by Walter Smith
Have you noticed that pharmacy ads on TV close with a long list of side effects and warn you to ask your doctor if BigPharma XYZ is right for you? How come there is no similar warning for COVID shots?
You must be an anti-vaxxer, I imagine you are thinking right now. A conspiracy theorist! A government hater! No, I am a sentient human being with a brain, and a finely attuned lie detector from being a lawyer for large companies for more than 30 years.
Some people are making a big deal out of the fact that the FDA has given the Pfizer-BioNTech COVID vaccination its full approval, not just an authorization for emergency use. It’s approved, they say. Hopefully more people will get the jab now.
But consider: the treatment got the thumbs up after less than a year when “vaccines” historically have taken ten to 15 years to gain approval. If anyone believes the government is inefficient, it is me… But a 1,500% improvement? Color me skeptical.
The FDA press release announcing the Pfizer-BioNTech approval aroused my suspicions. The tip-off: you have to get to paragraphs 13 and 14 to read about myocarditis, pericarditis and the ongoing studies conducted to ensure that “safety concerns continue [are] identified and evaluated in a timely manner.”
Seeing this casual dismissal of myocarditis prompted me to read the actual FDA “approval” letter. It was very heavy on bureaucratese, but pages 4 to 11 list a number of post-marketing studies of various risks.
Then I looked at the Summary Basis report for the approval. Page 23 mentions “pharmacovigilance” and has this reassuring verbiage :
Although some cases of vaccine associated myocarditis/pericarditis required intensive care support, available data from short-term follow up suggest that most individuals have had resolution of symptoms with conservative management. Information is not yet available about potential long-term sequelae and outcomes in affected individuals. A mechanism of action by which the vaccine could cause myocarditis and pericarditis has not been established.
The report goes on to explain how it did a best case/worst case analysis to justify approval. Those numbers now seem suspect – highly suspect. The post-vaccination studies cited as the basis for FDA approval had lasted only four to six months. While the FDA press release touts 91% effectiveness, Israel’s results, based on longer periods of time, show a marked loss of effectiveness. Effectiveness now is certainly nowhere near 91%, and the FDA is already approving “booster” shots. The vote to approve was 17 yes, four no, and one abstention. I’d like to shake the hands (after sanitizing them!) of the four scientists brave enough to vote as the real science indicated.
As if this weren’t enough (and I know for some of you it will never be), I then read the prescribing information. If you read page 1 and the footnote on page 1 of the prescribing information, you may be able to decipher that Pfizer’s Comirnitay vaccine has won approval, but Pfizer-BioNTech’s identical product is still EUA for children under 15.
On page 4 the FDA contradicts itself by saying that two doses three weeks apart “prevent” COVID, while the next sentence says the duration of protection is unknown. The rest of pages 4 and 5 have a long list of side effects and some wishy-washy language on reporting.
Why is this language at the top of page 6 – “Under the EUA, it is your choice to receive or not receive the vaccine. Should you decide not to receive it, it will not change your standard medical care.”
Why does page 7 mention a Countermeasures Injury Compensation Program?
Finally, please note the explanation on page 8 for the declaration of any EUA. First you need a public health emergency. Are we really in a public health emergency? Can the head of HHS just declare it? Is there any limit to that authority? (I’m asking for a friend.) Then you need no adequate, approved, available alternatives. Perhaps this explains why the FDA ignores the abundant evidence of the effectiveness of the Ivermectin (here, here and here) and HCQ protocols. But see, once the HHS declares the emergency, the FDA just needs to say HCQ and Ivermectin aren’t “approved,” and FDA can then move onto EUA when the product “may be effective” and the known and potential benefits outweigh the known and potential risks. So far, the known benefits are not as advertised and the known and unknown risks are greater than we have been told. The EUAs never should have been granted.
Look, if you want the shot, get the shot. If your personal health characteristics make COVID a risk for you, get the shot. But, for the University of Virginia to refuse to turn over FOIA-requested documents supporting its decisions or to hold a truly open public meeting, for the VDH to hide behind Attorney General Mark Herring’s spurious opinion, for vaccine supporters to demean anybody asking questions about legitimate concerns that vary by person (and belong to that person or the parents) is tyrannical and dishonest. If you wish to be trusted, act trustworthy – not like you have something to hide.
I confess my belief that natural immunity provides better protection than a vaccine concocted from the manipulation of spike protein. I believe the natural immunity will be fuller and longer lasting. This is not craziness. It used to be accepted by many doctors and individuals B.C. (Before COVID). I also admit what I don’t know.
That’s a lot more honesty about COVID than anything else you’ve read in the last year and a half.
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