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COVAX – Its opportunities and challenges

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Early in the pandemic (24 April 2020), long before any manufacturer had a vaccine ready for sale, long before results of trials had been published, a novel collaboration was established to ensure equitable global distribution of COVID-19 vaccines when any became available. This was done under the auspices of the WHO-sponsored ‘ACT accelerator’, supported by SAGE and the Centre for Epidemic Preparedness Innovations (CEPI). The goal of ‘COVAX’ was to be ‘to end the acute phase of the global pandemic by the end of 2021’. It was anticipated thatIf it succeeds in this goal, through the appropriate allocation of safe and effective doses of vaccines in phases determined by epidemiology and public health, to slow and ultimately to stop the pandemic, it could save millions of lives and transform the economic prospects of governments and individuals’. The idea was to deliver 2 billion doses of vaccine, guaranteeing fair and equitable access to a managed portfolio of vaccines through a risk-sharing mechanism. Individual countries would sign up to it (190 were participating by the end of January 2021), either to receive supplies at cost or to receive free supplies courtesy of the expected donations. They would still be free to buy in stocks through other channels if they wished. The hope was to avert the threat of hoarding by wealthier states rendering it impossible for Low- or Middle-Income Countries (LMIC) to access supplies.

A portfolio was planned to include a range of candidate vaccines. This was for two reasons:  firstly because it was unclear which vaccines would be ready (proved effective, licensed, manufactured) and secondly because different groups of people might benefit more from one or another vaccine. The differing range of contra-indications, adverse effects and type of immune response and the storage requirements of different products would limit where they were most conveniently used.

While the initiative has been widely praised, COVAX is not free of faults and challenges. Some of the obstacles encountered, as well as lessons to be learned, are described below. However, it represents incredible global cooperation and offers much for which to praise God.

The first challenge: Procuring supplies

The COVAX project seems to be predicated on philanthropy. However, in reality, there was self-interest operating from the start; our Prime Minister wrote in The Times, ‘you may wonder why we have done it, why the taxpayer has spent hundreds of millions of pounds to put jabs in the arms of other populations – the answer is obvious, the principle of enlightened self-interest.’ He continued that by ‘helping the rest of the world’ we ‘serve the British interest, I mean the economic interest of people up and down the country’. This suggests the limit to generosity could be determined by Britain’s economic condition rather than by the level of other countries’ needs.

Financial support for the COVAX project could be seen as an investment in the ‘fastest way to end the pandemic’. Advance promises of funds to purchase vaccines were actively sought from wealthier governments, charities, private donors, and the pharmaceutical industry. Generous donations (pledges of cash) were made early, from many countries, including the UK (through the Official Development Assistance (ODA) budget), but there was still a shortfall. At a later stage, governments were also invited to donate to COVAX any surplus stocks of vaccine in their possession, over and above what was needed for their own population. Whilst some have agreed to this, it is unclear when they will do so. For recipient countries to accept excess stocks from elsewhere (rather than new supplies direct from manufacturers), they will need verifiable documentation about storage conditions since the vaccines left the factories.

Large quantities of vaccine secured by wealthier countries for their own use through Advance Market Commitment (AMC) (advance purchase agreements) limited the amounts immediately available for purchase by COVAX when regulators gave approval.

Indemnity against claims for serious adverse effects was likely to be problematic, especially in resource-poor countries; this was addressed by the WHO on a global basis for the duration of the pandemic, relieving individual governments of the burden.

The executive director of UNICEF suggested that supplies might be increased by governments ‘simplifying barriers to intellectual property rights’, and the proposal brought to the World Trade Organisation to waive such rights was supported by Tedros Adhanom Ghebreyesus (director of WHO). However, it is probably not the intellectual property rights (IPR) that are currently the limiting factor for supply but rather physical manufacturing capacity. The abolition of IPR could discourage essential commercial investment in the development of future vaccines. The UK and the EU are considering the matter.

The second challenge: Distribution ethics

The allocation of limited supplies according to a pre-determined ethical plan was fundamental. For this, the SAGE values framework, published on 14 September 2020 was used. It has six principles. The second, which they based on the UN Declaration of Human Rights, is interesting for Christians as being a fundamental belief arising from God’s creation of man in his own image:

SAGE Principles

  1. Human Well-Being

Protect and promote human well-being, including health, social and economic security, human rights and civil liberties, and child development.

  1. Equal Respect

Recognise and treat all human beings as having equal moral status and their interests as deserving of equal moral consideration.

  1. Global Equity

Ensure equity in vaccine access and benefit globally among people living in all countries, particularly those living in low-and middle-income countries.

  1. National Equity

Ensure equity in vaccine access and benefit within countries for groups experiencing greater burdens from the COVID-19 pandemic.

  1. Reciprocity

Honour obligations of reciprocity to those individuals and groups within countries who bear significant additional risks and burdens of COVID-19 response for the benefit of society.

  1. Legitimacy

Make global decisions about vaccine allocation and national decisions about vaccine prioritisation through transparent processes that are based on shared values, best available scientific evidence, and appropriate representation and input by affected parties.

In trying to balance global equity and national equity, the COVAX team relied to some extent on mathematical modelling, which predicted the impact of different levels of coverage in populations. This modelling suggested that proportional allocation would be more efficient than an unregulated market and likely to reduce preventable deaths due to COVID-19.

In February 2021, 265 days after the COVAX initiative was launched, the first vaccines were distributed through the scheme. The plan is to distribute them in the way predicted to be most advantageous, as Annelies Wilder-Smith explains in this webinar. The first stage will give supplies in proportion to the total population of each country, initially without regard for prevailing epidemiology – enough to vaccinate three per cent of the population. This was expected to cover frontline healthcare staff at the highest risk of infection and some other groups at the highest risk of death if infected (to be identified by each country, eg older adults with comorbidity). The second stage will gradually increase supplies up to 20 per cent of the population (which could include other older adults, people with comorbidities, other sociodemographic groups with increased exposure to infection such as health workers engaged in delivering immunisations or high priority school staff). In the third stage, to vaccinate 21 to 50 per cent of the population in each country, distribution will be dependent on epidemiological indicators and vulnerability to the threat of COVID-19. We will consider below ethical aspects of this distribution plan.

The stages of prioritisation were only one side of the logistic challenge. Another was the many complicated arrangements that needed to be made within recipient countries: authorisation by the national regulators, storage, distribution, dispensing, calling up people to be vaccinated and recording the injections, etc. COVAX did not want to send vaccines until they knew the country was ready to handle them. All countries have experience of childhood vaccination programmes, but mass vaccination of adults requires different methods. Some of the candidate vaccines need unusual storage conditions. Vaccination centres had to be organised with suitable social distancing and environmental hygiene. In-country costs were not covered by COVAX, however some support for LMIC was available from charities. COVAX prepared and offered a toolkit of resources to assist government ministries in preparation for receiving their vaccines, including the development of a regulatory framework and in-country allocation policies. Since they were not starting from scratch – CEPI had experience with other epidemics – it was possible to prepare the plan rapidly.

The third challenge: Difficulties in implementation

Although wonderful progress has been made in facilitating the international efforts at mass vaccination, there have been some problems. Leadership-weakness issues were identified by an editorial in The Lancet, which concluded that ‘An authoritative voice with moral credentials is needed to support global access to vaccines, to intervene when that goal is under threat, and to call out unfair practices’.

Logistical difficulties have also been encountered: in March 2021, The Guardian reported that ‘a double blow of slower than expected production at a South Korean manufacturing plant and setbacks in securing export licences from the Indian government’ endangered delivery of up to 90 million doses of the Oxford/AstraZeneca vaccine for poor countries like South Sudan, Mauritius, Iraq, Bosnia and Herzegovina, and Yemen. There was also the threat of interruption in supplies to COVAX from some manufacturers. It is understandable that ‘the Serum Institute has competing commitments to AstraZeneca, the Indian government and to the contracts it signs privately to supply overseas governments’ (ibid). But perhaps people underestimated the likelihood of a complete ban on the export of a vaccine made by a commercial company. This has happened in India during the catastrophic increase in cases from April to May 2021.

Just as manufacturers may have difficulties ordering their priorities amongst customers, some governments may prioritise readily available vaccine sources over those handling only evidence-based vaccines compliant with the highest international standards of regulation. There is a chance that some LMIC may accept cheap vaccines offered as an ‘aid donation’, which might carry political overtones and lead to unanticipated consequences. Wealthier countries buying what they wanted regardless of others’ needs (through contracts made with companies well in advance of COVAX formation) meant that by mid-March, 70 per cent of the available vaccine had gone to 16 per cent of the world’s population, with not enough left for COVAX to buy all its requirements.

COVAX offers guidance (based on SAGE principles) but cannot control the in-country allocation of vaccines it supplies. This must be at the discretion of the government concerned. There are appropriate variations between countries based on demographic and societal factors, or pre-existing national health policy. Though a mixture might be chosen, two contrasting approaches are possible – a ‘pragmatic’ policy goal of suppressing community transmission or a ‘compassion focussed’ policy goal of protecting those most likely to die if infected (see, for example, this paper from the Nuffield Council on Bioethics). For example, in Indonesia, working people (more at risk of exposure) are prioritised over older people (more at risk of complications) – and it would be wrong for more privileged nations such as the UK to dictate a prioritisation scheme similar to its own for use in other countries. The one rule COVAX did put in place was that any national plan should not enshrine overtly discriminatory policies, such as the exclusion of refugees.

However, the actual implementation may digress from the policy in some cases because the population fails to cooperate. For instance, in the UK there has been a lower uptake of the vaccine among some minorities.

Policing discriminatory practices is another issue. Even in the UK, this possibility exists! It could be inadvertent. For example, a history of data sharing by health and immigration authorities deters asylum seekers in the UK from accessing vaccines. Or it could be produced by the system; for example, where registering to receive a vaccine requires the use of an app on a smartphone, which disadvantages those who cannot access one.

Possible Alternatives

Some have argued that, during a pandemic that has spread unevenly across the world, the underlying assumptions about the initial proportional allocation of available stocks of vaccines to different countries based on population size (without regard for epidemiological status) are unethical. This approach is transparent and better than an uncoordinated competition for supplies (as happened during the H1N1 epidemics in 2009), but it is poorly aligned with SAGE principles 2 (Equal Respect) and 3 (Global Equity) in that:

1) Treating people identically regardless of their circumstances is not equal to respect. Rather, Principle 2 requires responding to people’s different needs with equal consideration.

2) Global equity requires ensuring that ‘vaccine allocation takes into account the special epidemic risks and needs of all countries, particularly low- and middle-income countries.’ Ironically, proportional allocation disregards countries’ unique risks and needs.

An alternative model, such as the ‘Fair Priority Model’ suggested by Herzog et al, would have been possible, but given that allocation ‘must be based on clear metrics that can be consistently and transparently applied’ it seems unlikely that COVAX would change its approach midway through distribution. Proposals like Herzog’s are attractive, though, and should be considered when planning ahead for any other pandemic:

                The Fair Priority Model

Based on three widely shared ethical values—benefitting people and limiting harm, prioritising those who are disadvantaged, and equal moral concern—the Fair Priority Model allocates vaccines between countries in three phases.

Phase 1 aims at minimising premature deaths, based on the [] change in Standard Expected Years Of Life Lost (SEYLL)* per dose.

Phase 2 adds socioeconomic factors, measured in SEYLL, loss of gross national income (GNI), and reduction of the poverty gap.

Phase 3 aims at returning countries to their pre-COVID-19 situation.

Vaccine efficacy was not known when the model was proposed, so we assumed that approved vaccines would be safe and could reduce the risk of severe complications and death from COVID-19.

SEYLLs as a criterion for prioritisation would favour younger people (who have more years of life expectancy ahead of them), which some may feel is not morally justified, but the model is worthy of consideration.

COVAX will need to be critically reviewed as it progresses (one presumes that is written into the plan) and be ready to adapt its practices, particularly during phase three in response to the changing epidemiological situation (including the emergence of new “variants of concern”).

Progress to date

The project is still only in the first phase and is falling behind on some targets. Delivery of doses from Serum Institute of India (SII) for use in other countries in March and April 2021 was delayed because of the increased demand in India. Nevertheless, it was announced that 38 million doses of vaccines had been delivered to 100 different countries by the end of March, including 61 LMICs whose supplies were funded by GAVI’s AMC. One month later, doses that had been delivered through COVAX totalled more than 49 million.

An independent analysis stated that of the 187.2 million doses of the Oxford/AstraZeneca vaccine COVAX planned to distribute by the end of May, the programme had delivered only about 40.2 million or 21.5 per cent.

A Christian response

Our response as Christian health professionals to the COVAX project should be derived from Christian ethical premises. Dr Annelise Wilder-Smith has suggested some appropriate responses with which I would concur: we can advocate for our own government to support it; provide a rational explanation to help others understand why the UK should support COVAX generously; undertake advocacy for Vaccines For All in the UK, and within our own circle of contacts seek to dispel harmful myths about vaccines. However, she maintained that ‘boycotting’ is not useful. This last point refers to the idea some had entertained that they (being personally at low risk) should not accept a vaccination themselves while others abroad at higher risk could not have it. This type of protest is ineffective in improving vaccine distribution and would tend to undermine the national programme. Dr Wilder-Smith also challenged us with this thought: what we can and must do is pray! There is scope for misuse of vaccine doses within recipient countries. There is always scope for dishonesty in handling the funds. Let us pray that, at all levels, the implementation of the COVAX project will be characterised by integrity.

Conclusions

Facing this global emergency required a level of inter-country cooperative effort never before seen in the field of health to bring this pandemic under control. Without facilitation by the well-established World Health Organisation, it is hard to see how the COVID-19 vaccines could have been utilised as a precious shared resource belonging to humanity, rather than as commodities from which some companies could make huge profits.

It is right and good for wealthier governments to donate funds for the project, even if their motivations are mixed and they are acting partially in their own interests, to make the world safer for travellers, trade, industry, and peace! It is right to consider (in setting priorities) which groups have the highest risk of catching and/or transmitting infection and also which groups might suffer a more severe impact if infected. It is right to share the other resources necessary for worldwide vaccination, namely scientific knowledge, technical skills, manufacturing plant, components, and expertise in pharmaceutical regulation, etc.

The coverage of our world’s population by vaccination programmes is currently still uneven but probably better than it would have been without COVAX. For all its weaknesses, it is an exemplary piece of international cooperation. This an endeavour we as Christians can support wholeheartedly, but not uncritically! Let’s pray that God will bless it with success.

 

Ruth Butlin is a retired medical missionary

 

Footnote

*SEYLL is commonly used in global burden of disease estimates. It calculates life years lost compared with a standardised global reference lifetable

 

 

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