Emily
Editor, Senior Moderator
https://noorchashm.medium.com/a-sev...is-critical-for-determination-of-4d51042b9662
A SEVERE ERROR IN FEDERAL PUBLIC HEALTH POLICY: Antibody Testing Is Critical For Determination of COVID-19 Vaccine Necessity and Efficacy in Every American.
The Biden Administration’s FDA has made a dangerous error by closing the door to individual American citizens using COVID-19 antibody testing liberally to assess both vaccine necessity and efficacy.
Hooman Noorchashm
1 day ago
On May 19, 2021 the United States 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 the 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 persons is found to have no COVID-19 antibodies prior to vaccination, that persons 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, or take other precautions to protect themselves, when confronted with a negative antibody test.
I have, on multiple occasions now, 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 stoking further vaccine hesitancy through this very specific and misguided policy against antibody testing. And fundamentally, when federal executive agencies act to limit citizens access to their own highly relevant health information, especially in a national medical emergency where their lives could depend on it, a terrible dereliction of duty is at hand.
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 spoilt — 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. This inappropriate and dangerous FDA action very likely leaves a substantial number of vaccinated citizens susceptible to what would have otherwise been preventable COVID-19 infections, had these citizens been provided a pathway to confirm the efficacy of their vaccination...
A SEVERE ERROR IN FEDERAL PUBLIC HEALTH POLICY: Antibody Testing Is Critical For Determination of COVID-19 Vaccine Necessity and Efficacy in Every American.
The Biden Administration’s FDA has made a dangerous error by closing the door to individual American citizens using COVID-19 antibody testing liberally to assess both vaccine necessity and efficacy.
Hooman Noorchashm
1 day ago
On May 19, 2021 the United States 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 the 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 persons is found to have no COVID-19 antibodies prior to vaccination, that persons 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, or take other precautions to protect themselves, when confronted with a negative antibody test.
I have, on multiple occasions now, 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 stoking further vaccine hesitancy through this very specific and misguided policy against antibody testing. And fundamentally, when federal executive agencies act to limit citizens access to their own highly relevant health information, especially in a national medical emergency where their lives could depend on it, a terrible dereliction of duty is at hand.
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 spoilt — 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. This inappropriate and dangerous FDA action very likely leaves a substantial number of vaccinated citizens susceptible to what would have otherwise been preventable COVID-19 infections, had these citizens been provided a pathway to confirm the efficacy of their vaccination...