Criminals are already on the prowl, circulating fake COVID-19 vaccines, the National Agency for Food and Drug Administration and Control (NAFDAC) warned Nigerians on Friday.
And the trend is not peculiar to Nigeria, according to reports from across the world.
One report said a black market for fake vaccines has begun to emerge online as criminals look to rip off people seeking alternative means of securing a dose.
The Director of the International Institute for Research Against Counterfeit Medicine (IRACM), Bernard Leroy, said traffickers are selling the vaccine at $1,000 a piece.
Secretary General of the International Police Organisation (INTERPOL) Jurgen Stock said separately that the Covid-19 pandemic is providing new opportunities and vulnerabilities for criminals, such as “attacks” on vaccines.
Global death toll from coronavirus crossed the two million mark on Friday.
The Director-General of NAFDAC, Prof Mojisola Adeyeye, said during a virtual media briefing on Friday that Nigerians should be careful about any vaccine purported to be for Covid-19.
The agency, according to her, is yet to approve any Covid-19 vaccine.
She urged the public not to purchase any unapproved drug as they are capable of causing Covid-19-like illnesses and can even lead to death.
It asked government establishments, agencies and big corporations in particular not to order Covid -19 vaccines without confirming from NAFDAC if such vaccines have been approved.
She said: “The National Agency for Food and Drug Administration and Control (NAFDAC) has not received any application from Covid vaccine manufacturers yet and therefore no vaccines have been approved by NAFDAC.
“Covid-19 vaccines are new, and the side effects or adverse events must be well monitored. Therefore, if NAFDAC does not approve, the public should not use.
“There are reports of fake vaccines in Nigeria. NAFDAC is pleading with the public to beware. “No Covid vaccines have been approved by NAFDAC. Fake vaccines can cause Covid-like illnesses or other serious diseases that could kill.
“Vaccines should not be ordered by any company or corporation. The companies that manufacture the vaccines, if they are genuine, know they have to submit their application to NAFDAC.
“No government establishment or agency should order Covid vaccines without confirming from NAFDAC if the vaccine has been approved.”
She said NAFDAC was already discussing with manufacturers of COVID-19 vaccines concerning potential Emergency Use Authorization (EUA), registration or licensing of their product as the case may be.
The agency assured applicants that if Phase 3 clinical data are very convincing and robust with regards to safety and efficacy, and the vaccine has been submitted to WHO for Emergency Use Listing, it will welcome the application for Emergency Use Authorization in Nigeria.
Her words: “NAFDAC will use ‘Reliance’ or ‘Recognition’ to expedite Emergency Use Authorisation (EUA) for vaccines already approved by more matured regulatory authorities.
“The full dossier submitted by the manufacturer or Market Authorisation Holder (MAH) will be thoroughly reviewed by the Vaccine Committee that is made up of multiple directorates in the agency – Drug Registration and Regulatory Affairs, Drug Evaluation and Research, Pharmacovigilance and Post Marketing Surveillance, Drug, Biologics and Vaccines Laboratory Services.
“Safety of the Covid vaccine is premium to NAFDAC. This is why active pharmacovigilance is being used.
“Phase 4 pharmacovigilance is one of the core regulatory activities of the Agency. For COVID-19 vaccines, the Agency has been preparing for the COVID-19 vaccines and vaccination since the early phase of the pandemic – around April 2020.
“NAFDAC was positioned to a great extent to work online during the lockdown due to digitalization of many of our processes and continuous improvement.
“Despite the use of Reliance for the EUA, NAFDAC will note clinical peculiarities in form of Serious or Adverse Events Following Immunisation (AEFIs) in the dossier or application as a guide and caution for what to look out for in each subject after immunization, that is, during the active pharmacovigilance phase where monitoring of adverse events will be conducted.
“The Agency has been training her staff for this very important aspect of immunization.
“The Agency established COVID-19 Vaccine Committee that has been busy developing the guidelines and guidance.
“NAFDAC is the first National Regulatory Agency in Africa to have Guidance on Regulatory Preparedness for EUA, Licensing or Access to COVID-19 Vaccines.”
Experts outside Nigeria have also warned of the emergence of a black market online for fake vaccines as criminals look to profit off people seeking an alternative means of securing a dose.
The main cause is the short supply of Covid-19 vaccines, especially distribution across the world.
The slow rollout of vaccines has left long waiting lines for the life-saving drugs, leaving an opening for traffickers and criminals to exploit, often with light legal consequences and significant financial profits.
“On the dark web, traffickers are selling the [COVID-19] vaccine at $1,000 [a piece],” said Bernard Leroy, Director of the International Institute for Research Against Counterfeit Medicine (IRACM).
Trafficking in falsified medicines, including vaccines, is around 20 times less dangerous and 20 times more profitable than drug trafficking, research from the International Institute for Research Against Counterfeit Medicine (IRACM), with the global trade of illicit medicines valued at around $200 billion, according to Leroy.
Fake medicines, including vaccines, can “poison the people who use them, fail to generate immunity or cure, and in extreme cases, kill,” according to Jeffrey Kemprecos, GlaxoSmithKline (GSK) Director of Communication, Government Affairs and Market Access for the Gulf Region.
“There is a lot of money to be made with virtually no risk of punishment,” Abigail Jones, Communications Director at the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), explained.
‘Fake’ is popularly used to describe counterfeit, falsified, degraded and suboptimal medical products, including subscription drugs, protective equipment, and vaccines, an illegal industry that has only continued to grow.
“Faking medicines or vaccines is a crime and need to be punished as such … We only see the tip of the iceberg,” Jones warned.
The appearance and circulation of fake vaccines on the global market is a response to high demand and low supply, with criminal groups looking to prey upon people’s urgent need for vaccines and medicine caused by the pandemic’s spread across the world last year.
“During 2020, transnational organised crime switched to falsified medicine because it’s not so dangerous,” added Leroy.
“In the world, only around two to three and a half per cent of people are taking narcotics. But, of course, 100 per cent of the population needs medicine.”
As at last month Europol had seized 33 million medical devices, face masks, tests and diagnosis kits as well as eight tonnes of raw materials, chemicals and antivirals, which are touted as helpful to fight the coronavirus pandemic.
Also seized by Europol were 70 litres of hygiene sanitizers.
These scams have also now begun to shift towards hopes for a vaccine.
“As was observed at the beginning of the pandemic when criminals were advertising fake ‘corona cures,’ they are now adapting and attempting to exploit the development of the vaccine,” Jan Op Gen Oorth, Europol’s spokesperson said.
“Organised crime always goes where the risks are low and profits are high,” he added.
Authorities have also worried about the possibility of criminal gangs intercepting shipments of legitimate vaccine and then selling it on the black market for a profit.
In the US, the Immigration and Customs Enforcement (ICE) launched Operation Stolen Promise 2.0 in early December to identify and prevent the production, sale and distribution of illicit COVID-19 vaccines.
However, one of the main problems in stopping criminal activities with ‘fake’ drugs, including those related to COVID-19, is the absence of legal mechanisms to prosecute the wrongdoers.
In some countries, the penalty for peddling fake medicine is the same as that of any other fake product – such as bag.
“Many countries are using their laws on counterfeit materials. For example, for the things from the French [brand] Hermes, falsified in Thailand, it’s two months imprisonment. The same law that is applied to counterfeit materials is also applied to [trafficking] falsified medicine,” Leroy explained.
Pandemic has created new opportunities for criminals, says Interpol Secretary General
The Secretary General of the International Police Organization (INTERPOL) Jurgen Stock told the CNN that the Covid-19 pandemic is providing new opportunities and vulnerabilities for criminals, such as “attacks” on vaccines.
“I have never seen in my long career such a dynamic situation where criminals are quickly shifting to new opportunities,” Jürgen Stock said.
The international police organization has alerted governments and law enforcement to prepare for attacks on vaccines, including theft, warehouse break-ins and fake vaccines.
Two countries have already asked INTERPOL to help in combating criminal efforts, Stock said, one involving the production of a fake vaccine and the other the distribution of one.
The Interpol had, last year, issued an alert to 194 member countries to warn them about organised cybercrime groups targeting COVID-19 vaccines, using fake online pharmacy sites to spread malware, and spreading disinformation and fake news about upcoming vaccines.
Following reports of North Korean hackers targeting AstraZeneca employees with phishing emails arrived, Interpol warned that organised cybercrime groups were going all out to exploit uncertainty about the progress of COVID-19 vaccine research to carry out large-scale fraud, disseminate fake news, and distribute malware to a large number of devices.
The global law enforcement agency said cybercrime groups were exploiting the COVID-19 factor to set up thousands of fake domains that are disguised as online pharmacies.
Not only are these domains being used to sell illicit medicines and medical devices, a majority of them are also being used to spread viruses, especially phishing and spamming malware.
Hackers across the world are also conducting activities to advertise and sell fake vaccines online and are working in consonance with criminal groups that are carrying out a parallel production and distribution of unauthorised and falsified testing kits.
“Criminal networks will also be targeting unsuspecting members of the public via fake websites and false cures, which could pose a significant risk to their health, even their lives.
“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, which is why INTERPOL has issued this global warning,” said Stock.
The organisation also advised Internet users to take special care when going online to search for medical equipment or medicines and to always check with national health authorities or WHO for the latest health advice in relation to COVID-19.
“Given the variety of storage requirements the range of vaccines under current development are likely to require, and the understandable importance attached to these vaccines in the global recovery from the ongoing pandemic, it is almost certain that the continued and sustained targeting of supply chain operations which Mimecast has seen over the last year will increase yet further still,” says Carl Wearn, head of e-crime at Mimecast.
