In flight 737-MAX 8 with a red FDA Approved stamp over it

In 2019, every 737-MAX 8 in production was grounded, barred from commercial flights by countries around the world, after two crashes that resulted in the deaths of all passengers and crew on the airliners1. The recalled fleet of planes overflowed into the parking lots of Boeing maintenance facilities2, and Boeing was fined over $2.5 billion over charges of fraud and conspiracy3. A weakened regulatory process had shifted more of the responsibility of safety from the Federal Aviation Administration (FAA) to Boeing itself, leading to the horrific oversight of the design flaw in the 737-MAX 8’s MCAS software4. On Monday, in America, the Food and Drug Administration (FDA) granted full approval to the Pfizer COVID-19 vaccine5.

Last week, there were various news reports stating that approval for at least one of the COVID-19 vaccines would be coming this week. Robert Barnes addressed questions about the approvals on his weekly live stream with Viva Frei.

“…That doesn’t mean ‘approval’ approval [sic] usually. Usually that means an announcement of an intent to give a license within thirty days. That’s usually what that means. Now, maybe they’ll short circuit that too. I don’t know … every vaccine approved before, to my knowledge, has taken at least two years of FDA review. Again the average of twelve years for approval, but it takes at least two years of approval to go through multiple clinical stages; starts with general research, and design, idea and application. Then usually animal testing. Then a clinical testing on a certain group of humans. Then a third level of clinical testing. And the idea is that you would have, by that point, like a clinical test at least a year long, that would review certain risks. And ideally that you’re using methods that are not as novel as these are. That’s why most people said last year, that they thought there was no way a vaccine could be approved in less than two to three years … Kamala Harris was saying don’t take the vaccine approved faster than that…I’m not going to trust the result if the process is contaminated, and what’s taken place has serious legal problems…“ -Robert Barnes6

Is the FDA approval process contaminated? It certainly seems that way with Pfizer going from Emergency Use Authorization (EUA) to full approval, in record breaking time. Maybe we should ask Scott Gottlieb, the former FDA commissioner, who left the agency in 2019 to join the Pfizer board of directors7. Senator Elizabeth Warren urged Gottlieb to resign, criticizing his decision to join Pfizer as evidence of a “revolving door [of] influence pedaling8.”

The satire news website Babylon Bee has a piece titled 100 Million Vaccine-Hesitant Americans Will Get The Shot Now That A Government Agency Said It’s OK9. It’s a dark joke, backed by decades of failures that most Americans seem to have completely forgotten about. Everyone applauding the FDA approval, as some kind of achievement or milestone, should be reminded that Vioxx was approved by the FDA before the manufacturer pulled it from the market over increased risks for heart attacks and strokes in 200410. Fen Phen was another heavily prescribed drug combination for weight loss that was found to cause serious cardiovascular disease11. Thalidomide was used in the 1950s and 60s to treat nausea in pregnant women until it was learned it caused birth defects12. DDT was a pesticide that was proven to be safe, until it was also linked to birth defects13.

“…they’ll fast track an approval, in a way that’s never been done before. It will be wildly lucrative for share prices, probably, and it will permanently undermine any faith that reasonable critical minded people have in the process and FDA itself…“ -Viva Frei6

Deregulation led to the 2008 economic crisis, and that same corruption left the American taxpayer to foot the bill of massive bank bailouts. More recently, the cozy relationship between the FAA and the aviation industry caused lapses in oversight, leading to the catastrophic software failure, which the passengers and crew of two flights dead4.

Now the American people are told we can trust the least tested vaccine in the modern era of medical regulation because agencies that are rife with corruption, and littered with histories of mistakes, have vetted it through their diligent approval process? The same agency that actively campaigned against prescribing Ivermectin14 despite a growing body of scientific evidence that it is a safe and effective treatment for COVID-19?15 The only thing the FDA approval of the Pfizer vaccine has really changed, is Pfizer’s stock price16.

  1. Canada grounds Boeing 737 Max 8, bans jet from airspace following fatal crashes. 13 March 2019. Tunney. CBC News. 

  2. Grounded 737 Max 8 jets parked at Seattle’s Boeing Field. 24 May 2019. KING 5. 

  3. Boeing Charged with 737 Max Fraud Conspiracy and Agrees to Pay over $2.5 Billion. 7 January 2021. Department of Justice. Office of Public Affairs. 

  4. The Roots of Boeing’s 737 Max Crisis: A Regulator Relaxes Its Oversight. 27 July 2021. Kitroeff, Gelles and Nicas. The New York Times.  2

  5. FDA grants full approval to Pfizer COVID-19 vaccine. 23 August 2021. Pezenik. Yahoo! news. 

  6. Ep. 75: Biden Loses; Maddow Wins; Canadian Election; 7 MORE FBI Misconduct! Viva & Barnes LIVE!. 22 August 2021. Viva Frei. (Barnes: 1h:15m:00s / Viva: 1h:23m:38s)  2

  7. Former FDA head Gottlieb joins Pfizer board. 28 June 2019. McGinley. The Washington Post. 

  8. As @US_FDA Commissioner, @ScottGottliebMD & I worked together on a number of public health priorities. That’s why I found his new position on the Board of drug giant @Pfizer to be such a tough pill to swallow.. 2 July 2019. @SenWarren (Tweet) 

  9. 100 Million Vaccine-Hesitant Americans Will Get The Shot Now That A Government Agency Said It’s OK. 23 August 2021. Babylon Bee. 

  10. Vioxx (rofecoxib) Questions and Answers. 30 Sept 2004. FDA. 

  11. Fen Phen Nation. 13 NMovember 2003. Cohen. Frontline. PBS. 

  12. Thalidomide: the tragedy of birth defects and the effective treatment of disease. 19 April 2011. Kim and Scialli. Toxicol Science. 

  13. DDT - A Brief History and Status. EPA Retrieved 24 August 2021. 

  14. Why You Should Not Use Ivermectin to Treat or Prevent COVID-19. 5 March 2021. FDA. 

  15. The mechanisms of action of Ivermectin against SARS-CoV-2: An evidence-based clinical review article. Zaidi. Dehgani-Mobaraki. 11 May 2021. Japan Antibiotics Rsearch Association. DOI: 0.1038/s41429-021-00430-5

  16. Pfizer Stock Leaps on FDA Report, Dow Futures Higher as Global Stocks Rebound. 23 August 2021. Baccardax. MSN Money.