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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).

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