FDA Says It May Take 55 YEARS To Make Vaccine-Related Information Available To The Public
The U.S. Food and Drug Administration (FDA) has been asking for more than half a century to review and disclose information about the Pfizer-BioNTech vaccine.
The agency is being sued by Public Health and Medical Professionals for Transparency, a group made up of more than 30 professors and scientists, in hopes of accessing information they believe could help cure vaccine skeptics in some people.
The group filed a Freedom of Information Act (FOIA) petition in September, and they hoped the courts could expedite the process of getting the requested information.
The FDA is asking the court to give them 55 years, or until 2076, to collect the data and release it to the general population.
The FDA takes 55 years to provide more than 300,000 pages of information requested in a FOIA request. The agency wants to release the pages in 500-page chunks each month, which would last until 2076 (file photo)
The Pfizer-BioNTech vaccine is most widely used in the US and has been administered nearly 260 million times in the US.
The 1967 FOIA Act requires federal agencies to respond to requests for information within 20 business days.
However, the time it takes to actually get the documents “depends on the complexity of the request and any backlog of requests already pending at the agency,” the government’s central government said. FOIA website.
However, the agency cannot simply deliver the documents to those who request them.
They must first be reviewed by officials and any information that could reveal personal information about clinical trial participants, or sensitive information about Pfizer or BioNTech that could harm their business dealings, should be removed.
Justice Department lawyers representing the agency say the request requires about 329,000 pages of information.
They argue that with so many pages to flip through and the agency already processing about 400 FOIA requests, it will take them a long time to get the requested files ready.
The lawyers also report that the agency has only ten employees who handle these types of requests.
Meanwhile, the agency has proposed a plan to release 500 pages of information each month, which would take 55 years to complete.
“By processing and providing interim responses based on 500-page increments, the FDA can deliver more pages to more applicants, avoiding a system where a few large requests monopolize finite processing resources and fewer applicant requests are met.” lawyers representing the agency wrote.
The attorney reports that there have been other cases where the court allowed this type of 500-page information per month.
Plaintiffs argue that the agency should be able to get them the information by March 3, 2022, in just over four months.
“This 108-day period is the same amount of time it took the FDA to review the responsive documents for the much more complicated task of licensing Pfizer’s COVID-19 vaccine,” wrote Aaron Siri of Siri & Glimstad in New York and John Howie of Howie Law in Dallas in court documents.
‘The whole purpose of FOIA is to ensure government transparency’
“It’s hard to imagine a greater need for transparency than immediate disclosure of the documents the FDA relies on to license a product that is now being imposed on more than 100 million Americans on pain of losing their career, their income, their military service status, and much worse.’
To meet the March 3 target, the agency would need to process about 80,000 pages per month.
However, the plaintiffs argue that their request should take precedence over others as it is in the public interest for the information to be released.
The Pfizer-BioNTech vaccine is the most widely used in the US and the most eligible of all available injections.
It has been administered nearly 260 million times since it first became available about 11 months ago.
With so many getting the shot and so many claiming they are “doing their own research” on the vaccines, despite having little scientific expertise, the team of professors and scientists hopes the release of this data will give people more confidence to get the injection.
They also claim that the agency, with its $6 billion budget and 18,000 employees, has the resources it needs to release the information in a timely manner.