Table of contents

This means you can say: "I am deferring my choice until the end of the phase3 trials pending the outcome and results I will opt-in or opt-out of the therapy".

Update: 23.08.2021

Yep, 8 months after starting injections (normally needs 10 years for a new tech) the crazy idiots at the FDA did it. They approved a brand new mRNA gene-therapy which is still in phase3 testing for general use. still no liability if things go wrong tho so its on you.  

This is not science this is a travesty. Yes millions of doses given, but not enough time has passed to see if people will die from its emergency use. Over the next 3-10 years those data-points may die of side-effects and diseases they would never have gotten. And remember there are no control-groups so there will be almost no way to prove "the vaccine did it".

This is indeed a sad day for humanity and not the first time the FDA has approved a therapy that will kill many many people before being recalled. And still no ability to sue anyone should the worst happen.

Nothing to see here with conflict of interest cotizen
Explaining vaccine clinical trial phases
Clinical trials are conducted in phases, each with slightly different objectives and increasing numbers of volunteers. This is primarily to ensure subject safety but also to make sure the process is as cost-effective as possible. The data from each phase is thoroughly reviewed and must show both saf…
Phase 3 trials are the pivotal final trials before a vaccine is approved for widespread use. While safety remains a focus, these trials are primarily about showing that people that have received the vaccine have significantly lower rates of actual infection than those that have not. To show this typically requires large numbers of volunteers, in the order of 10's of thousands, depending however on many factors including how widespread the infection is that the vaccine is designed to protect from. While vaccines can fail to show sufficient effect and therefore fail to progress through any phase, it is the failure to provide sufficient protection in phase 3 studies where a number of potential vaccine candidates prove unsuccessful.
FDA Approves First COVID-19 Vaccine
FDA approved the first COVID-19 vaccine, now marketed as Comirnaty, for the prevention of COVID-19 disease in individuals 16 years of age and older.
Please review the list of drugs the FDA has had to recall below
This is not a coincidence

Pfizer

Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals - Full Text View - ClinicalTrials.gov
Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals - Full Text View.

https://www.pfizer.com/science/coronavirus/vaccine/about-our-landmark-trial

The Phase 3 clinical trial was designed to determine if the Pfizer-BioNTech COVID-19 vaccine is safe and effective in preventing COVID-19 disease. This trial began July 27, 2020, and completed enrollment of 46,331 participants in January 2021. On November 18, Pfizer and BioNTech announced that, after conducting the primary efficacy analysis, their mRNA-based COVID-19 vaccine met all of the study’s primary efficacy endpoints. On December 2, 2020, the Medicines & Healthcare Products Regulatory Agency (MHRA) in the U.K. authorized the Pfizer-BioNTech COVID-19 vaccine for emergency use, marking the first Emergency Use Authorization following a worldwide Phase 3 trial of a vaccine to help fight the pandemic. Shortly after on December 11, 2020, the U.S. Food and Drug Administration (FDA) authorized the Pfizer-BioNTech COVID-19 vaccine for emergency use.

The Pfizer-BioNTech COVID-19 vaccine has not been approved or licensed by the U.S. Food and Drug Administration (FDA), but has been authorized for emergency use by FDA under an Emergency Use Authorization (EUA) to prevent Coronavirus Disease 2019 (COVID-19) for use in individuals 12 years of age and older. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of the medical product under Section 564(b)(1) of the FD&C Act unless the declaration is terminated or authorization revoked sooner. Please see EUA Fact Sheet here.

Astra Zenaca too

Phase III Double-blind, Placebo-controlled Study of AZD1222 for the Prevention of COVID-19 in Adults - Full Text View - ClinicalTrials.gov
Phase III Double-blind, Placebo-controlled Study of AZD1222 for the Prevention of COVID-19 in Adults - Full Text View.

Moderna too

A Study to Evaluate Safety and Effectiveness of mRNA-1273 COVID-19 Vaccine in Healthy Children Between 6 Months of Age and Less Than 12 Years of Age - Full Text View - ClinicalTrials.gov
A Study to Evaluate Safety and Effectiveness of mRNA-1273 COVID-19 Vaccine in Healthy Children Between 6 Months of Age and Less Than 12 Years of Age - Full Text View.

Oh no thats not true

Actually, it is.

Fact check: It is standard practice for vaccine safety monitoring to continue after approval
Social media users have asked why clinical trials for COVID-19 vaccines are set to continue for several years if the jab is safe.

A list of drugs approved by the FDA that they later had to recall

As per https://old.reddit.com/r/NoNewNormal/comments/pa1lqa/heres_a_list_of_20_drugs_that_were_approved_by/ just incase it gets removed

Former Big Pharma executives work at the FDA and help approve drugs, and former FDA employees work with big Pharma to teach them how to get their drugs approved. This is called the revolving door and it's the pinnacle of corruption.

Sciencemag.org | FDA's Revolving door: : Companies often hire agency staffers who managed their successful drug reviews

NPR | A Look At How The Revolving Door Spins From FDA To Industry

The Hill | For Big Pharma, the revolving door keeps spinning

List of FDA APPROVED drugs that were later pulled from the market:

1. Accutane | 1982 - 2000

Cause for recall:

increased risk of birth defects, miscarriages, and premature births when used by pregnant women; inflammatory bowel disease; suicidal tendencies

Over 7,000 lawsuits were filed against the manufacturer over the side effects including a $10.5 million verdict and two $9 million verdicts.

2. Baycol (Cerivastatin) | 1998-2001

Cause for recall:

rhabdomyolysis (breakdown of muscle fibers that results in myoglobin being released into the bloodstream) which led to kidney failure; 52 deaths (31 in the US) worldwide; 385 nonfatal cases with most requiring hospitalization; 12 of the deaths were related to taking this drug in combination with gemfibrozil (Lopid)

3. Bextra (Valdecoxib) | 2001-2005

Cause for recall:

serious cardiovascular adverse events (like death, MI, stroke); increased risk of serious skin reactions (like toxic epidermal necrolysis, Stevens-Johnson syndrome, erythema multiforme); gastrointestinal bleeding

4. Cylert (Pemoline) | 1975-2010

Cause for recall:

liver toxicity

The FDA added a box warning to Cylert in 1999, alerting doctors and patients to the potential of liver damage.

5. Darvon & Darvocet (Propoxyphene) | 1955 - 2010

Cause for recall:

serious toxicity to the heart; between 1981 and 1999 there were over 2,110 deaths reported. The UK banned Darvon and Darvocet in 2005. The FDA was petitioned in 1978 and again in 2006 to ban the drug by the group Public Citizen.

6. DBI (Phenformin) | 1959-1978

Cause for recall:

lactic acidosis (low pH in body tissues and blood and a buildup of lactate) in patients with diabetes

7. DES (Diethylstibestrol) | 1940 to 1971

Cause for recall:

clear cell adenocarcinoma (cancer of the cervix and vagina), birth defects, and other developmental abnormalities in children born to women who took the drug while pregnant; increased risk of breast cancer, higher risk of death from breast cancer; risk of cancer in children of mothers taking the drug including raised risk of breast cancer after age 40; increased risk of fertility and pregnancy complications, early menopause, testicular abnormalities; potential risks for third generation children (the grandchildren of women who took the drug).

8. Duract (Bromfenac) | 1997-1998

Cause for recall:

4 deaths; 8 patients requiring liver transplants; 12 patients with severe liver damage

Duract was labeled for maximum use of 10 days but patients often received/took more than 10 days worth of pills; all cases of death and liver damage involved patients taking pills for longer than 10 days.

9. Ergamisol (Levamisole) 1989 -2000

Cause for recall:

neutropenia (a type of low white blood cell count), agranulocytosis (a type of low white blood cell count), and thrombotic vasculopathy (blood clots in blood vessels) which results in retiform purpura (a purple discoloration of the skin that can sometimes require reconstructive surgery)

10. Hismanal (Astemizole) 1998 - 1999

Cause for recall:

slowed potassium channels in the heart that could cause torsade de pointes (TdP; a heart condition marked by a rotation of the heart’s electrical axis) or long QT syndrome (LQTS; prolonged QT intervals)

11. Lotronex (Alosetron) Feb 2000- Nov 2000

Cause for recall:

49 cases of ischemic colitis (inflammation and injury of the large intestine); 21 cases of severe constipation (10 requiring surgery); 5 deaths; mesenteric ischemia (inflammation and injury of the small intestine)

Lotronex was reintroduced to the US market in 2002 with restricted indication.

12. Meridia (Sibutramine) 1997-2010

Cause for recall:

increased cardiovascular and stroke risk

FDA reviewer Dr. David Graham listed Meridia with Crestor, Accutane, Bextra, and Serevent as drugs whose sales should be limited or stopped because of their danger to consumers in Sep. 30, 2004 testimony before a Senate committee, calling the drugs “another Vioxx.”

13. Merital & Alival (Nomifensine) 1982 - 1985

Cause for recall:

haemolytic anemia; some deaths due to immunohemolytic anemia

14. Micturin (Terodiline) 1989-1991

Cause for recall:

haemolytic anemia; some deaths due to immunohemolytic anemia

15. Mylotarg (Gemtuzumab Ozogamicin) 2000-2010

Cause for recall:

increased risk of death and veno-occlusive disease (obstruction of veins)

16. Omniflox (Temafloxacin) | Jan 1992 - Jun 1992

Cause for recall:

Severe low blood sugar; hemolytic anemia and other blood cell abnormalities; kidney disfunction (half of the cases required renal dialysis); allergic reactions including some causing life-threatening respiratory distress

17. Palladone (Hydromorphone hydrochloride, extended-release) Jan-july 2005

Cause for recall:

high levels of palladone could slow or stop breathing, or cause coma or death; combining the drug with alcohol use could lead to rapid release of hydromorphone, in turn leading to potentially fatally high levels of drugs in the system.

18. Permax (Pergolide) 1988-2007

Cause for recall:

valve regurgitation (a condition that causes the valves to not close tightly, which allows blood to flow backward over the valve) in the mitral, tricuspid, and aortic heart valves, which can result in shortness of breath, fatigue, and heart palpitations

19. Pondimin (Fenfluramine) 1973 -1997

Cause for recall:

30% of patients prescribed the drug had abnormal echocardiograms; 33 cases of rare valvular disease in women; 66 additional reports of heart valve disease

Pondimin is better known as “Fen-Phen” when prescribed with Phentermine.

20. Posicor (Mibefradil) 1997-1998

Cause for recall:

fatal interactions with at least 25 other drugs (ex: common antibiotics, antihistamines, and cancer drugs) including astemizole, cisapride, terfenadine, lovastatin, and simvastatin

Full List with sources