FDA's hypocritical reversal on CV antibodies
FDA says testing Coronavirus antibodies is worthless after previously authorizing unapproved vaccines based on antibody test response
Rapid facts and implications:
[FACT 1] The new emergency-authorized drugs were conditionally authorized (not approved) based on antibody responses ("efficacy") even though
[FACT 2] this was inconsistent with the past 70 years of medical science, and
[FACT 3] now the FDA says that antibody response does not matter and is unreliable.
[IMPLICATION 1] If vaccines were authorized based on antibody “efficacy” and now antibodies are meaningless, then the authorization should be reversed.
[IMPLICATION 2] The FDA is demonstrating recklessness or cluelessness about this infection and the immune response.
Details:
Authorization is not Approval: Vaccines marketed against Covid/Sars-CoV-2 are not “FDA approved” because they have not been tested appropriately and for sufficient duration (which generally takes at least 5-7 years); rather, their status is that they are “authorized” for emergency use.
Antibody response was justification for authorization: Emergency use of vaccines marketed against Covid/Sars-CoV-2 was “justified” largely based on the meaningless laboratory response of elevated serum/blood antibodies against Covid/Sars-CoV-2 following administration of the experimental vaccines. In other words, people who had received the vaccine(s) developed antibodies against the injection and this was interpreted to indicate that the people now had “protective antibodies” that would protect them against the infection. Most politicians, doctors, pharmashills, and persons in the general public are unaware that antibody response against viral infections is mostly meaningless, serving mostly as a surrogate marker for the more important cell-mediated immune response.
Antibody response against viral infections is mostly meaningless, as noted in an award-winning article published by the American Academy of Pediatrics (see citation image below): Antibody response against viral infections is mostly meaningless; proof of this has been widely known in medical science since the 1950s based on the observation that persons with a genetic inability to produce antibodies (agammaglobulinemia) have a normal course of the most common viral infections and they have a typical response to vaccination against viral infections. Again: the serum/blood antibody response is itself clinically meaningless except as an indication of a cell-mediated antiviral response. The reasons that antibodies are tested are 1) it is an easy concept to sell to an uninformed and ignorant public, 2) antibodies are easy to measure in blood (simple protein measurement) whereas quantification of cell-mediated response is much more complicated, requiring maintenance of living cells and testing them against a standardized infected cell.
FDA now says that “antibody tests should not be used at this time to determine immunity or protection against COVID-19 at any time, and especially after a person has received a COVID-19 vaccination.” https://www.fda.gov/news-events/press-announcements/fda-brief-fda-advises-against-use-sars-cov-2-antibody-test-results-evaluate-immunity-or-protection
[IMPLICATION 1] If vaccines were authorized based on antibody “efficacy” and now antibodies are meaningless, then the authorization should be reversed.
[IMPLICATION 2] The FDA is demonstrating recklessness or cluelessness about this infection and the immune response.
"The immunization of the masses has been undertaken with almost a religious fervor. ... Without propaganda there can be no large-scale immunization, but how perilous it is to mix up propaganda with scientific fact. If we baldly told the truth, it is doubtful whether the public would submit to immunization.“ The Lancet 1938 Jan; 231(5966), 48-49. doi:10.1016/s0140-6736(00)92728-4
Dr Alex Kennerly Vasquez (introduction; brief Bio-CV) writes and teaches for an international audience on various topics ranging from leadership to nutrition to functional inflammology. Major books include Inflammation Mastery, 4th Edition (full-color printing, 1182 pages, equivalent to 25 typical books [averaging 60,000 words each]), which was also published in two separate volumes as Textbook of Clinical Nutrition and Functional Medicine (Volume 1: Chapters 1-4; Volume 2: Chapter 5—Clinical Protocols for Diabetes, Hypertension, Migraine, Fibromyalgia, Rheumatoid Arthritis, Psoriasis, Vasculitis, Dermatomyositis and most other major inflammatory/autoimmune disorders); several sections have been excerpted including Antiviral Strategies and Immune Nutrition (ISBN 1502894890) (aka, Antiviral Nutrition [available as PDF download] and Brain Inflammation in Chronic Pain, Migraine, and Fibromyalgia. Dr Vasquez’s books are available internationally via bookstores such as BookDepository, Amazon.com, Barnes and Noble, ThriftBooks, AbeBooks, BetterWorldBooks, WaterStonesBooks and his new Telegram channel is https://t.me/DrAlexVasquez.
Thank you Alex. I am curious if you have an opinion about Memory T-cell tests such as the "T-Detect" as a more accurate/reliable surrogate to indicate the possibility of actual immunity? https://www.t-detect.com/ Thank you.
Very much appreciate your way of looking at and analyzing data, Alex. Please refer me to any info that contradicts the following opinion as I'm eager to learn: In this specific case, from everything I can find, the FDA's primary reason for authorizing the vaccines was because of a very large drop in infections in people randomized to vaccines vs. those randomized to placebo. This was true with adults and later in a clinical trial with children down to age 12. To authorize (let alone approve) a vaccine based primarily on the presence of antibodies the FDA would first need to see extremely strong evidence that antibodies and protection from infection were very highly and consistently associated. The FDA clearly doesn't have that kind of evidence yet - hence their advisory. It would be great, as commenter Collins wonders, if there WAS a valid marker (like T cells, etc) because it would accelerate vaccine development and approval. Hope scientists are working on that but we definitely need to know more about how well the vaccines work, with what kinds of clinical scenarios, etc. That takes big secure data and deep cooperation among patients, clinicians, policy people, scientists, etc. Thank you for keeping us thinking!