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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.
This inappropriate 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.
Because the mRNA vaccines are likely to be susceptible to a significant rate of spoilage, some vaccinated Americans will be either partially or entirely un-immunized against COVID-19 – even though they are fully vaccinated. Because millions of American have vaccinated, tens if not hundreds of thousands, of inadequately immunized people are likely to be roaming around our nation now.
These individuals would be susceptible to so-called “breakthrough infections,” not because the vaccine is generally ineffective, but because they are actually not immune due to a spoilage of their vaccine dose. It is an unassailable clinical fact that such persons would benefit from knowing the status of their COVID-19 antibody immunity — in order to either take extra precautions or to get re-vaccinated.
Unfortunately, the FDA has discouraged vaccinated Americans from confirming the efficacy of their vaccination, effectively leaving the subset subjected to bad vaccinations open to the risk of infection — yet trusting and confident in the efficacy of a dead vaccine.
Although antibody tests have an important role in identifying previous exposure to SARS-CoV-2, at this time, these tests shouldn’t be used to determine immunity or protection from #COVID19 – including if you’ve received the vaccine. https://t.co/mPXXpfVD5Q
— Dr. Janet Woodcock (@DrWoodcockFDA) May 19, 2021
The incorrect May 19 FDA guidance blocking antibody testing was a shocking pronouncement from a medical perspective. Specifically because antibody testing is the gold standard medical test for immunity against EVERY viral and bacterial pathogen known to humankind — SARS-CoV-2 is no exception. The fact that the medical community has not unanimously objected to this dangerous guidance is a testament to the “group-think” governing our medical establishment and compromising American lives every day in many corners of the healthcare sector. “Group-think” kills!
“It’s truly tragic to be witnessing President Biden and his administration make this catastrophic public health and political error.” @noorchashm
— Robert F. Kennedy Jr (@RobertKennedyJr) June 18, 2021
So the question is: why would FDA and it’s commissioner, Dr. Woodcock, make such a terrible error in policy judgement?
Unfortunately, my only answer is that the agency is concerned that letting individual Americans gain access to information about the status of their own immunity to COVID-19 would either slow or discourage COVID-19 vaccination.
But, of course, like many other well-intentioned federal policies that ignore the intelligence of the American people at FDA and other executive agencies, they’ve got this one wrong too.
At this point in the pandemic, it is VERY likely that many of the vaccine hesitant in America would actually make a rational decision to get their shots, if they had access to objective data about the status of their antibody immunity and could establish the medical necessity of vaccination.
Furthermore, because mRNA is such a volatile material, it is inevitable that many fully vaccinated Americans are only partially immunized, or not at all. Thus, it is a matter of public safety to allow folks to determine whether the vaccine has worked for them or not.
Here, I am publicly calling on the FDA commissioner and FDA to urgently cease and desist in stoking vaccine hesitancy or leaving some susceptible to infection, by continuing to insist that individual Americans NOT be tested for the status of their antibody immunity to COVID-19, pre- or post-vaccination, respectively.
It is the right of every American to be informed about the status of their own body’s immunity to a potentially deadly pandemic virus. The May 19 FDA advisory has created a major challenge to Americans making an informed decision — both to establish the medical necessity of vaccination AND to ensure that the vaccine doses they have received effectively have induced the expected protective antibody response.
As an immunologist and physician, on this record I express my professional opinion that FDA’s May 19 advisory guiding against COVID-19 antibody testing is a severe hazard to American public health and a serious cause of vaccine hesitancy in this pandemic.
I shall hope that the Biden administration and FDA commissioner Woodcock are able to heed my warning and call to immediately eliminate a dangerous FDA guidance.
Originally published on Medium.