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Horowitz: The FDA’s indefensible approval of the Pfizer shot

Op-ed
Angela Weiss/AFP/Getty Images

Jesse Jackson and his wife are the latest victims of our government's refusal to focus on early treatment. After having been fully vaccinated, they are the latest high-profile people to be hospitalized with the virus.

Based on the government's own narrative, there is now nowhere for the lockdown/mask/shot cartel to run or hide from their failure nor their continued denial of the efficacy of prior natural immunity and early treatment for those without prior infection. Even for those vaccinated, the safest and most effective way forward is to test for prior immunity and treat pre-emptively or early those who have not yet been infected. Anything else will result in a growing death toll, endless life-altering side effects from the vaccine, an erosion of human rights, and the crushing of our economy and way of life.

The narrative of "the pandemic of the unvaccinated" collapsed quickly. As I predicted, not only did the data show the vaccine barely worked to stop infection, but the protection against critical illness wanes over time and might even induce a form of antibody-mediated viral enhancement, which continuously makes the virus worse. Thus, the more we push boosters, the more we suffer viral enhancement, waning antibodies, and the massive risk of side effects accompanying each shot.

In a CDC briefing from Aug. 18, director Rochelle Walensky let the cat out of the bag — that not only does the protection wear off, but it might enhance the disease.

"And even though our vaccines are currently working well to prevent hospitalizations, we are seeing concerning evidence of waning vaccine effectiveness over time and against the Delta variant," said Walensky during the briefing. "Additionally, reports from our international colleagues, including Israel, suggest increased risk of severe disease amongst those vaccinated early. Given evidence, we are concerned that the current strong protection against severe infection, hospitalization and death could decrease in the months ahead. Especially among those who are at higher risk or who were vaccinated earlier during the phases of our vaccination rollout. In the context of these concerns, we are planning for Americans to receive booster shots."

Stop the tape! Walensky now concedes the following:

  • There is zero justification to mandate the vaccine given that it doesn't stop infection and transmission.
  • Even the personal protection from serious illness wanes after about six months or so and increasingly so for those most vulnerable to the virus who need the protection the most.
  • The vaccine efficacy wanes both over time and with mutant strains that will likely continue.
  • In a stunning admission, she says that reports from Israel seem to "suggest increased risk of severe disease amongst those vaccinated early." This could indicate some degree of antibody dependent disease enhancement. After all, if the immunity is waning, then there is always a concern that the antibodies are strong enough to bind but not strong enough to block, which creates a more dangerous conduit for the virus into the cells, which is what people like mRNA vaccine inventor Dr. Robert Malone have been warning about. The FDA itself conceded in its memorandum (p.52) on the EUA approval of the shots, "Risk of vaccine-enhanced disease over time, potentially associated with waning immunity, remains unknown and needs to be evaluated further in ongoing clinical trials."

Yet what is Walensky's solution? To exacerbate this cycle and give yet another round of shots to everyone. Not only will this cause needless death and injury without long-term protection, but it will likely enhance viral immune escape even more. A pre-print study from Spanish researchers found that the antibody levels produced by booster shots to the Alpha variant seemed to net decreasing results. "Our results with the Alpha variant suggest that 3rd doses of present vaxes to the general population might not be the best approach to increase the immunity to the emerging VOCs," gently concluded the authors. However, if these boosters are going to produce half-baked levels from the get-go, not only will the efficacy wane quicker (after users suffer all the side effects), but the risk for antibody dependent disease enhancement grows more alarming.

Israel, a country where nearly every older adult is vaccinated and many have received booster shots, is now concerned about the discovery of an even more virulent strain. Scientists have been warning that the devastating results of mass vaccination, particularly with a narrow-spectrum preventive vaccine like the spike protein shots, would create a super virus through viral immune escape. "Plans to vaccinate those with high risk of fatal disease followed by a drive to reach herd immunity while in uncontrolled transmission among the rest of the population is likely to greatly increase the probability that a resistant strain is established," warned a group of European scientists in a paper published last month in Nature.

How can the FDA approve this shot when it has not fully studied the effects of myocarditis and other side effects? How can agency officials fully approve it when they themselves admit the shot requires an unknown number of boosters? Data from Israel revealed: "A full course of the Pfizer-BioNTech vaccine was just 39% effective at preventing infections and 41% effective at preventing symptomatic infections caused by the Delta Covid-19 variant, according to Israel's health ministry." Again, how can this be approved and marketed as a vaccine?

The FDA's industry guidance for EUA status (p.13) requires a 50% threshold of efficacy to even get emergency use authorization, much less full approval! With our government admitting it is now below this threshold and waning with every day and every new variant, how can full approval be justified, particularly of the Pfizer shot?

Contrast this to natural immunity, and it is simply indefensible for our government to treat vaccinated people as less a threat than those with prior infection. How good is natural immunity? The U.K., which is the only country that publishes granular weekly surveillance data, shows that the number of "probable" reinfections is just 0.025%. Almost all of them were likely very mild cases. The trend line also shows that the reinfection cases have not grown with the Delta variant.

This all demonstrates that not only should those who already have immunity shy away from the risk of these shots, but even those who don't should focus on early and prophylactic treatment to get them over the inevitable exposure to the virus. A truly honest government would be promoting this message rather than doubling and tripling down on failure as the only solution to a problem they continue to make worse.
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