More than 100 unvaccinated employees have filed a lawsuit against Houston Methodist Hospital over its vaccine mandate.
On Tuesday, the hospital suspended without pay 178 of its employees who refused to be vaccinated against COVID-19.
It is shocking to see a group of health care providers protesting vaccination amid a pandemic, but this is not the first time.
In 2007, nurses at Virginia Mason Hospital sued, arguing that the hospital’s vaccine mandate violated the union’s collective bargaining agreement.
Two years later, a group of nurses protested the New York Health Commission’s H1N1 vaccine requirement.
As recently as March 2020, a nurse filed suit against CarePartners Rehabilitation Hospital in Asheville, North Carolina, because she was terminated for failing to get a flu shot.
The suit against Houston Methodist is unique in that it argues that the health system’s vaccine mandate violates the Nuremberg Code.
The complaint further argues that “Methodist Hospital is forcing its employees to be human ‘guinea pigs’ as a condition for continued employment.”
The Nuremberg Code is at the heart of Western bioethics. Its origins date back to the Nuremberg Nazi doctors’ trial following World War II.
The code comprises 10 principles, establishing the rules for permissible medical experimentations on human beings.
The 74-year-old document was an early attempt to make significant legal contributions in defining the scope and limitations of medical experimentation, but it has since become the foundation for the ethical treatment of human subjects.
The application of the Nuremberg Code in the Houston Methodist lawsuit seems strange because it equates the COVID-19 vaccines with medical experimentation.
Much of this distinction is based on the two distinct, and often-misunderstood, paths for vaccine authorization used by the U.S. Food and Drug Administration (FDA).
Traditionally, vaccine manufacturers seek to apply for a Biologics License Application (BLA), but the FDA has an alternative route to vaccine authorization known as Emergency Use Authorization (EUA).
The FDA has only granted an EUA for the Pfizer, Moderna and Johnson & Johnson COVID-19 vaccines.
Both paths begin with manufacturers developing and testing a potential vaccine. After gaining FDA approval to test with human subjects, researchers will go through three phases of study.
Phase 1: Testing is conducted on a small number of generally healthy people to evaluate the safety, side effects and effectiveness of the product.
Phase 2: Testing is conducted on hundreds of subjects from diverse demographic groups and with different medical conditions.
Phase 3: Testing is conducted on thousands of subjects from diverse demographics. Subjects receiving the vaccine are compared to subjects who only received a placebo.
Only after Phase 3 are manufactures able to apply for either an EUA or a BLA. These avenues have one major difference in terms of the assessment process.
BLAs will have spent a longer period of time in evaluating the effectiveness of a vaccine, duration of protection and identification of rare adverse side effects.
How long depends on the product, but, typically, an EUA will have a few months of follow-up and a BLA will be six months or more.
While the follow-up period will take note of safety issues and effectiveness, its primary concern is verifying how long immunity will last.
After a vaccine enters the marketplace, the FDA continues to monitor the vaccine through its Vaccine Adverse Event Reporting System and its Biologics Effectiveness and Safety Program.
Many began to criticize Pfizer and Moderna for not seeking a BLA once millions of doses had been given.
On May 7, Pfizer and BioNTech announced they were submitting clinical and nonclinical data needed for full licensure. On June 1, Moderna announced it was seeking a BLA as well.
In both cases, neither Pfizer (which gained EUA on Dec. 11) nor Moderna (which gained EUA on Dec. 18) had been able to submit the necessary six months of follow-up data for a BLA.
Due to the overwhelming success of both vaccines, full FDA approval is expected.
Let’s return to the charge that the COVID-19 vaccines are a giant experiment and that mandatory vaccine requirements are a violation of the Nuremberg Code.
If true, then we are witnessing the largest human subject experiment ever conducted with over 2 billion doses already given worldwide. This would make these vaccines the most tested of all time.
The number of successful doses already given functions as an argument against the idea that the vaccines are still just an experiment and that they are not safe.
The truth is, the experiment ended at Phase 3, and the only functional difference between an EUA and a BLA is the amount of time invested in the follow-up period to determine how long the vaccine will grant immunity and to discover any extremely rare side effects.
In the case of the COVID-19 vaccines, the number of doses negates the latter; there has been enough time to ensure that immunity is granted for way more than six months.
So, let’s step back, look at the facts and make rational decisions based on the best science available.
Getting vaccinated is a personal decision that should be made by a patient in consultation with their health care provider.
With half the country already vaccinated, it is time to decide what is best for you and your family. We need to make sure that these decisions are based on facts and not rumors.
Equating the vaccines to Nazi-era experimentation by referencing the Nuremberg Code in a lawsuit is neither accurate nor helpful.
Senior Staff Chaplain and Clinical Ethicist at the Baptist Health Medical Center in Little Rock, Arkansas.
