Informed Consent Action Network (ICAN) advocates have won another major victory for transparency following another lawsuit against the FDA.
A federal judge ordered the FDA to disclose the documents it relied on in approving Pfizer’s COVID vaccine for children ages 12-15 and Moderna’s COVID vaccine.
Although FDA insisted on taking 23.5 years, the federal judge, who included the quote “Democracy dies behind closed doors” in the introduction to his decision, ordered FDA to release the records in just two years.
As can be read on the ICAN website, attorneys led by Aaron Siri obtained a court order in January 2022 requiring the FDA to make available all of Pfizer’s COVID-19 vaccine data for people 16 and older, at a rate of 55,000 pages per month, despite the FDA’s 75-year request.
New Request: ICAN attorneys filed another lawsuit, this time also on behalf of PHMPT. This was after Maddie de Garay, a young woman seriously injured in a Pfizer clinical trial for children ages 12 to 15, and her parents were affected.
The purpose of the lawsuit was to demand documents from the FDA related to Pfizer’s COVID-19 vaccine for children ages 12 to 15 and the Moderna vaccine.
They explained to the court the importance of timely disclosure. Once again, FDA argued that it would be “impractical” to disclose the 4.8 million pages, which means more than 1,000 to 16,000 pages per month, or, in other words, in at least 23.5 years!
ICAN’s lawyers have challenged this, demanding that the FDA release all documents before mid-2025.
In another significant victory for transparency, the federal judge ordered FDA to produce all requested documents by June 2025, or an average of about 180,000 pages per month – in other words, in just 2 years!
The court also agreed that plaintiffs had shown an urgent need to inform the public about the health and safety of COVID-19 vaccines.
This was recognized in light of the extensive vaccination campaigns, ongoing efforts to eradicate COVID-19, and government and private sector efforts to mandate these vaccines.
The court recognized the need for this information not only for the good of the US healthcare system but also for the health of society as a whole.
FDA, Covid vaccines, Informed Consent Action Network, ICAN,