Serious adverse events

Message from Dr. Fraiman If I have said anything that was incorrect please let myself or John know, and I will review it, respond and if necessary issue an apology and correction. Dr. Joseph Fraiman, Serious adverse events of special interest following mRNA COVID-19 vaccination in randomized trials in adults Paper in Vaccine, 31 August 2022. What stimulated you to carry out this research in the first place, what got you interested in the topic? You refer to the Brighton Collaboration, what is this and how did this feed in to your thinking? Brighton Collaboration identified adverse events of special interest following covid vaccinations, what adverse events were identified? You conducted a secondary analysis of the placebo-controlled, phase III randomized clinical trials of Pfizer and Moderna mRNA COVID-19 vaccines in adults. Tell us a bit about these trials, is this sort of trial standard in testing new pharmaceuticals? What is a secondary analysis? What do you mean by excess risk? What excess risk did you discover? Pfizer vaccines excess risk of serious adverse events 10.1 per 10,000 Higher than placebo baseline of 17.6 per 10,000 Is it fair to say that this transposes into one serious adverse event per 990 vaccines? Moderna vaccines excess risk of serious adverse events 15.1 per 10,000 Higher than placebo baseline of 42.2 per 10,000 Is it fair to say that this transposes into one serious adverse event per 662 vaccines? Combined RNA covid vaccines excess risk of serious adverse events 12.5 per 10,000 Is it fair to say that this transposes into one serious adverse event per 800 vaccines? You also gave reanalysis data in terms of risk ratio. What is risk ratio? Combined, Pfizer trial Exhibited, 36 % higher risk of serious adverse events in the vaccine group Risk ratio Moderna trial Exhibited, 6 % higher risk of serious adverse events in the vaccine group Risk ratio Combined Exhibited, 16 % higher risk of serious adverse events in the vaccine group Risk ratio These risks of harm sound high to me, how does this level of risk compare to other vaccines and treatments? You suggest a formal harm-benefit analyses, what is this and how would this be done? What are participant level datasets, are these important. Did you have access to participant level datasets The original vaccine papers indicated high levels of efficacy in protecting against infection. What is the difference between relative and absolute risk? Were these results presented as relative or absolute risk of infection? Would it have been useful if the original vaccine trial papers had presented absolute risk as well as relative risk? FDA Now using near real time surveillance for vaccine safety. Is this near real time claim working, are we getting timely data? Is there a risk of false positives in the FDA data collection, or are false negatives an issue? Can the FDA safely ignore AESIs that are of minimal clinical significance? Is the FDA methodology confirming previously known AESIs, or is it missing some? From where is the FDA collecting data and are the data from all sources pooled to improve the power of the analysis? Is all data being collected from all 50 States? Is all FDA data open to independent peer review?