effects, preliminary trial results showed on Monday. According to pharmaceutical company AstraZeneca, they have finalised a license agreement with Oxford University for the vaccine candidate.

Earlier this week, the BBC initially reported that the UK government has already ordered 100 million doses of the Oxford vaccine, and later added that the government signed deals for an additional 90 million doses of the other promising BioNtech/Pfizer and Valneva vaccines. (These two vaccines are being researched by an alliance between the pharmaceutical companies BioNtech and Pfizer, as well as the firm Valneva.)

AstraZeneca, however, doesn’t have any direct involvement with South Africa’s vaccine trial as the agreement to do the trial here preceded Oxford’s agreement with AstraZeneca for further clinical development and manufacturing of the vaccine, said Shabir Madhi, Professor of Vaccinology at the University of the Witwatersrand (Wits) in Johannesburg, during an ECN (Economist Corporate Network) Africa webinar today. Madhi is leading the SA trial. 

Many other countries in similar situation

South Africa’s Covid-19 vaccine trial is being funded by the South African Medical Research Council (SAMRC) and the Bill and Melinda Gates Foundation. At the moment, there is no agreement with AstraZeneca to prioritise access to the vaccine for South Africa, should it prove successful. But this wouldn’t be unique to South Africa, said Madhi.

“Many other countries are in a similar situation. I think for low-to-middle income countries, including South Africa, the best opportunity to gain access at an early stage (once the vaccines do become available) is through the initiative that is being led by CEPI (the Coalition for Epidemic Preparedness) and Gavi.

“Unfortunately we [South Africa] are not in the luxurious position of being able to have billions of doses become available in the next twelve months. There’s going to need to be some kind of prioritisation in terms of who’s targeted for vaccines, as well as which countries gain access to the vaccines at an early stage,” explained Madhi.

The initiative Madhi referred to is known as the COVAX Facility, and according to the World Health Organization (WHO), more than 150 countries are engaged in this global access to the vaccine. The website reads: “The COVAX Facility, and the AMC within it, is designed to guarantee rapid, fair and equitable access to Covid-19 vaccines for every country in the world, rich and poor, to make rapid progress towards slowing the pandemic.”

AstraZeneca notes that commitments to supply more than two billion doses of the vaccine have so far been agreed with the UK, US, Europe’s Inclusive Vaccines Alliance, CEPI, Gavi the Vaccine Alliance, and Serum Institute of India. The company is engaging with these international organisations for the fair allocation and distribution of the vaccine worldwide.

“South Africa, fortunately, has already expressed interest in procuring vaccines through the COVAX mechanism,” added Madhi.

Late-stage Phase II/III trials of the vaccine are currently underway in the UK, Brazil and South Africa and are due to start in the US. AstraZeneca also stated in a media release this week that they will continue to fulfil their commitment for broad and equitable access to the vaccine, should these late-stage clinical trials prove successful.  

Smart choice to order millions of doses?

Based on the UK’s decision to order 190 million doses of the promising vaccines, we chatted to two local experts on whether this is a wise move.

Professor Thomas Scriba, Deputy Director of Immunology and Laboratory Director at UCT, explained that although there is some risk involved in ordering doses for a vaccine that we don’t yet know for certain works, the UK is simply trying to ensure that they get an allocation, considering the excessive demands for this vaccine should it turn out to be effective.

“I guess because they’re developing it, they’re trying to get in their order to be first in line,” said Scriba. This, of course, borders on the topic of 'vaccine nationalism'.

Scriba explained: “In an ideal world, it should be equitable and everyone should have access to health products that can save lives and reduce morbidity and mortality. Of course, this is not an ideal world and what often happens is that certain governments and institutions invest a lot of effort and money into the development of these products, making them positioned to have more say about negotiating access to it.

“I think it’s really important that there’s strong advocacy for making it equitable around the globe, and one of the things that we can do in South Africa, for example, which will help to negotiate access to new products, is to take part in these clinical trials.

"If we are part of the international effort that develops interventions for Covid-19 (or for any other type of disease), then it also puts us in a position to negotiate access to the vaccine," said Scriba: “There’s actually an ethical obligation if South African participants take part in trials, in that they took some risk, and that risk should be offset by the agreement that they would then get access to the product, should it prove to be efficacious.”

Nonetheless, Scriba concluded that it potentially puts other countries which may not be in a position to participate in such trials at a disadvantage.

“It’s a very difficult situation, and as I said, ideally, access should be equal but, unfortunately, there’s not going to be enough vaccine for all countries, especially at the beginning."

To navigate this tricky space, there will have to be some system to select who gets the vaccine and who doesn’t, said Scriba.

Onus on investigators of trials to negotiate access 

Honorary Professor Robert Wilkinson from the Institute of Infectious Disease and Molecular Medicine (IDM) at the University of Cape Town (UCT), and Director of The Wellcome Centre for Infectious Diseases Research in Africa (CIDRI-Africa) echoed Scriba’s sentiments above, saying that “if you take the risk, then you should get the benefit”, and further commented that the investigators (scientists) running the trials must ensure negotiation of access to the product as part of their agreement to do the trial.

“I think that’s an ethical necessity. When you agree to do the trial, I think it’s ethically important to have negotiated potential access to the product in the event that efficacy is demonstrated.”

‘We need to guard against a nationalist approach’

Touching on the above topic of vaccine access, Madhi commented during the webinar that for most low-to-middle income countries who don’t have the financial power of the US or the UK, for example, the COVAX Facility is likely the best opportunity to gain access to vaccines at an affordable price and at an early stage, said Madhi, who further cautioned against a nationalist approach.

“We have been engaging locally with AstraZeneca to see what might be possible for South Africa, in terms of gaining early access, but, again, procuring it through the COVAX mechanism is our best opportunity.

“Even as South Africans, we need to guard against a nationalist approach. Even if a vaccine is shown to be effective here, we can’t exactly do what the US is doing right now, in insisting that because the vaccine is being developed there, they need to get priority access. I think the COVAX mechanism is a model of greater equity concerning distribution of the limited supply vaccine that will be available."

Madhi also explained that the model is an advanced market commitment to the procurement of vaccines from different manufacturers, and that middle-income countries would be able to source vaccines from the bulk that is procured, and at a cost which is extremely favourable. Low-income countries, he added, will probably have vaccines donated to them through the same mechanism. 

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