Trials and Tribulations: 'Vexinations' - Part 1 (Where we're at, how we got here)

Parallel Lines: Almost in direct proportion to the number of COVID cases diagnosed early in the pandemic, appeals were being made to government, scientific organizations, and yes, 'Big Pharma', to bring us a vaccine, bring it fast, and do whatever it takes; we were individually and collectively vexing for and about  a vaccine...vexing that continues to this day and will likely persist beyond this pandemic. Well, the day has almost arrived, we are told, the day that an effective and safe vaccine will start its distribution, first to those most at risk and those on the front lines, then to the masses. Most people don't seem to care much for the incredible complexity, millions of dollars, and millions of hours with which a legion of dedicated researchers have endeavored literally through the night in order to create a vaccine (does "I don't care much about the details, just bring me a vaccine" ring familiar?). I think it timely, overdue in fact, to highlight some of the key features of this process, in order to increase your awareness as to how you, yourself conceptualize what a vaccine is, its role(s) in curbing the pandemic, and your ambivalence towards those providing it. Even with brevity, this will require two parts.

What's My Line? (from a show popular enough to run for 17 years): "I'm a foreign agent killer"...Well, actually, "I'm a biological agent that provides active acquired immunity to a particular infectious disease (everyone wants some of me)...I also typically contain an agent that resembles a disease-causing micro-organism and is often made from weakened or killed forms of the microbe, its toxins, or one of the surface proteins (Yuk, you say?!)...the agent stimulates the body's immune system to recognize the agent as a threat, destroy it, and further recognize and destroy any of the micro-organisms associated with that agent it may encounter in the future. I can be prophylactic and/or therapeutic (oh, you want me badly again, huh?). 

Phasing in: Depending on how various scientific organizations conceptualize clinical trials of vaccines, it can extend up to six stages (no big controversy here, it's just how the phases are categorized). The one getting the most attention is that of Clinical Development (usually referred to as "Phase III"), which in turn has three sub-phases, each of which involves the testing of increasing numbers of human subjects. It is at this phase that a majority (yes, a majority) of promising ones fail (although some of the 'failures' add to either our scientific body of knowledge or may later shown to have other applications, an important topic for another post here perhaps). This is where we essentially are, to be followed by Phase IV, where some manufacturers and organizations opt for continued testing of safety, efficacy, and other potential uses,  following the formal release and distribution of a vaccine.

Peer or Smear, On Trial: One of the best and time tested insurances on behalf of the public against 'junk science' (including 'home made remedies' in treating viruses) are 'peer reviews' -- those that scrutinize studies though applying the most rigorous scientific standards to how research is developed, implemented, and interpreted. I had first hand experience with this process when proposing, implementing, and defending my doctoral dissertation (if you haven't been through this or ever had your research scrutinized by an independent organization, you probably won't fully appreciate why it's referred to as a defense). This type of scientific rigor and healthy skepticism is represented in how the FDA reviews applications as well as the results of pharmaceutical trials, including the vaccines under current consideration, those being prepared for release. Meanwhile, there are numerous, 'smear campaigns' being waged against the development of the vaccines of immediate interest, some of which have found their way into the mainline press, which are not based on the same scientific standards for which they are making insinuations if not outright accusations. Instead, they are appealing to people's base emotions (psychology!). One wonders, if held to the same level of scientific scrutiny, how many of their 'findings' would hold up. Hmm?                                                                                                                                            I finish Part 1 with only part of the operational definition of what constitutes a "Clinical Trial" and its implied value, to leave you today with an appreciation for, and reflection on, how this applies to pharmaceutical research in general and potential vaccines in particular: "Experiments or observations done in clinical research...designed to answer specific questions about biological or behavioral interventions, including new treatments (e.g., vaccines), as well as known interventions (e.g. 'therapeutics'), that warrant further study and comparison..." Part 2 - Where We're Going