On Monday, the FDA “approved” the Pfizer COVID-19 (which will be marketed as COMIRNATY) “for the prevention of COVID-19 disease in individuals 16 years of age and older.”
If you want an “approved” dose of COMIRNATY – too bad. It’s not yet available. You can still get the Pfizer Vaccine authorized under the Emergency Use Authorization, however. Much has been discussed about whether this is a real “approval” – and I won’t repeat that. I’ll walk through the source documents and data, showing just how weak this purported approval really is.
The Effectiveness is “unknown.”
The FDA says COMIRNATY is “safe and effective in preventing COVID-19 in individuals 16 years of age and older.” How effective? They state (~6 months after dose 2) that it is “91% effective in preventing COVID-19 disease,” citing to a study where Pfizer observed “77 cases of COVID-19 occurring in the vaccine group.”
This leaves us with an important question. The Pfizer study is from a “follow-up through March 13, 2021.” That is over 5 months ago. Is the FDA using outdated data in support of the COMIRNATY approval?
In other words, how long does the effectiveness really last?
Pfizer has an answer for us. According to its August 23, 2021 fact sheet, “The duration of protection against COVID-19 is currently unknown.”
If you’re looking for data on the waning effectiveness of the Pfizer Vaccine against COVID-19, you have to search for yourself. You won’t find it with the FDA or Pfizer, underscoring an apparent effort to cherry-pick the data for the “approval.”
According to one UK study of over 400,000 people (a study that is, by the way, much more rigorous than the one cited in the FDA approval), the “effectiveness fell to 74% five or sixth months after receiving both doses of the Pfizer vaccine.”
The news out of Israel is worse. For those who received two doses of the Pfizer Vaccine in January 2021, the vaccine is “only 16% effective against symptomatic infection.”
As we have observed, the CDC has promoted a misleading message on the risks the vaccines present to pregnant mothers. They used self-reporting studies that were racially skewed studies (~79% white and 1.4% black) and limited to looking at miscarriages from weeks 6-20. (This caused them to omit from the study 35 self-reported pregnancy losses at less than 6 weeks.)
The new approval mentions a study on the Pfizer Vaccine exposure during pregnancy to be completed in 2025. Four years from now pregnant women will know whether this vaccine is safe.
As for the current data? Here’s what the COMIRNATY package insert says about there being “insufficient” information on the vaccine risks to pregnancy.
Ok Techno, I’m with you so far… but did Pfizer do any studies on whether the vaccine was safe for pregnant women?
YES! They did toxicology studies on female rats.
Risks to the young.
This gets us to the risks of myocarditis and pericarditis in young people (especially young men). According to the Summary Basis for Regulatory Action from the FDA (dated August 23, 2021), “safety surveillance reports received by FDA and CDC identified serious risks for myocarditis and pericarditis following administration of COMIRNATY.”
Despite this, the FDA says the benefits of the vaccine outweigh the risks. That’s their opinion and they’re entitled to it, I guess. What is concerning is that they are turning this cost-benefit opinion into a mandate. In other words, they don’t think you can make this cost-benefit decision for yourself. They’ll make it for you. Take for example Dr. Fauci telling CNN’s Anderson Cooper that “the time is come, enough is enough.”
This is the same guy who was warned that sequences of COVID-19 looked engineered. Did he share that with the American public? No; instead, he told National Geographic that this virus “could not have been artificially or deliberately manipulated.”
To put all this in perspective: the same people who supported gain of function research at Wuhan are now in charge of approving the vaccines. Who are we to doubt their judgment?