Early on in all of this craziness, Anthony Fauci said that it would be at least 18 months before a safe, effective vaccine for COVID might be available. Now, you have to put that into context. The crazy orange man was talking about having a vaccine “very soon” and that the virus would “just disappear”. So, Fauci was trying to be the voice of reason without making our elected ignoramus look too foolish. Immediately, many vaccine scientists said that Fauci was being too optimistic in his projections and that an effective vaccine might take multiple years to develop and assess. Please keep in mind that Fauci’s optimistic timetable might offer us a vaccine by September of 2021. Never has a vaccine gone from development to market in under 4 years. Also, there has never been a vaccine developed for a coronavirus. But, we were going to do all of this in 18 months?

Flash forward a couple of months and people are now talking about having a vaccine by the end of this year or, at the very least, the beginning of next year. Scaled up and ready for mass inoculations. No chance.

There are numerous reasons for my skepticism, but primarily my doubts are based on the tortuous process necessary to bring a vaccine through development and into the market. Let’s quickly look at the required steps (information derived from the European Vaccine Initiative). These steps are only for the clinical development stage of vaccine development which happens subsequent to the laboratory steps. The laboratory steps have already taken place for many candidate vaccines for the COVID virus.

Phase I: Small clinical trials to assess the vaccine’s safety and initial immune response (antibody response, cellular response, antibody level).

Phase II: Larger clinical trials to test the efficacy of the vaccine against infection and clinical disease; also test for safety, immune response, and side effects.

Phase III: Hundreds of subjects, divided into groups, at multiple sites to evaluate the effectiveness and safety of the vaccine under natural disease conditions. In other words, healthy subjects are divided into groups and some groups get the vaccine and others are given a placebo and the groups are followed for a lengthy period of time to see if the vaccine is effective in eliminating infection for the vaccinated subjects. So, the subjects must be out in society for enough time that a significant proportion of them would have the opportunity to contract the virus.

Phase IV: Ongoing surveillance of the vaccine after initiation into the population to detect adverse effects and assess long term efficacy.

If the US and, in fact, the world are interested in offering a safe and effective vaccine to combat this virus, Phase II and Phase III cannot be rushed. Vaccine development is not like building a bridge or racing the Russians to the moon. The scientific community cannot rush all of these stages simply by adding billions of dollars or (much worse) because there in an election in November. You cannot rush good science. This is going to take time.

The consequences of inoculating 200 million Americans with a vaccine that is unsafe or ineffective are too terrible to contemplate. That scenario has never occurred in the history of the world, yet, to me, it is looking more like a real possibility. There is the obvious political pressure from a corrupt and unstable President surrounded by sycophants heading a disastrous administration approaching a likely loss in November. There is the financial pressure of Big Pharma investing literally billions of dollars as they gear up for massive production of a vaccine (which one?) that is just now entering into Phase II of clinical development. There is the scientific pressure of hundreds of clinical teams trying to earn the accolades and career reputations that will come from developing the chosen vaccine. Those types of pressures emanating from so many different fronts make the possibility of a vaccine going into production before the efficacy and safety are fully assessed, not only possible, but likely.

What happens if we rush a vaccine to the public prior to full assessment? One possibility is that the vaccine does not provide a robust immune response to the virus and vaccinated people, who believe they are protected, become ill with the virus with the same level of clinical symptoms and serious consequences as we are currently seeing. Another is that the vaccine causes serious and long term side effects in a substantial proportion of the vaccinated population. Beyond the immediate medical and public health consequences of either of those outcomes, the damage done to the populace’s trust in public health authority and in immunization as disease prevention would be catastrophic, even beyond COVID.

My best guess is that we may have an effective and safe vaccine by the end of 2021. I could be wrong and an immunization miracle may occur. I hope so. I’d love to be wrong, but I am much more worried about the possibility of the science being rushed in this mad race for a vaccine and the outcome being a catastrophe.

Like a mirage, the vaccine seems closer than it is.

 

Be careful Be informed. Be safe.