The US Food and Drug Administration (FDA) has been asking for more than half a century to review and release information about the Pfizer-BioNTech vaccine to the public.
The agency is being sued by Public Health and Medical Professionals for Transparency, a group of more than 30 professors and scientists, hoping to gain access to information they believe may help cure vaccine skepticism in some people.
A request for Freedom of Information Act (FOIA) was filed by the group in September, and they hoped the courts could speed up the process of getting them the information they wanted.
The FDA is asking the court to give them 55 years, or up to 2076, to collect and release the data to the general public.
The FDA is requesting 55 years of time to provide more than 300,000 pages of information requested in a FOIA request. The agency wants to release the pages in chunks of 500 pages each month, which will take until 2076 (file photo)
The Pfizer BioNTech vaccine is the most widely used in the United States, having been administered nearly 260 million times in the United States. The plaintiffs, who are requesting information from the FDA, hope that the request can help curb some vaccine skepticism
The 1967 FOIA Act requires federal agencies to respond to requests for information within 20 business days.
However, the time it takes to obtain the documents ‘will vary depending on the complexity of the request and any backlog of requests already pending at the agency’, according to the government’s central FOIA website.
However, the agency can not just deliver the documents to those who request them.
They must first be reviewed by officials, and any information that may reveal personal information about participants in clinical trials, or sensitive information about Pfizer or BioNTech that could damage their business relationships, should be removed.
Justice Department lawyers representing the agency say the request requires about 329,000 pages of information.
They claim that with so many pages to browse and the agency already processes about 400 FOIA requests, they need a long time to get the requested files ready.
The lawyers also state that the agency only has ten employees who are given the task of processing this type of request.
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 making preliminary responses based on steps of 500 pages, the FDA will be able to deliver multiple pages to multiple inquirers, thus avoiding a system where a few large inquiries monopolize limited processing resources and where fewer inquirers’ requests become fulfilled, “wrote lawyers representing the agency.
The lawyer reports that there have been other cases where the court allowed this kind of rollout of information on 500 pages per page. month.
The plaintiffs claim that the agency should be able to obtain the information from them by March 3, 2022, in just over four months.
“This 108-day period is the same time it took the FDA to review the responsive documents for the far 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 legal papers.
“The whole purpose of FOIA is to ensure government transparency,”
‘It is difficult to imagine a greater need for transparency than the immediate publication of the documents relied on by the FDA to license a product that is now mandated by over 100 million Americans under penalty of losing their careers, their income, their military service status, and far worse. ‘
To reach the March 3 goal, the agency had to process about 80,000 pages each month.
However, the applicants argue that their request should be given priority 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 United States and has the widest justification for any of the available shots.
It has been administered almost 260 million times since it first became available about 11 months ago.
Since so many have received the shot, and so many claim to be ‘doing their own research’ on the vaccines despite having little scientific expertise, the team of professors and scientists hope that the release of this data will give people more confidence to get the shot.
They also claim that the agency, with its $ 6 billion budget and 18,000 employees, has the necessary resources to release the information in a timely manner.