The Many Integrity Problems Regarding the Pfizer mRNA Vaccine
Covid-19: Researcher blows the whistle on data integrity issues in Pfizer’s vaccine trial
"Revelations of poor practices at a contract research company helping to
carry out Pfizer’s pivotal covid-19 vaccine trial raise questions about
data integrity and regulatory oversight."
All of the data and information that Pfizer collected during it's clinical trials phase, everything that it submitted to the FDA for it's EUA (Emergency Use Authorization), and all the data and information filed with the FDA for approval of the vaccine, has up until now been kept secret. This is not the way this has been handled in the past and is not considered ethical by existing standards. There is something called "medicine by PR" which means that sometimes doctors practice medicine based on PR releases rather than all of the actual data regarding a product or treatment. This is not uncommon in situations where the medication or other product is needed immediately, but what usually happens is that the PR release contains a fair amount of information and the rest of the information is provided soon afterwards. In this case not only was no additional information released, but the PR releases did not contain much info. Doctors were asked to promote Pfizer's vaccine on faith and while many of them were uncomfortable about this, they did have enough faith in the health authorities and the concept of vaccination that they went along with it. Over time there has been increasing frustration among many doctors and other health care professionals about the continued refusal to provide even the basic data, which is pretty much unprecedented, and a corresponding loss of faith in those medical authorities, to the point that there is a lot of anger at how the FDA and CDC have not only destroyed their own credibility but are actually destroying the credibility of medicine and science in general in the US. This is already having a harmful effect on the credibility of climate science in particular.
A non-profit called Public Health and Medical Professionals for Transparency (PHMPT) submitted a FOIA request (FOIA stands for Freedom of Information Act). On their website, they state that
"This non-profit, made up of public health professionals, scientists, and journalists exists solely to obtain and disseminate the data relied upon by the FDA to license COVID 19 vaccines. The organization takes no position on the data other than that it should be made publicly available to allow independent experts to conduct their own review and analyses. Any data received will be made public on this website."
ALSO:
"Four days after the Pfizer vaccine was approved for ages 16+, we submitted a Freedom of Information Act Request to the FDA for all of the data within Pfizer’s COVID-19 vaccine biological product file. We have now sued the FDA for not releasing the data. Click below for court documents and for productions of Pfizer’s documents from the FDA."
This is website of Public Health and Medical Professionals for Transparency (PHMPT)
This is the FOIA request that was filed on their behalf
This is the lawsuit that they filed against the FDA to compel them to release the data
These are two documents linked to in the above filing:
FDA Approves First COVID-19 Vaccine
Covid-19 vaccines: In the rush for regulatory approval, do we need more data? (published in the BMJ)
Neil Oliver discusses Pfizer releasing initial trial data
A guest on the show, who is a diagnostic pathologist, discusses her thoughts on the first set of papers released from Pfizer. She makes the point that one document, which lists harm and injuries reported to Pfizer, had already been released into the public domain. She also points out that this is a list of diagnoses and side effects that was reported to the surveillance systems of individual countries, not directly to Pfizer, and that the information is not there to be able to measure these outcomes or to confirm that they were caused by the vaccine. Additionally she notes that vaccine adverse events have a history of being highly under reported, for a number of reasons, some more than others. Adverse events in older people are often written off as just aging, common health problems are more likely to be written off as coincidental, while certain other conditions are rare and more widely known to be related to vaccination.
Another guest, Dr Anthony Hinton, suggests that their has already been a lot of data that is available, showing significant complications of vaccination, that the medical profession have been "burying their heads in the sand" about. For example the UK health service estimated that the rate of myocarditis in children was around two per million whereas careful record keeping (prospectively) in Hong Kong found a rate of 425 cases per million (a rate 200 times higher when it was specifically looked for rather than not). Both guests so far have floated the question of why Pfizer fought to keep this information hidden for up to 75 years, what were they trying to hide? They also point out that the most alarming information will likely be released last so what we are seeing already is not the worst of it. The original data from the original trial Pfizer only claimed a modest reduction in severe symptoms, they did not claim it would stop people from catching the disease or transmuting it to others, that claim came from somewhere else. They also didn't claim that it would reduce deaths or hospitalizations because there weren't enough people in the trials to show that. The trial participants were also healthy and in the age range of about 18 to 70 years old. They didn't include elderly people or people with existing conditions that increased their risk. So basically not the population that needed it. There are also other situations in which more information will probably be released including a legal case brought by Brooke Jackson, who is a whistleblower who worked at one of the sites hired by Pfizer to do the trials.
