WHO’s approval of Bavarian Nordic’s vaccine will help governments and international agencies such as the Gavi, the Vaccine Alliance, and UNICEF, buy it, MedicalXpress reported.

The MVA-BN vaccine — short for “Modified Vaccinia Ankara-Bavarian Nordic” — is a smallpox/mpox vaccine. It is sold in the U.S. under the name Jynneos.

WHO Assistant Director-General Yukiko Nakatani said, “The decision can also help national regulatory authorities to fast-track approvals, ultimately increasing access to quality-assured mpox vaccine products.”

Children’s Health Defense (CHD) Chief Scientific Officer Brian Hooker called the WHO’s approval of the shot for infants and children in Africa “a train wreck in the making.”

Hooker told The Defender:

“The safety profile is abysmal in adults (up to 2.1% serious cardiac events in clinical trials) and the vaccine has not been adequately tested for efficacy or safety in pediatric populations.

“In other words, the WHO has no idea whether it will work nor do they know how much damage it will do. The WHO has again abandoned good public health principles and waved their magic vaccine wand on the mpox outbreak.”

Dr. David Bell, a public health physician and biotech consultant, also criticized the WHO for overly focusing on mpox vaccines and neglecting to address broader public health issues in Africa.

“So far this year, about 40,000 children have died from malaria in the DRC [Democratic Republic of Congo] alone, and similar numbers of people from malnutrition, tuberculosis and HIV/AIDs,” Bell said.

Although these numbers “obviously dwarf” the number of mpox deaths, the WHO is allocating fewer resources to addressing them.

Bell — who formerly served as a medical officer and scientist at the WHO — explained what he sees occurring:

“We have become much better at detecting much rarer diseases such as mpox, and addressing these is certainly more lucrative for the growing industry feeding off the WHO’s misinformation regarding rapidly rising pandemic risk.

“However, it is clear that the people of DRC and Africa in general would benefit far more if WHO returned to impactful public health. There has been a move over recent years to a concentration on addressing the symptoms of diseases of poverty (which mpox is) with Western-developed commodities, rather than dealing with underlying causes.

“This signals a return to colonialist-era approaches rather than evidence-based public health. It presumably reflects the way WHO is now funded, with increasing control from the private sector and a few large Western nations with large Pharma industries.”

No clinical trials on kids

In its press release, the WHO said the MVA-BN vaccine can be administered to adults over 18 as a two-dose injection four weeks apart but can also be given as a single dose “in supply-constrained outbreak situations.”

“While MVA-BN is currently not licensed for persons under 18 years of age,” it said, “this vaccine may be used ‘off-label’ in infants, children and adolescents, and in pregnant and immunocompromised people.”

The WHO called for more data on the vaccine’s safety and efficacy in these situations.

The WHO Strategic Advisory Group of Experts on Immunization — which reviewed all available evidence and recommended the use of MVA-BN vaccine — noted in its Weekly Epidemiological Record report that “MVA-BN has not been specifically studied in clinical trials in children.”

However, they said:

“The same non-replicating MVA viral vector is used as a platform for other vaccines that include MVA-filo (Mvabea) against Ebola virus disease (EVD).

“The EVD vaccine is approved by the EU for adults and children aged 1 year and older. Data from 5 published studies on MVA-BN as a viral vector platform for the prevention of EVD, with a total population of 52 229 children, support the favourable safety profile of the product.”

The authors of a new study — published Sept. 11 in The BMJ — presented results on MVA-BN’s effectiveness in adult males but said nothing about children or pregnant women.

In 2023, researchers funded by the UK Health Security Agency looked at the health outcomes of 87 children who received a single dose of MVA-BN.

They reported that the vaccine was “well tolerated” but that larger studies needed to be done to fully assess the shot’s safety and efficacy in kids.

The Defender asked Bavarian Nordic for information about its mpox vaccine in pediatric populations but did not receive a response by the deadline.

The WHO’s process for granting a drug “prequalification” approval for “emergency use listing” requires drugmakers to “commit to continue generating missing information to fulfill prequalification requirements.”

“Once this information becomes available,” the WHO said, “a PQ [prequalification] application should be submitted to complete the full process to achieve  recommendation for international procurement in both emergency and non-emergency settings.”

It is unclear how much pediatric safety and efficacy data Bavarian Nordic has collected so far and what it showed.

Mpox vaccine approved for U.S. kids and teens since 2022

The U.S. Food and Drug Administration (FDA) in 2022 granted emergency use authorization for the vaccine for “in individuals less than 18 years of age determined to be at high risk for monkeypox infection.”

Jynneos has been licensed for use in U.S. adults since 2019.

The Centers for Disease Prevention and Control (CDC)’s mpox vaccination website states that while teens and children at risk for mpox can receive Jynneos, it is not recommended for babies under 6 months.

The CDC also says Jynneos can be given to pregnant or breastfeeding women.

Although it remains unknown if Jynneos may pose risks to a developing fetus if taken during pregnancy, animal studies haven’t shown any harm to developing fetuses when the vaccine was given to pregnant animals, the agency said.

So, clearly, there are three obvious requirements here to ensure good practice:

1. Accurate information is required, in context.
2. Those gaining financially can have no role at all in decision-making.
3. The organization tasked with coordinating any response would have to act with transparency, publicly weighing costs and benefits.

The World Health Organization (WHO), tasked by countries to help coordinate international public health, has just proclaimed Mpox (monkeypox) an international emergency. They considered an outbreak in the Democratic Republic of Congo (DRC) and nearby Central African countries to be a global threat, requiring an urgent global response. In declaring its emergency, WHO stated there were 537 deaths among 15,600 suspected cases this year. In its 19^th August Emergency Meeting on Mpox, WHO clarified its figures:

…during the first six months of 2024, the 1854 confirmed cases of Mpox reported by States Parties in the WHO African Region account for 36% (1854/5199) of the cases observed worldwide.

The WHO reiterated that there had been 15,000 “clinically compatible” cases, and about 500 suspected deaths. The implications of these 500 unconfirmed deaths, equaling just 1.5% of the malaria deaths in DRC over the same period, are discussed in a previous article.

Journals such as the Lancet have dutifully towed the WHO’s ‘emergency’ line, though intriguingly noting that the mortality could be far lower if “adequate care” had been provided. Africa CDC agrees, with more than 17,000 cases (2,863 confirmed) and 517 (presumably suspected) deaths of Mpox have been reported across the continent.

Mpox is endemic to central and west Africa, being present in species of squirrels, rats, and other rodents. While it was identified in monkeys in a Danish lab in 1958 (hence the misnomer ‘monkeypox’), it has probably been around for thousands of years, causing intermittent infections in humans between whom it is spread by close physical contact.

Small outbreaks in Africa mostly went unnoticed by the rest of the world, mainly because they were (as now) small and confined. Mass Smallpox vaccination may also have suppressed numbers still further a few decades ago, as Smallpox is in the same Orthopoxvirus genus of viruses. So, we may be seeing an upward trend of this generally milder illness (fever, chills, and a vesicular rash) over recent decades since Smallpox vaccination ceased. The Smithsonian magazine put an informative summary together in 2022, after the first out-of-Africa outbreak which was spread by sexual contacts within a limited demographic group.

So, here we are in 2024, on the tail of a massively profit-driving (and impoverishing) outbreak called Covid-19 that enabled the largest transfer of wealth from the many to the few in human history. The WHO’s announcement that 5,000 (or less) suspected Mpox cases is a Public Health Emergency of International Concern (PHEIC) allows it to fast-track vaccines through its Emergency Use Listing (EUL) program, bypassing the normal rigor required to approve such pharmaceuticals, and is suggesting Pharma start lining up.

At least one drugmaker is already discussing a supply of 10 million doses before year-end. The business case for this approach, from the corporate viewpoint, is well-proven. So are the harms in countries like DRC, as a mass vaccination program of this nature requires redirection of millions of dollars and thousands of health workers who would otherwise be addressing diseases of far larger burden.

The WHO is a large organization, and while some there have been on the hustings asking for money, others have been working hard to accurately inform the public (a core responsibility of the WHO, which retains some dedicated people). Like much of the WHO’s work in the past, this is thorough and commendable. Some of this information is summarized in the following graphics:

These charts provide data on confirmed cases, where someone with somewhat non-specific symptoms has been tested and shown to have evidence of Mpox virus in blood or secretions. Clearly, not everyone suspected can be tested, as Mpox is a very small issue for people facing civil wars, mass poverty, and vastly more dangerous diseases.

However, the WHO has absorbed a lot of money for outbreak investigation, and so have partner organizations, so we can assume there is a fairly good effort going on to detect and confirm numbers (or where has this money gone?).

In the past 2.5 years, the WHO has confirmed 223 deaths in the whole world, with just six in July 2024 (the time when the WHO Director-General warned the world of a rapidly increasing threat). Note here that 223 deaths are just 0.2% of the 102,997 confirmed cases. In Africa, just 26 deaths have been confirmed in 2024 among 3,562 cases (0.7%), spread across 5 countries (and 12 countries with cases). They are influenza-like mortality rates, not Ebola-like.

As severe cases are more likely to be tested than mild cases, the infection fatality rate may be far lower. We also don’t know (though someone does and should tell us) what the characteristics of those dying are. Most in Africa are reported to be children, so it is likely they are malnourished, otherwise immunocompromised (e.g. HIV), and have susceptibilities that could be addressed.

As is obvious from the third graphic below, nearly all the global deaths listed above were from the previous outbreak in 2022. This was a different clade (variant) and mostly occurred outside of Africa.

It is important to note a few things here. It is difficult to confirm all cases in areas with poor infrastructure and security. Mpox symptoms and signs are also frequently mild and overlap other diseases (e.g. chickenpox or even flu) so many cases may go unnoticed. Notification of results can also lag. However, the 19 confirmed DRC Mpox deaths amongst roughly 40,000 DRC malaria deaths so far this year is about 1 versus 2000. Whichever way you count it, it is not going to become much more significant. That is what the new international emergency looks like in actual data, or if you are the population of DRC at Mpox ground zero. It is likely you would not notice anything at all.

Why has the WHO declared an international emergency? Some claim it helps mobilize resources, which is a bit pathetic. Firstly, grownups should be able to discuss a situation that has persisted for two years in a rational manner and decide what might be needed, without banging a drum. Secondly, an outbreak that is killing a tiny fraction of malaria (or tuberculosis, or HIV) deaths, and far less than those currently dying in war, may not be an international emergency.

And what should be done? Diverting resources from DRC’s major priorities would undoubtedly kill far more than are currently dying from Mpox. It is quite probable that direct adverse events from vaccination alone will kill more than the 19 DRC Mpox victims confirmed this year. We likely undercount Mpox deaths, but we also undercount pharmaceutical deaths.

Perhaps a useful response would be to improve immune competence through nutrition, providing very broad benefits (but completely failing in terms of Pharma profit). Gavi’s half-billion dollars would provide vast and broad-based benefits if applied to sanitation. Perhaps limited, well-targeted vaccination may also help some communities, but there is no business case for such approaches.

What is clear, as noted above, is the following:

1. The data on Mpox, and other competing priorities, must continue to be shown in context, along with costs and opportunity costs of the response.

2. Those who will gain financially from vaccinating millions of people must not be part of the decision-making process (whether or not such a huge resource transfer can possibly be supported for such a small disease burden).

3. The WHO should continue to act with transparency, as the public has an absolute right to know what they are paying for, and the harm (and perhaps benefit) they can expect from it.

The number of Mpox deaths will rise as more are infected, and perhaps as some suspected cases are confirmed. However, we are facing a small problem in an area with far larger ones. It is posing low local risk and minimal global risk. It is not a global emergency, by any sane, rational, public health-based definition.

The rest of the world can respond by sending vaccines and lots of foreigners who need looking after, diverting local health and security personnel and almost certainly killing more DRC residents overall. Or, we can recognize a local problem, support local responses when local populations ask, and concentrate, as the WHO once did, on addressing the underlying causes of endemic disease and inequality. They are the things that make the lives of people in DRC so difficult.

About the Author

David Bell, Senior Scholar at Brownstone Institute, is a public health physician and biotech consultant in global health. He is a former medical officer and scientist at the World Health Organization (WHO), Programme Head for malaria and febrile diseases at the Foundation for Innovative New Diagnostics (FIND) in Geneva, Switzerland, and Director of Global Health Technologies at Intellectual Ventures Global Good Fund in Bellevue, WA, USA.

While angst is warranted, it is mostly misdirected. The WHO and the IHR emergency committee they convened had little real power – they are simply following a script written by their sponsors. The African CDC, which declared an emergency a day earlier, is in a similar position. Mpox is a real disease and needs local and proportionate solutions. But the problem it is highlighting is much bigger than Mpox or the WHO, and understanding this is essential if we are to fix it.

Mpox, previously called Monkeypox, is caused by a virus thought to normally infect African rodents such as rats and squirrels. It fairly frequently passes to, and between, humans. In humans, its effects range from very mild illness to fever and muscle pains to severe illness with its characteristic skin rash, and sometimes death. Different variants, called ‘clades,’ produce slightly different symptoms. It is passed by close body contact including sexual activity, and the WHO declared a PHEIC two years ago for a clade that was mostly passed by men having sex with men.

The current outbreaks involve sexual transmission but also other close contact such as within households, expanding its potential for harm. Children are affected and suffer the most severe outcomes, perhaps due to issues of lower prior immunity and the effects of malnutrition and other illnesses.

Reality in DRC

The current PHEIC was mainly precipitated by the ongoing outbreak in the Democratic Republic of Congo (DRC), though there are known outbreaks in nearby countries covering a number of clades. About 500 people have died from Mpox in DRC this year, over 80% of them under 15 years of age. In that same period, about 40,000 people in DRC, mostly children under 5 years, died from malaria. The malaria deaths were mainly due to lack of access to very basic commodities like diagnostic tests, antimalarial drugs, and insecticidal bed nets, as malaria control is chronically underfunded globally. Malaria is nearly always preventable or treatable if sufficiently resourced.

During this same period in which 500 people died from Mpox in DRC, hundreds of thousands also died in DRC and surrounding African countries from tuberculosis, HIV/AIDS, and the impacts of malnutrition and unsafe water. Tuberculosis alone kills about 1.3 million people globally each year, which is a rate about 1,500 times higher than Mpox in 2024.

The population of DRC is also facing increasing instability characterized by mass rape and massacres, in part due to a scramble by warlords to service the appetite of richer countries for the components of batteries. These in turn are needed to support the Green Agenda of Europe and North America. This is the context in which the people of DRC and nearby populations, which obviously should be the primary decision-makers regarding the Mpox outbreak, currently live.

An Industry Produces What It Is Paid for

For the WHO and the international public health industry, Mpox presents a very different picture. They now work for a pandemic industrial complex, built by private and political interests on the ashes of international public health. Forty years ago, Mpox would have been viewed in context, proportional to the diseases that are shortening overall life expectancy and the poverty and civil disorder that allows them to continue. The media would barely have mentioned the disease, as they were basing much of their coverage on impact and attempting to offer independent analysis.

Now the public health industry is dependent on emergencies. They have spent the past 20 years building agencies such as CEPI, inaugurated at the 2017 World Economic Forum meeting and solely focused on developing vaccines for pandemic, and on expanding capacity to detect and distinguish ever more viruses and variants. This is supported by the recently passed amendments to the International Health Regulations (IHR).

While improving nutrition, sanitation, and living conditions provided the path to longer lifespans in Western countries, such measures sit poorly with a colonial approach to world affairs in which the wealth and dominance of some countries are seen as being dependent on the continued poverty of others. This requires a paradigm in which decision-making is in the hands of distant bureaucratic and corporate masters. Public health has an unfortunate history of supporting this, with restriction of local decision-making and the pushing of commodities as key interventions.

Thus, we now have thousands of public health functionaries, from the WHO to research institutes to non-government organizations, commercial companies, and private foundations, primarily dedicated to finding targets for Pharma, purloining public funding, and then developing and selling the cure. The entire newly minted pandemic agenda, demonstrated successfully through the Covid-19 response, is based on this approach. Justification for the salaries involved requires detection of outbreaks, an exaggeration of their likely impact, and the institution of a commodity-heavy and usually vaccine-based response.

The sponsors of this entire process – countries with large Pharma industries, Pharma investors, and Pharma companies themselves – have established power through media and political sponsorship to ensure the approach works. Evidence of the intent of the model and the harms it is wreaking can be effectively hidden from public view by a subservient media and publishing industry. But in DRC, people who have long suffered the exploitation of war and the mineral extractors, who replaced a particularly brutal colonial regime, must now also deal with the wealth extractors of Pharma.

Dealing with the Cause

While Mpox is concentrated in Africa, the effects of corrupted public health are global. Bird flu will likely follow the same course as Mpox in the near future. The army of researchers paid to find more outbreaks will do so. While the risk from pandemics is not significantly different than decades ago, there is an industry dependent on making you think otherwise.

As the Covid-19 playbook showed, this is about money and power on a scale only matched by similar fascist regimes of the past. Current efforts across Western countries to denigrate the concept of free speech, to criminalize dissent, and to institute health passports to control movement are not new and are in no way disconnected from the inevitability of the WHO declaring the Mpox PHEIC. We are not in the world we knew twenty years ago.

Poverty and the external forces that benefit from war, and the diseases these enable, will continue to hammer the people of DRC. If a mass vaccination campaign is instituted, which is highly likely, financial and human resources will be diverted from far greater threats. This is why decision-making must now be centralized far from the communities affected. Local priorities will never match those that expansion of the pandemic industry depends on.

In the West, we must move on from blaming the WHO and address the reality unfolding around us. Censorship is being promoted by journalists, courts are serving political agendas, and the very concept of nationhood, on which democracy depends, is being demonized. A fascist agenda is openly promoted by corporate clubs such as the World Economic Forum and echoed by the international institutions set up after the Second World War specifically to oppose it. If we cannot see this and if we do not refuse to participate, then we will have only ourselves to blame. We are voting for these governments and accepting obvious fraud, and we can choose not to do so.

For the people of DRC, children will continue to tragically die from Mpox, from malaria, and from all the diseases that ensure return on investment for distant companies making pharmaceuticals and batteries. They can ignore the pleading of the servants of the White Men of Davos who will wish to inject them, but they cannot ignore their poverty or the disinterest in their opinions. As with Covid-19, they will now become poorer because Google, the Guardian, and the WHO were bought a long time back, and now serve others.

The one real hope is that we ignore lies and empty pronouncements, refusing to bow to unfounded fear. In public health and in society, censorship protects falsehoods and dictates reflect greed for power. Once we refuse to accept either, we can begin to address the problems at the WHO and the inequity it is promoting. Until that time, we will live in this increasingly vicious circus.