Picture: Getty Images/Mark Lennihan - Pool
Picture: Getty Images/Mark Lennihan - Pool

On March 6 2020, a day after SA recorded its first confirmed case of Covid-19 and a few weeks after Egypt became the first African country to register an infection, Ugandan police arrested a traditional healer and his daughter in a village 120km east of Kampala.

As police spokesperson Fred Enanga told Uganda’s News Vision newspaper, the pair visited a number of families "telling them that they had discovered a vaccine for the coronavirus disease". Understandably, the families bought the "vaccine".

Then, on November 19, a far more sinister incident unfolded at a warehouse in Germiston on Gauteng’s East Rand. According to Mlungisi Wondo, acting manager of the regulatory compliance unit of the SA Health Products Regulatory Authority (Sahpra), the police tracked "suspicious freight" from the OR Tambo airport to the building. After opening a "lot of boxes", an officer called Sahpra for assistance.

"Our inspectors got there and then they saw prefilled syringes [with labels] written in Chinese," says Wondo. "The two people who were at the site, the owner of the warehouse and the Chinese owner of the consignment, were arrested."

Interpol says the "vaccines" had been advertised for sale on Chinese social media app WeChat, and imported from Singapore as "cosmetic injections".

"There were clear indications that the contents of the boxes were going to be sold as genuine Covid-19 vaccines."

Wondo says the police, in co-operation with Sahpra, are still trying to find out if any units were released into SA.

"If people are injected with those [fake] vaccines, we don’t know what is in them because we are still doing the tests at the National Control Laboratory in Bloemfontein," he says.

A few weeks ago, on January 15, Nigeria’s National Agency for Food & Drug Administration & Control (Nafdac) said it was aware of fake vaccines circulating in that country.

Mojisola Adeyeye, the agency’s director-general, pleaded with the public: "No Covid vaccines have been approved by Nafdac. Fake vaccines … could kill."

Not that it helped. Just two weeks later, on January 31, a "Dr H Losho from Lagos", who advertises sex toys, clothes and shoes, said on Twitter: "If you’re interested in 2 shots of Covid Vaccine at 50k each, contact @ad_de_moles. AstraZeneca. Arrives in 2 weeks. You get a card."

These anecdotes show that Africa is fertile ground for fake or stolen vaccines. That’s only likely to increase, with the emergence of new variants of SARS-CoV-2 (the virus that causes Covid-19), such as the 501Y.V2 variant first identified in SA. So far, at least, these variants have proven more infectious than the original form of the virus. Some are also able to escape the immunity that current vaccines induce, leading to greater desperation for protection from those jabs that are effective against variants.

Caption
Caption

Statistics show how vulnerable the continent is to vaccine crime. A report by the World Health Organisation (WHO) in 2018 said between 2013 and 2017, almost half of all substandard and falsified medicines found were in Sub-Saharan Africa.

The reasons are clear: regulations are often weak, borders porous and the distribution of fake pharmaceutical products is often not considered a crime — despite the harm they do.

"We’ve found very toxic substances in falsified medicines," says Cyntia Genolet, associate director of Africa engagement at the International Federation of Pharmaceutical Manufacturers & Associations, which represents the world’s top pharmaceutical firms.

So not only do the products not provide a cure, she says, but people have died as a result of the products they’ve taken.

Fake malaria drugs alone cause up to 158,000 deaths every year in Sub-Saharan Africa, the WHO estimates. In total, the global market for substandard or falsified medicines could be worth $200bn (about R3-trillion) — 10%-15% of the continent’s entire pharmaceutical market.

We’re not ready for the onslaught

In SA, the health department says at least 67% of the country’s 60-million people must be vaccinated to achieve the herd immunity to effectively end the epidemic.

SA’s vaccine rollout, which would have started with the AstraZeneca vaccine, was temporarily suspended this week, after early data showed the jab provides just 10% protection against mild to moderate Covid-19 caused by the new 501Y.V2 variant.

The health department will now launch an implementation study to compare how well some jabs — Johnson & Johnson, Pfizer and possibly AstraZeneca — protect against severe Covid-19 disease caused by the new variant.

Once the rollout finally takes off, it will be huge — and fraught with challenges.

"This rollout will be unprecedented in scale, importance and complexity," says Salim Abdool Karim, the co-chair of SA’s scientific ministerial advisory committee on Covid-19. "Will there be crime around that? Probably. But I think we have bigger problems, like how are we going to get the vaccine into the arms of millions of people?"

On the whole, he believes the system used to regulate the vaccines "seems pretty strong; they say security around the vaccines will be strong".

Perhaps — but it won’t be anywhere as strong as in Europe and the US, where almost every entity involved in distributing the jabs, from airports to transport firms to manufacturers, has formed a task team to keep them safe.

Companies have done background checks on staff; GPS trackers are inside every box of the vaccines, which are stored in secret locations; and some vials contain black-light verification technology (only visible using equipment that emits ultraviolet rays) to prevent falsification. The system is so watertight that some firms are even using bogus vaccine shipments to throw criminals off track.

But many African authorities, entangled in negotiations to secure vaccines and preparing for the logistical nightmare of distributing them, are nowhere near ready to safeguard the process.

Ready to go: Boxes containing the Moderna Covid-19 vaccine are prepared to be shipped. Picture: Getty Images/Paul Sancya - Pool
Ready to go: Boxes containing the Moderna Covid-19 vaccine are prepared to be shipped. Picture: Getty Images/Paul Sancya - Pool

Worryingly, this is a view held by numerous sources interviewed by Bhekisisa, including law enforcement, crime intelligence, customs and border officials, government representatives and crime analysts.

Back in November, the WHO warned that Africa, with its 1.4-billion inhabitants, "is far from ready for what will be the continent’s largest-ever immunisation drive". That analysis found the continent had an average readiness score of 33% for a Covid-19 vaccine rollout. The desired benchmark is 80%.

Less than half of Africa had identified "priority populations" for vaccination and had plans to reach them, while only 44% had "co-ordination structures" in place.

The WHO report says that only 24% had "adequate plans for resources and funding", a mere 17% had data collection and monitoring tools ready, and just 12% had plans to communicate with communities "to build trust and drive demand for immunisation".

Nigeria-based crime analyst Maurice Ogbonnaya says it is precisely these sorts of inadequacies that will allow organised crime groups to insert falsified vaccines into supply chains, and to steal vaccines.

Why Africa?

Inspired by a brother addicted to illegally trafficked codeine in Nigeria, Ruona Meyer spent more than a year infiltrating gangs dealing in illicit pharmaceuticals in West Africa.

She went undercover as a buyer — her contribution to a 2018 Emmy Award-winning documentary called Sweet, Sweet Codeine, which led to several arrests and convictions, including of a pharmaceutical company executive.

"In Africa, you have all the elements necessary to allow a black market in vaccines to flourish," says Meyer. "Lack of resources, logistics and technical capacity means it’s going to take incredibly long for the rollouts to happen.

"That gives organised crime the time and space needed to strategise, adapt to security measures and to insert their products into supply chains."

Corruption only makes this easier.

In a July research brief on Covid-19 and organised crime infiltration, the UN Office on Drugs & Crime (Unodc) said: "Though no country is completely immune from fraud, countries with a high level of corruption are at a much greater risk of being affected."

Meyer adds: "It also doesn’t help that health-care workers in Africa, many [of whom] are going to be in charge of vaccine supplies, are very poorly paid … Of course criminals will take advantage of this."

Organised crime groups are already "ideally placed" to smuggle falsified, substandard and stolen vaccines, with "well-developed networks and methodologies", says Interpol East Africa crime intelligence analyst John Patrick Broome.

"Illicit medications are primarily entering the market in eastern Africa through three key areas. There’s the avoidance of regulations, there’s violence-based criminality and there’s corruption."

Meyer says rising infections and deaths, and further waves of Covid-19, could cause fear to spike, further driving up demand for vaccines.

Containment: A container stacked at the Indira Gandhi International Airport, which will be used as a Covid-19 vaccine handling and distribution centre. Picture: AFP via Getty Images/Sajjad Hussain
Containment: A container stacked at the Indira Gandhi International Airport, which will be used as a Covid-19 vaccine handling and distribution centre. Picture: AFP via Getty Images/Sajjad Hussain

"At certain stages, supplies will be low. This is the gap that the criminals will fill. We’ve seen it happen already with personal protective equipment [PPE] and chloroquine, when the crime groups got their fakes into global supply chains quite easily," she says.

Demand for chloroquine, a medication used to treat rheumatoid arthritis, lupus and malaria, rocketed after a French microbiologist claimed in March that it was "efficient" at combating Covid-19.

Former US president Donald Trump also touted a form of chloroquine, hydroxychloroquine, as a potential cure, even though there was no evidence to prove its efficacy.

In the months that followed, as Voice of America reports, authorities in West and Central Africa seized large quantities of falsified and substandard chloroquine, including tablets made of compressed chalk.

Right now, there’s immense demand for the antiparasitic drug Ivermectin, which is being punted by some in the medical community for the prevention and treatment of Covid-19, though there’s no credible evidence to substantiate these claims.

Nevertheless, seizures of illicit Ivermectin are happening globally, including in SA.

The mafia gets involved …

Lawyers Marius Schneider and Nora Ho Tu Nam, who advise some of the world’s biggest pharmaceutical companies, warned of the probability of fake Covid-19 vaccines in Africa in a report published in the Journal of Intellectual Property Law & Practice in May.

"Why are we going to have an issue with the vaccines? Well, it’s very easy: because the demand will be high, access will be limited, everybody will want to have his shot, and in that kind of situation this vaccine is liquid gold … for these criminal syndicates," says Schneider.

Schneider’s practice sometimes co-ordinates anticounterfeiting raids with law enforcement agencies.

"We have seen instances where NGOs have been engaged in the distribution of these [falsified] vaccines. These NGOs had a mission to distribute real vaccines to the people," he says.

The stakes are so high, in part, because there’s so much money involved.

The IQVIA Institute for Human Data Science calculated that global spending on pharmaceuticals in 2019 was $1.25-trillion. By 2023, this will exceed $1.5-trillion.

And big money equals big crime, says Ho Tu Nam.

In September 2015, a UK court jailed two former UN consultants for rigging a contract for life-saving drugs between a Danish pharmaceutical firm and government officials in the Democratic Republic of Congo.

Guido Bakker and Sijbrandus Scheffer took a bribe of £650,000 (about R13.2m) to help the firm land the £66m tender.

Organised crime has always been interested in pharmaceuticals because of the high profit margins and low risks involved, says Mark Micallef of the Global Initiative against Transnational Organised Crime.

Help is at hand: A shipment of the Pfizer-BioNTech Covid-19 vaccine are is loaded into a UPS plane in Lansing, Michigan. Picture: Getty Images/Rey Del Rio
Help is at hand: A shipment of the Pfizer-BioNTech Covid-19 vaccine are is loaded into a UPS plane in Lansing, Michigan. Picture: Getty Images/Rey Del Rio

"They move wherever the greatest profits are to be made at a specific time, so it is quite obvious they will get involved in whatever ways they can in the vaccine supply."

The Unodc says Italian and Sicilian mafia have for decades trafficked in falsified, substandard and stolen pharmaceutical products, mostly sourced in Asia.

One senior police investigator in the UK, who asked not to be named because he’s not authorised to give information to the media, told Bhekisisa in early December: "The mafia are moving illicit vaccines in locations throughout Europe." He says links have been established between these mafia groups and "criminal gangs in Nigeria, Morocco, Egypt and Ivory Coast".

Using Tramadol routes for fake vaccines

In 2019, the UN estimated that 75% of falsified and substandard medicines globally originated in China, Africa’s biggest trade partner, and India.

Sources at international anti-crime agencies argue that Africa’s strong trade routes with China and India will allow criminals to introduce shipments of falsified vaccines into supply chains.

SA secured its 1.5-million AstraZeneca Covid jabs, of which 1-million arrived on February 1, from India’s Serum Institute. On Sunday, the health department announced that SA is in talks with Chinese company Sinopharm, with regards to its Covid jab.

A former trafficker of illegal pharmaceuticals in West Africa, who now helps authorities investigate these cases, tells Bhekisisa that organised crime groups are "simply waiting for chaos, desperation and no organisation" in rollouts before distributing falsified vaccines, or stealing the genuine product.

"Their networks are activated. They will use the same networks, the same corrupt officials that they are using [for other illegal products]. They have the printers and the packaging they need."

Meyer adds: "There have been cases in which employees of pharmaceutical manufacturers sell genuine medicine packaging to criminal groups."

The ex-trafficker speaks of a "well-established route" for illegal analgesic Tramadol between Nigeria and India that is "waiting to be fuelled" with fake Covid vaccines.

He says links exist between "front companies in Nigeria and their partners in India, so they will try to replace Tramadol with Covid vaccines because the money to be made is much more. We talk here of 1,000%-plus profit.

"I’m sure in some cases the police and soldiers are going to be protecting bad [falsified or stolen] vaccines."

The Global Initiative’s Micallef collects his information about trafficking of falsified medicines in North Africa from a network of 160 field monitors in Algeria, Chad, Libya, Morocco, Niger, Sudan and Tunisia. He says organised crime groups dealing in fake vaccines exploit gaps in health services — and this will be especially true of Covid-19 shots.

"This form of trafficking … is tapping an actual health sector need. And the fear is that in the case of the vaccines, a similar scenario might unfold where there are shortages, especially in the [Sahel] border areas, that are preyed upon by criminal enterprises trying to fill that gap."

In West Africa, vaccine rollout is due to happen at a time when regional governments, especially Nigeria’s, have been cracking down on Tramadol trafficking.

Last June, Nigerian authorities seized illegally imported containers of the drug worth more than 300-million naira (about R11.6m), reports Enact, an organisation that works to combat organised crime in Africa.

According to the former trafficker, this crackdown will provide an extra incentive to organised crime groups in the region to turn their attention to fake Covid-19 vaccines.

One senior security official in Nigeria, who requested anonymity, says criminals in India have been "rebranding and renaming" Tramadol to import into the country "as something harmless … The concern is they will do the same with Covid vaccines."

Nigerian analyst Ogbonnaya says many parallels can be drawn between Tramadol trafficking in West Africa and the "likely" illicit trade in coronavirus vaccines.

"It boils down to weak regulation by state regulatory agencies; it boils down to corruption by those who are saddled with the responsibility of ensuring that the regulations are put in place. It also boils down to a complete absence of a continent-wide regulatory framework."

Shoddy regulation

The African Medicines Agency (AMA) was meant to be the vehicle through which medicine regulation in African countries is "harmonised".

Last February, the AU said the AMA was the "proposed specialised agency … intended to facilitate the harmonisation of medical regulation" on the continent. Though this treaty was unanimously adopted by the AU assembly in 2019, only a few nations have so far ratified it.

Picture: 123RF
Picture: 123RF

"There are so many elements that will make Africa more vulnerable during this time of the vaccines being distributed," says Genolet. "The weak regulatory system is also something that’s been identified by the WHO."

It must be said that Africa isn’t alone in this. According to a WHO report, only three in 10 countries globally have medicine regulators that function "according to acceptable standards".

"Many African countries don’t have [functional medicine] regulatory systems at all," the report notes. "That’s very important to make sure that medicine that enters a country is safe, and that you can also control what happens after [that]."

Though there are 54 medical product regulators in Africa, the WHO says there is "varying capacity among them".

Only one in Sub-Saharan Africa (Tanzania’s) has been formally assessed by the WHO. In 2018 the WHO gave that regulator a maturity level of three, the second highest on its scale.

Andy Gray, senior lecturer in pharmacological discipline at the University of KwaZulu-Natal’s school of health sciences, says previous WHO reports have not identified which African regulators "were acceptable and which were not, due to political sensitivity, and the assessment has not been updated. The more mature are certainly the South African, Zimbabwean, Kenyan, Tanzanian, Ghanaian and Nigerian agencies."

It "does not sound far from the mark" to say that only 10% of African medicine regulators have "moderately developed capacity", with 90% having "little to no capacity".

Practically, this translates into African medicine supply chains that are "very porous", says Gray. According to Genolet, even SA, which has one of the better regulatory systems in Africa, "has thousands of kilometres of unregulated borders".

But Sahpra’s Wondo says SA’s controls are strong. "Vaccines that are substandard or falsified will be blocked by our processes at the points of entry."

Typically, he says, vaccines come into the country through four points of entry, depending on their origins: Durban, Cape Town, Port Elizabeth (all by sea and air) and Joburg (air).

"Medicines can’t come into the country [legally] without going through one of those points. At those points we have customs and port health officials who have been trained to assess medicines coming in," Wondo says.

The concern, however, is that this assessment is done merely based on the particular consignment’s appearance: labelling, relevant registration numbers and attached documentation.

"If the registration certificate of the product is in order, it is released to the pharmaceutical company for eventual release to the market.

"Those that do not fulfil registration requirements, the officials refer to Sahpra for further investigation," says Wondo.

This isn’t exactly comforting, as it’s a different matter when something has the wrong label on it — an obvious strategy for vaccine smugglers.

Wondo acknowledges that fake and substandard pharmaceutical products do sometimes "slip through" the checks. For example, "where people are declaring clothes, then maybe in the middle of the container they’ll put those boxes of medicines. Those then may go through, because of the false declarations," he says.

"But, with the help of the regulatory compliance inspectors and the SA Police Service, we do pick the fakes up inside the country, eventually."

Vaccine theft will be SA’s challenge

Gray says SA has a reputation for its secure medicine supply chain. But because Sahpra doesn’t proactively sample the market — instead, relying on good manufacturing practices by pharmaceutical companies and the "vigilance" of their forensic units — it could be missing "problems".

"If our medicines go across into neighbouring countries, is somebody slipping falsified versions into those countries? We don’t know. Are some of the importers’ medicines that are arriving on our shelves not the ones that we expect to find? We haven’t detected any, but it’s not impossible that they are happening," he says.

As it is, many of SA’s vaccines are expected to be made at India’s Serum Institute, which is contracted by the Covax facility to make vaccines for developing countries.

It’s approved by the WHO to manufacture vaccines, says Wondo, "so we know it will manufacture good quality products".

But, as Ho Tu Nam points out, medicines from every manufacturer in the world have been falsified. "No-one’s immune."

Wondo is less concerned on this count. "Each batch of vaccines that comes into SA will be tested, either by us, or by our trusted partner countries," he says. "[Falsified] vaccines will not get past our systems. We will keep our people safe."

While Gray believes SA is "vulnerable" to falsified vaccines, he — like Abdool Karim — believes the country will have "much bigger problems" to deal with.

At the top of his list are the transportation and the distribution of shots. Then there’s the risk that vaccines will be stolen.

"I think we are far more vulnerable than we even know," he says. "We’ve certainly had theft from the provincial depots, and we have a lot of theft happening from hospitals. In fact, we’ve had problems with theft on demand, where people just phone in to a member of staff and a box gets packed up for them."

Holes in the distribution chain

In SA, like many other African countries, inoculations will happen at public and private hospitals and clinics, pharmacies, mobile centres and places of work. There might also be bigger venues where a large number of people can be vaccinated.

Gray believes these sites will be the most vulnerable points along the distribution chain, as they will be under much less scrutiny than vaccine shipments.

Meyer says this will be true continent-wide. "I’ve got confidence in the AU getting verified, real vaccines into Africa. After a few initial issues with fake PPE, it did a great job co-ordinating PPE supplies. Where we’re going to have the problem in Africa is with the distributors — in this case, the ministries of health, the little primary health-care centres that get it from the ministry of health, and further down the line."

There are no super-secure facilities on the continent — so this is where Meyer believes you could have theft of vaccines, or people tampering with the content of those jabs. This could happen "the same way somebody would take pure kilos of cocaine and they’ll mix it with all sorts of things, so they can make more profit".

Abdool Karim is sure there will be "some" theft related to SA’s vaccine rollout. But he adds: "I can’t see how people are going to really steal vaccines and sell them in the black market. If they do, it’ll be a very small, niche population of the very wealthy who will want to jump the queue. Because everybody’s going to get the vaccine; the government is giving it to everybody for free."

What it means:

There are concerns about theft and corruption linked to Covid vaccines — but some experts say SA will have bigger problems

Free or not, Meyer warns that if vaccines are in short supply and infections continue, demand will "skyrocket" and "the door will be open" to theft, and fake or substandard vaccines being inserted into the chain.

"To stop narcotics crime, you cut the supply. It’s going to be the opposite way with vaccines: to stop vaccine crime we are going to have to boost supply," says Meyer. "The more legitimate vaccines on the market, the less space that criminals are going to have, the less demand there will be for their fake or stolen products."

Gray agrees, citing how, at the beginning of the pandemic in SA, people were encouraged to get flu jabs. However, the state had bought most of the jabs to give to "high-risk" employees in the public sector, which led to a shortage in the private sector.

"Many patients were phoning around pharmacies … everyone was trying to buy something somewhere."

It’s not hard to imagine this scenario being repeated at some stage during the vaccine rollout, he says.

"That is a perfect breeding ground for a criminal to step in and say, ‘I’ve got some stock which I can get you, which fell off the back of a truck.’"

*This article was produced by the  Bhekisisa Centre for Health Journalism, as part of a series on Covid-19 and organised crime. This investigation was made possible with a grant from the Global Initiative Against Transnational Organised Crime (GI-TOC). Sign up for Bhekisisa’s newsletter here.

subscribe

Would you like to comment on this article or view other readers' comments?
Register (it’s quick and free) or sign in now.

Speech Bubbles

Please read our Comment Policy before commenting.