Counterfeit vaccines and drugs are a problem in controlling Covid-19

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A The notable rallying cry that emerged at the start of the Covid-19 pandemic was ‘flatten the curve’. This reflected the reality that hospitals lacked the resources, knowledge and therapies to accommodate all those in need.

Almost 18 months later, the situation in the world is different. Clinicians have a better understanding of how to prevent Covid-19 and how to treat people with severe cases. Vaccines have provided much needed relief.

But the picture is now complicated by the emergence of substandard and falsified Covid-19 vaccines and medical products, which are becoming more and more prevalent.

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Counterfeit vaccines and drugs, which include substandard and falsified products, can undermine efforts to control the pandemic. These products cannot prevent or treat Covid-19, thus contributing to its spread. People developing Covid-19 after receiving counterfeit vaccines would erode confidence in vaccination and contribute to vaccine reluctance. Substandard and falsified drugs and vaccines could lead to a proliferation of worrisome variants and ultimately lead to resistance down the road.

Counterfeit drugs are nothing new to Covid-19. The World Health Organization, which has followed them for several years, once called them “substandard / spurious / falsely labeled / falsified / counterfeit medical products”. WHO estimates that one in ten medical products in low- and middle-income countries is falsified or of substandard quality, resulting in huge personal and public health losses. The economic burden is $ 200 billion per year.

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Now that “flattening the curve” is no longer the goal in many parts of the United States and other countries, we believe it should be replaced by “steepening the gradient”. The gradient being the slope of the curve indicating the total number of people vaccinated. The steeper the slope, the faster people are vaccinated.

The frantic pursuit of vaccines and therapeutics has been described in the media as the “Vaccine Hunger Games”. The shortage of vaccines and drugs, and the potential for damage from counterfeits, have already taken hold of the popular imagination, as in the 1949 film “The Third Man”, based on Graham Greene’s short story about Harry. Lime, a fake penicillin smuggler in post-war Vienna. In early March of this year, talk show host Jimmy Kimmel aired a skit with Sacha Baron-Cohen posing as an unauthorized peddler of Covid vaccines, suggesting problems ahead to ensure strict quality control.

The potential of counterfeit vaccines and drugs for immediate harm to the individual is quite clear. By not preventing or curing a disease, counterfeit therapy could lead to a worse course, or even death. At a societal level, fake drugs or vaccines could lead to infectious epidemics and increased spread as those infected stop socially distancing themselves and adhering to other precautions because they mistakenly assume they are protected. .

While resistance to a particular therapy is a natural evolutionary process, human activities can accelerate the proliferation of drug-resistant pathogens. In the case of antibiotics, overprescribing, improper use and poor adherence all contribute to the development of antibiotic resistance. The role of substandard and falsified drugs is less well studied, although there is new evidence linking the use of substandard and falsified drugs to antibiotic resistance.

The dynamics of resistance (within and between hosts) can be understood in the light of mathematical models describing the epidemiology and evolution of microbial populations. In a network approach, researchers are able to demonstrate that the presence of a bogus drug can increase the level and duration of resistance. Hence the need to accentuate the vaccine quality gradient to overcome this resistance.

While the development of resistance to vaccines and therapeutics by SARS-CoV-2, the virus that causes Covid-19, is a real concern, substandard and falsified products are affecting public health efforts of a way that goes beyond resistance. The presence of counterfeit vaccines could lead an individual to receive a fake vaccine for their second injection, giving the SARS-CoV-2 virus a chance to multiply and mutate in the host. False therapies could lead to repeated outbreaks in areas believed to have the disease under control.

Substandard and falsified products are also likely to disproportionately affect socio-economically disadvantaged communities and countries with weak regulatory frameworks. The erosion of trust in the system, among residents of areas where quality and fake drugs are mixed, can have long-term implications for millions of people.

By tackling the problem of substandard and falsified vaccines and therapies in the battle against Covid-19, data regarding drug resistance can offer political insight. The regions of the world most affected by antibiotic resistance correspond fairly well to regions where the problem of substandard and falsified treatments is acute. But this information could also be misappropriated and used as a monitoring and forecasting tool: in areas of the world where new strains appear regularly, it may be worth investigating whether they are plagued by substandard or falsified treatments. Swift action in these locations could save lives and contain the deadliest variants.

Criminogenesis studies indicate that there are a variety of human-made factors that cause peddlers of counterfeit drugs to locate in certain areas. Being human-mediated means that they can often be thwarted by policy changes and the effective enforcement of those policies.

With social media and the dark web, the speed and extent of the spread of fake drugs is frightening and can be even faster than the speed at which a mutant strain arrives in a community.

Left unchecked, the annual death rate from antimicrobial resistance could increase twenty-fold, from around 700,000 today to over 10 million by 2050. A significant portion of these deaths could be avoided through greater recognition by the scientific community, awareness of the larger society and action by policy makers to tackle head-on the problem of substandard and falsified treatments.

It is essential to strengthen and harmonize international cooperation in the creation of surveillance networks to detect and contain the spread of fake vaccines and drugs. This will require adopting common definitions and policy standards, improving the capacity to share information between monitoring networks and enforcement agencies, and strengthening existing coordination structures. The development of innovative epidemiological and microbiological methods is also necessary for better surveillance, data collection and faster identification of drug-resistant pathogens.

The graph below shows that the total number of “discovery incidents” – discrete events triggered by the discovery of counterfeit, illegally diverted or stolen materials – more than doubled between 2014 and 2020. Rather than interpret this increase as a symptom of a growing problem out of control, we prefer to take the half-full glass perspective and see it as an encouraging sign that the world has woken up to the problem of substandard and falsified treatment and is striving to solve it.

Patrick Skerrett / STAT
Source: Institute of Pharmaceutical Safety

There is a real danger that the presence of counterfeit vaccines and drugs could allow Covid-19 to become endemic, a near-permanent and potentially overwhelming disease, especially in low and middle-income countries. What we need now is to increase the gradient and ensure equitable access to quality treatment, because it is good public health policy and morally the right thing to do.

Muhammad H. Zaman is Professor of Biomedical Engineering at Boston University. Ravi Sundaram is Professor of Computer Science at Khoury College of Computer Sciences at Northeastern University in Boston. Walter Gabriel is a postgraduate associate researcher at the Yale School of Medicine. They are part of a multi-institution consortium to study counterfeit and substandard medical products. The authors would like to thank their colleagues Nikos Passas, Mansoor Amiji and Ioannis Kakadiaris for their contribution and advice.


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