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Covid-19: Norway investigates 23 deaths in frail elderly patients after vaccination

BMJ 2021; 372 doi: https://doi.org/10.1136/bmj.n149 (Published 15 January 2021) Cite this as: BMJ 2021;372:n149

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Rapid Response:

A little story about Covid-19 vaccine safety, CDC and FOIA

Dear Editor

Following Peter Doshi's rapid response [1] discussing the way the FDA is monitoring the safety of vaccines currently used in the US, I filed a FOIA request to the CDC (Request Number: 21-00899-FOIA), requesting :

1. All reports / preliminary reports / correspondences (including emails) and statistical tables owned by the CDC or any of it’s employee and/or contractor related to the disproportionality analyses done on the VAERS
2. All reports / preliminary reports / correspondences and statistical tables owned by the CDC or any of it’s employee and/or contractor related to the safety analyses done on the Vaccine Safety Datalink (VSD Rapid Cycle Analysis) for the Covid-19 vaccines currently used.

Here is the response I got (in short) :

"CDC located data records responsive to your request.

[...]

This statute and the assurance of confidentiality prohibits the release of information that would permit identification of any individual. Therefore, under the authority of the Freedom of Information Act, 5 U.S.C. Section 552, pertaining to exemption(b)(3), records exempted by other statutes, and in compliance with Section 308(d) of the Public Health Service Act, the data is withheld in full.

The data provided by submitter entities also contains confidential and/or proprietary information and the information is withheld under Exemption (b)(4).

Exemption (b)(4) protects trade secrets and commercial or financial information obtained from a person that is privileged or confidential. [...]"

It's hard to understand how statistical tables and associated reports / correspondences can represent "trade secrets and commercial or financial information" - exemption (b)(4) - or contain "personal information" - exemption (b)(3) - they can even redact all those sensitive information if they appear in the documents. It seems that "opacity" is still the gold standard for everything that's related to vaccine safety while billions $ have been spent by taxpayers to develop those vaccines, and manufacturers are exempt from liability.

[1] https://www.bmj.com/content/372/bmj.n149/rr-25

Competing interests: No competing interests

22 April 2021
Surya ARBY
Contractor
25 rue de la liberation - 92500 Rueil-Malmaison, France