Pfizer in Texas showdown: Court hearing this week will decide if it can assist FDA in providing COVID documents

By Kevin Dunleavy, Fierce Pharma, Jan. 27, 2022

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.

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