Skip to Content

An FDA laboratory in Maryland. Photo: Wikipedia / FDA

Not very confident: FDA to publish info on Pfizer’s Covid-19 jab in 55 years

The request for information on the shots would have been a great opportunity for vaccine manufacturers and advocates to demonstrate the success of their products with the data that exists on vaccine safety, effectiveness and "rare" side effects.

Published: November 24, 2021, 9:15 am

    But according to documents filed in a district court for the Northern District of Texas, the US federal government plans only to share the data it relied upon in licensing Pfizer’s COVID-19 vaccine, in the year 2076.

    If the judge approves the FDA’s request, the plaintiffs, Public Health and Medical Professionals for Transparency, would have to wait until the United States celebrates its 300th anniversary to see the full report. Waiting for more than half a century to publicize the data does not bode well for transparency in government.

    The plaintiffs, a group of more than 30 professors and scientists from universities including Yale, Harvard, UCLA and Brown, filed suit in September, seeking expedited access to the records.

    The group had originally asked for documentation after the Comirnaty vaccine was approved in August, but the FDA has not yet provided any material.

    The plaintiff’s attorneys say the FDA must provide the information to “resolve the ongoing public debate” over the agency’s review process and to confirm their conclusion that the Pfizer vaccine is safe, effective, and worthy of public trust.

    Vaccines were approved within a short time

    After a month of no response from the FDA, the group filed a lawsuit against the agency, demanding that all documents and data submitted by Pfizer be submitted within 108 days. That was the same amount of time it took the FDA to carry out the much more consequential review of Pfizer’s data for the emergency approval and licensing of its Covid-19 vaccine.

    To meet that deadline, the FDA would need to process approximately 80 000 pages a month. It was simply not feasible, the DOJ lawyers claimed.

    “Reviewing and editing documents for exempt information is a time-consuming process that often requires government information specialists to review each page line by line,” the defense said in the court application. “When a party requests a large amount of data, as the plaintiff did here, the courts usually establish a schedule where the processing and production of the non-secret parts of the documents is done on a rolling basis,” they said.

    The time it takes for an authority to process a FOIA request varies “depending on the complexity of the request and the possible delay of requests made to the authority”, according to the information on an official fact page about FOIA.

    Instead, the FDA has proposed releasing 500 pages per month. “By processing and making interim responses based on 500-page steps, the FDA will be able to provide more pages to more customers, avoiding a system where some large inquiries monopolize finite processing resources,” the agency’s defense attorneys said.

    The FDA breaks its own rules on transparency

    But the plaintiffs pointed out that the FDA was breaking its own regulations on data transparency as Title 21, subchapter F of the FDA’s own regulations stipulates that the agency “is to make ‘immediately available’ all documents underlying licensure of a vaccine”. The FDA “should have been preparing to release [the data] simultaneously with the licensure. Instead, it has done the opposite.”

    The plaintiff’s request covers about 329 000 pages, which must first be processed and edited before the FDA can submit them, said the US Attorney General (DOJ) lawyers representing the FDA.

    US District Judge Mark Pittman has decided on a scheduling hearing on December 14, 2021, to consider the timeline for the plaintiff’s request, Reuters reported.

    The FDA had previously claimed that the examination and analysis of the documents had been intensive, reliable, thorough and complete in order to guarantee the safety and effectiveness of Pfizer’s Covid-19 treatment. However, if they do not respond, US federal authorities will make it clear that they have cleared Pfizer of any responsibility and liability for their product.

    The data being investigated comes not only from Pfizer/BioNTech, but also from the Israel Ministry of Health, the University of Bristol, UK, and the Centers for Disease Control and Prevention (CDC, part of the US Health authority).

    Consider donating to support our work

    Help us to produce more articles like this. FreeWestMedia is depending on donations from our readers to keep going. With your help, we expose the mainstream fake news agenda.

    Keep ​your language polite​. Readers from many different countries visit and contribute to Free West Media and we must therefore obey the rules in​,​ for example​, ​Germany. Illegal content will be deleted.

    If you have been approved to post comments without preview from FWM, you are responsible for violation​s​ of​ any​ law. This means that FWM may be forced to cooperate with authorities in a possible crime investigation.

    If your comments are subject to preview ​by FWM, please be patient. We continually review comments but depending on the time of day it can take up to several hours before your comment is reviewed.

    We reserve the right to del​ete​ comments that are offensive, contain slander or foul language, or are irrelevant to the discussion.

    Americas

    Covid-19 has killed more people in 2021 than 2020 in the US

    Covid-19 was reported as the underlying cause of death for some 377 883 people in 2020, accounting for 11,3 percent of deaths, according to the CDC. More than 770 000 people have died from the Coronavirus as of Monday, according to Johns Hopkins University data.

    The strange link between the sterilization of wild horses and mRNA vaccines

    A strange link has been made between the sterilization of wild horses and the Covid-19 vaccines. Vaccination against the porcine zona pellucida (PZP) is designed to contain the wild horse population by generating antibodies that prevent the mares from producing fertile eggs.

    US judge in the Rittenhouse trial defies media onslaught

    Kenosha, WisconsinThe right to own firearms and use them to defend oneself in an emergency is deeply ingrained in the American consciousness. When protests by the Black Lives Matter movement degenerated into civil war-like riots and looting across the United States over the past year, civil militias and private individuals took up arms to protect their property.

    Some 92 percent of American LGBTQs took the jab

    In a Human Rights Campaign Foundation survey, led by Community Marketing & Insights and supported by The Rockefeller Foundation, data on LGBTQ+ adults and Covid-19 vaccinations in the US show that this community has bought into Big Pharma marketing in a big way.

    Hospital emergency rooms swamped by patients with ‘heart conditions’

    In one hospital in the US state of Michigan, patients are flooding into emergency rooms with “respiratory problems”, “blood clots” and... “heart conditions”.

    US vaccine deaths linked to small percentage of Pfizer and Moderna batches

    Graphical analysis of data from the Official US Vaccine Side Effects Database (VAERS) found that a very small percentage of certain lot numbers of Pfizer and Moderna's Covid-19 vaccines were responsible for most side effects and deaths in the United States.

    Conflict of interest: FDA reviewers of Pfizer’s child vaccine work/ed for Pfizer

    The FDA’s Vaccines and Related Biological Products Advisory Committee on Tuesday October 26, discussed pushing their jab for children between the ages of 5 to 11 years old.

    Second caddy dies of heart attack on Latin America golf tour

    Nuevo VallartaThe PGA Tour Latinoamerica, which has already suffered the death of a caddy, was struck again by tragedy last week when another caddy collapsed on the golf course and died in a hospital in Nuevo Vallarta, Mexico.

    US Air Force doctor warns pilots of ‘sudden cardiac death’ after jabs

    WashingtonThe affidavit of Lieutenant Colonel Theresa Long is also part of a federal lawsuit against the US Army's forced vaccination regime.

    Fully jabbed Harvard Business School sees huge surge in cases

    BostonHarvard Business School has been forced to move classes for all first-year and some second-year MBA students online, following a spike in Covid-19 cases among their fully-vaccinated student body.

    Go to archive