What Are the Main Challenges That Global COVID-19 Immunisation Efforts Must Now Overcome?

This document is part of a series of discussion notes addressing fundamental questions about COVID-19 and response strategies. These documents are based on the best scientific information available and may be updated as new information comes to light.

Written by Gonzalo Fanjul, Adelaida Sarukhan and Rafael Vilasanjuan (ISGlobal), this document analyzes some of the present fundamental challenges of a global inmunization strategy.

Now that several safe and effective vaccines have been approved by health authorities in various countries, global immunisation efforts against COVID-19 are finally underway. The development of these vaccines—and the many others still in the pipeline—has shattered all previous scientific achievement records and given us a glimpse of the light at the end of the pandemic tunnel. However, without an immunisation strategy that promises to eventually achieve herd immunity and bring us back to normality, even these advances will be insufficient.

Unfortunately, the foreseeable vaccine access gap forces us to reckon with what the World Health Organisation (WHO) recently described as a “catastrophic moral failure”— a race among unequal competitors that threatens this global public good.

In this document, we will analyse some of the fundamental challenges involved in achieving this goal, particularly with regard to the safety and reliability of the available vaccines and the need to overcome barriers to production, distribution and access for all countries. The ultimate impact of COVID-19 will, in many respects, be shaped by the decisions we make in the coming months on this critical issue.

Science Has Delivered: The Portfolio of Vaccines Approved or in Development Gives Cause for Hope

All of the vaccines under development use one of four strategies:

The conventional vaccines contain either:

• inactivated whole virus
• viral proteins

The more innovative vaccines contain a genetic sequence that prompts the body to synthesise the viral protein in question. This genetic sequence can either be delivered:

• directly to the cells via messenger RNA or DNA
• by means of a harmless viral vector that infects the cells

The European Union (EU)—like most high-income countries, as well as some others—has established an ambitious immunisation strategy that started with the approval and distribution of the Pfizer-BioNTech and Moderna vaccine candidates. The AstraZeneca-Oxford vaccine, based on viral vector technology, is expected to secure EU approval shortly.

In other parts of the world, distribution of other vaccines—such as those developed in Russia (Gamaleya Institute) and China (Sinopharm). India has granted emergency use authorisation of its Covaxin vaccine, despite the fact that phase III safety and efficacy findings have not yet been published.

We Can Trust the Safety and Efficacy of the Vaccines Used in Spain and the Rest of the EU. But What About the Others?

COVID-19 vaccines have been developed in record time thanks to major technological advances and experience with the SARS and MERS coronaviruses. This does not mean that the process was not rigorous or that the usual steps were not followed. All vaccines approved by the EU will besafe, as they will have undergone all three clinical trial phases.

Messenger RNA (mRNA) vaccines —such as the first vaccines distributed in the EU—are based on technology that is new but not unknown. Although it had never previously been approved for use in humans, mRNA vaccine technology is the result of more than a decade of progress in the biomedical field. Furthermore, the safety of these vaccines has been demonstrated throughout the three-phase clinical trial process. The main unanswered question is how long it will protect against COVID-19.

What about the vaccines being distributed in other regions of the world? Doubts regarding their efficacy will be cleared up once the details of the final results are released and published.

Vaccines Do Not Mean the End of COVID-19 (at Least for Now)

Firstly, although several of the most advanced vaccines have shown efficacy rates of more than 90% in clinical trials, none have demonstrated 100% efficacy. The vast majority of people who receive the vaccines will be protected against COVID-19, or at least the most severe forms of the disease. However, we can expect that some percentage of vaccinated people will nevertheless become ill with COVID-19. Therefore, we cannot rule out the possibility that some vaccinated people may die as a consequence of becoming infected and developing COVID-19.

Secondly, while we know the vaccines protect against the development of disease, we do not yet know whether they prevent viral transmission —that is, whether they prevent us from becoming infected and infecting others. Therefore, until a significant percentage of the population has been vaccinated, preventive measures such as mask-wearing and social distancing will remain essential.

Finally, although preliminary results suggest that vaccines are effective against the viral variants that have emerged in the United Kingdom, South Africa and Brazil, SARS-CoV-2 is likely to eventually develop mutations that will require the adaptation of vaccines and treatments.

The Challenge of Global Immunisation: Sink or Swim Together

The only scenario in which COVID-19 can be brought under some semblance of control in the medium to long term is wordwide herd immunity, such that transmission is interrupted, further uncontrolled outbreaks of SARS-CoV-2 are avoided and new variants are prevented from emerging. This scenario necessarily implies widespread access to safe and effective vaccines.

Vaccines Are Reshaping the Global Geopolitical Landscape

Vaccines have become an instrument of geopolitics. Vaccine-producing and donor countries are exerting their influence to benefit partner regions. In today’s highly unstable international context, adversaries are prepared to exploit any omissions.

In Latin America, for example, uncertainty regarding the scope of international solidarity mechanisms and the availability of the Pfizer-BioNTech, Moderna and AstraZeneca vaccines has prompted some countries—Brazil, Mexico, Venezuela, Argentina and others—to commit to acquiring the Russian vaccine.

COVID-19 Will Reshape Our Model of Pharmaceutical Innovation and Access to Essential Medicines

The COVID-19 pandemic and the international pharmaceutical response pose a double challenge to the global model of innovation and access to medicines.

1. Firstly, difficulties in the production and supply of diagnostics, treatments and vaccines have prompted India and South Africa to spearhead a proposal calling for the World Trade Organisation to temporarily suspend the intellectual property rights related to these products. Such a suspension would allow the decentralisation of production and increase manufacturing capacity, thereby making these products available to more people at more affordable prices. Dozens of low- and middle-income countries support the proposal, but key high-income countries have rejected it outright. The high-income countries argue that the intellectual property system is necessary to incentivise the development of new vaccines, diagnostics and treatments, and that the removal of such incentives could cause supplies of these products to run out.
2. The second challenge has to do with the public sector’s unprecedented investment in generating and developing these innovations. The question is whether this investment will give public authorities the ability to set the price and conditions of access to pharmaceutical innovations.

What the EU and Spain Are Doing to Support the Challenge of Global Vaccination— and Why It Isn’t Enough

Spain participates in the COVAX scheme, fundamentally via the EU. The Team Europe programme is the vehicle for Europe’s cooperative response the pandemic, which has taken the form of €400 million in guarantees and €100 million in direct contributions to COVAX. This amount is expected to fund the purchase of at least 88 million doses. In addition, Spain has made a direct contribution of €50 million. These are valuable initial contributions which must continue in the future if we are to put an end to the pandemic.

In addition to their financial contributions, Spain and the EU have an important role to play in this battle, namely, not leaving the nearly 2.4 billion people living in self-financing middle-income countries—including much of Latin America

Finally, like its peers, Spain has made the same mistake of overbuying vaccines. As noted above, market saturation could be a serious obstacle to achieving the goal of global immunisation.

What more can Spain and the EU do to achieve this goal?

Success in the battle against COVID-19 depends on how well we manage to consolidate a safe, effective, universal and equitable global immunisation strategy. Recommendations:

• Consolidate COVAX as the global benchmark for the negotiation, purchase and supply of vaccines
• Lead an offensive within the EU and the G20 to guarantee access to vaccines for middle-income countries.
• The most developed countries, starting with those of the EU, must reconsider their stockpiling strategy, which threatens the availability of vaccines in other regions.
• Lead a debate on research model reforms and access to essential medicines.
• Strengthen the public health systems that are enabling the success of vaccines against COVID-19.
• Spain must define a Global Health Strategy to organise and guide its actions in this field