It seems that the final batch of the Pfizer docs are revealed by the FDA. The funny thing is that this is happening after 800 days since the approval of the terrible threat for humanity.
Final batch of Pfizer vaccine docs revealed
The FDA released the final batch of documents it relied upon in licensing Pfizer’s Comirnaty COVID-19 vaccine for ages 16 and up—more than 800 days after the agency approved the shot.
The documents are “finally in the hands of the public, where they belong,” the Informed Consent Action Network said in a press release. “Now, independent scientists and researchers can see everything FDA saw when it made its decision that this vaccine was ‘safe and effective.’”
Recently disclosed documents as part of a Freedom of Information Act (FOIA) lawsuit against the U.S. Food and Drug Administration (FDA) suggest that the agency was aware of the insufficiency of its safety monitoring system in assessing the risk of heart conditions associated with Pfizer’s COVID-19 vaccine when it licensed the “Comirnaty” vaccine.
The documents also reveal several manufacturing issues in Pfizer’s batches released to the public.
Also, the FDA was aware of a phenomenon called vaccine-associated enhanced disease (VAED) in those vaccinated who experience breakthrough COVID-19.
Federal health agencies have claimed that the COVID-19 vaccines are being monitored for safety more intensively than any other vaccine in the history of the United States.
They have stated that there is a continuous and robust safety monitoring system in place to ensure that the benefits of the vaccine outweigh any risks.
However, the final documents released from Pfizer’s biologic product file reveal that the agency was aware that its safety monitoring program was not sufficient to assess the serious risks of myocarditis and pericarditis associated with Pfizer’s COVID-19 vaccine.
An FDA memo that was found among the 51,893 pages of disclosures specifically addressed the agency’s CBER Sentinel Initiative and its ability to evaluate the risk of myocarditis and pericarditis following COVID-19 vaccination.
The Sentinel program is the FDA’s national electronic system used to monitor the safety of its regulated products and is a major part of the agency’s mission to protect public health.
