Regulatory Capture

Up to now, all the vaccines have been the same.  The only differences in the vials are the concentrations of genetic material for various age groups and boosters.  As the virus continues to mutate at a rapid pace, current vaccines are becoming irrelevant.  That may be about to change, but not for better.  The roadmap to release of future vaccine versions will be the subject of the FDA’s Vaccines and Related Biological Products Advisory Committee meeting on Tuesday.  This plan could open the door to genetic engineering without safety oversight. 

Simplicity and standardization reduce error, yet vaccine rules are becoming more complex.  Instead of mandating standardization, the FDA has allowed manufacturers to establish packaging, dosing, and interval parameters.  This is the result of regulatory capture—regulators overtaken by those they are charged with regulating.  Regulatory capture has caused FDA to authorize so many versions that it is easy to forget there are still just three vaccines available in the United States.  

Pfizer, Moderna, and Janssen vaccines have not changed since their introductions.  All three are designed to produce immunity against a virus which is no longer a threat.  Although the many different vials in the Pfizer and Moderna vaccine families make it appear these companies have been hard at work making new vaccines, they only adjusted the product concentrations and doses for different age groups and boosters without the slightest change in the immunity target.  We’re skating to where to puck has been, not to where it is going.  

The FDA and vaccine manufacturers are aware of the problem.  Like the needlessly complicated vaccine landscape, their solution will be another example of regulatory capture.  If approved, future Covid-19 vaccines versions will skip clinical trials.  The manufacturer can change the genetic material in these vaccines without understanding the consequences of the change.  If you want plan details, read this Substack article by Dr. Toby Rogers of Brownstone Institute.

Why is this dangerous?  Afterall, if we are going to keep up with this virus, shouldn’t we give scientists the freedom to engineer the vaccines on the fly?

The first problem with this idea is that scientists do not know what they are doing.  Because the understanding of genetics and immunology is incomplete, we cannot expect scientists to flawlessly produce genetic code that is safe for human injection.  If I download and install a hack I find online, the worst outcome is a bricked phone (it’s happened; ask my wife).  If genetic engineers make a mistake, the consequences are frightful—think Zombie movies, Frankenstein, and Jurassic Park.  Afterall, they are tinkering with the operating system of life.  Genetic engineering should require more oversight, not less.

The motives of vaccine manufacturers represent a worse problem.  These companies have a duty to their boards and shareholders that supersedes the health and wellbeing of their customers.  We regulate the healthcare industry for this reason.  If we give pharmaceutical companies license to sell untested versions of genetic code, they will use it to bulk up balance sheets.  Honest clinical trials are the only way to check these corrupt intentions.

We must get integrity back into the oversight and approval process, and we do this by getting the money and corruption out.  Safety cannot be ensured when studies performed at universities and published in journals by scientists are presented to advisory committees.  At least not when the company pays for the study, endows the university, advertises in the journal, pays royalties to the scientists, and funds committee member projects.  These cozy arrangements must end.  Anti-kickback laws must apply to all parties in the biomedical-industrial-regulatory complex.