Texas federal judge Mark Pittman will conduct a hearing on Friday to consider whether to allow Pfizer to participate in the redaction and release of information about the development of its COVID-19 vaccine, Comirnaty.
Earlier this month, Pittman ruled that the FDA would have to turn over 55,000 pages of documentation on the vaccine per month, starting on March 1. This will be a huge task for the regulator, which would need to hire a team of 15 specialists at an expense of “some $3 million,” the FDA said in a Jan. 18 court filing.
Last Friday, Pfizer provided the court a memorandum outlining why it should participate in the process.
“Pfizer supports the public disclosure of the vast majority of this information to promote transparency and the public’s confidence in the vaccine,” the company wrote in the filing. “Pfizer seeks to intervene for the limited purpose of ensuring that information that is exempt from disclosure under FOIA is not disclosed inappropriately.”
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Pfizer’s concern is that without its participation, trade secrets and other confidential information could be compromised.
The case began in September of last year when a group of more than 30 doctors and scientists, referring to themselves in court documents as Public Health and Medical Professionals for Transparency, filed a Freedom of Information Act (FOIA) to see the documents surrounding the approval of the BioNTech-partnered vaccine. The request covers 329,000 pages, which must be processed and redacted before release.
The branch in charge of processing the request only has 10 employees and is already saddled with about 400 outstanding bids for information, Department of Justice lawyers representing the FDA said in a November court filing. The regulator added that it would need 55 years, or until 2076, to complete the request.
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On Jan. 6, Pittman ordered the faster timeline calling the case “of paramount public importance.”
More appears to be in play with the motives of the Texas plaintiffs than transparency. One of the lawyers representing the group, Aaron Siri, of New York City-based Siri & Glimstad, has been an ardent critic of vaccine mandates. Last February, he penned an op-ed for STAT News arguing against them.