Back in July 2020, when the U.S. Government committed to purchasing millions of doses of Pfizer’s Covid vaccines prior to the vaccines actually being authorized for use in the American public, some wondered whether the FDA’s “review” process for granting Emergency Use Authorization (EUA) was just a mere formality. Then, when two high-level FDA members resigned over the lack of autonomy in the face of the White House’s announced booster plan, it raised even more questions about whether the FDA’s “decisions” surrounding the Covid vaccines were all but a forgone conclusion.
Based on an FDA document that ICAN’s attorneys recently obtained, it appears we can now say that the FDA’s post-EUA procedure for determining whether to formally license Pfizer’s Covid vaccine was indeed just that – a mere formality.
On June 17, 2021, the FDA drafted a memo announcing that it was issuing a license number for Pfizer’s Covid vaccine. The problem? The FDA didn’t actually license the Pfizer’s Covid vaccine until several months later on August 23, 2021.
In the document, the FDA makes the stunning admission that, while granting a BLA license number prior to actual licensing was a “deviation from [the FDA’s] normal practice,” it was doing so to “facilitate product labeling and distribution” because it had reviewed “much” of the information in Pfizer’s licensing application. Although the memo states in wink-wink-nod-nod fashion that, “[w]hen providing the license number, we should communicate that this license number does not constitute any determination by FDA on the application,” it seems here, too, that licensure was a foregone conclusion.
Stay tuned as ICAN continues to uncover the truth about what went on behind-the-scenes with the Covid vaccines. In the meantime you can read the FDA’s June 17, 2021 document here.