Why Does the FDA Not Clearly Publish Information on Clinical Trials at Their Website?

Executive Summary

• The FDA declares when they approve drugs but provides encapsulated information around the clinical trials on their website.

Introduction

The FDA is considered the official approving body of drugs in the US, and its influence goes far beyond the US. Observe this quote from the Mayo Clinic in an article titled “Are the Vaccines Safe.”

Data must show that a COVID-19 vaccine is safe and effective before the Food and Drug Administration (FDA) can give emergency use authorization or approval. The safety of COVID-19 vaccines is closely monitored by the Centers for Disease Control and Prevention (CDC) and FDA.

The FDA has approved the Pfizer-BioNTech COVID-19 vaccine, now called Comirnaty, to prevent COVID-19 in people age 16 and older. The FDA approved Comirnaty after data found the vaccine is safe and effective.

Observe that this is not a statement that the Mayo Clinic has evaluated and found the clinical trials safe.

The FDA states that it only approves vaccines that are safe and effective. However, the FDA has often approved drugs that are neither safe nor effective. Therefore, this statement by the Mayo Clinic is not correct. The Mayo Clinic, US medicine, and to some degree, international medicine are outsourcing their drug approval and validation process to the FDA without understanding how the FDA operates, its incentives, or evaluating the individual clinical trials the FDA is reviewing.

When investigating the FDA website, I found that the FDA publishes remarkably encapsulated information about the clinical trials it reviews.

The Effect and Safety of the Vaccines

The following is a quotation from the book Why Most of What You Know About Covid is Wrong on the topic of health policy and Covid 19. As I will show, any analysis like this is absent from the FDA’s website.

Vaccine #1: The AstraZeneca Vaccine

So it is possible that the AstraZeneca vaccine causes traverse mylitas. In a small portion of those vaccinated at present, it seems like the risk of developing travers myelitis after getting the vaccine is about one to 3000. But it could be much higher or much lower. We don’t know until many more people have received the vaccine.

Would I take this vaccine personally No, because I’m young and healthy, and I therefore estimate that the risk of me getting severe COVID is infinitesimal. And I’m not convinced that the benefits outweigh the potential harms, considering the possible risk of transverse myelitis where I let my children to have it, no way not until there are studies showing that it’s safe and effective in children. It’s all it’s only a little over a decade since an influenza vaccine was rushed through and given to children based on limited evidence causing hundreds in Europe to develop narcolepsy, debilitating, lifelong disease.

Vaccine #2: The Pfizer Vaccine

With a Pfizer vaccine among those getting the placebo point 9% develop symptomatic COVID. And among those getting the vaccine point oh 5% develop symptomatic COVID. That’s a 95% relative risk reduction and it is highly statistically significant. That is an impressive result much better than I ever would have thought would be possible in such a short space of time. The result appears at first sight to hold up even for people aged 75 and older, with five cases among those getting placebo and zero cases among those getting the vaccine. Unfortunately, due to the small size of the group, the result is not statistically significant. So we can’t actually say based on this study, that the vaccine protects people aged 75 and older. With that said, the vaccine does seem to protect most people against infection.

Overall there were 240 events in the vaccine group that were classified as severe compared with 139 in the placebo group that is concerning several adverse events were 73% more common in the vaccine group than in the placebo group, the vaccine should ideally decrease severe adverse events. It shouldn’t increase them. Unfortunately Pfizer aren’t kind enough to provide a breakdown of what the adverse events are so it’s impossible for us to figure out whether the drastic increase in severe adverse events after vaccination is something we need to be concerned about and whether it should cause us to avoid the vaccine. Would I personally be willing to take the Pfizer vaccine. No, first of all because Pfizer hasn’t presented a detailed breakdown of what the adverse events are. So, what I can show that I can tell if there’s something in there that I should be worried about.

Vaccine #3: The Moderna Vaccine

As for the Moderna vaccine among those who had received the placebo injections 1.3% develop COVID, among those who had received the vaccine .07% develop COVID That represents a 94% reduction in cases 1% of the participants in the placebo group, experienced a serious adverse event and 1% of the participants in the vaccine group experienced a serious adverse event.

Overall the moderna vaccine does appear to be both effective and safe for two months of follow up, would I be willing to take it.

Yes, maybe two months of follow up is short so I would rather wait a few months more to see that the vaccine is truly safe, but I feel more convinced by what my journal has made public than I am by what AstraZeneca and Pfizer have put forth.

All Three Vaccines

So let’s wrap up.

All three vaccines appear to be highly effective in preventing relatively young, healthy people from developing symptomatic COVID Although both the Pfizer vaccine and the modern a vaccine are clearly more effective than the AstraZeneca vaccine in terms of safety.

I have significant concerns about the AstraZeneca vaccine.

I also have concerns about the Pfizer vaccine.

Since there was a 73% increase in severe adverse events. Among those taking the vaccine. An issue that Pfizer hasn’t bothered to address at all and I’m also concerned about the fact that Pfizer does not provide a detailed breakdown of adverse events.

The Moderna vaccine does appear to be safe. However, Based on the data available up to now.

Finally, none of these studies can tell us whether the vaccines are safe and effective in children, it would be unethical to start vaccinating children without first having made sure that the vaccines are safe for them. Especially considering that the risk to children from COVID is infinitesimal. – Why Most of What You Know About Covid is Wrong

What the Establishment Media Normally Says About FDA Approved Drugs

The following is a typical establishment media segment where doctors oversimplify and generally misrepresent the results of clinical trials of a drug.

This video follows the same pattern. In this segment, a mother says, “she believes in science, and I believe the facts are there,” However, there is still no study on children, so how are the facts there?

Also, isn’t the fact that children have a near-zero risk from Covid 19 also a fact and part of science? Why is a woman who knows nothing about clinical trials being interviewed in this segment?