People who know my philosophy on vaccines know that I am a firm believer in informed consent coupled with personal choice. In other words, patients should be provided all relevant information and then be allowed to make an informed decision based on what is best for themselves and their families.
With this in mind, I want to address the federal government’s apparent approach, known as “Operation Warp Speed”, which can lead to rushing the distribution of a coronavirus vaccine to the general public before adequate safety and efficacy testing has been done (though “adequate” is in the eyes of the beholder). Vaccine experts are warning against this, and history shows why they are right.
Rushing the Vaccine Approval Process: Hard Lessons Learned
Under normal circumstances, the FDA will only approve a vaccine after evaluating data, gathered by scientists through large-scale studies that prove it is safe and effective, which takes years. Historically, when the vaccine approval process has been circumvented (i.e., not meticulously conducted with due diligence), there have been disastrous outcomes.
For example, in 1955 the government approved the first vaccine to protect children from acquiring polio. One company’s batches accidentally contained live polio virus, which resulted in an outbreak (see The Cutter Incident: How America’s First Polio Vaccine Led to a Growing Vaccine Crisis).
In another case, in 1976 scientists discovered a new swine flu that was a novel virus like COVID-19, and predicted a pandemic would develop. After being persuaded by advisers, President Ford decided to make immunization compulsory. As a result, according to the CDC, in roughly seven months 40 million people got vaccinated against the swine flu. It was later determined that this aggressive vaccination campaign was linked to cases of Guillain-Barre Syndrome, a hyper-inflammatory neurological condition that can cause muscle paralysis, weakness, and difficulty breathing.
The Danger of Widespread Distrust of the System
After several of these types of incidents, some Americans understandably started distrusting vaccines. Widespread mistrust can be detrimental to overall public health because vaccinations, when produced responsibly, can provide protection from the virus or bacteria being targeted.
The potential for mistrust is applicable in the fight against COVID-19 because roughly 35% of Americans currently report they will not get the COVID-19 vaccine when it first becomes available (see Poll: 35% Of Americans Won’t Get COVID Vaccine). This suggests “Operation Warp Speed” is not instilling confidence in people. The FDA recently announced it may provide Emergency Use Authorization (EUA) for a vaccine before the larger (though in my opinion still not large enough) Phase III studies are complete. This move would likely further reduce people’s confidence.
According to Dr. Howard Markel, a pediatrician, distinguished professor, and director of the Center for the History of Medicine at the University of Michigan, “All it takes is one bad side effect to basically botch a vaccine program…. [Rushing it is] a prescription for disaster.” Source: Past vaccine disasters show why rushing a coronavirus vaccine now would be ‘colossally stupid’ (CNN)
“Being ready is reasonable. Cutting short phase 3 trials before you get the information you need isn’t,” said Dr. Paul Offit, a Children’s Hospital of Philadelphia immunization expert who sits on the FDA’s vaccine advisory committee. Peter Hotez, dean of Baylor University’s tropical medicine school, would be “very concerned” if the FDA uses an emergency use authorization to approve a vaccine before knowing if it works and is safe. “It gives the appearance of a stunt rather than an expression of public health concern” (see: https://apnews.com/71e616bb423c6d3e97fbaa7a97bca7e7).
As time passes and more data becomes available, I will continue to share my thoughts about the forthcoming COVID-19 vaccines. To say the least, right now I am approaching the prospects with much trepidation.