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Dipping into huge government stockpiles may help the global effort to contain a dangerous strain of mpox spreading in east Africa
Wealthy countries with millions of smallpox vaccines stockpiled for national security should urgently donate more doses to African countries battling the latest outbreak of mpox, the World Health Organization has warned.
For decades governments including the UK, Japan, United States and South Korea have been stockpiling shots of smallpox – the only disease ever eradicated – in case the lethal pathogen makes an accidental or intentional comeback.
Many of these smallpox vaccines are also effective against mpox as the two viruses are closely related. Yet, as a worrying outbreak of a dangerous new mpox strain intensifies in east Africa, few vaccines have reached the hardest hit regions.
“We understand that nations would want to keep a stockpile,” Dr Maria Van Kerkhove, interim director of the department of Epidemic and Pandemic Threat Management at the WHO, told The Telegraph.
“But right now we have an immediate need in the Democratic Republic of the Congo (DRC) and in neighbouring countries. The vaccines that are sitting on shelves or in a stockpile are useless.”
She added that the WHO does not know how many doses are being kept in national reserves, though a recent Reuters tally estimated it stands at several hundred million. Dr Van Kerkhove said governments should assess their stockpiles and share a proportion urgently.
More than 26,500 people have been infected with mpox and 724 have died since January, with 14 countries across Africa so far recording cases.
Despite an assessment from the Africa Centre for Disease Control suggesting the region needs between 18 and 22 million doses to vaccinate 10 million people at high risk, Dr Van Kerkhove said just 3.6 million shots have been pledged at the time of speaking.
That has now jumped, after the United States on Tuesday pledged a donation of 1 million mpox vaccine doses and at least $500 million to African countries to support their response to the outbreak.
Making the announcement at the United Nations General Assembly in New York, US President Joe Biden called on other countries to follow suit, adding: “We must now move quickly to face mpox.”
Yet as it stands, only 265,000 vaccines have arrived in the DRC, the epicentre, which is set to roll out its first shots within weeks.
Many countries deem smallpox stockpiles as a national security necessity and are reluctant to dilute their stocks.
Although the infectious disease was eradicated in 1980, samples remain in high security laboratories in the United States and Russia.
The threat of a smallpox reemergence, accidental or otherwise, remains – and it could be devastating.
It is estimated that the virus killed between 300 and 500 million people worldwide in the 20th century.
Some countries are on especially high alert.
South Korea has long feared smallpox may be one ingredient of a lethal cocktail of viruses and bacteria that North Korea could weaponise against it, and it maintains an emergency stockpile of vaccines to protect against that eventuality.
Local media reports in 2022 indicated a stash of some 35 million doses for the country of 51 million. Smallpox vaccines are made by Korean pharmaceutical company HK inno.N, which was granted approval to make the drug in 2008.
The Korea Disease Control and Prevention Agency (KDCA) on Monday confirmed the existence of its stockpiles to counter a “bioterrorism outbreak” but would not reveal its size, citing security reasons.
“According to WHO recommendations, we aim for a stockpile level of 80 per cent of the population, taking into account herd immunity,” it said in a statement.
During the 2022 mpox outbreak, South Korea donated 50,000 vaccines to the Africa Centres for Disease Control and Prevention to help protect health workers and people living in the hardest-hit areas.
The KDCA said there were currently no plans to make further donations from its smallpox supplies.
“The current stockpile of smallpox vaccine is a second-generation vaccine and is intended for the purpose of preparing for domestic outbreaks of bioterrorism infectious diseases (smallpox) in accordance with relevant laws,” it said.
It is not known if North Korea, which is technically at war with the South and continually threatens it with nuclear annihilation, actually possesses samples of smallpox for bioterror purposes.
South Korea’s biennial defence white papers have reported on Pyongyang’s possible biological weapons programme since 2000.
In 2006, the paper said the North was “able to produce biological weapons such as the bacteria of anthrax, smallpox and cholera,” but a decade later was more cautious about their existence. Independent experts have also taken a more sceptical view of the regime’s bioweapons capabilities.
The UK, like South Korea, has not revealed how many vaccines it has stockpiled. The government holds medical countermeasures for a range of biological threats and hazards, but does not comment on these publicly.
And although the Department for Health and Social Care last week announced it had ordered more than 150,000 mpox doses made by Bavarian Nordic for domestic use, the government has not donated shots directly to the DRC.
The Telegraph understands that most of Bavarian Nordic vaccines currently available were purchased in 2022, and there are concerns that expiry dates are too tight to donate them to the DRC. Instead, the UK is funding Gavi, the Vaccine Alliance, which procures shots for lower and middle income countries and last week purchased 500,000 mpox vaccines for the outbreak.
Dr Javier Guzman, director of global health policy at the Center for Global Development, said most wealthy countries have enough doses stored to share mpox shots from smallpox vaccine reserves while protecting national security.
“For instance, Japan has a stockpile of around 200 million doses of the LC16 vaccine. Donating just three million doses, as Japan has done, marginally reduces their reserves. Similarly, Spain has pledged 500,000 doses, approximately 20 per cent of its mpox vaccine stockpile,” he said.
“If more high-income countries take similar steps, they significantly increase the chances of containment, reducing the need for African countries to wait for new vaccine manufacturing.”
Dr Guzman also reiterated that it would be a “mistake” to overlook the current threat posed by a more lethal strain which is already spreading widely.
“When high-income countries conduct their risk-benefit analysis, they should consider that the risk of smallpox in high-income countries is very low, according to WHO, despite concerns about the possibility of deliberate release. In contrast, the risk of mpox spreading further is a real and present threat.”
However, limited donations are not the only reason the rollout of mpox shots has been slow.
“We have a real challenge in the world right now around access to medical countermeasures,” said Prof Rebecca Katz, director of the Center for Global Health Science and Security at Georgetown University Medical Center.
“It happens for a lot of reasons – it’s everything from national security implications, to the cost of production, to the legal and regulatory barriers, to getting the product to the right populations. And none of these have easy solutions attached to them.”
In this outbreak, regulatory issues have hit the headlines. It was only on September 13 that the WHO authorised the first shot for mpox, made by Bavarian Nordic, in a process called pre-qualification.
This is significant for two reasons. First, because many low and middle income countries without strong regulators also rely on the WHO to determine which medical tools are safe and effective – although, in the case of the DRC, the country gave two mpox vaccines the green light in late June.
Second and perhaps more importantly, UN agencies and Gavi require the WHO approval to buy and distribute shots. Which is why Gavi only last Wednesday announced its first purchase of Bavarian Nordic mpox shots for use in this outbreak.
Dr Gavin Yamey, associate director for policy at Duke Global Health Institute, said the “long delays point to how WHO’s medicine and vaccine approval system is too slow, bureaucratic, and risk-averse”.
“Mpox vaccines were approved by the US regulator, the FDA, back in September 2019 and by the European Medicines Agency in July 2022, so the long delay by the WHO to give the green light was deeply frustrating,” he added.
But Dr Van Kerkhove said the agency had moved as quickly as possible, adding that it was only on August 23 that Bavarian Nordic shared the final tranche of data the UN agency needed to green light the shot.
“We will not compromise on safety. So that’s paramount,” she said. “We did not receive the full dossier until August 23, we can’t evaluate these vaccines without the full package of information… the EMA, the FDA, they gave exceptional approval to use this vaccine.”
She added that the WHO’s team is also in the process of assessing a Japanese vaccine called LC16 and made by KM Biologics. She expects an announcement on this to be made “soon.”
But even with shots on the horizon for the DRC, challenges remain. The Bavarian Nordic vaccine requires two doses, which could be difficult in areas with a highly mobile or hard to reach population.
Meanwhile KM Biologics’ shot, which has been approved for use in children, is an intradermal vaccine (meaning it is scraped between layers of skin) and needs specialised training to administer. Both are expensive.
“Vaccines are not the silver bullet,” said Dr Van Kerkhove. “What’s going to stop these outbreaks? Strong surveillance, really targeted risk communication materials, making sure patients are cared for appropriately in either healthcare facilities or through home care, making sure that families have access to clean water to wash clothes and linens.
She added: “Vaccines are an additional component to that. They are an important one… but I really want emphasise this over-reliance on vaccines, because this is not how this outbreak is going to stop.”
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