On December 4, the European Union’s crime agency Europol issued a warning about fake vaccines being sold online. “As the vaccine is now becoming available, the large demand will trigger different criminal activities,” Europol spokesperson Jan Op Gen Oorth told DW. This includes circulation of falsified vaccines on illicit markets or their introduction into the legal market, trafficking of fake or substandard vaccines that have fallen out of the cold chain, and the theft of cargo and even medical waste such as empty vials.
The World Health Organization (WHO) issued a warning in March about unregistered websites claiming that products on sale can treat or prevent COVID-19. “A culture of self-diagnosis and self-prescribing has led to the emergence of thousands of unregulated websites providing unsupervised access to substandard and falsified medical products,” said Pernette Bourdillon Esteve, the WHO’s acting team lead for incidents and substandard and falsified medical products.
Esteve told DW that the WHO was aware of some versions of falsified COVID-19 vaccines but so far there was no need to be concerned and appropriate regulatory action had been taken. “The general public in Europe should not be alarmed about falsified versions of vaccines as long as they procure products in the regulated and controlled supply chain,” Esteve said. Though some people may think that fake medications are only a problem in poorer countries or those with weakened health care systems, they are a problem globally. “No country is untouched by substandard and falsified medical products and work is being done in all WHO Regions,” said Esteve. “What was once considered a problem suffered by developing and low-income countries has now become an issue for all.”
It is difficult to assess the harm caused by substandard and falsified medical products, Esteve said. Often the product does not cause a toxic reaction but fails to prevent or treat illness. Some products, however, can harm or kill people. Fake vaccines can make people lose faith in the public health organizations that are trying to protect them from disease. “It is important to stress that any harm caused by a falsified vaccine does not reflect any safety failure of an authentic or genuine version,” Esteve said. “Genuine vaccines which have been subject to regulatory approval are considered to be safe, efficacious and quality-assured.”
The global trade in counterfeit medical drugs was estimated to have reached $4.4 billion in 2016, according to a report published in March by the Organisation for Economic Co-operation and Development (OECD), a group of 37 wealthier countries. This number does not include the large amount of counterfeit pharmaceuticals that do not cross borders. Up to 2 billion people around the world lack access to necessary medicines, vaccines, medical devices and other health products, according to the United Nations, which leaves a gap that is often filled by substandard and falsified products. Between 72,000 and 169,000 children may die from pneumonia every year globally after receiving counterfeit drugs, according to the OECD report, and fake anti-malarial medication might be responsible for an additional 116,000 deaths.
Even when crime isn’t involved, the quality of authorized vaccines can be damaged during production if an ingredient is faulty, or during transportation, as vaccines often need to be kept at certain temperatures to remain effective. The BioNTech-Pfizer COVID-19 vaccine that is now being rolled out has to be stored at ultralow temperatures before use. About 1000 vaccines headed to seven towns in the Upper Franconia region of Bavaria on December 27 were returned to BioNTech after storage temperatures hit unacceptable levels. The Lichtenfels District Office told DW that Lichtenfels and the six other affected towns received replacement vaccines the following day. In contrast to substandard vaccines — vaccines that have been authorised but fail to meet quality standards or specifications — falsified vaccines deliberately misrepresent their identity, composition or source, according to the WHO’s definitions.
This article was provided by Deutsche Welle