Regarding Brook Jackson v.Ventavia v.Pfizer- complaint was dismissed. Still- there is interesting information in the below docs.
For example: In October 2020, FDA issued guidance regarding the data and information needed to
support issuance of an Emergency Use Authorization (EUA) for COVID-19 vaccines. The
guidance explained that FDA may…
Regarding Brook Jackson v.Ventavia v.Pfizer- complaint was dismissed. Still- there is interesting information in the below docs.
For example: In October 2020, FDA issued guidance regarding the data and information needed to
support issuance of an Emergency Use Authorization (EUA) for COVID-19 vaccines. The
guidance explained that FDA may issue an EUA after FDA has determined that the following
key criteria are met:
• Based on the totality of scientific evidence available, including data from adequate
and well-controlled trials, if available, it is reasonable to believe that the vaccine may
be effective to prevent, diagnose, or treat such serious or life-threatening disease or
condition that can be caused by SARS-CoV-2.
• The known and potential benefits of the vaccine, when used to diagnose, prevent, or
treat the disease or condition that can be caused by SARS-CoV-2, outweigh the
known and potential risks of the vaccine.
On November 20, 2020, Pfizer submitted an EUA request to FDA for the PfizerBioNTech COVID-19 vaccine. (page 4). FDA had “full confidence in the data that were used to support the
Pfizer-BioNTech COVID-19 Vaccine authorization and the Comirnaty approval.(page 6).
The SOW, which is attached to the complaint, further specifies that the Army did not regulate the conduct of the clinical trial, which is “out-of-scope” for the purchase agreement between the Army and Pfizer.In short, the complaint does not plead factual content to support a conclusion that compliance with the clinical trial protocol or regulations was necessary under the contract between Pfizer and the Army.
So, the Army did not pay for the conduct of the study- leaving Pfizer and CROs to make sure they get the necessary data from clinical trials for EUA (although these data are submitted if available, per guidance issued in Oct2020), and so Army is not interested in clinical trial data quality, as this is not included in their agreement with Pfizer.
In the second document- Pfizer motion to dismiss the amended complaint- it is explained among others that Relator (Brook Jackson) may not pursue the claims against Pfizer without the Government first pursuing them in an administrative proceeding. Also, Relator’s views are impossibly at odds with the Government’s. She is not entitled to hijack the qui tam process to pursue an anti-vaccination agenda that the Government rejects. Also Pfizer Explains about operation warp speed, and that Such agreements are executed under DoD’s Other Transaction Authority(“OTA”) ,“Other Transactions are legally binding contracts that are generally exempt from federal procurement laws and regulations”. And the Government continues to make the vaccine “free to everyone age 5 and older living in the
United States, regardless of immigration or insurance status.”
Regarding Brook Jackson v.Ventavia v.Pfizer- complaint was dismissed. Still- there is interesting information in the below docs.
For example: In October 2020, FDA issued guidance regarding the data and information needed to
support issuance of an Emergency Use Authorization (EUA) for COVID-19 vaccines. The
guidance explained that FDA may issue an EUA after FDA has determined that the following
key criteria are met:
• Based on the totality of scientific evidence available, including data from adequate
and well-controlled trials, if available, it is reasonable to believe that the vaccine may
be effective to prevent, diagnose, or treat such serious or life-threatening disease or
condition that can be caused by SARS-CoV-2.
• The known and potential benefits of the vaccine, when used to diagnose, prevent, or
treat the disease or condition that can be caused by SARS-CoV-2, outweigh the
known and potential risks of the vaccine.
On November 20, 2020, Pfizer submitted an EUA request to FDA for the PfizerBioNTech COVID-19 vaccine. (page 4). FDA had “full confidence in the data that were used to support the
Pfizer-BioNTech COVID-19 Vaccine authorization and the Comirnaty approval.(page 6).
The SOW, which is attached to the complaint, further specifies that the Army did not regulate the conduct of the clinical trial, which is “out-of-scope” for the purchase agreement between the Army and Pfizer.In short, the complaint does not plead factual content to support a conclusion that compliance with the clinical trial protocol or regulations was necessary under the contract between Pfizer and the Army.
So, the Army did not pay for the conduct of the study- leaving Pfizer and CROs to make sure they get the necessary data from clinical trials for EUA (although these data are submitted if available, per guidance issued in Oct2020), and so Army is not interested in clinical trial data quality, as this is not included in their agreement with Pfizer.
In the second document- Pfizer motion to dismiss the amended complaint- it is explained among others that Relator (Brook Jackson) may not pursue the claims against Pfizer without the Government first pursuing them in an administrative proceeding. Also, Relator’s views are impossibly at odds with the Government’s. She is not entitled to hijack the qui tam process to pursue an anti-vaccination agenda that the Government rejects. Also Pfizer Explains about operation warp speed, and that Such agreements are executed under DoD’s Other Transaction Authority(“OTA”) ,“Other Transactions are legally binding contracts that are generally exempt from federal procurement laws and regulations”. And the Government continues to make the vaccine “free to everyone age 5 and older living in the
United States, regardless of immigration or insurance status.”
https://bailiwicknewsarchives.files.wordpress.com/2022/10/2022.10.04-jackson-v.-ventavia-us-gov-intervene.pdf
https://bailiwicknewsarchives.files.wordpress.com/2022/10/2022.04.22-pfizer-motion-to-dismiss.pdf