US District Judge Mark Pittman has ruled that the US Food and Administration (FDA) must release thousands of pages of documents in relation to its COVID-19 vaccine. These are the papers the government agency relied on to license the jab, known as its “safety data”. They were due to be fully released in 75 years, but now the FDA has just over eight months to do so.
The order stems from a Freedom of Information Act (FIA) request by a coalition of doctors and scientists with the nonprofit Public Health and Medical Professionals for Transparency (PHMPT).
The group seeks an estimated 450,000 pages of material about the vaccine-creation process during the COVID-19 pandemic that came into full force in the US in March 2020.
The FDA had proposed to produce 500 pages a month, but Judge Pittman ordered the agency to turn over 55,000 a month.
Based on the agreed timeline, all the Pfizer vaccine data should be public by the end of September, rather than the year 2097.
The ruling noted: “Here, the court recognises the ‘unduly burdensome’ challenges that this [Freedom of Information Act] request may present to the FDA.
“But, as expressed at the scheduling conference, there may not be a ‘more important issue at the Food and Drug Administration than the pandemic, the Pfizer vaccine, getting every American vaccinated, [and] making sure that the American public is assured that this was not rush[ed] on behalf of the US.”
Judge Pittman’s ruling requires the FDA to produce more than 12,000 pages before January 31.
But then the judge has ordered the agency to “produce the remaining documents at a rate of 55,000 pages every 30 days, with the first production being due on or before March 1, 2022, until production is complete”.
PHMPT said the data should be made public quickly because the FDA took just under four months to review the data before granting full approval for the Pfizer-BioNTech COVID-19 vaccine.
The supply of this vaccine has changed to be in accordance with the conditional Marketing Authorisation (CMA).
This CMA was issued by the European Medicines Agency (EMA) on December 21, 2020, and became a UK CMA on January 1, 2021.
Manufacture of the vaccine remains unchanged, as do the clinical, pharmacological and pharmaceutical properties of the vaccine.
The MHRA regularly publishes reports on the safety of the COVID-19 vaccines.
You can read the full reports here.