In the fastest time in history and before the clinical trials are complete, On August 23, 2021, the US FDA granted BLA approval of Pfizer/ BioNTech COVID-19 vaccine called COMIRNATY for 16 years and older, even though their own data shows higher all-cause deaths amongst the vaccinated group in the clinical trial. [5]
On the same day, the FDA publishes another letter addressed to Pfizer which burried in the fine print confirmed that EUA product is “legally distinct” from COMIRNATY. [6, 7]
Dr Robert Malone shares that he doesn’t believe these are legally the same products, but FDA documents state licensed and EUA formulations are the same, and can be used “interchangeably to provide the vaccination series without presenting any safety or effectiveness concerns”. Pfizer appear to be intentionally not marketing their newly approved product labelled COMIRNATY, which is unusual.
“…the FDA approval does not change the fact that we don’t have long-term safety data with the vaccine.”
stated Dr Jay Bhattacharya
Granting approval is suspicious in light of 9,024 reported deaths in US following the Pfizer COVID-19 vaccine, which could be as many as 200,000 deaths, for a product with no solid long-term safety data, because the Pfizer placebo control group was un-blinded in December 16, 2020.
Did Pfizer’s early 2020 lobbying efforts to the FDA and CDC help with this approval? Totaling $13.2 million in 2020, the most since 2009.
This product approval is another example of unprecedented deviation from normal protocols; failing to adhere to the normal regulatory process with checks and balances. [1, 2, 3, 4]
- June 4, 2022 – Pfizer quietly admit they will never manufacture the FDA approved COMIRNATY! [5]
- June 24, 2024 – House Judiciary release report on Biden Administration pressuring the FDA to grant BLA for the vaccine. “During the pandemic, politics overruled science at the government institutions entrusted with protecting public health”. [6]