The Food and Drug Administration’s (FDA’s) emergency use authorization of the Moderna and Pfizer-BioNTech coronavirus disease 2019 (COVID-19) vaccines in late December 2020 represented a major positive shift in the tide of the pandemic. Unfortunately, criminals now also have another way to take advantage of patients. As of late January 2021, over 20 million Americans have received at least one dose of the vaccine, and, in recent weeks, many states have expanded inoculation efforts beyond the original priority populations to those in the general public ages 65 and older. However, patients who are not yet eligible to receive the vaccine or who live in a jurisdiction with limited supplies may encounter bad actors trying to take advantage of the high demand by peddling fraudulent vaccines or “cures” online.
At the current pace of 1 million vaccinations a day, it would take approximately 18 months to vaccinate up to 80% of the United States population, creating pressure on the federal government to work with states to scale quickly and satisfy high demand. Despite the federal government’s exclusive control of the COVID-19 vaccine supply in the US, state public health departments are responsible for developing and executing their own distribution plans, which means vaccination sites and public information vary significantly, making it challenging for consumers to spot misinformation. At the same time, consumers have become increasingly more comfortable with using the internet for health-related information and services over the past year, creating an environment ripe for illegal online drug sellers and cyber criminals to prey on eager and unsuspecting individuals.
In response to this growing concern, over the past few months, FDA, the Federal Trade Commission (FTC), and other federal law enforcement agencies have ramped up efforts to crack down on fraudulent online COVID-19 product schemes and educate consumers on how to spot COVID-19 vaccine scams.
Before FDA had even issued authorization of the Moderna vaccine, FTC and the National Association of Attorneys General released a new consumer education blog post offering tips on how to recognize and avoid vaccine-related scams. State Attorneys General Offices, including Illinois, New York, and North Carolina, have recently followed suit, issuing their own statements and public announcements.
In December, the US Attorney for the District of Maryland seized two domain names, “mordernatx.com” and “regeneronmedicals.com.” These domain names duped would-be customers into providing personal information such as name, company/institution, title, phone, and email by replicating the logos, markings, colors, and text on the websites of Moderna and Regeneron, the manufacturer of a popular antibody-based treatment.
In perhaps the most disturbing case reported to date, following a months-long investigation led by the FDA Office of Criminal Investigation (OCI), Johnny T. Stine, founder and president of purported biotech company North Coast Biologics, was arrested on January 21 on charges of introducing misbranded drugs into interstate commerce. In online posts starting as early as March 2020, Stine claimed to have a COVID-19 vaccine, which he offered to inject into customers for $400-$1,000 each. FDA OCI received complaints that at least one individual who Stine had injected was hospitalized with COVID-19 and, in a sting operation, Stine offered to travel across state lines to vaccinate undercover agents.
FDA also continues to actively monitor and issue warning letters against bad actors peddling other fraudulent products claiming to cure, treat, or prevent COVID-19, many of which take place online. For example, in September, FDA issued a warning letter to websites “innovativemedicine.com” and “nadovim.com” for marketing a product referred to as “Nadovim” for the prevention and treatment of COVID-19. In November, FDA issued a warning letter to the owner of “vibranthealthcare.org” for offering stem cells to prevent and cure COVID-19.
This past month, NABP, the ASOP Global Foundation (ASOP Global Foundation), and the Alliance for Safe Online Pharmacies (ASOP Global) met with FDA’s Center for Biologics Evaluation and Research (CBER) to discuss some of the online trends CBER has been observing and ways in which public health stakeholders might help support FDA’s work against the online peddling of fraudulent COVID-19 treatments, vaccines, and information. CBER representatives stressed the importance of raising awareness of the safety of COVID-19 vaccines and of informing Americans of fraudulent or misbranded COVID-19 products being sold online. All participants also acknowledged the challenges of striking the right balance to avoid sowing additional seeds of vaccine mistrust and anti-vaccine misinformation that also permeates the internet.
Public confidence in the safety and efficacy of COVID-19 vaccines and treatments is needed to help end this public health crisis. Government agencies public health stakeholders, patient advocates, and policymakers alike must help ensure consumers are well-armed with the necessary and correct tools to identify legitimate sources of COVID-19 products and information online.