The original article was originally published on Health Policy Watch on 7 December 2020.
New Alliance Formed To Fight Fake COVID-19 Vaccines & Medicines – In Wake Of Interpol Warning Of Looming Threat
The approval of the world’s first COVID-19 vaccine candidate last week in the United Kingdom is stoking fears that the global rollout of vaccines to fight the pandemic could also stimulate a counter-pandemic of fake online cures as well as criminal attempts to sabotage or interrupt vaccine supply chains.
To counter the growing threat, a new industry-backed alliance to fight fake COVID-19 medicines and vaccines was launched on Monday. Building on the informal Fight the Fakes advocacy campaign and week (7-13 December), the new Fight the Fake Alliance aims to muster more government, civil society and private sector awareness and support about the risks posed by the attempts of organized crime, individual profiteers and hackers to interfere with the COVID-19 vaccine and medicines supply chain, as well as profit from fake products.
The Alliance was formed just a few days after Interpol, the international criminal police organization, issued a sharp warning to law enforcement agencies in its 194 member states that criminal networks were laying plans to target COVID-19 vaccine supply chains, physically and online, disrupting distribution of legitimate products and sowing confusion.
“As governments are preparing to roll out vaccines, criminal organizations are planning to infiltrate or disrupt supply chains,” said Jürgen Stock, Interpol Secretary General, in a statement released last Wednesday (2 December). “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.”
The Alliance is composed of 15 groups involved in various aspects of the medical supply chain and representing health care professionals, manufacturers, wholesalers, researchers and patients. Its members include the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), International Alliance of Patients’ Organizations (IAPO), and International Council of Nurses (ICN).
“In the current environment of misinformation – the so-called ‘infodemic’ by the World Health Organization (WHO) – it is particularly important to prevent the manufacture and trade of falsified COVID-19 vaccines as they have the potential to undermine trust in modern medicine, health care professional and health care systems as a whole,” the Alliance’s new Vice Chair and Director of Partnerships & Programmes at the World Heart Federation, Andrea Vassalotti told Health Policy Watch.
“With the on-going COVID-19 pandemic and the rise in falsified medicines now and in the future, our combined efforts to mitigate, control and ultimately eradicate the damage they cause to patient health and lives are more crucial than ever,” said Adam Aspinall, Chair of the new Fight the Fakes Alliance and Senior Director of Access and Product Management at Medicines for Malaria Venture, in a press release.
“The threat of fake medicines knows no borders,” said Miriam Holm, co-head of the Secretariat for Fight the Fakes, in a podcast Monday hosted by King’s College London lecturer, Bahijja Raimi-Abraham. “I think it’s only a matter of a few weeks until we have fake COVID vaccines circulating.”
“We have joined forces with the Fight the Fakes Campaign to raise awareness of the dangers of fake medicines,” said the International Council of Nurses (ICN), one member of the new alliance, in a statement. “ICN supports international initiatives to combat counterfeiting and urges nurses and national nurses associations to collaborate with pharmacists, physicians and others to disseminate accurate information on detection and elimination of counterfeit medicines.”
High Income Countries not Immune to Attacks
While low- and middle-income countries with weaker regulatory systems have been the most typical targets for the trade in fake medicines, high-income countries are not immune either.
That was evident as news emerged last week about cyberattacks targeting the vaccine distribution networks in the United States that are being prepared to roll out new COVID-19 vaccines, following expected approval of a Pfizer vaccine later this week.
According to the Cybersecurity and Infrastructure Security Agency, which operates under the Department of Homeland Security, cyber actors were impersonating a biomedical company in phishing emails, which aimed to steal log-in credentials of executives and officials at companies and government organizations involved in distributing vaccines. One aim of the hackers was the disruption of sensitive vaccine cold chain processes.
The cold chain process is the refrigeration system critical for the storage, transportation, and distribution of vaccines, especially mRNA vaccines, such as the ones developed by Pfizer and Moderna, which require sub-zero storage temperatures. Interference with this system could affect the quality or effectiveness of the vaccine and compromise the infrastructure to deliver vaccines to billions of people globally.
Organizations in Taiwan, South Korea, Germany, and Italy, involved in development of solar-powered vaccine cooling systems, as well as UNICEF, which has been part of the WHO co-sponsored vaccine planning in low-income countries, were targeted in similar cyberattacks, the New York Times reported.
Rise In Falsified COVID-19 Diagnostic Kits Heralded New Threat
The launch of the new Fight the Fakes Alliance coincides with the third annual Fight the Fakes week, designed to raise awareness about the dangers of falsified and substandard medicines among governments, industry and civil society.
“Fight the Fakes Week 2020 is appropriately timed to inform the general public of the importance of consulting health care professionals for legitimate advice on COVID-19 vaccines,” Vassalotti told Health Policy Watch.
“While we saw a rise in falsified diagnostic testing kits and substandard personal protective equipment during the initial stages of the pandemic, falsified COVID-19 vaccines will likely emerge sooner rather than later,” she added.
Early on in the pandemic, when numerous countries were experiencing shortages of personal protective equipment for healthcare workers, there was a surge in the circulation of poor quality and fake masks, gloves, and diagnostic testing kits. Additionally, with the speculation of hydroxychloroquine as a treatment for COVID-19 came reports of falsified versions, particularly in the African region.
WHO’s Global Surveillance and Monitoring System for Substandard and Falsified Medical Products issued a medical product alert in late March to warn consumers, healthcare professionals, and health authorities against a range of falsified products claiming to prevent, treat, or cure COVID-19
The convergence of falsified medical products with the infodemic, characterized by the overabundance of misinformation and falsified information, is highly damaging. Together, these crises have the potential to undermine the already shaky trust of the public in the reliability of vaccines and health institutions. The existing hesitancy of accepting a COVID-19 vaccine could be further fueled by the circulation of falsified products and misinformation.
Substandard and Falsified Medicines
Substandard medical products are authorized products that nonetheless fail to meet quality standards, perhaps due to incorrect storage or damage during transportation. Falsified products, on the other hand, deliberately misrepresent their identity, composition and source and do not meet regulatory requirements.
One in 10 medical products in low- and middle-income countries is either substandard or falsified, according to a study by the WHO. These medicines not only fail to treat or prevent diseases, but can also cause serious illness or death.
The higher burden in developing countries is due in part to less rigorous regulatory requirements and more porous borders, which allows for illegal trade between countries. While fake medicines have posed a danger in all disease areas for decades, COVID-19 has amplified the threat of fake medicines to public health.
Fake Medicines Also Can Fuel Antimicrobial Resistance
Along with the immediate issues of the COVID-19 pandemic, falsified and substandard antibiotics, anti-viral and anti-parasitic medications can also contribute to another major global health threat, antimicrobial resistance (AMR).
The administration of weakened drugs may foster the development of drug-resistant microbes that will then be resistant to full drug course as well. While a great deal of research has documented how the overuse of antibiotics is stimulating the rise of antimicrobial resistance, there is, however, relatively little work examining the role of poor drug quality in fostering resistance of bacteria, fungi, viruses and parasites to drugs.
Antibiotics are, however, among the most frequently reported falsified medical products. One study found that antimicrobials with low doses of active ingredients lead to low levels of the drug in the patient. Exposing drug-resistant microbes to subtherapeutic doses of medicines, through falsified or substandard drugs, enables the survival and spread of resistance.
Falsified medical products also cause very immediate and direct damage because they compromise the treatment of potentially deadly chronic and infectious diseases, causing disease progression and even death.
For instance, falsified pneumonia medicines cause an estimated 170,000 children to die each year, according to the Alliance.