A recent court ruling in Texas directed the Food and Drug Administration (FDA) to release the data it used to grant emergency authorization for COVID-19 vaccines by 2025.. FDA US Food and Drug Aministration .The FDA proposed releasing the documents over approximately 23.5 years, but the court mandated all relevant information be made public by mid-2025..A court ruled in favour of transparency on May 9 in a lawsuit against the FDA by parents of a child allegedly injured by a COVID-19 vaccine..The court ordered the FDA to expedite the release of data on Moderna's adult vaccine and Pfizer's vaccine for children, about 10 times faster than the FDA’s original proposed release..The plaintiffs' lawyer said the decision was a significant win for transparency..“Democracy dies behind closed doors,” said US District Judge Mark Pittman..Pittman directed the FDA to produce data on Moderna's and Pfizer's COVID-19 vaccines at a minimum rate of 180,000 pages per month..The FDA said it would be “impractical” to release the projected 4.8 million pages at a rate exceeding 1,000 to 16,000 pages per month, a process that would have taken at least 23.5 years..The plaintiffs' attorney, Aaron Siri of Siri & Glimstad, said the decision is “another blow for transparency and accountability.”.This ruling builds on a previous court order focused on the COVID-19 vaccine data of individuals aged 16 and above, specifically targeting Pfizer..Pittman's January 2022 order directed the FDA to release Pfizer's COVID-19 vaccine data for those aged 16 and above at a rate of 55,000 pages per month..This rate was significantly faster than the 75-year timeline initially proposed by the FDA..“That production should be completed in a few more months,” said Siri in a statement..The new order mandates the FDA release all of its data on Pfizer's COVID-19 vaccine for 12- to 15-year-olds and Moderna's vaccine for adults by June 31, 2025..Pittman acknowledged the FDA restricted resources for fulfilling freedom of information requests (FOIA) in his order. However, Pittman stated the FDA’s resources do not define an individual's FOIA rights..“Instead, the court must ensure the fullest possible disclosure of the information sought is timely provided, as ‘stale information is of little value,'” said Pittman..To help the FDA meet the new deadline, Pittman instructed the parties involved in the lawsuit to collaborate and present a joint production schedule for the data by May 23..The FDA argued it could only review and publish 500 pages per month out of an estimated 450,000 pages of data on Pfizer's COVID-19 vaccine for those aged 16 and older in the earlier case, where Pittman was also the judge..Although the FDA did not dispute its obligation to release the information in either case, it said that its FOIA office, which is understaffed, cannot keep up with the pace of production demanded by the plaintiffs..The judge rejected the argument, stating transparency and accountability are crucial imperatives in both cases..Pittman said in the January order excessive delays and secrecy by federal agencies fuel conspiracy theories and erode public trust in the government.
A recent court ruling in Texas directed the Food and Drug Administration (FDA) to release the data it used to grant emergency authorization for COVID-19 vaccines by 2025.. FDA US Food and Drug Aministration .The FDA proposed releasing the documents over approximately 23.5 years, but the court mandated all relevant information be made public by mid-2025..A court ruled in favour of transparency on May 9 in a lawsuit against the FDA by parents of a child allegedly injured by a COVID-19 vaccine..The court ordered the FDA to expedite the release of data on Moderna's adult vaccine and Pfizer's vaccine for children, about 10 times faster than the FDA’s original proposed release..The plaintiffs' lawyer said the decision was a significant win for transparency..“Democracy dies behind closed doors,” said US District Judge Mark Pittman..Pittman directed the FDA to produce data on Moderna's and Pfizer's COVID-19 vaccines at a minimum rate of 180,000 pages per month..The FDA said it would be “impractical” to release the projected 4.8 million pages at a rate exceeding 1,000 to 16,000 pages per month, a process that would have taken at least 23.5 years..The plaintiffs' attorney, Aaron Siri of Siri & Glimstad, said the decision is “another blow for transparency and accountability.”.This ruling builds on a previous court order focused on the COVID-19 vaccine data of individuals aged 16 and above, specifically targeting Pfizer..Pittman's January 2022 order directed the FDA to release Pfizer's COVID-19 vaccine data for those aged 16 and above at a rate of 55,000 pages per month..This rate was significantly faster than the 75-year timeline initially proposed by the FDA..“That production should be completed in a few more months,” said Siri in a statement..The new order mandates the FDA release all of its data on Pfizer's COVID-19 vaccine for 12- to 15-year-olds and Moderna's vaccine for adults by June 31, 2025..Pittman acknowledged the FDA restricted resources for fulfilling freedom of information requests (FOIA) in his order. However, Pittman stated the FDA’s resources do not define an individual's FOIA rights..“Instead, the court must ensure the fullest possible disclosure of the information sought is timely provided, as ‘stale information is of little value,'” said Pittman..To help the FDA meet the new deadline, Pittman instructed the parties involved in the lawsuit to collaborate and present a joint production schedule for the data by May 23..The FDA argued it could only review and publish 500 pages per month out of an estimated 450,000 pages of data on Pfizer's COVID-19 vaccine for those aged 16 and older in the earlier case, where Pittman was also the judge..Although the FDA did not dispute its obligation to release the information in either case, it said that its FOIA office, which is understaffed, cannot keep up with the pace of production demanded by the plaintiffs..The judge rejected the argument, stating transparency and accountability are crucial imperatives in both cases..Pittman said in the January order excessive delays and secrecy by federal agencies fuel conspiracy theories and erode public trust in the government.
