Showing posts with label Phase III clinical trial. Show all posts
Showing posts with label Phase III clinical trial. Show all posts

Friday, October 29, 2021

COVID-19 SYMPOSIUM [FEBRUARY] 2021: DR BYRAM BRIDLE, VIRAL IMMUNOLOGIST, UNIVERSITY OF GUELPH

This YouTube video was published back on February 14, 2021. 

Those being vaccinated now are part of Phase III clinical experiment, and the companies have openly acknowledged this to the agencies, regulatory agencies because . . . for example, there's a minimum of time for which they have to track things like, ah, safety of the vaccine.  Indeed, they've even indicated . . . so most people . . . we're used to . . . as scientists to being able to see published scientifically peer-reviewed data before the vaccines are rolled out and this won't happen probably for about two more years, and the reason for this is that it's going to take that long to complete the Phase III clinical trials.  A Phase III clinical trial cannot be declared complete until they have monitored the safety of the vaccine for multiple years.  This is important to keep in mind.  So as a consequence, these have been approved in a remarkable time but that alone has raised legitimate questions that are unique to these coronavirus vaccines.  And I also want to highlight the nature of the virus itself and I'll get into this in a little bit.  And as well, some perplexing decisions about the rollout have legitimate questions.  COVID-19 vaccines have indeed raised hopes that the pandemic is nearing an end.  I, like all others, am hopeful that this is the case, because we'd all like to get out of these severe lockdowns or isolation.  But I want to highlight some potential sticking points.  As an academic scientist and a public servant, I hope the end is near, but if the vaccine rollout does not go as planned, I don't want anybody asking the question, "Why didn't anybody tell me that there was a possibility of a failure with the rollout?"  So I just want to   

POTENTIAL STICKING POINTS TO THE VACCINES [Remember, these were questions raised back on February 14, 2021]

As a viral immunologist who develops immunization strategies to prevent infectious diseases and treat cancers, I would like to highlight outstanding questions I have been repeatedly asked about the emergency use of vaccines against severe acute respiratory syndrome-coronavirus-2 (SARS-CoV-2), which is the causative agent of the coronavirus disease that emerged in 2019 (COVID-19).

1.  What is the long-term safety of COVID-19 vaccines? 
2.  COVID-19 vaccines are being distributed with uniquely short safety profiles (months-worth).  These didn’t exist three months ago.   Safety assessment starts in Phase I, but need to be confirmed in Phase III. 
3.  Short-term safety profiles of the approved COVID-19 vaccines looks good.  You have to do your own risk assessment of the value of the vaccines. 
4.  However, induction of anaphylactic reactions in a very small percentage of vaccine recipients hasn’t helped the optics for those with vaccine hesitancy.
5.  Some questions have also arisen about vaccinating the frail elderly:
6.  23 frail elderly individuals in Norway died shortly after receiving the Pfizer vaccine.
7.  UK open letter: increase in non-COVID deaths in long-term care homes compared to before the vaccines.  It is difficult to ascertain the reason for these deaths; they may have had nothing to do with the vaccines.
8.  However, too many unpredicted severe long-term side-effects accruing over time could be cause for withdrawal of approval for a vaccine.