As the COVID-19 vaccine sees imminent, large scale release in jurisdictions around the world, pharmaceutical manufacturers are faced with the complex challenge of a coordinated global roll out. There is little question that this process will be executed under the watchful eye of government authorities every step of the way. While this oversight may leave some believing the risk of counterfeiting or fraud may be low, with the eyes of the world watching, now is not the time for stakeholders to let their guard down.
Never before has a single new product been so important to countless individuals, regulatory bodies, government agencies, and private entities across the world. As such, it has never been more critical to ensure it is protected against bad actors seeking to take advantage of an uncertain situation. Global law enforcement has warned jurisdictions about the possibilities of opportunistic criminal behavior, including "advertising, selling and administering fake vaccines." How can healthcare providers and manufacturers fight back against potential counterfeits?
- Only purchase from reputable sources. As manufacturers source equipment for large-scale development and delivery, and the healthcare sector and government prepare procurement processes for the vaccine on a parallel path, it is critical that these purchases are only made from reputable sources. There are currently only a handful of well-known, highly regarded pharmaceutical companies slated to launch vaccines, and it is of utmost importance those procuring vaccine doses remain vigilant in ensuring their purchases are legitimate.
- Conduct physical inspections. Once a vaccine is purchased from a reputable source, it is critically important that purchasers inspect their deliveries for any inconsistencies. Does the packaging look like it may have been tampered with? Is the branding and labeling consistent with the manufacturer? Was the vaccine stored correctly in accordance with manufacturer and CDC guidance? There will be little opportunity for individuals receiving the vaccine to inspect packaging themselves, as they may be able to with other over-the-counter goods, heightening the need for healthcare purchasers apply extra safeguards to this process.
- Ensure proper tagging and tracking of vaccines. Beyond counterfeits, risk remains regarding the theft of COVID-19 vaccines. Manufacturers can help combat this by leveraging tracking techniques and technology to securely track and identify legitimate vaccines. This can help ensure what leaves the origin production facility is indeed what is delivered to the end vaccination provider.
- Monitor facilities that may be falsely advertising vaccine distribution online. For manufacturers, it is valuable to get ahead of bad actors before they can begin. Opportunistic fraudsters may take advantage of vulnerable groups who are seeking access to the vaccine, and falsely advertise the vaccine's availability. The result could yield ineffective and fake "vaccinations" at best, and dangerous or toxic product at worst. As a result, manufacturers should keep a close eye on those who are publicly advertising vaccine distribution to root out potential scammers who may leverage the manufacturer's name fraudulently.
- Report suspicions to the appropriate authorities. To encourage law enforcement and regulators in a particular jurisdiction to pursue counterfeiters, companies should establish strong ties with relevant agencies and promote an open dialogue about the presence of potential counterfeiting. This may include encouraging an environment where stakeholders up and down the logistics chain feel empowered to "blow the whistle" when something appears off, and to ensure those in monitoring positions are taking each report seriously, regardless of whether some are ultimately false alarms.
While maintaining the integrity of the vaccine process will largely rely on government, medical provider, and pharmaceutical company safeguards, there are also steps the general population can take. Consumers can stay vigilant by only pursuing vaccinations through their doctors or at locations recommended by trusted medical professionals, and staying up to date on the progress of vaccinations through reliable resources, such as the Center for Disease Control's website. As the old adage goes, if it seems too good to be true, it probably is – and suspicious activity should be reported to appropriate authorities for further scrutiny and investigation.
As the global community enters the beginning stages of an unprecedented logistical challenge, all eyes will be on vaccine integrity and safety. Now, more than ever, it is critical that safeguards and checkpoints are put into place to protect this system from bad actors – the return to "normalcy" may depend on it.
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