Public Health & Medical Professionals for Transparency - PHMPT.org - is made up of Hundreds of public Health professionals, medical professionals, scientists, and journalists from all over the world and exists solely to obtain and disseminate the data relied upon by the FDA to license COVID-19 vaccines. The organization takes no position on the data other than that it should be made publicly available to allow independent experts to conduct their own review and analyses. Any data received will be made public on this website.
Four days after the Pfizer vaccine was approved for ages 16+, we submitted a Freedom of Information Act Request to the FDA for all of the data within Pfizer’s COVID-19 vaccine biological product file. We have now sued the FDA for not releasing the data.
Immediately following the approval of Pfizer’s vaccine for use in 12-15-year olds and after the approval of Moderna’s Covid-19 vaccine, we submitted Freedom of Information Act requests to the FDA for that data (in addition to the Pfizer data for 16 years and older which we had already submitted and sued to obtain). The requests sought all of the data within these two products’ biological product files. We then sued the FDA for not releasing the data. Click below for the court documents and for productions of Pfizer’s and Moderna’s documents from the FDA.
Freedom of Information Act Request Expedited Processing Requested
VIA ONLINE PORTAL - August 27, 2021 - Re: Pfizer-BioNTech COVID-19 Vaccine Biological Product File (IR#0546)
Food and Drug Administration
Division of Freedom of Information
Office of the Secretariat, OC
5630 Fishers Lane, Room 1035
Rockville, MD 20857
Dear Sir or Madam:
This firm represents Public Health and Medical Professionals for Transparency (“PHMPT”).
On August 23, 2021, the Food and Drug Administration (“FDA”) approved the Pfizer- BioNTech COVID-19 Vaccine, marketed as Comirnaty (the “Pfizer Vaccine”) for individuals 16 years of age and older.
On behalf of PHMPT and its individual members, please provide the following records to foia@sirillp.com in electronic form: All data and information for the Pfizer Vaccine enumerated in 21 C.F.R. § 601.51(e)1 with the exception of publicly available reports on the Vaccine Adverse Events Reporting System.
PHMPT is an organization made up of public health professionals, medical professionals, scientists, and journalists. PHMPT exists for the sole purpose of disseminating to the public the data and information in the biological product files for each of the COVID-19 vaccines. PHMPT intends to make any records produced in response to this FOIA request immediately available to the public through both its website and its individual members’ platforms.
Many of PHMPT’s individual members, including all its members that are journalists, are primarily engaged in disseminating information to the public and do so across various platforms, including through interviews, articles, blogs, essays, and podcasts. Therefore, PHMPT and many of its members are “primarily engaged in disseminating information to the general public,” and, as explained below, there is a clear “urgency to inform the public concerning actual or alleged Federal Government activity,” here, the data and information underlying the licensure of the Pfizer Vaccine. Accordingly, expedited processing of this request is warranted...