Reanalysis of mRNA trial data

Swine flu vaccine (1976), 1 serious event per 100,000 vaccinees, Vaccine withdrawn Rotavirus vaccine Rotashield, (1999),1 to 2 serious events per 10,000 vaccinees, Vaccine withdrawn Covid mRNA vaccines, 1 serious event per 800 vaccinees, Vaccine officially promoted Serious adverse events of special interest following mRNA COVID-19 vaccination in randomized trials in adults https://pubmed.ncbi.nlm.nih.gov/36055877/ Free full text available https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9428332/ Why We Question the Safety Profile of mRNA COVID-19 Vaccines (Robert M Kaplan and Sander Greenland) https://sensiblemed.substack.com/p/why-we-question-the-safety-of-covid Using publicly available data from Pfizer and Moderna studies, we found one serious adverse event for each 800 vaccinees. That translates to about 1,250 serious events for each million vaccine recipients. US, Spain, Australia Study to evaluate serious adverse events of special interest observed in mRNA COVID-19 vaccine trials. Secondary analysis of serious adverse events reported in the placebo-controlled, phase III randomized clinical trials, of Pfizer and Moderna mRNA COVID-19 vaccines Results Pfizer and Moderna mRNA COVID-19 vaccines were associated with an excess risk of serious adverse events of special interest Pfizer 10.1 per 10,000 vaccinated over placebo baselines of 17.6 Moderna 15.1 per 10,000 vaccinated over placebo baseline of 42.2 Combined, the mRNA vaccines Associated with an excess risk of serious adverse events of special interest of 12.5 per 10,000 vaccinated Pfizer trial Pfizer vaccine group 52 serious AESI (27.7 per 10,000) were reported Pfizer placebo group 33 serious AESI (17.6 per 10,000) were reported 36 % higher risk of serious adverse events in the vaccine group Risk difference 18.0 per 10,000 vaccinated Moderna trial Moderna trial, vaccine group 87 serious AESI (57.3 per 10,000) were reported Moderna trial, placebo group 64 serious AESI (42.2 per 10,000) were reported 6 % higher risk of serious adverse events in the vaccine group Risk difference 7.1 per 10,000 vaccinated Discussion The excess risk of serious adverse events found in our study points to the need for formal harm-benefit analyses, particularly those that are stratified according to risk of serious COVID-19 outcomes. These analyses will require public release of participant level datasets. Full transparency of the COVID-19 vaccine clinical trial data is needed, to properly evaluate these questions. Unfortunately, as we approach 2 years after release of COVID-19 vaccines, participant level data remain inaccessible. Level of adverse reactions in the past The 1976 swine flu vaccine Small increased risk of Guillain-Barré Syndrome The increased risk was approximately 1 additional case of GBS for every 100,000 people who got the swine flu vaccine. When over 40 million people were vaccinated against swine flu, federal health officials decided that the possibility of an association of GBS with the vaccine, however small, necessitated stopping immunization until the issue could be explored. The Institute of Medicine (2003) https://www.ncbi.nlm.nih.gov/books/NBK221528/ Concluded that people who received the 1976 swine influenza vaccine had an increased risk for developing GBS. Exact reason for this association remains unknown. Rotavirus vaccine Rotashield, (1999) https://www.cdc.gov/vaccines/vpd-vac/rotavirus/vac-rotashield-historical.htm The U.S. Advisory Committee on Immunization Practices (ACIP) October 22, 1999 to no longer recommend use of the RotaShield® vaccine for infants, because of an association between the vaccine and intussusception. The results of the investigations showed that RotaShield® vaccine caused intussusception in some healthy infants Within 2 weeks Intussusception increased 20 to 30 times over the expected risk (Less after the second and third dose) CDC estimated that one or two additional cases of intussusception would be caused among each 10,000 infants vaccinated with RotaShield® vaccine.