- Criminal gangs exploiting desperation for COVID-19 vaccines
- Fake flu vaccines discovered in Mexico amid supply shortage
- Risks: falsified vaccines do not work; could pose health hazard
- Genuine vaccines are produced to the highest standard
- In Europe, licensed medicines are traceable and fitted with security features to ensure hospitals and clinics deliver quality vaccines
Law enforcement agencies have issued a public warning amid concerns that criminals could seek to capitalise on the high demand for COVID-19 vaccines. As supply of vaccines will remain lower than demand throughout 2021, health authorities are prioritising those in most need.
Europol, the European Union’s law enforcement agency, published an Early Warning Notification this month (December 2020) saying it has already seen advertisements on dark web marketplaces claiming to sell vaccines.
In April, Europol said criminal gangs were distributing counterfeit vaccines, as well as falsified medicines and personal protective equipment. The problem, the agency said, would only worsen as demand grew. ‘As legitimate vaccines enter the market, counterfeit versions of the brand are expected to circulate rapidly to meet the high demand’.
While some online scams that advertise vaccines are designed to extract money or to trick people into downloading computer malware, others ship vials purporting to contain.
Separately, it emerged last week that the European Medicines Agency, the EU’s medicines and vaccines regulator, was the victim of a cyberattack. Hackers appear to have targeted information on COVID-19 vaccines that the EMA has been reviewing. It is not clear whether cybercriminals or state-backed hackers were behind the attack.
Counterfeit vaccines may be prepared under poor conditions, may contain dangerous substances or may not offer any protection against disease. Unlike commonly counterfeited medications, such as antibiotics and medication for erectile dysfunction, users will not be aware that fake vaccines have not worked until it is too late: infection will be the first sign that they have bought a useless product.
‘These counterfeit vaccines may pose a significant risk to public health if they are ineffective or toxic, given their production in labs without the required hygiene standards,’ Europol said. ‘These fake vaccines may circulate on illicit markets or be introduced to the legal market for distribution.’
The Europol statement echoes warnings from Interpol, the international police organisation, and the FBI in the United States. Both agencies expressed concern that high-value vaccine shipments could even be targeted by criminal gangs seeking to steal the products.
‘It is essential that law enforcement is as prepared as possible for what will be an onslaught of all types of criminal activity linked to the COVID-19 vaccine,’ said Jürgen Stock, Interpol Secretary General.
In October, the WHO issued a Medical Product Alert after counterfeit flu vaccines were seized in Mexico. As demand for flu vaccines outstripped supply during the autumn, criminals saw an opportunity to capitalise on demand.
In the past two years, there have also been reports of falsified rabies vaccines in the Philippines, meningitis vaccines in Niger, oral cholera vaccines in Bangladesh and hepatitis B vaccines in Uganda.
As well as counterfeit medicines, counterfeit vaccination certificates and false negative tests are a growing concern. The WHO has said false immunization travel certificates – particularly for yellow fever – are widespread in some countries.
After authorisation, EMA is urging citizens not to get #COVID19vaccines from unauthorised websites & vendors aiming to exploit fears during #COVID19. Citizens should follow official vaccination programmes rather than seeking out alternative sources of vaccines. #EMAPublicMeeting
— EU Medicines Agency (@EMA_News) December 11, 2020
Adam Aspinall, Senior Director, Access and Product Management, at Medicines for Malaria Venture (MMV), and chair of the Fight the Fakes Alliance, said the pandemic had added renewed urgency to tackling counterfeit medicinal products.
‘With the ongoing COVID-19 pandemic and the rise in falsified medicines now and in future, our combined efforts to mitigate, control and ultimately eradicate the damage they cause to patient health and lives are more crucial than ever,’ he said.
Europe’s medicines supply chain is among the most secure in the world. Genuine vaccines are fitted with tamper proof seals and barcodes to ensure traceability. The public can be confident that COVID-19 vaccines offered by hospitals and immunisation clinics are legitimate.
‘Europe has a secure pharma supply chain, made even more secure by the European Medicines Verification System (EMVO), which is there to protect patients from falsifications,’ EMVO said in a statement to Vaccines Today. Together with National Medicines Verification Organisations (NMVOs), EMVO has formed a COVID-19 Task Force. ‘This is to ensure that our system is ready for the arrival of COVID-19 vaccines entering the European market.’
While most members of the public must patiently wait their turn, police forces and medical experts are advising the public not to seek or accept vaccines outside the healthcare system.
Crucially, across Europe, COVID-19 vaccines will be provided for free. There is no need to pay for the vaccine.
December 20th, 2020
Thanks for this heads-up on what – one must fear – may become a headline-grabbing story as we head into 2021.
It is true that the European Medicines Verification System, that has been established to fulfil the requirements of the EU Falsified Medicines (EU-FMD) directive, provides a very high level of protection against counterfeiters (and other criminal activities) – but only if also these Covid vaccines are supplied in compliance with the EU-FMD/EMVS processes: They need to serialised, tamper-evidenced and the unique identifiers (serial numbers) must be uploaded when the batch is released to market and checked against the appropriate National Medicines Verification System at the point of dispense.
While it is understandable that temporary exemptions may be granted for the first batches in order to make the vaccines available as quickly as possible, extending such exemptions beyond the initial batches would negate the full protection that the EU-FMD (Falsified Medicines Directive) offers.
It is therefore essential that Covid vaccines should be supplied soon after they are approved in EU markets, even if this presents particular – and novel – challenges due to the nature of these products, their supply chain and how they are being dispensed. Finding ways to avoid the ‘onerous obligations’ that he EU-FMD brings may look like an understandably expedient way of dealing with an extraordinary situation but will ultimately deprive patients from benefitting from the unique security that the EU-FMD and the EMVS system and processes have established.