Here's Why FDA Approval Doesn't Mean Much For Many

Despite FDA approval, the Pfizer shots are still experimental. Studies assessing long-term safety and efficacy won't be done for another two years.

The COVID-19 Vaccines Are Still Experimental

Every Pfizer shot is still less than a year in use but is already FDA approved. On average, that process takes 10 years.

By definition, all mRNA vaccines are experimental: mRNA vaccines have been researched for over thirty years. By the time COVID-19 came around, companies like Pfizer and Moderna had the technology ready to create an mRNA vaccine. Within weeks they had a vaccine prepared.

However, this was the first time mRNA technology had been used on such a scale. Regardless of efficacy and safety, these are new testing grounds.

This is one of the largest field tests of a vaccine ever conducted.” 

- Benjamin R. Bates, Ph.D.

Health officials openly acknowledge these vaccines as “field tests.” FDA approval doesn't change that.

Unfinished Safety Research

Even though Pfizer is FDA-approved, it still has an incomplete two-year long study. The study is intended to "assess long-term protection and safety for an additional two years after their second dose."  [Pfizer]

Moderna has taken a similar route in requesting FDA approval without additional research completed. They'll continue researching "longer-term safety" for another two years despite already being FDA approved.

That long-term safety data doesn’t exist yet. FDA approval does not change that.

Flawed Safety Research

No control group: In February, NPR reported that long-term studies of the vaccines were compromised because the control group - those who were given placebos - were also vaccinated.

Essentially, there was no control group for the studies, which makes finding long-term safety problems very difficult.

Ignored Safety Concerns

A group of clinicians, scientists, and patient advocates penned a memo arguing about slowing the FDA approval process. Among the many reasons, they mentioned that proper studies, which would be required of any new drug, were not required for Pfizer.

The group was dissatisfied with the lack of thorough research on:

  1. The implications of mRNA translation in distant tissues.

  2. All serious adverse events reported to pharmacovigilance systems (carried by independent and impartial individuals).

  3. Safety data from individuals receiving more than two vaccine doses to understand the effect of booster shots.

No independent advisory committee to FDA processes: A year ago the FDA promised it would "use an advisory committee composed of independent experts to ensure deliberations about authorization or licensure are transparent for the public.” It later went back on that and claimed it was not necessary.

Why is something like this necessary? The FDA advisory process can be, and is, corrupted by money coming from pharmaceutical companies to those supposed to be regulating them.

Pfizer's Record

Between 1991 and 2017, the three main vaccine makers had a terrible record of paying settlements.

Pfizer: In 2009, Pfizer had to pay a settlement of $2.3 billion for fraudulent marketing. In other words, they were advertising their drugs for unintended uses to sell more drugs. It was the largest health care fraud settlement in the history of the DOJ.

Johnson & Johnson: In 2004, J&J paid $90 million for settlements linked to prescription heartburn medication. It lead to several hundred deaths and more cases of cardiac issues. In 2013, J&J was forced to pay more than $2.2 billion for similar reasons to the Pfizer settlement. The full rap sheet of J&J's problems is dozens of settlements long.

Public Health Disasters Happen, Even After FDA Approval

This is a non-exhaustive compilation of medical disasters. The full list is much longer.

Thalidomide: This was a sedative given to pregnant women in the 1950s. It wasn't until the end of 1963 that it was removed from the markets for causing irreversible damage to the fetus. Thousands were born malformed.

DES: This was a drug used to prevent certain pregnancy complications, used since the early 1940s. In the 1950s, the research found that it was ineffective through clinical studies. In the late 1960s, scientists discovered it was causing a rare form of cancer among young women.

1976 Swine Flu: In late 1976, a virus appeared looking concerningly similar to the 1918 flu pandemic strain. Public health officials began preparing for the worst, and President Ford's administration planned to vaccinate everyone in the United States. After 10 months, 25% percent of Americans were vaccinated. However, the government botched the vaccine and ended up with many adverse reactions. Over four hundred developed the rare and debilitating Guillain-Barré syndrome.

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