New FDA antibody-testing statement: What might it signify? Opinion

New FDA antibody-testing statement: What might it signify? Opinion

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On May 19, 2021, the FDA posted an announcement on its website advising against antibody testing to evaluate immunity from natural COVID infection or from the vaccine [1]. The FDA states that even though these tests can identify people who have been exposed to COVID and developed an immune response to the infection, they should not be used “at this time” because “currently authorized SARS-CoV-2 antibody tests are not validated to evaluate immunity or protection from COVID-19 infection.”

We are over a year into the pandemic. Why haven’t they been validated yet? Is lack of validation just a technical matter? And what does “at this time” mean?

The FDA also states that these tests cannot evaluate immunity from the vaccine in people who were not previously infected because the antibody tests are looking for natural antibodies that are different from vaccine-induced antibodies.

Why is the FDA contradicting itself? On the one hand – the tests are not to be used to detect COVID antibodies to natural infection, yet, on the other hand – they do detect antibodies from natural infection but not from those produced as a result of the vaccine.

What does their statement imply about the COVID vaccine technology since Pfizer, Moderna, Johnson and Johnson, and AstraZeneca went ahead with production of their vaccines once they saw that the test animals developed antibodies?[2]

It is known that traditional vaccines can have a primary failure rate of up to 10%. This means that a portion of the population will never develop protective antibodies. However, the COVID vaccines are not vaccines by the traditional meaning of the term. Traditional vaccines contain either whole weakened virus or dead virus (among other ingredients) which are injected into the body and against which the immune system mounts a defense. The COVID injections are different. They are means of making the body manufacture the thing against which it is supposed to mount a defense, in this case, an altered version of the virus’s spike protein (not the virus itself); it is the spike protein that attaches to the cell’s ACE2 receptors, enabling entry of the virus into the cell.

If the antibodies developed against the vaccine’s spike protein are different than antibodies produced after natural infection, like the FDA claims, will they actually be protective against natural infection, or is that the reason why they are not attributing post-vaccination COVID to vaccine failure but instead calling them “breakthrough” cases? [3]

Is the FDA trying to hide the fact that the vaccines were not designed to work against COVID? We had been told initially that the vaccine wouldn’t stop infection but just reduce symptoms. What changed?

Even more troubling is the fact that the COVID vaccine has been found to be contraindicated in people who had COVID because they develop more serious adverse effects from the vaccine than those who never had COVID [4]. (Scientists claim that this means they are developing better immunity; however, considering the high morbidity and mortality rate from the vaccines, this can hardly be a welcome occurrence.) Many of us may have already had subclinical disease or were ill but didn’t know it was COVID. Not allowing people to take an antibody test before vaccinating (although not recommended in any case) would mean that these individuals are being put at significantly greater risk of vaccine harm than those who never had COVID.

Why would the FDA knowingly put more people at risk of serious adverse effects?

Is the vaccine program more important than people’s lives?


[1]FDA In Brief: FDA Advises Against Use Of SARS-Cov-2 Antibody Test Results To Evaluate Immunity Or Protection From COVID-19, Including After Vaccination“. U.S. Food And Drug Administration, 2021, accessed 22 June 2021.

[2] While there are many other immune responses to infection, development of antibodies is the one that is accepted as proof that the vaccine provokes an immune response and the only one for which a test is available to the public. See: Sanders, Robert. “For An Effective COVID Vaccine, Look Beyond Antibodies To T-Cells“. Berkeley News, 2020.

[3] For example, on June 17, 2021, Massachusetts reported nearly 4,000 breakthrough cases of COVID-19 and urged even those vaccinated to get tested for COVID. (Markos, Mary, “Nearly 4,000 Breakthrough COVID Infections Have Now Been Reported In Mass.“, NBC Boston, 2021.)

[4]  Vanessa Chalmers. “If You’ve Had COVID You’re TWICE As Likely To Suffer Vaccine Side Effects“; The Sun, 4 Feb, 2021.


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