A Level-Headed Look at The Florida Vaccine Study

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    by Tracy Beth Hoeg, The Pulse:

    Last Friday October 7th, Dr. Joe Ladapo, Surgeon General of Florida, released a vaccine safety analysis along with updated guidance from the Florida Department of Health. The press release stated Dr. Ladapo “recommends against males aged 18 to 39 from receiving mRNA COVID-19 vaccines” has caused, predictably, quite the controversy. As full disclosure: I am someone who has been working as a consultant epidemiologist for the Florida Department of Health, who knows the Florida Epi team and is friends with Dr. Ladapo. At the same time, I was not one of the authors of the study, and I will be expressing my opinions.

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    Joe’s tweet, announcing the study results and new guidance now has over 90k likes and was accompanied by the additional information: Their “analysis found that there is an 84% increase in the relative incidence of cardiac-related death among males 18-39 years old within 28 days following mRNA vaccination. With a high level of global immunity to COVID-19, the benefit of vaccination is likely outweighed by this abnormally high risk of cardiac-related death among men in this age group. Non-mRNA vaccines were not found to have these increased risks”

    First, let’s look at this study:

    An 84% increase definitely sounds scary. But 84% increase from what? Many assumed this was compared with unvaccinated controls, but actually this was compared with other 18–39-year-old males who had also received either one or two doses of mRNA vaccine and also died… but just died later than 28 days after the vaccine but no later than 25 weeks.

    Both on Twitter and in the mainstream media, people were quick to try to criticize the study design for inappropriate controls or for lack of information on benefits of the vaccine. But the so-called “self-controlled case series (SCCS)” method has a very smart built-in control group of only people who have experienced the adverse event and is simply not designed to assess benefits.

    The SCCS method was actually created to assess vaccine safety. It was first introducedby Paddy Farrington, Elizabeth Miller and team in The Lancet in 1995 as a way to look for association of the adverse events of febrile seizure and immune thrombocytopenia from DPT and MMR vaccines.

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