Plaintiffs assert that FDA should be able to get them the information by March 3, 2022. Meanwhile, talk of changing definition of “fully vaccinated” begins.
In response to a Freedom of Information Act request, the Food & Drug Administration is asking a federal court to grant the agency until 2076, 55 years, to process and release all the data on the Pfizer COVID-19 vaccine.
The agency seeks to release 500 pages per month until the enormous volume of information has been completely processed.
Justice Department lawyers representing the FDA note in court papers that the plaintiffs are seeking a huge amount of vaccine-related material – about 329,000 pages.
The plaintiffs, a group of more than 30 professors and scientists from universities including Yale, Harvard, UCLA and Brown, filed suit in September in U.S. District Court for the Northern District of Texas, seeking expedited access to the records. They say that releasing the information could help reassure vaccine skeptics that the shot is indeed “safe and effective and, thus, increase confidence in the Pfizer vaccine.”
But the FDA can’t simply turn the documents over wholesale. The records must be reviewed to redact “confidential business and trade secret information of Pfizer or BioNTech and personal privacy information of patients who participated in clinical trials,” wrote DOJ lawyers in a joint status report filed Monday.
The FDA proposes releasing 500 pages per month on a rolling basis, noting that the branch that would handle the review has only 10 employees and is currently processing about 400 other FOIA requests.
The plaintiffs in this case assert that the FDA should be able to get them the information by March 3, 2022, in just over four months.
‘This 108-day period is the same amount of time it took the FDA to review the responsive documents for the far more intricate task of licensing Pfizer’s COVID-19 vaccine,’ wrote Aaron Siri of Siri & Glimstad in New York and John Howie of Howie Law in Dallas in court papers.
‘The entire purpose of the FOIA is to assure government transparency,’
‘It is difficult to imagine a greater need for transparency than immediate disclosure of the documents relied upon by the FDA to license a product that is now being mandated to over 100 million Americans under penalty of losing their careers, their income, their military service status, and far worse.’
I would argue that the expedited review is reasonable and essential, in light of the fact that public health agencies are considering changing the definition of “fully vaccinated” to three shots.
Waning vaccine immunity and rising infections due to the Delta variant has prompted wealthy nations to reconsider the definition of “fully vaccinated” — which usually means two Covid-19 jabs.
UK Prime Minister Boris Johnson admitted as much on Monday, saying boosters were vital to prevent pandemic restrictions from being reintroduced. “It’s very clear that getting three jabs — getting your booster — will become an important fact and it will make life easier for you in all sorts of ways,” he told a press conference.
Other European nations are moving towards mandates on booster jabs. By December 15, anyone over the age of 65 will need a third dose to revalidate their vaccination pass in France, President Emmanuel Macron announced last week. In Austria, full vaccination status expires after nine months of the second dose, which in effect enforces booster doses. In Israel, unless you received your second dose of the Covid-19 vaccine within the last six months, you now need a third dose to become eligible for a green pass, which allows entry to gyms, restaurants and other venues.
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