Do COVID-19 Vaccines Still Qualify for Emergency Use Authorization?

Studies on Current Efficacy in Newly Vaccinated Persons With and Without Past COVID-19 Infection Are Needed. Whether That Happens is Up to Us. That Means You.

Consider this new study on veterans published in Science magazine:

SARS-CoV-2 vaccine protection and deaths among US veterans during 2021

In this study, it was found that after 6 mos. Moderna vaccine effectiveness has dropped to 60% and Pfizer vaccine effectiveness has dropped to 49%. J&J’s effectiveness? 13%.

Study link: https://www.science.org/doi/10.1126/science.abm0620

This quote from the abstract should take your breath away:

“Although breakthrough infection increased risk of death, vaccination remained protective against death in persons who became infected during the Delta surge.”

In the study text, the authors write

“However, breakthrough infections were not benign, as shown by the higher risk of death in fully vaccinated Veterans who became infected compared to vaccinated Veterans who remained infection-free.”

Who might remain infection-free if they are not vaccinated? That would be those with natural immunity, either due to COVID-19, or the 21% of Americans who had prior immunity to the SARS-CoV-2 virus due to past infections of related coronaviruses.

When the US FDA provided Pfizer, Moderna and Johnson & Johnson the Emergency Use Authorization, it required that the vaccines demonstrate a minimum of 50% efficacy.

Mutations in the virus since then have caused the vaccines to become less effective.

Before we get to that, let’s remember a few facts

  • Moderna’s 95% efficacy was based on studies of vaccination of atypical American people with no health issues. No autoimmunity, no comorbidities. Robert F. Kennedy, Jr. called them “Marvel Superheroes” regarding their health.

  • In all of the vaccine studies of the Moderna and Pfizer shots, the efficacy was and is overestimated due to the practice of excluding people from the calculations who received only one vaccine. People who died, or got COVID-19 before the second dose were simply dropped from the calculations. Putting them back in lowered the initial estimates substantially (Moderna’s 95% became 75%, for example) See "Discrepancies in Moderna’s FDA Report Demand Answers".

  • CDC now defines “Fully Vaccinated” as people who have lived to two weeks after the second dose of Pfizer or Moderna (5 weeks after initial dose), or people who have lived two weeks after the J&J. Therefore, the CDC’s calculations of breakthrough cases is a massive distortion. My study in April 2020 predicted immunodeficiency in patients exposed to COVID-19 epitopes via vaccination or infection. CDC knows this, and they are preventing discovery of near-term events, including breakthrough cases, adverse events, and deaths in the first two weeks following vaccination.

  • Estimates of efficacy in newly vaccinated persons have dropped dramatically in studies in populations more representative of the full population.

The durability of protection from the COVID-19 vaccines in people vaccinated early on is deplorably low. A collection of links are provided below on that issue. But that’s not the focus of today’s article.

The question we should be demanding answers to is “Would COVID-19 Vaccines Still Qualify for Emergency Use Authorization if new RCTs were performed on vaccine-naïve persons who did not have past COVID-19 infection?

This question is highly relevant because the vaccines are being advertised as still being able to protect persons against hospitalization, but discussions and commentary in the media conflate discussions of the durability of past vaccination with the baseline efficacy in the newly vaccinated.

There are a few ways to consider current efficacy and whether the vaccines should still be under EUA. The first is that long-term, sterilizing immunity is more important than the short-term immunity the vaccine affords. (Clearly, the vaccine efficacy wanes quickly over time, see links below).

Another is to ask whether everyday people who have not been vaccinated - and who do not have past exposure to SARS-CoV-2 - benefit at all from vaccination.

A third way to consider current efficacy is to ask whether everyday people who have not been vaccinated, including those who have and who have not been exposed to benefit at all from vaccination.

Real-world data tell us that COVID-19 vaccination has failed in the United States. The data from Barnstable County, MA show us (by my non-peer reviewed calculations) 0% efficacy, considering persons with any exposure to vaccination, and -26% efficacy if persons receiving both doses of the vaccine are considered. Then there’s the Israeli data and data from the UK that show no, or negative efficacy.

The doctor in Belgium has reported that everyone - 100% - of ICU admissions are vaccinated persons in the GZA Hospital where he works. Belgium has between 40%-75% vaccination coverage.

We must demand that before any mandates are considered - or even before any further vaccination is conducted - that new studies be conducted that

(a) calculate efficacy based on ‘vaccine exposure’

(b) are based on newly vaccinated persons, as described above.

Regulatory agencies must respond to adverse events following vaccinations, but the VAERS pathway is a dead-end. For FDA to require new trials, persons with breakthrough infections must report the vaccine failure to the vaccine manufacturer directly and CDC the FDA.

If the FDA receives a sufficient number of reports of vaccine failure (and there are plenty), it should trigger a requirement for Pfizer, Moderna and J&J to go back to the drawing board and provide new data demonstrating continued efficacy. In the case of Pfizer, the FDA approval would be at stake.

Clearly, the media outlets are all going to push the official narrative distortion and say that vaccination is still your best chance to be protected from COVID-19 - right in the face of the evidence that this is not true. The true estimates of efficacy - those based on “vaccine exposed”, not those based on CDC’s bullshit definition of “fully vaccinated” (those who survive 5 week after their initial dose and who receive the second dose) show that we’re in for an epidemic in the vaccinated, that all of the data manipulations and semantics in the world are not going to be able to hide.

What We Must Do

So it’s up to us. Entirely. 100%. If you know anyone who has had a breakthrough infection, have them directly contact Pfizer, Moderna, or J&J, in writing, CC’ing the FDA. Use delivery confirmation at the post-office so you receive notification that the vaccine manufacture and the FDA both have received your report.

While we’re at it, if you are unvaccinated or vaccinated and had COVID-19 and survived, congratulations on your durable and diverse immunity. Please also let the FDA know what supplements and protocols you followed.

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Related:

https://www.latimes.com/science/story/2021-11-04/study-shows-dramatic-decline-in-effectiveness-of-covid-19-vaccines

https://www.webmd.com/vaccines/covid-19-vaccine/news/20211105/covid-vaccine-protection-drops-study

https://newatlas.com/health-wellbeing/coronavirus-vaccine-effectiveness-decline-protection-breakthrough-infection/

https://www.news-medical.net/news/20211019/Waning-COVID-vaccine-efficacy-especially-against-reinfection.aspx

https://www.medrxiv.org/content/10.1101/2021.10.13.21264966v1