"where are the U.S. Government’s own studies of adverse events?"
The Editor of one of the world's most respected medical journals, the BMJ, has analysed data from the Pfizer and Moderna Covid vaccine trials and found that the vaccines are more likely to put you in hospital with a serious adverse event than keep you out by protecting you from Covid.
A secret 'priority list' of potential adverse events relevant to COVID-19 vaccines was drawn up by the World Health Organisation and it is this list that Dr. Peter Doshi and his team focused on for their analysis.
A serious adverse event was defined as per the trial protocols as an adverse event that results in any of the following conditions:
life-threatening at the time of the event;
inpatient hospitalisation or prolongation of existing hospitalisation;
persistent or significant disability/incapacity;
a congenital anomaly/birth defect;
medically important event, based on medical judgement.
What Dr. Doshi and colleagues found proves, beyond a shadow of doubt, that a thousand internet trolls were wrong.
They team found that the Pfizer and Moderna mRNA COVID-19 vaccines were associated with an increased risk of serious adverse events of special interest of 10.1 events per 10,000 vaccinated for Pfizer and 15.1 events per 10,000 for Moderna (95% CI -0.4 to 20.6 and -3.6 to 33.8, respectively). When combined, the mRNA vaccines were associated with a risk increase of serious adverse events of special interest of 12.5 per 10,000 vaccinated (95% CI 2.1 to 22.9).
The authors note that this level of increased risk post-vaccine is greater than the risk reduction for COVID-19 hospitalisation in both Pfizer and Moderna trials, which was 2.3 per 10,000 participants for Pfizer and 6.4 per 10,000 for Moderna. This means that on this measure, the Pfizer vaccine results in a net increase in serious adverse events of 7.8 per 10,000 vaccinated and the Moderna vaccine of 8.7 per 10,000 vaccinated.
Dr. Doshi addressed the difference between their findings and those of the FDA when it approved the vaccines, the authors note that the FDA’s analysis of serious adverse events “included thousands of additional participants with very little follow-up, of which the large majority had only received one dose”. The FDA also counted ‘people affected’ rather than individual events, despite there being twice as many individuals in the vaccine group than in the placebo group who experienced multiple serious adverse events.
The authors wonder where the U.S. Government’s own studies of adverse events are. They note that in July 2021, the FDA reported detecting four potential adverse events of interest following Pfizer vaccination – pulmonary embolism, acute myocardial infarction, immune thrombocytopenia and disseminated intravascular coagulation – and stated it would further investigate the findings. However, no update has yet appeared.
They also note that “while CDC published a protocol in early 2021 for using proportional reporting ratios for signal detection in the VAERS database, the agency has not yet reported such a study”.
Noting their study is limited by the fact that the raw data from COVID-19 vaccine clinical trials are not publicly available, they stress that “given the global public health implications, there is an urgency to make all COVID-19 trial data public, particularly regarding serious adverse events, without any further delay”.