A group of scientists asked the federal government to share the data it relied upon in licensing Pfizer’s COVID-19 vaccine. It should have been a routine Freedom of Information Act request.
The response by the Food and Drug administration was anything but routine. They said that they would have to review 329,000 pages of documents in order to fulfill the plaintiff’s FOIA request. The agency suggested they could “process and produce the non-exempt portions of responsive records at a rate of 500 pages per month.” They claimed they could provide the plaintiffs with prioritized documents and release the non-exempt portions of the records on a “rolling basis.”
That rate of reviewing and approving the documents means that it will be 55 years before the plaintiffs get everything they wanted. Public Health and Medical Professionals for Transparency can expect all documents relating to their request to be made available by 2076.
The plaintiffs, a group of more than 30 professors and scientists from universities including Yale, Harvard, UCLA and Brown, filed suit in September in U.S. District Court for the Northern District of Texas, seeking expedited access to the records. They say that releasing the information could help reassure vaccine skeptics that the shot is indeed “safe and effective and, thus, increase confidence in the Pfizer vaccine.”
But the FDA can’t simply turn the documents over wholesale. The records must be reviewed to redact “confidential business and trade secret information of Pfizer or BioNTech and personal privacy information of patients who participated in clinical trials,” wrote DOJ lawyers in a joint status report filed Monday.
It’s also a question of manpower. The FOIA office at the FDA has only 10 employees and they are currently processing 400 other FOIA requests.
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The PHMPT wants to look under the fingernails of the FDA and take a deep dive into the justification for declaring the Pfizer vaccine “safe and effective.”
The PHMPT had filed the lawsuit on Sept. 16, 2021, stating that although the Pfizer vaccine was approved and described by the FDA as meeting “the high standards for safety, effectiveness, and manufacturing quality the FDA requires of an approved product,” others with large social or media platforms have publicly raised questions regarding the sufficiency of data used in the review of Pfizer’s vaccine.
The PHMPT states in the lawsuit the importance of releasing this information to the public, as federal law provides that “After a license has been issued, the following data and information in the biological product file are immediately available for public disclosure unless extraordinary circumstances are shown.” The PHMPT stated that the purpose of their organization is to adequately disseminate information to the public regarding all COVID-19 vaccines and to ensure that the FDA is maintaining its commitment to transparency.
It’s a virtual certainty that the FDA took some shortcuts in approving all the vaccines for emergency use. There’s no way they could have gotten approval otherwise.
Would it matter if the FDA had waited for a few years until the vaccines were perfected and successfully went through all the human trials? We’re seeing more and more breakthrough infections, but thankfully, few of those infections are serious or led to hospitalization and death.
It depends on your point of view. If you’re vulnerable to serious disease, you probably want to thank the government for approving the vaccines. If not, you almost certainly have questions.
And we shouldn’t have to wait 50 years to find out how the FDA arrived at their decision.
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