Trials and Tribulations: 'Vexinations' - Part 2 (Where We're Going and How We'll Get There)

Back to the Future: Starting with yesterday's news (literally), followed by a few steps back in time (just enough to gain appreciation of what some unsung heroes working behind the scenes on our behalf have accomplished), and on to what we hope, yearn for in the next several months...                                              Newsweek, November 28, 2020 (Health Section): "Why Oxford-AstraZeneca vaccine could be more important than Pfizer in ending pandemic..." An article chronicling not only the development of this third vaccine of major world interest, but more specific 'attributes' this one may have which may in turn play a different part (perhaps in coordination with the others) in curbing the pandemic in many low and middle income countries in particular. This, due in part to its ease of transport and storage capabilities (not requiring the super low temperatures of the other two), but also to the current commitment to distribute "equally", on a not-for-profit basis (as long as COVID designated a pandemic, and to developing nations indefinitely). This followed  another news outlet declaring that we have two glimmers of hope as the dark winter months loom around here, due to the efforts of ('big pharma') Pfizer and Moderna, who are both reporting high (e.g., 95%) efficacy and safety rates for their COVID vaccines, which have been brought to the FDA for approval at warp speed. 

On the Verge, A 'Mazing': The results of the Phase III clinical trials have led Pfizer to seek approval from the FDA for emergency use, with Moderna expected to follow suit presently. Millions of doses of both of these vaccines should be available to certain groups by end of next month, according to the HHS secretary.  In addition to all the research and clinical phase trials (see yesterday's post) that leads to even emergency approval (let alone "full approval", which may come later as noted by the FDA), the other 'maze' through which a vaccine gets distributed includes those of a more bureaucratic nature: the CDC and Prevention Committee on Immunization will have final say on who gets vaccinated first. That committee in turn follows guidance from the National Academy of Science, Engineering and Medicine (members of which are not yet as familiar to us as are Drs. Fauci and Birx). 

Phasing In: As an interesting parallel to the clinical phases, there are notable phases by which the vaccines of interest will become accessible:

Phase I: health care and others most vulnerable (e.g., nursing home residents) - approx. 15% U.S. pop. 

Phase II: K-12 teachers, school staff, child care, other noted groups (see articles) - 30-35& U.S. pop.  

Phase III: young adults, children, and workers in various settings noted -40-45% U.S. pop.

Phase IV: all the rest of my friends...

Vaccinate Locally, Distribute Globally: "Flying the Friendly Skies"...Beyond clearing the hurdles of even emergency distribution approval, Pfizer and Moderna face the challenge of logistics (another COVID career I previously mentioned), specifically the demand for the vaccine being stored at about minus 94 degrees Fahrenheit (below even Wim Hof ice bath temps!). Initially, they will be shipped in special temperature controlled thermal boxes packed in dry ice (there goes all your dry ice, if you need any). But up steps American Airlines, announcing it has established a network of team members that specialize in "temperature critical shipments" (more than COOL!).

Ad VAERS Reactions: Okay, so the vaccines get distributed and you get vaccinated at whatever schedule you fall into, what about side effects and/or adverse reactions to look out for? Well, the FDA has already emphasized that "emergency approval" is not the same as "full approval", indicating that anyone getting vaccinated in the near future will get a "fact sheet" containing potential benefits and risks (like the ones we already get but rarely read; we probably will now), "as studies clarifying their efficacy and safety continue". But did you know there is actually yet another committee, whose role is to look out for us in this critical context--a vaccine surveillance system, jointly run by the CDCP and FDA since 1990, is called the Vaccine Adverse Event Reporting System, incorporating a highly coordinated effort between health providers, those that administer vaccinations directly, and ourselves when vaccinated, with advanced computer methods. Which allows for quicker accumulation of data and dissemination of 'alarms' when necessary (kind of like when you are notified of a potential problem on your car based on the number of complaints, with potentially more serious implications here). 

Hesitant, Ambivalent? I don't have enough space here to adequately detail the social, political, psychological, and philosophical dynamics related to 'anti-vaxxers'. Sufficient to say that there have always been and always will be a group opposed to having their children and themselves vaccinated. This, despite an overwhelming amount of sound science as to the efficacy and safety in preventing various diseases (reflected, for example, by a recent African nation citing that polio had finally been eradicated due to the acceptance and distribution of  the polio vaccine). Regarding this 'vaccine hesitant' group, the World Health Organization refers to them as "one of the top ten global health threats", as a group who could encumber the successful distribution of the COVID vaccine in particular. The debate between those advocating for and against will continue past the current pandemic. We can only hope that the debate will be based more on sound science that driven by emotion, such as fear and unfounded suspicions. 

Turning to, Away, from 'Big Pharma": The articles detailing the reasons 'Big Pharma' has earned a degree of distrust and skepticism, including the financial windfall some expect they'll experience from the COVID vaccine, are about equal in number to those hailing them as the champions of COVID. The ambivalence we have with these companies is embedded with politics, medical economics, and yes, psychology. In a previous post, I predicted that following our embrace of the efforts of a legion of researchers with degrees in biochemistry, chemical engineering, and physiology, will come a time where we turn against them, even sue them. This, when accusations of such legalistic issues as uneven distribution and revelations of new found side effects (even many years after) are brought to us by a legion of lawyers. If we are going to maintain a healthy skepticism for companies like Pfizer and Moderna and the omnipresent ads inducing us to ask our docs for prescriptions, we should have at least as much skepticism for the cacophonous ads of legal firms who at this very minute have teams of underemployed legal grads trolling in preparation for such class action suits--whose annoying and equally omnipresent commercials have filled the air again in the vacuum left from the election.

In the Meantime: Regardless of your orientation to vaccines in particular and 'Big Pharma' in general, I hope you will agree that, in addition to thanking health care workers, first responders, and others serving us throughout the pandemic, we should add "Thank You Research Geeks" to our signs. I plan to, even before getting vaccinated.

Coming, Sometime in 2021: Part 3 - "A Fond Farewell"