Youtor
Serious adverse events
>> YOUR LINK HERE: ___ http://youtube.com/watch?v=vsh5xNjc1Fs
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. • https://pubmed.ncbi.nlm.nih.gov/36055... • 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, 1.43 • • Pfizer trial • • Exhibited, 36 % higher risk of serious adverse events in the vaccine group • • Risk ratio 1.36 • • Moderna trial • • Exhibited, 6 % higher risk of serious adverse events in the vaccine group • • Risk ratio 1.06 • • Combined • • Exhibited, 16 % higher risk of serious adverse events in the vaccine group • • Risk ratio 1.16 • • 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?
#############################
