FDA was ordered to disclose complete review documents for Pfizer COVID-19 mRNA vaccine

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FDA was ordered to disclose complete review documents for Pfizer COVID-19 mRNA vaccine

FDA was ordered to disclose complete review documents for Pfizer COVID-19 mRNA vaccine.

FDA lost a lawsuit and was ordered to disclose 329,000 pages of complete review documents for Pfizer’s COVID-19 mRNA vaccine.

A few days ago, the FDA lost a lawsuit with the American Organization of Transparency Public Health and Medical Professionals. The court ordered the FDA to complete the publication of the 329,000-page full review document of Pfizer’s COVID-19 vaccine this summer. Now the FDA has released the first documents.

The Transparency Organization of Public Health and Medical Professionals publicly posted the documents obtained from the FDA on its website, although it did not provide any kind of interpretation or organization of the documents. A total of 150 documents are currently published on its website for free download .

Regarding the above official account, reply to “Pfizer” to download the above 150 review documents.

FDA was ordered to disclose complete review documents for Pfizer COVID-19 mRNA vaccine.

Caused by the incident

In November last year, a piece of news that the US FDA would take 55 years (ie, until 2076) to fully disclose the review materials of Pfizer’s COVID-19 vaccine was hotly discussed on the Internet.

The incident stemmed from a Freedom of Information Act (FOIA) request by the American Organization of Transparency for Public Health and Medical Professionals to provide all details to support Pfizer’s COVID-19 vaccine license.

On the fourth day after the approval of Pfizer’s vaccine, the organization requested the FDA to disclose the data. After a month, the FDA did not reply, and then the organization formally sued the FDA.

FDA was ordered to disclose complete review documents for Pfizer COVID-19 mRNA vaccine.

The group said it had been three months since Pfizer’s vaccine was fully authorized by the FDA, and the FDA had not released a single page of Pfizer-related information, which violated federal law that “once authorized, the biological product is in the license approval process.

Immediate public disclosure of data and information”, which runs counter to the FDA’s commitment to “complete transparency” before and after the approval of a COVID-19 vaccine.

According to The Wall Street Journal, the group believes that this effectively amounts to the U.S. government giving Pfizer effective immunity from legal action, while at the same time sending Pfizer billions of dollars through the purchase of vaccines.

At the same time, independent scientists cannot perform the proper analysis to ensure that the vaccine is safe and effective until the FDA publishes all the documents.

In a 91-page document released by the FDA, data show that in the first two and a half months of the Pfizer vaccine’s launch, Pfizer received 42,086 adverse event reports, including 1,223 deaths.

The FDA asked a U.S. federal judge to allow the agency to disclose 500 pages of information per month, and Pfizer provided the FDA with 329,000 pages of vaccine approval documents, which also means that all data will not be fully disclosed until 2076.

FDA attorneys cite reasons why only 500 pages of documents can be processed each month, including the fact that processing documents too quickly can lead to errors and accidental disclosure of confidential material, lack of resources within FDA to speed things up, BLA’s requirement for all relevant data more than FOIA The data requested is less wait.

The group blamed it, saying it was able to “conduct what it calls an intensive, robust, thorough and complete review and analysis in as little as 108 days to ensure a vaccine is licensed when it is licensed, given the agency’s claimed 329,000 pages of data. is safe and effective”, which is a huge miracle, and now it takes more than 55 years to make the full document available to the public, which is a fantasy.

It is therefore hoped that the court will require the FDA to provide all documents and data submitted by Pfizer on a rolling basis for full release on or before March 3, 2022.

Published documents

On March 1, the FDA lost the case, which also means the agency will fully release the relevant documents by this summer, rather than 55 years.

A total of 150 documents are currently published by Transparency Public Health and Medical Professionals on its website, which the public can freely download.

According to related reports, in the released documents, the documents marked as priority review requests contain more than 100 pages of anonymous safety-related data sheets, and some other documents also include unidentified participants’ gender, age and BMI tables; some Typical drug or vaccine application documents; a document showing Pfizer paying the FDA nearly $2.9 million in standard user fees; fast-track designation letter (usually not published); non-clinical confidential summary of vaccine; vaccine trials not randomized list of anonymous subjects, etc.

These documents can give the public a good overall idea of the documents needed to apply for FDA approval of a drug or vaccine, but it is unclear whether they will provide new insights into the safety or effectiveness of the vaccine, especially given the true nature of the vaccine World data has been published in major medical journals.

“Our job is to get the documents, and the rest is for scientists and others to analyze,” said anti-vaccine lawyer Aaron Siri, managing partner at Siri & Glimstad, which represents the nonprofit.

FDA was ordered to disclose complete review documents for Pfizer COVID-19 mRNA vaccine.

(source:internet, reference only)

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