The FDA did NOT grant full approval to the Pfizer shots

August 26, 2021 (American Thinker) – You may have heard that the Pfizer-BioNTech COVID-19 shot received FDA approval this past Monday.  Politicians, national health officials, and journalists are breathless with excitement about how this approval will finally induce the remaining “vaccine-hesitant” into stepping forward to receive their jab.  The FDA even has a press release on its website about it.

There’s just one problem.

If you read the actual letters that the FDA sent to Pfizer on August 23, 2021, you’ll see that the FDA did no such thing.  In the sense that the term “FDA approval” is generally understood, this drug is not approved by the FDA.  It is still under EUA (Emergency Use Authorization).  It is still an experimental drug.

The FDA sent two letters.  The first one was a letter of BLA (Biologics License Application) approval, and the second was a letter of EUA extension to COMIRNATY.

The BLA approval letter approves Pfizer’s application for a license to label its COVID-19 drug with the brand name COMIRNATY.  This letter also spells out the terms and requirements for nine additional clinical trials over five years, and yearly status reports, to study the acknowledged occurrences of myocarditis and pericarditis that have followed the administering of the Pfizer shots.  This license to label and manufacture is not a full approval of the drug, which clearly is still subject to many years of clinical trials.

The EUA extension letter extends the term of the EUA for the current drug and authorizes (licenses) the experimental use of the brand-name drug COMIRNATY.  In the first paragraph on page 2, this letter references the license approval letter.  In the second paragraph on page 2, the August 12 EUA is re-issued to include the name-branded drug in the emergency use authorization, and to add “language regarding warnings and precautions related to myocarditis and pericarditis.”  In the last paragraph on page 4, the EUA nature of the drugs is re-iterated, and COMIRNATY is additionally authorized for use for individuals aged 12 through 15 years.

The mRNA gene therapy shots are still experimental.  Mandating them is still wrong — by a wide variety of ethical standards.

Dr. Meryl Nass, M.D. found the truths that the FDA buried in the blather of these letters and offers a theory about why it was done this way.  The drug-manufacturers were granted immunity from liability for the drugs produced under the EUAs.  The granting of the license re-applies the customary liability for injury and death caused by the product.  Pfizer, the health officials, and the politicians get to take a fictitious victory lap for the “approval,” while Pfizer-BioNTech continues to stealthily enjoy immunity from product liability because there are many millions of the unlicensed doses on the shelves and in the manufacturing pipeline that will be administered first.  The licensed version will not arrive on shelves or be jabbed into arms for many months to come.

Of great concern, considering the factual content of the FDA EUA letters to Pfizer, is the breezy way the press release on the FDA website repeatedly uses the words “approve” and “approval” in reference to the Pfizer drug.  If only there were a word for intentionally saying things to the public that do not match reality…

COMIRNATY seems like an unusual name for anything, much less a cutting-edge-technology gene therapy.  Out of idle curiosity, I ran the name through an anagram solver.  For a result, it gave TIROMANCY, which is divination or prophecy by examining how curds form during the coagulation of cheese.  How apropos.  That’s something I’m willing to try for forecasting the results of the next election!

By Carl Schwitzer

Twenty-five minutes to infamy

August 28, 2021 (American Thinker) – On what was arguably the worst day of Joe Biden’s presidency, he was scheduled to address America and the world at 5 P.M. on August 26, 2021.  We’d been told earlier that day that the president and commander-in-chief was going to address the bomb that killed Marines and a Navy corpsman in Kabul.  Biden was 25 minutes late.

That delay is not trivial.  It has direct consequences on an ever-present 24/7 strategic threat that Russia, China, and North Korea pose to America.  All three have “ready now” ICBMs with multiple warheads aimed at targets in the continental United States.

I know this because I was President Reagan’s principal director of mobilization planning and requirements in the Pentagon at the height of the Cold War.  In those days, as is true today, we focused on building a survivable American nuclear force, land-based ICBM silos, USN Boomers, and USAF strategic bombers.  Recently, as I pointed out in an earlier American Thinker post, the threat level has been increasing, especially directly from President Putin:

Is President Putin diabolically smart or simply a psychopath? Perhaps he is both, because by his direct action, the world is now a much more dangerous place as the former KGB officer creates a nuclear doomsday scenario backed by real Russian naval capabilities:

  • Russia is said to have built a new 100-megaton underwater nuclear doomsday device, and it has threatened the US with it.
  • The device goes beyond traditional ideas of nuclear war fighting and poses a direct threat to the future of humanity or life on Earth.
  • Nobody has ever built a weapon like this before, because there’s almost no military utility in so badly destroying the world.

With that threat, it’s fair to ask why Joe Biden delayed his address for 25 minutes.  The delay could have been excused if the White House national security staff and leaders had high-level actionable information that justified a delay in ensuring that the information presented was accurate and fact-based.  But that was proven not to be the case because of Biden’s colossal and historic communication goof:

Ladies and gentlemen, they gave me a list here.  The first person I was instructed to call on was Kelly O’Donnell of NBC.

Q  Mr. President, you have said leaving Afghanistan is in the national interest of the United States.  After today’s attack, do you believe you will authorize additional forces to respond to that attack inside Afghanistan? And are you — are you prepared to add additional forces to protect those Americans who remain on the ground carrying out the evacuation operation?

His answer was priceless; blame the military:

[T]he military — from the Chairman of the Joint Chiefs, the Joint Chiefs, the commanders in the field — have all contacted me one way or another, usually by letter, saying they subscribe to the mission as designed to get as many people out as we can within the timeframe that is allotted. That is the best way, they believe, to get as many Americans out as possible, and others.

As an aside “by letter”?  Heck!  Why doesn’t he channel President Lincoln and at least use the telegraph for faster electric combat coms, huh?

To be fair, O’Donnell did not ask an unreasonable military policy question — but that doesn’t justify a delay to gather additional information.  Or at least one hopes so, or it is even worse, because the Biden national security team would be seen as truly making it up as they go.

Those Americans who watched and, more importantly, our world leader friends and enemies just saw a president needing an additional twenty-five minutes to get prepared after having earlier announced a hard deadline time.

It may appear to be just a typical Biden trivial time-delay moment.  However, the entire American strategic deterrence posture, especially during the Cold War, was measured in thirty minutes.  That was the time of flight for incoming missiles to destroy us.  Today, I suspect the time is even shorter.  Regardless, the fundamental building block to make sure we would never be attacked was competent, determined presidential leadership with the “football” launch codes to unleash hell on our enemies.

If anything leads Russia, China, or North Korea to believe strongly that President Biden is not mentally together — and his 25-minute delay may have proven that — America is in even greater danger than we thought.  The global consequences of terrorism with Afghanistan’s fall to committed fanatical killers are yet to be seen.

But the damage to our strategic response time and Presidential Biden’s capability and intellectual will to launch a retaliatory strike if threatened with nuclear war has also come into question.  That issue cannot be solved by unelected enablers such as Dr. Jill or whoever “instructed” him to call on Kelly O’Donnell.

Make no mistake: the world is watching one of the most inept presidential performances in either war or peace in American history, and it is just beginning, not ending.

Image: Biden’s collapse into a fetal position.  YouTube screen grab.

By Ed Timperlake

Putting the cart before the horse.

Trump’s strategy for leaving Afghanistan:

  • Evacuate American citizens
  • Evacuate American civil personnel
  • Destroy the cache of 83B in U.S. military equipment: auto guns, helicopters, planes, jeeps, buildings, computers, etc.)
  • Order military soldiers, etc. to leave.
  • Allow Taliban to take over the country after all U.S. interests have been removed/destroyed

Biden’s strategy for leaving Afghanistan

  • Allow SOME military personnel and soldiers, etc. to leave
  • Allow Taliban to confiscate the cache of 83B in U.S. military equipment: auto guns, helicopters, planes, jeeps, buildings, computers, etc.)
  • Allow Taliban to laugh at the weakness of Biden, the entire Dem administration, and America, in general
  • Force Americans to endure humiliation as the Taliban rejoice that ALLAH has given them these “gifts” to use against their enemies, i.e. U.S.A.
  • Allow the Taliban to kill 13 U.S. soldiers and other Americans, and kidnap, enslave and/or rape American girls and women
  • Demand that the pleas from abandoned Americans be ignored

And to think, their elitist arrogance and pathological hatred of Trump caused them to scorn and reject his plan simply because it was his…..all to the detriment of the U.S. and her citizens. Damn him and his cohorts.

God help us.