FDA Records on the Effectiveness of the Pfizer-BioNTech COVID-19 Vaccine, Complaints, and Other Related Documents
| Tracking # |
2023-3157 FDA23091626 |
| Submitted | April 15, 2023 |
| Est. Completion | None |
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Communications
From: Jordan Lassiter
To Whom It May Concern:
Pursuant to the Freedom of Information Act, I hereby request the following records:
To the effectiveness of the Pfizer-BioNTech COVID-19 vaccine, including any reports or analyses of its efficacy, side effects, and complaints received by the U.S. Food and Drug Administration (FDA) or any other government agency.
Specifically, I am requesting access to any and all records related to:
The efficacy of the Pfizer-BioNTech COVID-19 vaccine, including any studies, reports, or analyses conducted by the FDA or any other government agency
The side effects of the Pfizer-BioNTech COVID-19 vaccine, including any reports of adverse events or complaints received by the FDA or any other government agency
The number of doses of the Pfizer-BioNTech COVID-19 vaccine administered in the United States
The distribution of the Pfizer-BioNTech COVID-19 vaccine to different states, territories, and other jurisdictions
Any guidance or recommendations issued by the FDA or any other government agency related to the Pfizer-BioNTech COVID-19 vaccine
To help facilitate the search for these records, I provide the following keystring search terms:
Pfizer-BioNTech COVID-19 vaccine efficacy
Pfizer-BioNTech COVID-19 vaccine side effects
Pfizer-BioNTech COVID-19 vaccine complaints
Pfizer-BioNTech COVID-19 vaccine administration
Pfizer-BioNTech COVID-19 vaccine distribution
FDA guidance Pfizer-BioNTech COVID-19 vaccine
I request that any redactions made to the records be kept to a minimum and that any exemptions claimed by the FDA be explained in detail.
I advise the FDA not to delete, redact, or withhold any responsive records. If any responsive records are withheld, redacted, or destroyed, I reserve the right to file a complaint and take legal action to compel the release of these records.
In support of this request, I refer you to the following court cases:
Federal Open Market Committee v. Merrill, 443 U.S. 340 (1979): Agencies cannot withhold records under FOIA merely because they consider them confidential. The agency must show that the information is actually exempt under one of the nine statutory exemptions.
FBI v. Abramson, 456 U.S. 615 (1982): Agencies cannot rely on a "mosaic theory" of withholding, where they argue that release of some information, in combination with other publicly available information, would reveal sensitive information.
Washington Post Co. v. U.S. Dep't of Health and Human Servs., 690 F.2d 252 (D.C. Cir. 1982): Agencies cannot withhold documents simply because they contain both exempt and non-exempt material. Rather, the agency must segregate and release the non-exempt material.
The requested documents will be made available to the general public, and this request is not being made for commercial purposes.
In the event that there are fees, I would be grateful if you would inform me of the total charges in advance of fulfilling my request. I would prefer the request filled electronically, by e-mail attachment if available or CD-ROM if not.
Thank you in advance for your anticipated cooperation in this matter. I look forward to receiving your response to this request within 20 business days, as the statute requires.
Sincerely,
Jordan Lassiter
From: Food and Drug Administration
*** This is an automated message. Please do not reply to this email. ***
Reference: FDA23091626
Dear Requester,
This is to confirm that you submitted a request for record(s) from the Food and Drug Administration
pursuant to the Freedom of Information Act.
FOIA staff will review your request to determine whether it has sufficient information to be processed;
if so, you will receive another email as a formal acknowledgement of your request, with a control number for your request.
If your request is not sufficiently described,
or if there are any other deficiencies with your submission, FOIA staff will contact you via telephone or email.
From: Food and Drug Administration
Control number: 2023-3157
Please find the attached acknowledgement regarding your FOIA request. Note: Do NOT reply directly to this E-mail
From: Muckrock Staff
To Whom It May Concern:
I wanted to follow up on the following Freedom of Information Act request, copied below, and originally submitted on April 17, 2023. Please let me know when I can expect to receive a response. You had assigned it reference number #2023-3157.
Thanks for your help, and let me know if further clarification is needed.
From: Food and Drug Administration
Good morning. FDA received the attached, which you mailed to FDA. Please note that the correct address for our office is:
Division of Freedom of Information
US Food & Drug Administration
5630 Fishers Lane
Room 1035
Rockville, MD 20857
Regarding your request, the Center for Biologics is processing an unprecedented number of FOIA requests and FOIA litigation due to COVID-19. We expect it will be at least 18-24 months for response.
Thanks,
Sarah B. Kotler, J.D.
Director, Division of Freedom of Information
US FDA
301-796-8976
From: Muckrock Staff
To Whom It May Concern:
I wanted to follow up on the following Freedom of Information Act request, copied below, and originally submitted on April 17, 2023. Please let me know when I can expect to receive a response. You had assigned it reference number #2023-3157.
Thanks for your help, and let me know if further clarification is needed.
From: Muckrock Staff
To Whom It May Concern:
I wanted to follow up on the following Freedom of Information Act request, copied below, and originally submitted on April 17, 2023. Please let me know when I can expect to receive a response. You had assigned it reference number #2023-3157.
Thanks for your help, and let me know if further clarification is needed.
From: Food and Drug Administration
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Public Health Service
Food and Drug Administration
Silver Spring MD 20993-0002
Bldg 22, Mailstop 4447
Date : 23-Jan-2024
Dear Reporter:
Thank you for submitting your report to MedWatch, The FDA Safety Information and Adverse Event Reporting Program.
This acknowledgement confirms that your report was received. Reports are added to a postmarketing safety database with similar reports and reviewed by the FDA postmarketing safety staff. Voluntary reports are essential for ensuring the continued safety of FDA-regulated products. One or two well-documented case reports may provide an early signal of unexpected problems and lead to additional evaluation. This may result in FDA regulatory actions that improve the safety of the products used in patient care each day.
You might be contacted by an FDA staff member if additional information on your report is needed.
If this is a medical emergency, please call 911.
If you have a mental health crisis, please call 988.
You can also report by using the Internet, from our MedWatch website, www.fda.gov/medwatch<http://www.fda.gov/medwatch>.
Again, thank you for taking the time to submit your report.
Sincerely yours,
MedWatch
__________________________________________________________________
Subscribe to the MedWatch E-list, www.fda.gov/medwatch/elist.htm<http://www.fda.gov/medwatch/elist.htm>, to receive e-mail safety alerts about FDA regulated medical products.
DO NOT RESPOND TO THIS EMAIL, IT IS A SEND-ONLY ACCOUNT
From: Muckrock Staff
To Whom It May Concern:
I wanted to follow up on the following Freedom of Information Act request, copied below, and originally submitted on April 17, 2023. Please let me know when I can expect to receive a response. You had assigned it reference number #2023-3157.
Thanks for your help, and let me know if further clarification is needed.
From: Muckrock Staff
To Whom It May Concern:
I wanted to follow up on the following Freedom of Information Act request, copied below, and originally submitted on April 17, 2023. Please let me know when I can expect to receive a response. You had assigned it reference number #2023-3157.
Thanks for your help, and let me know if further clarification is needed.
From: Muckrock Staff
To Whom It May Concern:
I wanted to follow up on the following Freedom of Information Act request, copied below, and originally submitted on April 17, 2023. Please let me know when I can expect to receive a response. You had assigned it reference number #2023-3157.
Thanks for your help, and let me know if further clarification is needed.
From: Food and Drug Administration
It looks like this agency uploaded responsive documents to a portal or link sharing site. Our team is working on moving them over, so please check back soon.
Dear Mr. Lassiter,
This e-mail is in reply to your request for a status update regarding your submitted Freedom of Information Act request # 2023-3157. Your request is currently pending in CBER's complex Track.
CBER's FOIA resources are currently stretched to capacity due to CBER marshaling its resources to comply with court-ordered record productions that are without precedent in volume and time to produce. Recently, CBER has been ordered to collectively produce 90,000 to 180,000 pages per month (from July 2023 to June 2025) in Pub. Health & Med. Pros. for Transparency ("PHMPT") v. FDA, Case No. 4:21-cv-1058 (N.D. Tex.) and PHMPT & Stephanie and Patrick de Garay v. FDA, Case No. 4:22-cv-915 (N.D. Tex.). Further, beginning in fiscal year 2019, the number and complexity of overall FOIA requests received by CBER began to increase. In fiscal year 2019, CBER received 391 FOIA requests, and in fiscal year 2020, CBER received 399. By fiscal year 2021, CBER began to receive annual requests exceeding 500 (509 in fiscal year 2021 and 633 in fiscal year 2022), exacerbated by requests for records related to the COVID-19 global pandemic. Some of these more recent requests collectively seek millions of pages of records.
FOIA administration is an unfunded mandate-that is, it is not a separate "line item" category in legislative appropriations for the agency, and thus FOIA operations must be funded from general budgetary appropriations. See, e.g., DOJ, FOIA Update: FOIA Affected by Budget Constraints, https://www.justice.gov/oip/blog/foia-update-foia-affected-budget-constraints. Accordingly, when the agency receives more FOIA requests than usual, it cannot hire more employees with specific FOIA funding to assist with the additional work.
Due to the above-mentioned circumstances, it is difficult to provide more specificity than an estimated completion date of at least 2 years.
However, please see below for some public website links which you may find useful:
* https://vaers.hhs.gov/data.html
* https://wonder.cdc.gov/vaers.html
* https://www.fda.gov/vaccines-blood-biologics/coronavirus-covid-19-cber-regulated-biologics/pfizer-biontech-covid-19-vaccine
* https://www.fda.gov/vaccines-blood-biologics/comirnaty
* https://www.fda.gov/about-fda/center-biologics-evaluation-and-research-cber/biologics-electronic-reading-room-efoia
* https://fdahhs.ent.box.com/s/xaaal1mghm0wxl56iqeenyk2t396zueh
* https://www.fda.gov/vaccines-blood-biologics/guidance-compliance-regulatory-information-biologics/biologics-guidances
Sincerely,
Elizabeth Sly
Branch Chief, ALFOIB