This summer, the world was reminded that monkeypox – renamed mpox – existed when the World Health Organization (WHO) once again declared it a “public health emergency of international concern” in light of the continued rise in cases in the Democratic Republic of Congo (DRC). Outbreaks have been worsening on the continent since 2022, but Africa has still not received a single vaccine, incomprehensibly. This is despite countries like the DRC having been calling for them for two years and wealthier states promising donations. There has been no shortage of well-intentioned calls for solidarity in the face of what appears to be a repeat of the mistakes of covid-19.
“Many parallels are made with the time of covid-19 and the hoarding of vaccines by the European Union and the United States, but in this case it is not so clear to what extent this played a fundamental role in the delays in the entry of vaccines into Africa and the DRC,” Belén Tarrafeta, a researcher in pharmaceutical policies at the Institute of Tropical Medicine in Antwerp (Belgium), tells elDiario.es. Where were the doses and why were these places not receiving them?
As published The New York TimesWhat happened with the vaccine doses was that they were “trapped in a byzantine WHO drug regulatory process.” The summary of this bureaucratic saga: Many low- and middle-income countries rely on the WHO to judge which drugs and vaccines are safe and effective, but the agency had not yet approved the two existing MPOX vaccines. As a result, they were unable to receive the doses because the organizations that help them buy them – the Vaccine Alliance (Gavi) – will not be able to start acquiring them until they get the green light from the WHO.
The fact that the WHO has yet to rule may seem contradictory considering that the vaccine is approved for use in countries like the United States and Europe, where millions of people have received their doses without issue. The devil is in the details: “The mpox vaccines were originally developed for smallpox, and that was the initial authorization,” Tarrafeta says.
The regulatory agencies of the United States (FDA) and the EU (EMA) have authorized its use for mpox through emergency processes, provided that more data are available. Therefore, Tarrafeta clarifies, the WHO “cannot consider that the vaccine has received authorization from rigorous regulatory bodies and that it is considered ‘unlicensed’, unauthorized.”
Many things have failed and it is a bit paradoxical that in the year when all we were talking about was the pandemic treaty, there was so much negligence in the response to the mpox emergency in the DRC.
Belen Tarrafeta
— Pharmaceutical Policy Researcher (Antwerp Institute of Tropical Medicine)
It also doesn’t help that we are facing different outbreaks with different variants of the virus. The data required by the FDA and EMA do not necessarily have to coincide with what the WHO wants: “Clade II has been circulating in the US and Europe, while what the WHO is most interested in is how to collect data on clade I.” [que circula en RDC]especially Ib, and in various populations,” Tarrafeta explains.
The paralysis shows how difficult it is to enforce regulatory processes when data is lacking, particularly in emergencies. Last Friday, WHO began the unblocking by ensuring that Gavi could begin purchasing doses through UNICEF before WHO approves them – likely in September – in order to speed up the process of getting them to African countries.
Still, donations are even more complicated than they seem. While Gavi could not buy vaccines, it could facilitate third-party donations, provided the recipient country’s regulatory agency allowed it. The DRC approved the MPOX vaccine in June this year, which allowed it to receive donations – but no one was donating before the emergency declaration in August – and buying them was unthinkable given their price: around $100 per dose.
Finally, the first mpox vaccines began arriving in Africa this week, more than two years after the WHO declared the emergency. This delay, added to the lack of funds and the difficult political situation in countries like the DRC, have worsened a preventable epidemic that rich countries like Spain were able to control in 2022. Of course, it remains to be seen whether manufacturers will be able to meet demand.
“A lot of things have failed and it is a bit paradoxical that in the year when we were only talking about the pandemic treaty, there has been so much neglect in the response to the mpox emergency in the DRC,” Tarrafeta laments. “It is very difficult to explain that WHO and Gavi are working together to facilitate donations of mpox vaccines, but that these cannot be acquired through UN agencies.”
Global health cannot depend on solidarity
This story reminds us that when it comes to global health, the challenges and solutions go far beyond solidarity and donations from rich countries, even if many discourses still focus on this.
“There is no single factor that determines the lack of access to medicines, but it affects transversally the lack of alignment between the pharmaceutical industry ecosystem and public health needs,” Tarrafeta explains about these complexities. He considers that global health initiatives try to serve as a “buffer” between the two, but that “economic and other dependencies have been created.”
Thus, Tarrafeta considers that “the gifts [de vacunas] They may be a temporary solution to a very specific problem,” but “it is not a solution.” According to him, “it is necessary for the ministries of health of the affected countries to be able to plan and manage the supply chain from procurement to end use.”
As was the case with Covid-19 vaccine donations, let us recall that “distribution plans and logistics will be complicated”. It is not just a question of countries like the DRC receiving vaccines, but also of being able to manage, store, transport, inoculate and dispose of expired doses. This is without taking into account possible vaccine hesitancy on the part of the population.
The Democratic Republic of Congo’s ability to cope with MPOX, despite international aid, is undermined by a precarious health situation, seven million displaced people and a lack of hygiene in the cities.
“I understand that solidarity is called an international response to a situation that goes beyond the framework of a country, but the ideal would be for each region to have the capacity to respond, which is strongly conditioned by the economic, social and political context,” says the expert.
“The most important thing is that a country’s ability to respond to a health emergency depends fundamentally on its structure and the strength of its basic health system, not on foreign aid,” Tarrafeta adds. “No pandemic treaty or international coordination mechanism can compensate for the lack of basic systems.”
In this sense, the DRC’s ability to cope with MPOX, despite international aid, is undermined by an extremely precarious health situation. In addition to the seven million internally displaced people, there are security problems, the floods of 2023, the lack of hygiene in cities, the difficulty of communications within the country and an operational capacity strongly affected by internal conflicts.
However, Tarrafeta stresses that “there will be no agreement [de pandemias] valid until there are strong health systems. Moreover, even though we are grouping together more than 50 countries when we talk about Africa, the entire continent is not the same: “Kenya, Rwanda and Uganda have more capacity and may be able to contain MPOX outbreaks more easily, even in conflict zones.”
“This is perhaps the first step, recognizing that there are many scenarios and that no one has a universal solution. There is sometimes a condescending discourse on the capacity of other countries and also a very Eurocentric vision on how to approach solutions,” adds the researcher. “In the meantime, we continue to patch up. It is not that the declaration of emergency is useless: it is useful in a context of many deficiencies.”
Selfish altruism only thinks about pandemics
Calls for solidarity usually resort to selfish altruism as an argument: these countries must be helped in the face of emergencies such as MPOX, if not by ethics, to prevent these diseases from ending up affecting rich countries. The problem is that this reduces global health to a purely microbiological issue, something that many experts criticize.
“It makes me very pessimistic to see that we are almost inadvertently moving from a discourse on the ‘right to health’ as the basis of global health to a discourse on ‘solidarity in the face of new emergencies’, as if everything were reduced to infectious diseases,” says Tarrafeta.
The pandemic treaty itself is based on infectious diseases with pandemic potential. “The question is whether the international response is simply aimed at reducing global health risks through extraordinary control measures or whether we understand global health from the right to health and put back at the center the goal of universal health coverage, access to quality medicines and the development of health systems and, if necessary, access to humanitarian aid,” Tarrafeta argues.
The solution is not simple, but the African Union and the Africa CDC [Centros para el Control y Prevención de Enfermedades] They are already working to strengthen the continent’s health sovereignty through local production, regional regulatory systems and technology transfer. “These are innovative projects, but they are long-term, costly and also involve many uncertainties,” Tarrafeta concludes. “Without a doubt, a different dynamic is being established in the relations between the African Union and the EU.”
