Spartangator - as promised, here is my response to your response from my first post. As you will remember, the primary reason for my initial foray into this controversial subject was to wonder aloud how it could be that those running many of our healthcare systems were not mandating the Covid-19 vaccine for its employees, and further, how it could be that so many of our medical professionals were hesitant to get the vaccine. To the first point, while I thank you for your considered response, the four possible explanations provided, while possibly true, do not fully resolve the matter for me. How, in the face of a pandemic, could such shallow and easily overcome personnel matters be more important than the lives of hospitalized patients, most of whom are compromised by one comorbidity or another? Whatever happened to the Hippocratic Oath?
This only makes sense to me if, in contrast with what we hear on the nightly news, the Covid-19 vaccine is either not as effective or not as safe, or both, as we are led to believe. This goes to the second point of my post, with which your explanation also leaves me wanting. Simply opinionating that healthcare professionals who view the vaccine as risky are extreme outliers and that they are poorly informed is not a convincing argument. Had you ended your response at that point there really would have been nothing for me to respond to and the conflicting in my own mind over the disconnects and double standards would continue just as they do now.
However, since you took issue with my use of the work "experimental" in describing the Covid-19 vaccine, I was inclined to continue my research nd herewith are some of my results in the form of a response which I hope you will find satisfactory.
You support your assertion that Covid-19's Emergency Use Authorization (EUA) is not experimental because it has undergone the same amount of rigor as a fully authorized vaccine, and that more is known about Covid treatments and their impacts than almost anything else in modern pharmacy. I concede the fact that the EUA process is rigorous in nature. The problem is that it is a process that is far from complete, as it is when a fully authorized vaccine enters the market. Only Phase 1 and Phase 2 trials are required to be completed before a drug receives EUA status from the FDA. Phase 3 trials, the longest and most complex, require a 2-year period in which participants are followed for serious or clinically significant adverse events. These evaluations of the Covid-19 vaccine are ongoing and only interim results are being obtained by the FDA, which explains why we continue to hear about newly discovered side effects up to and including death. Hence, just to continue EUA status a drug maker is required to perform ongoing risk-benefit determinations. It should be noted that the FDA regularly removes EUA status from drugs/vaccines that fail to pass the established risk-benefit threshold. It should also be noted that all of the information in this paragraph comes directly from the FDA's website so please do not accuse me of spreading disinformation.
The British Medical Journal (BMJ) in concert with the British Medical Association, which by the way is also not known for disseminating disinformation, just last month published the following eye-opening snippets: "The Covid-19 vaccines in widespread use have EUA and not actual approval, a crucial regulatory distinction that reflects major differences in the level of regulatory scrutiny and certainly about the risk-benefit balance." According to the BMJ, Phase 3 trials are not simply efficacy studies, but also necessary and important safety studies. Consequently, the BMJ has called on the FDA "to require a more thorough assessment of spike proteins produced by the body following vaccination, including studies on their full bio distribution, pharmacokinetics, and tissue-specific toxicities." The BMJ also advises the FDA to demand that vaccine manufacturers complete proper bio distribution studies that would be expected of any new drug in addition to studies to better understand the implications of mRNA translation in distant tissue. Finally, the BMJ requests that the FDA obtain necessary studies in specific population groups including those previously infected with SARS-CoV-2, pediatric subjects, and those with immunological or other underlying medical complexities (heart valve patients perhaps?). In other words, studies in specific populations have either not been completed or not even conducted in the first place.j
It is clear to me, and should be to everyone, that there remains open, unanswered questions surrounding the efficacy and safety of the Covid-19 vaccines and calling them experimental at this stage of the process seems fitting to me. In a sense, those of you who have taken the vaccine are unwittingly participating in large scale trials.
I thank you.
