FDA Made ‘Dangerous Error’ by Advising Against COVID Antibody Testing

 

.By  Hooman Noorchashm, M.D., Ph.D.

Antibody testing is critical for determining COVID vaccine efficacy and necessity, but FDA continues to recommend against the testing for anyone, including people who already had COVID and those who have been vaccinated against the virus.

On May 19 the U.S. Food and Drug Administration (FDA) released a dangerous and totally inappropriate guidance advising against COVID-19 antibody testing pre- or post-vaccination.

This FDA guidance is dangerous because it discourages and blocks most American physicians from using a gold standard assay for immunity to COVID-19.

But, it is of paramount importance for every American citizen and resident and his/her physician to be able to assess the status of one’s immunity to COVID-19 during this pandemic for two reasons.

First, if a person is found to have no COVID-19 antibodies prior to vaccination, that person will know that he/she is at high risk of developing an infection. In other words, antibody testing would allow determination of medical necessity of COVID-19 vaccination — and being that most persons act rationally given correct information, it is anticipated that most non-immune Americans will seek vaccination when confronted with a negative test.

I have on multiple occasions publicly called on the Biden administration, the FDA commissioner and the CDC to open the door to antibody testing for establishment of medical necessity as a means of combating vaccine hesitancy. Because I believe Americans to be a rational people and, I know from personal experience in medical practice, that when most hesitant Americans are confronted with the FACT that they are NOT immune, a majority choose to get vaccinated.

Americans are a rational people and want to protect themselves from harm. But, by placing barriers to pre-vaccination antibody testing for determination of medical necessity, the Biden administration’s FDA is dangerously, albeit inadvertently, stoking further vaccine hesitancy through this very specific and misguided policy against antibody testing.

Second, the mRNA vaccine is a highly unstable preparation. Thus, it is very likely that a significant number of mRNA vaccine doses entering individual American arms are either partially or completely spoiled — and, thus, ineffective. The fact that FDA’s May 19 guidance is placing a barrier in the way of post-vaccination antibody testing, effectively blocks determination of vaccine efficacy in individual Americans.

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Via https://childrenshealthdefense.org/defender/fda-dangerous-error-advising-against-covid-antibody-testing/