FDA Safety Surveillance of COVID-19 Vaccines. Analysis of “Adverse Effects Outcomes”

Slide 16 & Table 2: Everything Being Reported to VAERS

By Informed Choice Washington

Global Research, July 09, 2021Informed Choice Washington 2 July 2021

All Global Research articles can be read in 51 languages by activating the “Translate Website” drop down menu on the top banner of our home page (Desktop version). 

Visit and follow us on Instagram at @crg_globalresearch.

***

At the Vaccines and Related Biological Products Advisory Committee (VRBPAC) on October 22, 2020 Meeting, Steve Anderson, PhD, MPP, Director, Office of Biostatistics & Epidemiology, Center for Biologics Evaluation and Research (CBER) gave a presentation on CBER “Plans for Monitoring COVID-19 Vaccine Safety and Effectiveness”.

His presentation included a slide, below, about COVID-19 vaccine adverse event outcomes (injuries and deaths) which the FDA and CDC would be specifically monitoring. But he did not show the slide to VRBPAC, or the viewing public. He clicked right by it.

These side effect choices were not random. He explained they were based on evidence from the clinical trial data and from known science on the vaccine platform and components. This is from the transcript of the meeting.

These vaccine adverse event outcomes are being reported to VAERS in unprecedented numbers.

In the presentation, Anderson says that “Tom” also has information about adverse outcomes. By “Tom” he means Tom Shimabukuro of the CDC, and his presentation started at about 1:59 in the video — before Anderson — but Shimabukuro didn’t talk about the information at all and he also clicked right through two slides without pausing. One was a list of vaccine adverse event outcomes they would be looking for in the passive Vaccine Adverse Event Reporting System (VAERS).

The other was a list of vaccine adverse event outcomes they would be looking for in CDC’s Vaccine Safety Datalink System (VSD). The public and most independent researchers have no access to this data for independent review.

The FDA has a new system launched in 2017 (a full decade after FDA Amendments Act of 2007 that required them to create an active postmarket risk and analysis system covering at least 100 million persons) called Biologics Effectiveness and Safety (BEST) System. The BEST system is now being used to try to establish background rates for the COVID-19 vaccine “Adverse Events of Special Interest” that the CDC and FDA will be monitoring with their systems.

Given that global data analysis has shown a possible association between seasonal flu vaccination and COVID-19 disease severity, it’s interesting that the BEST study says:

To estimate incidence rates of AESIs in special populations of interest stratified by calendar year, sex, age group, and race/ethnicity (where reliably available) in each data source over the period 2017–2020. These populations will include:

o Older adults(i.e.,65 years old and abovea tcohort entry)
o Pediatric population(i.e.,0–17 years old at cohort entry)
o Pregnant women
o Individuals who received a seasonal influenza vaccine in the previous calendar year

During this COVID-19 crisis, both the FDA and CDC have made decisions that have not been in the best interest of the population or individuals. They have approved investigational products without sufficient safety or efficacy data, and they have actively censored or ignored existing treatments and natural immunity. They are actively partnering with the COVID-19 vaccine makers.

There are two important aspects of establishing whether reported adverse events are related to receipt of a vaccine. One is epidemiological. The rates of certain health issues in the general population are compared to the rates in people getting vaccinated. That’s what the FDA’s BEST study is about. Obviously, this information alone cannot rule causation in or out. Biological studies are also needed. Can the product cause the outcome seen? Ever since the 1986 National Vaccine Injury Act passed, removing from vaccine makers liability for injury or death for products recommended to children and pregnant women, the CDC has been in charge of vaccine safety and utterly failed in their duties. Biological studies are almost non-existent. The CDC prefers to use weaker epidemiological studies that are easily manipulated to desired outcome, to try to claim reported events are not associated.

Will they do the same for the COVID-19 vaccines? If so, will they get away with it?

Fortunately during COVID, researchers around the world have been awakened to the capture and corruption of public health agencies and they are beginning to do their own, independent studies. They are starting their own journals that have no ties to governments or the drug industry. A revolution is beginning within the ranks of doctors and scientists who believe in honest and ethical science and medicine.

*

Note to readers: Please click the share buttons above or below. Follow us on Instagram, @crg_globalresearch. Forward this article to your email lists. Crosspost on your blog site, internet forums. etc.

Related Articles

What We Know So Far About U.S. Government’s Plan to Track COVID Vaccine Recipients

7 December 2020

COVID-19 Vaccines are Killing “Huge Numbers” of People: Government Scrubs Stats on Vaccine-Related Deaths

18 May 2021

Here’s How the U.S. Could Release a COVID-19 Vaccine before the Election—and Why that Scares Some

31 August 2020The original source of this article is Informed Choice WashingtonCopyright © Informed Choice WashingtonInformed Choice Washington, 2021

https://www.globalresearch.ca/fda-slide-16-table-2-everything-being-reported-vaers/5749714

Leave a Reply

Fill in your details below or click an icon to log in:

WordPress.com Logo

You are commenting using your WordPress.com account. Log Out /  Change )

Twitter picture

You are commenting using your Twitter account. Log Out /  Change )

Facebook photo

You are commenting using your Facebook account. Log Out /  Change )

Connecting to %s

This site uses Akismet to reduce spam. Learn how your comment data is processed.

Up ↑

Our World Legends.

Past+Present. World Legends Reloaded+Retold. Martial+More.

~Burning Woman~

This WordPress.com site is for thoughts from "the other side"

Plumber and Hardware

Responsible Plumbing for clean portable water and safe sanitation.

Counterpoint

"International Topics, discussed logically"

Thoughts of a Wolf in Sheep's Clothing

Musings from someone who is NOT a Sheeple...

Declaration Of Opinion

{Mark Catlin's Blog} Agitate, Educate and Organise

Pet Human

Political and social commentary

Piazza della Carina

Geopolitics and Foreign Policy ... english and italian

God, dogs, and miracles

How I learned about God, and how dogs were involved

The PPJ Gazette

PPJ Gazette copyright ©

© blogfactory

Truth News

Rangitikei Environmental Health Watch

Watching our environment ... our health ... and corporations ... exposing lies and corruption

The Alchemist's Studio

Raku pottery, vases, and gifts

THE CHRONICLES OF HISTORY

READING INTO THE PAST .....

Emma's History Review

Want to find out about interesting historical topics and books?

Dispatches from the Asylum

“The story so far: In the beginning the Universe was created. This has made a lot of people very angry and been widely regarded as a bad move.” ― Douglas Adams

Documentary Film Festival. Los Angeles & Toronto

Submit your feature or short DOC and get it showcased at the FEEDBACK Film Festival

%d bloggers like this: