Documents related to Pfizer vaccines have attracted worldwide attention in the last six months.
The FDA’s loss in Texas district court means the agency has begun releasing a large number of documents related to the review of Pfizer’s safe and effective Covid-19 vaccine.
Approximately 126 million doses of Pfizer vaccine (126,212,580 doses) were administered worldwide in the three months from the date of receipt of the first emergency temporary authorization on December 1, 2020, through February 28, 2021
In August 2021, a group called Public Health and Medical Professionals for Transparency (PHMPT) submitted a Freedom of Information Act (FOIA) request to the FDA for all data used to approve the Pfizer-BioNTech Covid-19 vaccine. Initially, the FDA said it would release 500 pages per month, which PHMPT considered too slow. in January 2022, a Texas judge ruled that the FDA should release documents at a rate of “more than 12,000 pages” on or before January 31, and then starting on or before March 1 “55,000 pages “every 30 days.
Someone summarized some of the facts revealed by the publicly available information so far.
Pfizer documents show a large number of spontaneous adverse event reports, hiring about 600 additional full-time employees to handle adverse event reports in the three months after its COVID-19 vaccine was licensed. It plans to hire an additional 1,800 employees by June 2021 to handle the influx of adverse event reports.
Pfizer claims that as of Feb. 21, they had received 3,067 case reports, of which 1,013 were medically confirmed. At the time of their reporting, 547 were unresolved, 558 were resolved, and 136 proved fatal. both the FDA and Pfizer are aware that the Covid-19 vaccine has killed at least 12 people with autoimmune diseases. In medically confirmed cases, this equates to a 13.4% mortality rate (136/1013). And Pfizer concluded that “this cumulative case review does not raise new safety concerns.”
The documents show that Pfizer was well aware of the presence of natural antibodies during their experiments: natural immunity. They knew that the natural antibodies (the antibodies that recover from infection with C-19) were 100% effective. But in the conclusion, the paper says that the final efficacy results showed that with or without evidence of prior infection, the Pfizer vaccine provided protection for both participants.
Moreover, after the first dose of the vaccine, the white blood cells in the vaccine recipient’s body drop significantly because the immune system is affected. The vaccine increases the chance of infection up to 7 days after vaccination.
Pfizer also documented that the first adverse event associated with the vaccine was 1P36 Deletion Syndrome. This is a congenital genetic disorder that affects fetuses and deletes parts of their chromosomes, causing them to be born with severe intellectual disabilities.
A survey of official government data found that people fully vaccinated with Pfizer were up to three times more likely to contract Covid-19, two times more likely to be hospitalized with Covid-19, and three times more likely to die from Covid-19 than those who were not vaccinated. Translated into human terms, this means that the more you get vaccinated, the more likely you are to become infected.
The documents show that in February 2021 Pfizer and the FDA were aware of the existence of VAED (antibody-dependent enhancement effect), and they both knew that vaccine-related enhancement disease was a possible outcome of mRNA vaccination. Antibody-dependent enhancement: Also known as antibody-dependent enhancement of infection effect, this is when a non-neutralizing antibody to a virus (antibody to the C-19 vaccine) binds to the virus, but instead of killing the virus, it brings the virus into the immune system, making it easier for the virus to invade cells and cause more serious disease. Because the antibodies do not kill the virus, but rather promote the virus to travel freely in the cells and multiply, the more booster doses are given, the worse the situation becomes.
The situation mentioned in the report shows that the FDA was clearly informed.
The mortality rate of COVID among vaccinated and booster vaccine recipients exceeded that of unvaccinated individuals. The Pfizer document states that as of February 28, 2021, there were 317 reported incidents of antibody-associated enhanced vaccine-dependent disease (VAED) that may be related to the vaccine. Of the 101 subjects diagnosed with infection after vaccination, 75 had serious illnesses that resulted in hospitalization, disability and death. But none of these 75 individuals could be considered VAED.
The two sets of publicly available review documents confirm a challenge raised by an industry expert back in January 2021.Peter Doshi is a senior editor at BMJ and an associate professor of pharmaceutical and health services research at the University of Maryland School of Pharmacy. He notes.
Pfizer’s clinical report begins by counting a large number of patients who could not be identified as covid19 in the clinical data.
“In the overall study population, there were 3,410 suspected but not confirmed cases of covid-19, and 1,594 occurred in the vaccine group versus 1,816 in the placebo group.”
He noted that there were 20 times more suspected cases than confirmed cases and that this category of disease cannot be ignored just because there are no positive PCR tests. In fact it makes it even more urgent to know. A rough estimate of the vaccine’s efficacy in the presence of covid-19 symptoms, with or without a positive PCR test result, would reduce the relative risk by 19% (see footnote) – well below the 50% threshold for authorized effectiveness set by regulators. Even after excluding cases that occurred within 7 days of vaccination (409 cases for Pfizer vaccine and 287 cases for placebo), which should include most of the symptoms due to short-term vaccine reactogenicity, vaccine efficacy remains low: 29% (see footnote).
If many or most of these suspected cases were people with false-negative PCR test results, this would significantly reduce the efficacy of the vaccine. But given that influenza-like illnesses always have a myriad of causes – rhinovirus, influenza virus, other coronaviruses, adenovirus, respiratory syncytial virus, etc. – some or many of the suspected covid-19 cases may be caused by different causative agents.
But Pfizer’s 92-page report does not mention the 3,410 “suspected covid-19” cases. Neither does its publication in the New England Journal of Medicine. Nor is there any report on the Moderna vaccine. The only source where the report appears is the FDA review of the Pfizer vaccine.
Second, the inexplicable removal of a group of trial subjects.
Another reason we need more data, he said, is an unexplained detail found in the analysis of FDA tables reviewing the Pfizer vaccine. 371 people were excluded from the efficacy analysis because of “important protocol deviations on or before 7 days after dose 2.” Of concern is the imbalance in the number of these excluded individuals between randomized groups. 311 individuals in the vaccine group and 60 in the placebo group. (In contrast, in Moderna’s trial, only 36 participants were excluded from the efficacy analysis due to “major protocol deviations” – 12 in the vaccine group vs. 24 in the placebo group).
What were these protocol deviations in the Pfizer study and why were participants in the vaccine group excluded 5 times?The FDA report doesn’t say, and these exclusions are hard to even find in Pfizer’s reports and journals.
Worse, he found that the results of the Pfizer vaccine were determined by three Pfizer employees, not by independent university-affiliated physicians, as was the case with the Modena vaccine. And in the Pfizer vaccine trial, there were seven subjects in the placebo group, while only one subject in the vaccine group tested positive for covid-19 at baseline, thus “stacking the deck”.
We also do not know enough about the procedures of the main event adjudication committees that count covid-19 cases. Did they blind antibody data and patient symptom information in the first week after vaccination? What criteria did they use and why is such a committee even necessary in a primary event consisting of patient-reported outcomes (covid-19 symptoms) and PCR test results? It is also important to know who the members of these committees are. While Moderna has appointed its four-person adjudication committee – all university-affiliated physicians – Pfizer’s protocol says three Pfizer employees did the work. Yes, Pfizer employees.
More importantly, additional comments have been made about why you vaccinate people over the age of 70 with no data on its efficacy for that age group and make unfounded claims that they are 70% protected after at least 12 weeks of a single dose of vaccine
In addition, recent publicly available information. also show that the Pfizer vaccine test did not provide complete information to the adolescent study participants.
So, all things considered, we need an explanation from Pfizer!
