Author: Tracey Young. (March 3, 2022). Pfizer Adverse Health Reactions and Fatalities During Clinical Trial Phases to February 28, 2021. Canadian Advocacy Centre for Health, Safety and Justice. Retrieved from: https://canadianadvocacycentre.blogspot.com/2022/03/pfizer-covid-19-vaccine-adverse-health.html.
In this article, I present the
following:
■ Overview of PHMPT v FDA Legal Case which prompted disclosure of Pfizer's COVID-19 vaccine Adverse Health Reactions statistics, data and information
■ U.S. FDA Presentation on COVID-19 Vaccines in October 2020
■ Pfizer COVID-19 Vaccine Adverse Health Reactions of Special Interest
■ APPENDIX 1. LIST OF ADVERSE EVENTS OF SPECIAL INTEREST
■ Link to Pfizer's full report, 5.3.6 CUMULATIVE ANALYSIS OF POST-AUTHORIZATION ADVERSE EVENT REPORTS OF PF-07302048 (BNT162B2) RECEIVED THROUGH 28-FEB-2021
■ Fatality Statistics Out of Adverse Event Cases Reported During Clinical Trials
Introduction
A group called Public Health and Medical Professionals for Transparency requested Pfizer's clinical trial data and information for their COVID-19 vaccine application from the U.S. Food and Drug Administration (FDA) under freedom of information legislation. When the FDA refused to provide it, they initiated legal action to force the disclosure of the vaccine-related information.
Overview of PHMPT v FDA Legal Case
These two articles provide concise overviews of the legal case and decision that has led to the disclosure of Pfizer's COVID-19 vaccine Adverse Health reaction clinical trial data. Key highlights of the article are reported below.
Why a Judge Ordered FDA to
Release Covid-19 Vaccine Data Pronto.
Siri, A. (Jan. 18, 2022).
Bloomberg Law. Retrieved from: https://news.bloomberglaw.com/health-law-and-business/why-a-judge-ordered-fda-to-release-covid-19-vaccine-data-pronto.
“In
response to a Freedom of Information act request, the Food and Drug
administration asked a federal judge for permission to make the public wait
until the year 2096 to disclose all of the data and relied upon to license
pfizer's COVID-19 vaccine.
“…
after the vaccines licensure in August 2020, public health and medical
professionals for transparency, a group of highly credentialed scientists submitted
a FOIA request to the FDA for the data submitted by Pfizer. The scientists
explained that, until all the data has produced a proper review cannot be
conducted because missing even a single data set could throw off any analysis.
In
response, the FDA produced nothing. Therefore in September 2021, the scientists
represented by their attorneys at Siri and grimstad, sued the FDA demanding it
produced this data by March 2022.
The
agency originally estimated it would need to produce 329,000 pages, and asked
the court for permission to produce just 500 pages per month, which would have
taken 55 years. In its final brief to the court, the FDA admitted that the
total page count was at least 451,000, but still sought permission to produce
just 500 pages per month period meaning that it could have taken 75 years, when
most Americans alive today would be dead, to fully publicly disclose this
information.
U.S.
District Judge Mark T. Pittman, Northern District of Texas, expressed dismay at
the FDA's proposed rate of production. He found the duration requested by the
FDA unreasonable, comparing it to the actions of totalitarian nations. As such,
the judge on January 6th, 2022 ordered the FDA to produce at least 55, 000
pages per month.
In his ruling, the judge recognized that the release of this data is of paramount public importance and should be one of the FDA's highest priorities. He quoted James Madison as saying a “popular Government, without popular information, or the means of acquiring it, is but a Prologue to a farce or a tragedy quote and John F Kennedy as explaining that a “nation that is afraid to let its people judge the truth and falsehood in an open market is a nation that is afraid of its people.”
Article #2
On January 7, 2022, "A federal judge in Texas on Thursday ordered the Food and Drug Administration to make public the data it relied on to license Pfizer’s COVID-19 vaccine, imposing a dramatically accelerated schedule that should result in the release of all information within about eight months.
That’s roughly 75 years and four months faster than the FDA said it could take to complete a Freedom of Information Act request by a group of doctors and scientists seeking an estimated 450,000 pages of material about the vaccine.
The court “concludes that this FOIA request is of paramount public importance,” wrote U.S. District Judge Mark Pittman in Fort Worth, who was appointed to the bench by former President Donald Trump in 2019.
Rather than producing 500 pages a month — the FDA's proposed timeline — he ordered the agency to turn over 55,000 a month. That means all the Pfizer vaccine data should be public by the end of the summer rather than, say, the year 2097.
The Justice Department, which represented the FDA in the litigation, did not immediately respond to a request for comment on Thursday evening. Pfizer, not a party to the suit, also did not immediately respond to a request for comment.
Pittman in his order made clear that the FOIA request, even if burdensome, has to be a priority for the FDA.
Quoting from remarks made during the hearing before him on December 14, he wrote that “there may not be a ‘more important issue at the Food and Drug Administration . . . than the pandemic, the Pfizer vaccine, getting every American vaccinated," and assuring the public that the vaccine was not "'rush[ed] on behalf of the United States.'"
Source: Greene, J. (2022). ‘Paramount importance’: Judge orders FDA to hasten release of Pfizer vaccine docs. Reuters. Retrieved from: https://www.reuters.com/legal/government/paramount-importance-judge-orders-fda-hasten-release-pfizer-vaccine-docs-2022-01-07/.
U.S. FDA Presentation on COVID-19 Vaccines in October 2020
CBER Plans for Monitoring COVID-19 Vaccine Safety and Effectiveness
Source: Food and Drug Administration (FDA). (Oct. 22, 2020). Vaccines and Related Biological Products Advisory Committee October 22, 2020 Meeting Presentation. Retrieved from: https://www.fda.gov/media/143557/download.
Pfizer COVID-19 Vaccine Adverse Health Reactions of Special Interest
In the three months from the start of the Emergency Use Authorization (EUA) for Pfizer's COVID-19 vaccine, there were 42,086 Adverse health reports with a total of 158,893 adverse reactions and 1,223 deaths reported up to February 28th, 2021.
APPENDIX 1. LIST OF ADVERSE EVENTS OF SPECIAL INTEREST (AESI)
Note: I have only included page 1 & page 8 out of the full 8 pages listed from page 30-38. The full list of AESI's can be viewed at the link below.
Link to Pfizer's Full Report
Pfizer. (2021). 5.3.6 CUMULATIVE ANALYSIS OF POST-AUTHORIZATION ADVERSE EVENT REPORTS OF PF-07302048 (BNT162B2) RECEIVED THROUGH 28-FEB-2021. Retrieved from: https://phmpt.org/wp-content/uploads/2021/11/5.3.6-postmarketing-experience.pdf.
Fatality Statistics Out of Cases Reported During Clinical Trials
➡️1,223 fatalities out of 42,086 Case reports = 2.9% post-Pfizer COVID19 vaccine Fatality rate in 3 months.
➡️However, data shows 9,400 Unknown Case outcomes. It's possible there could have been higher post-vaccine fatalities that were not reported by Pfizer.
Copyright © 2022.Tracey Young/Canadian Advocacy Centre for Health, Safety and Justice. All Rights Reserved.
___________________________________________________
#Canada #cdnpoli #COVID19 #COVID19vaccines #DigitalID
