Ok, here you go:
Here is the link to the Pfizer mRNA trials:
Study to Describe the Safety, Tolerability, Immunogenicity, and Efficacy of RNA Vaccine Candidates Against COVID-19 in Healthy Individuals - Full Text View.
clinicaltrials.gov
directly cut/paste:
| Actual Study Start Date : | April 29, 2020 |
| Estimated Primary Completion Date : | January 31, 2023 |
| Estimated Study Completion Date : | January 31, 2023 |
With regard to how these things are supposed to go, look here:
Phase I
Phase I trials are concerned primarily with establishing a new drug's safety and dose range in about 20-100 healthy volunteers. How a drug is absorbed, distributed, metabolized and excreted by the human body is called Pharmacokinetics. This is determined through frequent blood draws (usually in an inpatient environment) to check for the level of drug in the blood plasma.
Pharmacokinetic trials are usually considered Phase I trials regardless of when they are conducted during a drug's development.
Dosage range of a new drug is determined by administering increasingly larger doses to one or more groups of subjects, who are closely monitored for harmful side effects. The goal is to learn the maximum tolerated dose that does not produce unacceptable side effects.
Phase I studies may involve risks even though an investigational drug has passed the Preclinical phase of testing. Phase I studies typically offer little or no benefit to the volunteer subjects; therefore they typically are compensated for their time and effort. Although usually conducted with healthy volunteers, Phase I trials are sometimes conducted with severely or terminally ill patients, for example those with AIDS or cancer.
A Phase I trial takes several months to complete. About 70 percent of experimental drugs pass this initial phase of testing.
Phase II
Phase II studies determine the effectiveness of an experimental drug on a particular disease or condition in approximately 100 to 300 volunteers.
This phase may last from several months to two years.
A Phase II trial answers the question,
"Does Drug X improve Disease Y?"
A secondary objective for a Phase II trial is to ascertain therapeutic dose level and dosing frequency. This answers the questions, "What quantity of Drug X works better on Disease Y, (1 mg, 2 mg or 3 mg)?" and "Does Drug X work better on Disease Y taken once or twice a day?"
Most Phase II studies are randomized, which means that subjects are assigned randomly (by chance not by choice) to receive either the experimental drug, a standard treatment or a placebo (harmless, inactive substance). Those who receive the standard treatment or placebo are called a control group.
Randomized Phase II studies are often double-blind, which means that both subject and physician don't know which treatment is being used.
Blinding prevents any unscientific influence on the study results that could be caused by knowledge of the treatment. In a single-blind study, only the subject is unaware of the treatment used.
Since larger numbers of patients receive a treatment in Phase II studies than in phase I studies, there is a greater chance to observe and compile side effect information. Subjects in a Phase II trial may benefit from their participation if they receive an active treatment. Approximately 33 percent of experimental drugs which pass Phases I and II will go on to Phase III.
from here:
https://med.uc.edu/depart/psychiatry/research/clinical-research/crm/trial-phases-1-2-3-defined
So, these new mRNA drugs had no pre-clinical evaluation, then had aborted phase 1 and phase 2 combined clinicals last lasted about 2-3 months. The manufacturers did not, and could not have completed phase 3, and most certainly have not completed further studies about adverse events post approval. The FDA approved opioids, and still does, and approved Vioxx and removed that.
Here is some handy information about Pfizer and ongoing lawsuits......one has to ask if this is now a litigation firm with a sideline in pharmaceuticals:
Pfizer Lawsuits
Pfizer has faced thousands of lawsuits filed for medical injuries caused by some of its most popular drugs. It has also set a record for the largest fine paid for a health care fraud lawsuit filed by the U.S. Department of Justice. Pfizer paid $2.3 billion in fines, penalties, and settlement for illegal marketing claims and allegations of fraud for the promotion and sales of arthritis medication Bextra (valdecoxib). The company has also faced legal challenges over other products including transplant drug Rapamune, neurology drugs Geodon and Lyrica, Shiley heart valves, Celebrex, and Trovafloxacin.
Some of the Pfizer lawsuits have been dismissed, others have been settled, and still others remain in court systems. Some of the most notable lawsuits have included:
Protonix
As part of a larger group of proton pump inhibitor lawsuits, Pfizer faced a number of Protonix lawsuits after it acquired drug company Wyeth who had been accused of marketing the drug for unapproved uses. In 2013, Pfizer agreed to pay $55 million to settle illegal marketing claims and in 2016, paid $784 million for accusations that Wyeth had overcharged Medicaid for Protonix. The company may still be facing PPI lawsuits for kidney injuries caused by Protonix.
Prempro
An estimated 13,000 Prempro lawsuits were filed against Pfizer acquisition, Wyeth by women who had been diagnosed with breast cancer. The lawsuits were largely settled by 2012 for about $1.2 billion.
Chantix
Pfizer faced about 3,000 Chantix lawsuits filed by people who claimed they experienced suicidal thoughts and psychiatric disorders after using Chantix for smoking cessation. Pfizer set aside about $288 million and at least some of the cases were settled. A new lawsuit against Pfizer was filed in September for reported carcinogenic chemical contamination of Chantix and the generic form of Chantix. A similar case had already been dismissed in at least two other district courts.
Depo-Testosterone
Thousands of medical injury lawsuits have been filed against multiple pharmaceutical companies including Pfizer, over claims that testosterone replacement therapy was marketed for unapproved disorder “Low-T” and may have resulted in serious heart damage in men who did not need the medication. Other drug companies have paid $ billions to settle their cases, however many of the Pfizer Depo-testosterone lawsuits were dismissed.
Zoloft
About 700 federal and hundreds of state Zoloft drug injury lawsuits were filed against Pfizer, claiming the company actively promoted the use of the SSRI antidepressant, Zoloft to pregnant women despite knowledge of birth defect risks from their research. These cases have been dismissed by several courts over conclusions that there was not enough evidence to prove a link between birth defects and Zoloft use. Concerns have continued to be raised, particularly with women who claim their children developed Autism and other developmental disorders. Some of these families may still be considering lawsuits against Pfizer.
Effexor
Effexor was also an antidepressant medication originally produced by Wyeth which has also been the cause of multiple lawsuits. Wyeth had been accused of misleading advertising claims by the FDA in 2007 and in 2012, people began filing drug injury lawsuits. People who filed Effexor lawsuits claimed that it caused birth defects, and separately, suicidal thoughts and behaviors. In September 2015, most Effexor lawsuits were dismissed but some of the plaintiffs may have been eligible to refile. Other lawsuits have been filed and largely dismissed for medications including blood thinner Eliquis and cholesterol medication Lipitor.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.
from here:
https://www.drugdangers.com/manufacturers/pfizer/
www.conservativereview.com
