“Secondary analysis of serious adverse events reported in the placebo-controlled, phase III randomized clinical trials of Pfizer and Moderna mRNA COVID-19 vaccines in adults (NCT04368728 and NCT04470427), focusing analysis on Brighton Collaboration adverse events of special interest.”
“Pfizer and Moderna mRNA COVID-19 vaccines were associated with an excess risk of serious adverse events of special interest of 10.1 and 15.1 per 10,000 vaccinated over placebo baselines of 17.6 and 42.2 (95 % CI −0.4 to 20.6 and −3.6 to 33.8), respectively. Combined, the mRNA vaccines were associated with an excess risk of serious adverse events of special interest of 12.5 per 10,000 vaccinated (95 % CI 2.1 to 22.9); risk ratio 1.43 (95 % CI 1.07 to 1.92).”
1,010 serious adverse events of special interest per mil vaccinated over placebo baseline for Pfizer, 1,510 per mil for Moderna, 1,250 per mil combined.
“Our analysis is restricted to the randomized trial data, and does not consider data on post-authorization vaccination program impact. It does however show the need for public release of participant level trial datasets.” (Emphasis mine)
“In July 2021, the FDA reported detecting four potential adverse events of interest: pulmonary embolism, acute myocardial infarction, immune thrombocytopenia, and disseminated intravascular coagulation following Pfizer’s vaccine based on medical claims data in older Americans. [18] Three of these four serious adverse event types would be categorized as coagulation disorders, which is the Brighton AESI category that exhibited the largest excess risk in the vaccine group in both the Pfizer and Moderna trials. FDA stated it would further investigate the findings but at the time of our writing has not issued an update.” (Emphasis mine)
"While CDC published a protocol[24] in early 2021 for using proportional reporting ratios for signal detection in the VAERS database, results from the study have not yet been reported." (Emphasis mine)
“Although our analysis is secondary, reanalyses of clinical trial data have led to the detection of adverse events well after the market entry of major drugs such as rofecoxib and rosiglitazone. [36], [37] Our analysis has an advantage over postmarketing observational studies in that the data are from blinded, placebo-controlled randomized trials vetted by the FDA, which were matched against a list of adverse events created before the availability of the clinical-trial results and designed for use in COVID-19 vaccine trials.” (Emphasis mine)
“We emphasize that our investigation is preliminary, to point to the need for more involved analysis.”
I’m not claiming that this or any other study is definitive wrt the current Covid mRNA vaccines. The study authors emphasize that their investigation is preliminary. I do think that studies like this do point to a greater risk than was originally stated and subsequently reinforced, and the need for urgent study to assess the risk.