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China's ban on research monkey exports hits vaccine testing

An article has appeared in the Spanish publication Quo setting out the concerns of the European biomedical community about the current ban on the export of research monkeys by China. The article includes an interview with EARA executive director Kirk Leech.

Her is the English translation.


By Lorena Sánchez Romero

February 17, 2021

There are not enough macaque monkeys to test the vaccines against Covid-19 that are still in Phase 1, including the most advanced Spanish one. The supply of Non-Human Primates (NHP) for experimentation is currently dependent on China, which has banned their export.

China banned trade with wild animals when the pandemic broke out, and the law included macaques supplying European and North American centres for biomedical research.

Without testing the vaccines in macaques, no drug agency will approve them, neither the vaccines, nor any other treatment in development that may be effective against Covid-19 or any other disease. Without the Chinese macaques, European and North American research centres are starved. More than 500 procedures are on an eerie waiting list that China has under control.

With desperate demand, the average price of the most widely used animals in research (rhesus macaques, cynomolgus macaques and marmosets) has doubled to 12,000 euros in the last year.

From the German Primate Center (DPZ), in Germany, where they carry out biological and biomedical research in all areas with studies on non-human primates playing a central role, they explain the situation to as follows: “Most of our centres face problems in the supply of macaques from China, due to the stopping of flights and the fact that the Chinese authorities do not allow the export of monkeys. Hopes have been expressed that China will resume exporting after the Chinese New Year."

Unless this shortage is addressed, the West will be dangerously dependent on China to test new treatments not only for Covid-19, but for all those in development for heart disease, cancers, neurological disorders and a long etcetera. The shadow of the giant looms sharply over the human health of the future.

Monkeys are essential for the vaccine against Covid-19

Researchers who have developed vaccines against the current Covid-19 pandemic have relied heavily on being able to test them first on monkeys.

The Pfizer/BioNTech vaccine (i.e. the Covid-19 vaccine first approved by the European Commission on 21 December) was based on preclinical data generated by BioNTech in Germany, using rhesus macaques to show that vaccine recipients were fully protected against the SARS-CoV2 virus, and to ensure their safety.

Other vaccine candidates for Covid-19, such as the Oxford/AstraZeneca and Janssen vaccines, have also used pre-clinical testing with NHP to verify their safety and efficacy. The Spanish vaccine developed by Mariano Esteban, from the CSIC, is awaiting trials in macaques.

Kirk Leech, executive director of the European Association for Animal Research (EARA) warns that we are facing a major crisis, which may leave the control of human health in the hands of China.

“With more than 500 treatments and vaccines in pre-clinical development to address the Covid-19 pandemic, China's ban on the export of monkeys poses a significant challenge for researchers from European industry, academia and charities, who will have to find the animals they need to continue this vital research, ”explains Kirk Leech with concern.

“Part of this European research was carried out in the US, imagine how we would fight to cope with the next pandemic if researchers in the US and Europe cannot have access to the NHP they need? This is a real fear.”

How many monkeys are we talking about?

In 2001 Hans-Erik Carlsson and Steven Schapiro, of Uppsala University, in Sweden, reviewed 3,000 publications on biomedical research during 2001. Their study was published in PUBMed. They found that 4,411 research projects had experimented with about 41,000 monkeys and other apes. They extrapolated the data that medical research uses about 200,000 primates a year. A look at Google now shows that the biomedical research in which NHP have been necessary in the last decade has multiplied.

In 2019, 2,015 NHPs were used in experiments in the UK alone. Only 220 of them were not imported. 1,154 came mainly from Mauritius and 782 from Asia, about 75% of which came from China. China depends on at least a quarter of the primates needed for research in the world. The United States depends on China for 60% of its monkeys, about 35,000 a year.

With the increase in demand, the average price of animals has reached 12,000 euros in the last year and Kirk Leech warns that he has seen exceptional cases of companies and even researchers who have negotiated individually, and have come to pay $30,000 per monkey.

Mauritius has announced that it does not have enough research monkeys available for export

Mauritius, in the Indian Ocean, maintains one of the most important supply centres for long-tailed macaques for research. Each year they export up to 10,000 monkeys, about 4,000 to the EU (including the UK) and thousands more to the US. This year, overwhelmed by the pandemic, they have announced that they do not have any more macaques available.

“There is certainly a supply crisis, with demand that exceeds supply. The percentage of monkeys imported into Europe from China is small compared to the percentage that came from Mauritius. However, from Mauritius they have reported that the island's breeding facilities are at maximum capacity and it is not possible to recover that difference in weeks, or even years (the breeding and gestation time of a macaque is long). In addition, US researchers are also trying to get monkeys from anywhere they can, so the demand and the price is increasing. "

China's strategy to control future research and health

Suspicions of attempted China pharmaceutical dominance are not new. In 2016, David Cyranoski, of the journal Nature, was able to access the Yunnan Key Primate Biomedical Research Laboratory near Kunming in southwest China. In his article "Monkey Kingdom," he described a research paradise where animal rights activism does not exist and bureaucracy presents no obstacles.

"With the support of central and local governments, high-tech primate facilities have sprung up in Shenzhen, Hangzhou, Suzhou, and Guangzhou over the past decade," David Cyranoski wrote in the Nature article. "These Chinese centres can provide scientists with monkeys in large numbers with little bureaucracy."

Kirk Leech reinforces his fear that future research will be controlled by China: “Non-Human Primates are essential for the development of new drugs and vaccines, in particular to test the safety of candidates before they enter clinical trials, with landmark breakthroughs in HIV, smallpox, and polio vaccines also made possible by research with these animals.

With China's current export ban, these animals are used for drug and vaccine R&D and testing exclusively in China, strengthening the Asian giant's biomedical research capacity relative to the rest of the world and, therefore, it makes China a more attractive market to invest in.

"This policy is fully in line with the 'Made in China 2025' strategy that was first appeared in the Government Work Report presented by Prime Minister Li Keqiang in 2015," warns Kirk Leech.

The straightforward reading of Leech's statements is this: If it can only be tested in China, the all-powerful pharmaceutical industry will invest in China.

The new 'Made in China' advances

Made in China 2025 is the name of a strategic plan announced by Prime Minister Li Keqiang and his cabinet in May 2015. With it, China aims to stop being the "world's factory" (producing cheap and low-quality goods) and move on to producing higher value products and services. The plan focuses on high-tech fields such as the automotive industry, the aerospace industry, semiconductors, computing, robotics, and also the pharmaceutical industry, currently in foreign hands.

Would the solution be to breed more macaques of your own? Leech, who represents European pharmaceutical companies, private research contractors and universities, has called on the UK government and the European Commission to demand that China lift the ban on exporting monkeys for research, arguing that it violates the general trade rules and tariffs of the World Trade Organization.

“One solution,” Leech says, “would be for Western governments to help create the infrastructure to breed monkeys. These animals can't just be raised just anywhere, ”she admits. “They need sub-tropical conditions, you couldn't have a breeding facility in Norway, for instance. In principle, southern Europe would be more suitable."

Leech stresses that a new breeding facility would need at least the support and backing of the national government: "It would inevitably become a focus of media attention - which is fine and we should be prepared to argue why we need more facilities breeding grounds, we shouldn't hide this - and the biomedical research industry should publicly argue why we need to use monkeys in research."



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