The United States Food and Drug Administration (FDA) is saying that it needs a full 75 years in order to fully release all data concerning the Pfizer and BioNTech vaccine against COVID-19. Previously, the FDA claimed it needed 55 years to release vaccine information such as safety, efficacy, test protocols, and adverse reaction reports, among other data.
The release of the vaccine data was prompted by a Freedom of Information Act (FOIA) request brought by the group Public Health and Medical Professionals for Transparency (PHMPT). The group claims that the information should be available quickly since the FDA spent only 108 days reviewing the same data prior to granting an emergency use authorization for the vaccine.
PHMPT is comprised of more than 30 accomplished academics, professors, and scientists from medical schools all over the world. The group boasts scientists and physicians from some of the top medical schools in the United States as well as from Denmark, the United Kingdom, Germany, and Australia.
According to Justice Department lawyers representing the FDA, the amount of data being requested is vast — approximately 451,000 pages — and each page must be reviewed in order to redact what it terms “confidential business and trade secret information of Pfizer or BioNTech and personal privacy information of patients who participated in clinical trials.”
Even if that’s true, it’s hard to believe it would take three-quarters of a century to redact names and secret trade information from the documents. It’s “difficult to believe,” according to Aaron Siri, an attorney working on behalf of PHMPT.
“And if you find what you are reading difficult to believe — that is because it is dystopian for the government to give Pfizer billions, mandate Americans to take its product, prohibit Americans from suing for harms, but yet refuse to let Americans see the data underlying its licensure,” Siri pointed out. “The lesson yet again is that civil and individual rights should never be contingent upon a medical procedure.”
The FDA has offered to prepare 12,000 pages of information for release by January of 2022. Thereafter, the federal bureaucracy will only commit to releasing documents at the rate of 500 pages per month.
That’s not fast enough for PHMPT, for some rather obvious reasons. An excerpt from a previous brief objecting to the 55-year timeline lays out one really good reason.
“The federal government mandating that millions of people be injected with a liability-free vaccine requires complete government transparency — not the government’s suppression of information,” that brief states.
And that’s true. Because the federal government is literally mandating millions of citizens — including the military, all federal employees, and all employees of businesses with over 100 employees — to either get vaccinated or be tested for COVID-19 up to twice weekly, some transparency regarding that vaccination should be expected. Instead, the Biden administration’s FDA appears to want to hide the full information on the Pfizer vaccine instead of releasing it.
But the FDA claims it doesn’t have the manpower to process this particular FOIA request so quickly.
“Plaintiff’s FOIA request is being processed by the Access Litigation and Freedom of Information Branch (the ‘Branch’) in FDA’s Center for Biologics Evaluation and Research (‘CBER’). The Branch has a total of ten employees, including the director and two trainees,” FDA lawyers claimed in a recent brief on the case.
The FDA also claims that any speeding up of the process would take time away from at least 400 additional FOIA requests that its CBER is currently processing.
While the FDA claims it doesn’t have the manpower to move more quickly on the release of documents, PHMPT argues that the bureaucracy not only has the ability, but it has a responsibility to move faster.
“The entire purpose of FOIA is government transparency. In multiple recent cases, in upholding the FOIA’s requirement to ‘make the records promptly available,’ courts have required agencies, including the FDA, to produce 10,000 or more pages per month, and those cases did not involve a request nearly this important — i.e., the data underlying licensure of a liability-free product that the federal government requires nearly all Americans to receive,” said Siri.
The Biden administration and its FDA are obviously slow-walking this particular FOIA request — but why, exactly? Does it fear a review of the Pfizer vaccine by scientists who are not beholden to them?
It certainly appears that way. In the Biden administration, the public’s right to know is secondary to the government’s need to control.
