A Maryland resident could be the first individual in the world to be vaccinated against SARS-CoV-2, the virus behind COVID-19, thanks to participation in a clinical trial at the University of Maryland site. David Rach, an immunology graduate recently declared he was a participant in the BNT162 clinical trial sponsored by BioNTech and Pfizer. One of the first to be dosed in the early stage trials, Kirsten O’Connor reports that his virus-fighting antibody count grows. It may actually be producing results. But the study was blinded: how could he know? Humanity needs some inspiration today; Mr. Rach helped deliver some.
The television journalist takes us to a positive, upbeat and attentive state while she reports on these recent observations via regional news WJLA 7. As a subject in a blinded study, Mr. Rach of course cannot know whether he received the placebo or the experimental vaccine product. He did recall however, that when he did receive the second dosage of the study vaccine that he experienced what he felt were minor side-effects. That could be of course a psychological “placebo effect” response. If in fact his perceived response was due to the fact that he received BNT162 and if the antibody count continues to accumulate then he could be one of the first individuals in the world successfully vaccinated against SARS-CoV-2. Rach reported, “There is a component of relief seeing that it’s actually producing results, that the vaccine is producing antibodies.”
What is Status of the BioNTech/Pfizer Studies?
TrialSite News last week provided a vaccine race update and recently summarized updates based on the uploaded preprint server on medRxiv revealing a robust immunogenic response and promising safety profile for BNT 162b1, the RNA-based vaccine targeting COVID-19. The study authors suggested that the data indicates a greenlight to proceed with acceleration of clinical development and other “at risk” activity. However, they acknowledged the present data was insufficient to make any conclusions.
Due to these recent positive reports last week, Pfizer’s CEO Albert Bourla suggested that the company could possibly have vaccine product ready by the Fall. In fact, he so confident, Time reported that Pfizer (again BioNTech’s development and commercialization partner) projects it will increase the amount of vaccine dosages from tens of millions to one hundred million. And Bourla is putting “skin in the game” gearing up to manufacture at risk, that is prior to FDA approval. All the more impressive, the pair are doing all of this without nearly as much government funding as some of the other candidates. Could the Pfizer/BioNTech be the new leading candidates in the global COVID-19 vaccine race?
Although solely depending on a vaccine in the short run isn’t wise as it will not prevent accumulated mounting health, economic, and societal damages. As TrialSite News has articulated, a flexible, dynamic and real-world evidence-based regionally tailored approach should be employed to mitigate the worst of the pandemic in a bid to free up economic forces and reduce social and political tensions. Over the long run, a vaccine strategy combined with a comprehensive data-driven disease management program will undoubtedly help to better control this deadly pathogen much like HIV/AIDs was to a great extent controlled (at least in many demographics in wealthy countries) and brought under control. In the meantime, anytime Ms. O’Connor brings promising news forward we certainly take notice and appreciate the positive instant —it is needed.