Access to COVID-19 vaccines: Global approaches in a global crisis

 The immunisation effort is underway, and already showing promising results

In the United Kingdom, the United States and the European Union, the first vaccinations began immediately after authorisations were granted, with priority given to high-risk older adults, such as long-term care facility residents, as well as frontline health care workers.

As of mid-March 2021, 380 million doses of COVID‑19 vaccine had been administered globally; 29% of which in the United States, 13% in the European Union, and 7% in the United Kingdom. By contrast, South America accounted for less than 6% of doses administered globally. The proportion of the population who had received at least one dose was 60% in Israel, (see Figure 1), followed by the United Kingdom (36%), the United Arab Emirates (35%) and Chile (26%).5 Rapidly emerging evidence of the effectiveness of vaccination in Israel and the United Kingdom – not only in terms of preventing severe illness, hospitalisation and death, but also in reducing infections – is encouraging (see Box 2).

 

Figure 1. Percentage of the population having received at least one dose of vaccine in selected countries

As of 15 March 2021

Source: Our World in Data, 15 March 2021.

The European Union plans to vaccinate 70% of its adult population by the end of August 2021. As of 15 March 2021, more than 51 million doses of vaccine had been administered in the EU, with Denmark and Spain reporting the highest levels of vaccination per capita (respectively 10.1% and 8.4% of their population had received at least one dose).6

As of 15 March 2021, in the United States 71 million people (22% of the population) had received at least one dose of vaccine and almost 40 million were fully vaccinated. A total of 110 million doses had been administered, more or less equally divided between the Pfizer/BioNTech and Moderna products.7

Russia began public vaccination in Moscow on 5 December 2020, using the non-replicating viral vector vaccine developed by Gameleya Institute. By 10 February 2021, 2.2 million Russians, or just under 2% of the population, had received their first dose of the two‑dose vaccine, and more than 1.7 million had received both doses. The Ministry of Health has announced plans to vaccinate 60% of the population by the end of June.8

In China, authorities have already approved four COVID‑19 vaccines (developed by three Chinese manufacturers) for emergency use (see Annex 1.A). As of 28 February 2021, China had administered 52 million COVID‑19 vaccine doses, or roughly 3.6% of its population.9 In early March, China’s most senior COVID‑19 health official announced plans to vaccinate 40% of China’s 1.4 billion people by the end of June 2021.

In light of their relative success in limiting transmission through non-pharmaceutical interventions, some countries in Asia and Oceania reportedly delayed the initiation of their vaccination campaigns. In Australia, the government announced plans to administer the Pfizer/BioNTech vaccine to the highest priority groups, but to use mainly locally-manufactured Oxford/AstraZeneca vaccine in the broader population.10 In New Zealand, the government announced plans to vaccinate the entire population (5 million), largely in the second half of 2021.11 South Korea announced that it began COVID‑19 vaccination in February 2021 in line with the delivery of its initial batches of vaccine, while Japan also commenced its vaccination campaign in mid-February, focusing initially on health care workers and older adults.12

 Limited supplies are slowing vaccination campaigns in many countries

Most OECD countries are yet to receive supplies sufficient to vaccinate all their priority populations. As a result, some countries, such as the United Kingdom, have decided to delay administration of the second dose in order to provide more people with the initial dose (see Box 3).

Manufacturers frequently cite production problems in explaining delays in supply. Pfizer undertook to deliver 350 million doses to the European Union by the end of September 2021 but announced in January 2021 a temporary halt to supply in order to increase production in the future. The company has said it will make up for the shortfall and honour the total first-quarter deliveries to which it has committed. Nevertheless, the disruption has slowed immunisation efforts. Romania received only 50% of its planned volume in February (the other half to be allocated gradually by the end of March); Poland also received 50% less than expected.13

AstraZeneca has also faced production issues in the European market. In late January 2021, the company announced that it would reduce EU supplies of its COVID‑19 vaccine in the first quarter due to low cell culture yields.14 This led to concern within the European Commission and among Member States that the manufacturer appeared to be prioritising markets outside the EU with products manufactured in its territory.15 More recently, AstraZeneca said it would be able to deliver only half the vaccine it was contracted to supply to the EU in the second quarter of 2021, an estimated reduction of 90 million doses.16

Many vaccine manufacturers have significantly scaled-up production capacity, and have sub-contracted manufacturing to other major (at times, rival) bio-pharmaceutical manufacturers lacking vaccine candidates of their own. For example, Johnson & Johnson (J&J) and Merck & Co. recently announced they will work together to manufacture the Johnson & Johnson vaccine. Merck will convert two of its manufacturing facilities to produce the new vaccine.17 Despite this, demand will continue to outstrip supply for some time yet and recent pharmacovigilance issues might also contribute to delaying the immunisation effort in some countries.18

 Protecting the most vulnerable

The most direct way to protect populations from COVID‑19 and reduce morbidity and mortality is to prioritise vulnerable populations for vaccination, including the elderly, people with pre‑existing conditions and those particularly exposed to SARS‑CoV‑2, such as health care workers. In their phase III clinical trials, all of the vaccines authorised thus far have been shown to reduce both mortality and the incidence of severe COVID‑19 (see Annex 1.A).

Most countries are currently pursuing this approach. As vaccines began receiving authorisation in December 2020, many OECD countries were experiencing community transmission and supply was initially heavily constrained. Most national vaccination campaigns have initially been focussed on those for whom COVID‑19 poses the greatest health threat.

In Denmark and Poland, for example, 59% and 42% of the respective populations over 80 years of age had been vaccinated with one dose by 15 March 2021, in contrast to 13% and 26% of people aged 70 to 79, and less than 10% in all other age groups (ECDC, 2021[13]). In the United Kingdom, more than 90% of the population aged 65 years and over were reported to have received at least one dose by 11 March 2021 (NHS England, 2021[14]). In the United States, 26% of the population aged over 65 years was reported to have been fully vaccinated by 15 March 2021, compared with 8% to 19% in all other adult age groups (CDC, 2021[15]). Several EU member states also report having vaccinated more than 50% of their health care workers.

Indonesia is one of only a few countries that is prioritising working-age over elderly adults for vaccination, reportedly because of insufficient data on efficacy in older people of the Chinese vaccine being used.20 Maintaining productivity in the population has also been reported as a motivation for this approach (Lloyd-Sherlock, Muljono and Ebrahim, 2021[16]).

 Slowing the emergence of new variants

Another strategy is to prioritise the use of vaccine to reduce transmission of SARS‑CoV‑2. This is an advantageous strategy for two reasons. First, containing the spread of the virus reduces the number of incident infections and the occurrence of symptomatic disease, and this confers protection on high-risk populations indirectly. Second, and perhaps more importantly, reducing transmission reduces viral replication, thereby also reducing the frequency of mutation and the potential emergence of new variants (see Boxes 4 and 5). If existing vaccines prove to be inadequately effective against the dominant emergent strains, high rates of (re)-infection could occur, leading to third and fourth waves of the pandemic as vaccine manufacturers strive to catch up, particularly if new variants are associated with higher rates of transmission, or more severe disease. Thus, in a context of high community transmission, strategies that prioritise interrupting the spread of the virus, and thus the potential for emergence of new variants, should be considered a priority.

Although the effects of vaccination on transmission were not a primary endpoint of the phase III clinical trials, evidence is now beginning to emerge that some COVID‑19 vaccines, in particular the Pfizer/BioNTech product studied in Israel (see Box 2) and the United Kingdom (Weekes et al., 2021[17]), are also effective in averting new infections, including asymptomatic cases. A number of studies are still underway to determine how effective the various vaccines are in terms of blocking transmission (Mallapaty, 2021[18]). At this stage, available evidence suggests that protection from symptomatic COVID‑19 is associated with lower viral load and thus a lower propensity for viral shedding, thereby reducing transmission to some degree. According to the World Health Organization, the evidence about the performance of the COVID‑19 vaccines to prevent infection or transmission remains limited, but it appears at this stage “reasonable to assume there will be some level of protection against transmission”.21

 Accelerating vaccination is essential to recovery

The fact that all countries are giving priority to vaccinating their own populations reflects legitimate concerns by politicians whose primary accountability is to their own citizens. However, in the context of a pandemic, the skewed distribution of limited vaccine volumes between rich and poor countries is inequitable and inefficient. Allocating scarce resources for health care according to need – equitable access according to need – is a basic principle of equity supported by health policy in most OECD countries. Such an allocation is also efficient because it maximises the overall health benefits that can be generated from available resources.

Beyond the ethical imperatives, the efficiency arguments are compelling. First, prioritising the administration of vaccine according to need will minimise the number of deaths due to COVID‑19 on a global scale. Second, prioritising the administration of vaccine where community transmission is the greatest is also essential to gaining control of the pandemic. It is thus in the interest of high-income countries who have vaccinated their priority populations to allocate some proportion of their existing supplies to areas of high need in other countries, rather than attempting to immunise their entire populations first. International supply chains and movements of people and goods will inevitably lead to the transmission of emerging variants across borders, potentially inflicting further damage on populations (and economies), even those fully vaccinated. The economic costs in high-income countries could well exceed the costs of helping poorer countries become fully vaccinated by as much as 10 to 100 fold (Bown, de Bolle and Obstfeld, 2021[20]), although even these estimates may be conservative.

Recent models estimate that faster progress on ending the pandemic will raise global income cumulatively by USD 9 trillion over between 2020 and 2025, with benefits for all countries, including around USD 4 trillion for advanced economies (Cakmakli et al., 2021[21]). The latest OECD Economic Outlook further emphasises that everything necessary should be done to enhance the capacity for a faster pace of vaccinations and that failure to do so would raise the long-lasting economic and social costs from the pandemic (OECD, 2021[22]).

Unlike the scientific collaboration seen during their development, recent actions taken by governments have not shown commensurate levels of international co‑operation and solidarity with respect to the production and distribution of vaccines. Some countries continue to threaten restrictions on vaccine exports, similar to those seen in 2020 in relation to personal protective equipment and other medical supplies. In a more promising development, in February 2021, G7 leaders issued a joint statement pledging improved international collaboration and support for the global COVID‑19 response, including additional funding for the COVAX facility, offering some signs of greater emphasis on collaboration.22

 Most high-income countries placed large advance orders to ensure priority access

Several OECD countries with domestic vaccine R&D and manufacturing capacity invested in both, the development of COVID‑19 vaccine candidates and the building of manufacturing capacity, in return for supply commitments and/or guaranteed purchase of specified vaccine volumes. Backed by this public funding, several manufacturers built production capacity in parallel with vaccine development, thus allowing significant quantities of vaccines to be available immediately on regulatory approval. This has led to a scenario in which several OECD countries have secured quantities of vaccine that would enable them to vaccinate their populations many times over.

Figure 2 shows the number of doses secured by some OECD countries relative to their populations, based on publicly available information on supply agreements. As of mid-March 2021, high-income countries (16% of the global population) had negotiated supply agreements amounting to approximately half of the world’s vaccine supply,23 leading to allegations of ‘vaccine nationalism’. The limited data available on prices suggest that high-income countries also pay higher average prices per dose than low- and middle‑income countries, which may be another reason for being supplied first (see Annex 1.C). Some countries, such as Argentina, Brazil and India, gained priority access through hosting clinical trials and “licensing-in” of technology for local manufacturing.24

 

Figure 2. Number of possible vaccinations per capita (based on volumes secured through supply agreements)

As of 15 March 2021

Note: The numbers of doses per country are based on publicly available information; data are likely to be incomplete and more supply agreements may exist than are publicly disclosed. The number of doses secured does not include purchase options and may therefore underestimate the number of doses secured by countries. The number of doses for COVAX only includes confirmed supply agreements, but not 1 billion doses that COVAX has a first right of refusal access as a result of R&D funding by CEPI. The number of doses for the European Union includes supply agreements with the European Commission but not bilateral contracts between EU member states and manufacturers.

Assumes that 2 doses of any given vaccine are necessary for full initial immunisation, except the single‑dose vaccine produced by Johnson & Johnson. The populations of the COVAX-eligible countries represent the global population minus OECD countries and non-OECD countries with national production capability (Brazil, China, India, Russia).

Source: OECD analysis based on data on vaccine doses published by UNICEF, https://www.unicef.org/supply/COVID-19-vaccine-market-dashboard, 5 March 2021, and OECD population estimates.

 COVAX remains underfunded

The Gavi COVAX facility is currently the only mechanism that aims to secure access to successful vaccine candidates multilaterally and proposes a rational allocation sequence between governments. It is essentially a joint procurement scheme that negotiates supply contracts with manufacturers on behalf of participating countries.25 Self-funding countries (middle‑ and high-income countries) will be allocated vaccines for 10‑50% of their populations depending on their financial contributions to the mechanism. Vaccine will also be supplied for 20% of the populations of 92 low- and middle‑income countries (LMICs) eligible for donor funding.

To date, however, COVAX remains underfunded, and continues to compete for supply against bilateral supply agreements between governments and manufacturers. In 2020, the goal was to raise initial funding of USD 2 billion for LMICs, and this was reached by December 2020. However it is estimated that a further USD 5 billion will be needed for LMICs in 2021, excluding funds for self-financing countries. Although the G7 Leaders’ Summit in February 2021 resulted in additional pledges,26 COVAX is still USD 800 million short of its funding needs for the year. Despite this progress, doubt persists as to the ability of COVAX to attain its goal of delivering 1.8 billion vaccine doses in 2021.

On 2 March 2021, Gavi published an updated information regarding the first round of COVAX allocations (Gavi, 2021[27]). The first allocation includes 237 million doses of the Oxford/AstraZeneca vaccine to 142 countries, with projected deliveries through May 2021. Additionally, there is an “exceptional distribution” of 1.2 million doses of the Pfizer/BioNTech vaccine to countries that requested it and demonstrated the ability to manage the logistical requirements. Deliveries for the first round of allocations has already begun, with India, Ghana and Cote d’Ivoire receiving doses of the Oxford/AstraZeneca vaccine. Both Ghana and Cote d’Ivoire began vaccination campaigns utilising these doses on the 1 March 2021.

Yet, even with the acceleration in vaccine distribution through COVAX, questions remain over how low- and middle‑income countries will be able to achieve extensive levels of coverage in the medium term. A recent report by The Economist Intelligence Unit (2021[28]) estimates that some parts of South America, Africa, and Asia will not achieve widespread vaccination coverage until 2023.

 Countries must continue to increase supply and act now to build capacity for vaccination campaigns

In the first quarter of 2021, production capacity and supply remain a key constraint for the pace of national vaccination campaigns. Little information is available about the delivery sequences specified in supply contracts or the stipulations of licensing contracts around the destinations of vaccine doses produced locally. Some producers with licenses for local production are only supplying national markets first. The Serum Institute of India, for example, will initially supply India only with the Oxford/AstraZeneca vaccine, which was approved in India for emergency use on 3 January 2020, before distributing it to other countries.27 The Serum Institute is the world’s largest vaccine manufacturer by volume, and has been licensed to produce 1 billion doses. The Oxford/AstraZeneca vaccine is also being manufactured under license in Australia, the Netherlands, Germany, Brazil, Argentina and the United States.

Efforts in the near term need to continue to focus on building production capacity and increasing supply. This includes not only a massive scale‑up of manufacturing capacity for the approved vaccines and late‑stage candidates, but also the building of additional capacity to produce ancillary products (e.g. vials, syringes, refrigeration equipment). This requires more extensive sharing of intellectual property at low or no cost, but also, and as importantly, technology transfer to enable local production.

Increased capacity is likely to lead to very different scenario in a few months’ time, when the bottleneck will move from securing the supply of vaccine doses to vaccinating people. Figure 3 shows an illustrative projection of supply increases through 2021 in selected OECD countries. By Q3 2021, the United States and EU Member States are likely to have received more than one full vaccine regimen for each individual. Governments therefore need to anticipate the surge in supply now and act decisively to ensure that the logistics and infrastructure are in place to support future warehousing and distribution in order administer available vaccine doses swiftly and avoid waste.28 Sufficient human resources must also be made available, and governments should engage actively with their populations to ensure that people receive their vaccinations as planned.

In addition to logistics and distribution, the success of vaccination campaigns will be strongly influenced by the extent to which people trust the effectiveness and safety of the vaccines, the competence and reliability of the system that delivers them, and the principles that guide the underlying government decisions and actions (OECD, forthcoming[2]).

 

Figure 3. Vaccine supply is poised to increase in the coming months in Europe and the United States

Note: Data are intended as illustrative only. The following assumptions have been made: all expected deliveries have been cut by 20% to account for unforeseen production issues; deliveries of J&J vaccine starts in April, June for Novavax and September for Sanofi and Curevac.

Source: Based on Knowledge Network on Innovation and Access to Medicines (2021[29]), “COVID‑19 Vaccine Purchases and Manufacturing Agreements”, www.knowledgeportalia.org/COVID-19-vaccine-arrangements, accessed 15 March 2021.

 Governments must share surplus vaccine

By the end of 2021, high-income countries will likely have large quantities of vaccine doses in excess of that needed to vaccinate their priority populations. These should be transferred rapidly to areas of greatest need around the globe, to protect vulnerable populations and slow the emergence of new variants, as discussed in the section “Deploying vaccines globally to save lives – and end the pandemic”. As explained above, this is not only an ethical imperative but also the only way to end the pandemic as quickly as possible and in all countries’ best interests.

Some governments have already announced that they would share surpluses they have purchased with their neighbouring or other countries. For instance, government officials in Australia and New Zealand announced that they would provide vaccines and logistical assistance to neighbouring islands.29 According to news reports, Canada and the European Union are making plans to donate excess quantities;30 India has launched a 49‑nation “friendship programme;” and China is shipping vaccine to several African countries, Turkey, and Afghanistan. While Canada is reported to be planning to donate to COVAX, the European Commission has announced that some vaccine would be shared directly with selected countries and with COVAX. It remains unclear as to how ‘surplus’ will be defined and at which stage of their national vaccination campaigns countries will begin sharing.31 Also, at least one advance purchase agreement that has been made public includes provisions that preclude resale and donation of doses to other countries without prior consent of the pharmaceutical firm.32 Meanwhile, government officials in the United Kingdom have suggested that supplies will only be shared once the entire UK population has been vaccinated.33

Gavi has encouraged countries with bilateral supply agreements to share vaccine through COVAX to complement the supplies secured through the contracts negotiated by COVAX itself. The principles laid down by COVAX for this purpose (Gavi, 2020[30]) could contribute to more equitable and efficient global allocation. While donations are to be welcomed, they should not be the principal avenue for sharing vaccine. WHO has repeatedly warned against a focus on bilateral or selective vaccine donations, arguing that they could result in further inequities among lower-income countries.34 Also, various issues may need to be addressed to ensure that donations can be made and used effectively in their destination countries. These include potential contract limitations between manufacturers and governments, the need for regulatory authorisation in the destination countries, and indemnification and liability provisions (Cohen, 2021[31]). A co‑ordinated effort is therefore key.

 Sustained global access to vaccines cannot hinge on philanthropy

Although some progress is being made through COVAX and direct sharing of surplus vaccine doses between countries, globally efficient and equitable distribution of vaccines cannot solely rely on the goodwill of donors and ad-hoc solutions. Governments urgently need to commit themselves to structured approaches that are sustainable in the longer term and provide binding safeguards that ensure that vaccines are available where needed most. This will be particularly important if COVID‑19 becomes endemic, similar to seasonal influenza, requiring vaccines to be adapted periodically and populations to be vaccinated repeatedly.

In the current stage of the pandemic, availability could be improved by making further efforts to expand production capacity and supply. There are a number of approaches to this. Several of the principal vaccine developers have established voluntary licensing arrangements with other bio-pharmaceutical companies – in some cases, their competitors. For example, Merck will also manufacture the Johnson & Johnson vaccine; Sanofi and Novartis, have been licensed to produce the Pfizer/BioNTech product; and AstraZeneca has granted licenses for the manufacturing of its vaccine in several countries, including for 1 billion doses to be manufactured by the Serum Institute of India. As a result, production is now actually being scaled-up quite rapidly, and a major increase in the supply of vaccines can be expected at the global level in the coming months, at which time the current bottleneck will likely shift from supply to the actual delivery at patient level.

But similar to donations by governments, voluntary licensing relies on the willingness of individual intellectual property rights holders, who have strong commercial incentives to constrain supply, to license their assets. Capacity could have arguably been scaled up even more rapidly, had governments made the massive R&D funding mobilised in 2020 conditional on subsequent licensing of intellectual property and technology transfer. This opportunity was largely missed but should serve as an important lesson for future policy.

While compulsory licensing remains a legitimate option for governments to enable additional manufacturers to produce existing vaccines, it does not on its own address the equally important issue of the technology transfer needed to do this. It might therefore only be beneficial for countries that already have the know-how and excess capacity to manufacture vaccines. To the extent that excess manufacturing facilities exist, these could instead be used to expand fill-and-finish capacity and bring the final stages of production closer to the end of the distribution chain. In addition, the unilateral and unco‑ordinated use of compulsory licensing by some countries could lead to tit-for-tat trade disputes, with uncertain effects on international co‑operation and the system of incentives for private investment in R&D that intellectual property protections are intended to create. Unilateral action could also potentially undermine the development of rapid and innovative responses to future health emergencies.

A co‑ordinated and multilateral approach to intellectual property and technology transfer would therefore be preferable. While the large amounts of public funding for R&D of COVID‑19 vaccines provide a strong justification for imposing limitations to private intellectual property rights, greater access could, for example, be achieved through broader use of the WHO COVID‑19 Technology Access Pool (C‑TAP). This mechanism aims to compile, in a single and centralised repository, pledges to voluntarily share knowledge on COVID‑19 health technology, intellectual property and data. However, thus far only a small number of countries have endorsed C‑TAP, among them none of the countries that host major R&D and production capacity, nor have any of the principal vaccine manufacturers agreed to participate.35 Another proposal, currently being debated at the World Trade Organization, involves temporarily suspending intellectual property rights for the duration of the pandemic. Whatever the outcome, multilateral approaches can broaden access to COVID‑19 vaccines and will be important in shaping approaches to sharing intellectual property and facilitating technology transfer in future public health crises.