Posted by Roger Mallett Posted on 26 June 2022

The Moderna Spikevax Covid-19 Vaccine. Nonprofit Sues FDA to Obtain Documents Related to Approval

A nonprofit group is suing the U.S. Food and Drug Administration in an effort to obtain documents relating to the FDA’s approval of Moderna’s Spikevax COVID-19 vaccine after the agency told the group there was “no compelling need” to expedite the release of the documents.

A nonprofit group is suing the U.S. Food and Drug Administration (FDA) in an effort to obtain documents relating to the FDA’s approval of Moderna’s Spikevax COVID-19 vaccine after the agency told the group there was “no compelling need” to expedite the release of the documents.

Dallas, Texas-based Defending the Republic on June 7 filed the lawsuit in the U.S. District Court for the Northern District of Texas.

This is the same court that previously ordered the release of the FDA’s documents pertaining to the approval of the Pfizer COVID-19 vaccine, rejecting the FDA’s proposed release schedule that would have meant those documents would be made public over a period of 75 years.

The FDA granted full approval of Spikevax on Jan. 31. Just a few days later, on Feb. 3, Defending the Republic filed a Freedom of Information Act (FOIA) request with the FDA, “seeking the expedited production of records relating to the FDA’s approval of the Moderna COVID-19 vaccine.”

According to the lawsuit, Defending the Republic:

“… is a public interest group committed to the rule of law and the principles on which this country was founded.

“It defends victims of unlawful governmental actions, informs Americans on matters of public concern, and works tirelessly on behalf of those who are subject to unlawful government actions and mandates.”

The lawsuit notes the organization previously filed an amicus brief relating to the Biden administration’s vaccine mandate for private businesses.

Two FDA rejections led to Defending the Republic’s lawsuit

According to Defending the Republic’s lawsuit:

“On February 3, 2022, Defending the Republic made a FOIA request for all documents, data, and records submitted by Moderna to the FDA concerning the approval of Spikevax. Defending the Republic asked for expedited processing for this request.

“The request was made consistent with, and in furtherance of, Defending the Republic’s mission to ensure public access to essential information relating to COVID-19.”

The original FOIA request made the following request:

“Please provide all data and information submitted by Moderna relating to the FDA review and approval of Spikevax.

“This includes, but is not limited to, all safety and effectiveness data and information; all data and information in the biological product file; and all ingredients.”

The FDA on Feb. 9 refused this initial request for expedited production of the Spikevax records, arguing the group had not demonstrated “urgency” or a “compelling need” for the swift release of the documents.

Sarah Kotler, director of the FDA’s Division of Freedom of Information, wrote:

“I have determined that your request for expedited processing does not meet the criteria under the FOIA.

“You have not demonstrated a compelling need that involves an imminent threat to the life or physical safety of an individual. Neither have you demonstrated that there exists an urgency to inform the public concerning actual or alleged Federal Government activity.

“Therefore, I am denying your request for expedited processing. The responding agency office will process your request in the order in which it was received.”

Defending the Republic appealed the decision, stating in its lawsuit:

“The public deserved to know the requested information when making life-altering decisions including whether and when to vaccinate, and which vaccine—if any—to take, considering facts such as vaccine mandates affecting millions of Americans and the waning effectiveness of the Moderna vaccine.”

Read More – The Moderna Spikevax Covid-19 Vaccine. Nonprofit Sues FDA to Obtain Documents Related to Approval


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