Mariam Salmanzadeh
Associate Editor
Loyola University Chicago School of Law, JD 2025
On March 6th, 2024, it was announced that a 62-year-old man from Magdeburg, Germany, intentionally got 217 COVID-19 vaccine shots in the span of 29 months, which went against national vaccine recommendations. That’s an average of one vaccine every four days. Although this man is from Germany, what if an American were to attempt the same self-experimentation as him? Would a doctor allow it? Would a regulatory agency get involved? Is it even legal?
What regulatory agency oversees vaccinations?
In the United States, the Food and Drug Administration (FDA) oversees the regulation and approval of vaccines. They ensure vaccines meet rigorous safety, efficacy, and quality standards before the population can use vaccines. The Centers for Disease Control and Prevention (CDC) also guides vaccine usage and schedules, while the Advisory Committee on Immunization Practices (ACIP) advises the CDC on vaccine recommendations.
The FDA does not control the number of vaccines an individual receives. So, how do they manage those who abuse the lack of guidelines and attempt to get unlimited vaccines? Instead, the FDA’s Center for Biologics Evaluation and Research (CBER) is responsible for evaluating and approving vaccines for safety and effectiveness before they can be marketed and distributed to the public. Once a vaccine is approved, its usage and recommended dosing schedules are typically determined by the ACIP. These guidelines are based on factors such as how safe and effective the vaccine is when given at specific ages, how severe the vaccine-preventable disease is, and how many would get the disease if there was no vaccine. However, the FDA plays a crucial role in ensuring that vaccines are manufactured and distributed per regulatory standards to maintain their safety and efficacy.
Are unlimited vaccines legal?
The man in Germany got 134 officially recorded doses of the COVID-19 vaccine, while the rest were self-reported, including eight different vaccines. The CDC claims that COVID-19 vaccines are safe and effective. At the same time, the CDC and FDA continue to monitor the safety of updated vaccines and share information with the public as they become available. Receiving vaccines beyond the recommended dosing schedule may be unnecessary and pose potential health risks that are still unknown.
While there may not be specific laws prohibiting an unlimited number of vaccinations, medical professionals are expected to follow evidence-based practices and prioritize patient safety as mandated by The Code of Medical Ethics of the American Medical Association (AMA). Administering vaccines beyond what is considered appropriate or necessary may raise ethical and safety concerns.
What about ethical considerations?
Ultimately, one should make decisions about vaccination in consultation with a healthcare provider, who can provide personalized recommendations based on an individual’s health status and vaccination history. But what if I wanted to get 217 COVID-19 vaccine doses? Would I be arrested? Would a doctor even allow it? One might think that because there may not be a specific law explicitly prohibiting doctors from allowing someone to receive a COVID-19 vaccine every week, any doctor will let what happened in Germany happen in the United States.
Nevertheless, is a doctor legally allowed to refuse a patient the ability to over-vaccinate themselves? Healthcare providers must adhere to evidence-based practices and prioritize patient safety and well-being. Administering vaccines more frequently than recommended by health authorities, such as the CDC, may not align with established medical guidelines. Doctors are also required to take an oath, like that of attorneys, to hold a higher duty of care towards their patients. The Hippocratic Oath is a traditional pledge that includes the promise to use medical knowledge for the benefit of patients, to avoid harm, and to avoid harming patients through unethical practices such as unnecessary procedures. Therefore, healthcare providers in the United States will likely adhere to established guidelines and recommendations regarding vaccination frequency and refuse a patient who could be experiencing hypochondria symptoms.
Another potential consequence of over-vaccination that the man from Germany might have faced if he were in the United States is a possible healthcare fraud charge. Healthcare fraud is a deliberate deception or misrepresentation of services that results in an unauthorized reimbursement. Additionally, healthcare abuse refers to practices inconsistent with accepted medical practices. Although it is questionable that he engaged in healthcare fraud, maybe the man in Germany misrepresented how many vaccine doses he was receiving so as not to raise suspicions by authorities. However, he did engage in healthcare abuse by taking more than the recommended dosage of the COVID-19 vaccine, which is a widely accepted medical practice. The CDC recommends that people aged 12 years or older who are not vaccinated should get either one updated Pfizer or Moderna COVID-19 vaccine or two doses of the updated Novavax COVID-19 vaccine. However, there is no mention of the potential implications of receiving additional vaccines past the recommended dosage. Regulatory agencies and healthcare providers must work together to structure a more specific framework concerning vaccines and dosage limitations.