That Florida “analysis” on COVID vaccines is—you guessed it—total garbage

Epidemiologists and public health experts spent the past weekend shaking their heads at the surgeon general of Florida, Joseph Ladapo, who on Friday recommended against the use of COVID-19 vaccines for men who are 18 to 39 years old.

The analysis Ladapo used was posted online by the Florida Department of Health. According to a misleading press release from the department, the analysis found an 84% increase in the relative incidence of cardiac-related death among males 18 to 39 years old.

The analysis was carried out by the department, but it was posted as a simple PDF without the health department's official letterhead, and no authors are listed. It has not been peer-reviewed or thoroughly edited.

Studies of the safety and efficacy of any medication, including vaccines, is an important part of public health.

The analysis was dubbed "utter rubbish" by experts. One epidemiologist said the analysis method was the most batshit study design he had ever seen. The conclusion smells of p-hacking and data cherry picking.

The reactions are unsurprising to anyone who has followed Ladapo's work. Ladapo was brought in by the governor to fight public health measures and to attack life-saving COVID-19 vaccines.

Fearmongering and discouraging use of the COVID-19 vaccine has the potential to harm public and individual health. The US booster rates are not good. A majority of people who got a primary series have gotten a single booster. Only a small percentage of older people who are more vulnerable to severe disease have gotten a second booster. According to the latest figures from the Centers for Disease Control and Prevention, only a small percentage of Americans have received the updated bivalent booster.

The Covid-19 vaccines and boosters have proven to be very safe and effective. Right-wing politicians and anti-vaccine voices are still attacking them. The new analysis is a good example.

There are too many things wrong with the analysis to focus on a single story. Some of the highlights of the analysis are listed below.

The “batshit” study design

The self-controlled case series design is used in the analysis. Ladapo used this study design to assess vaccine safety, but not necessarily vaccine-related deaths. The study design has been used before for similar purposes, so it is legitimate. That doesn't mean it's the best design or a good one.

To assess a vaccine's safety and effectiveness, you would expect a study to compare a group of people who have received a vaccine to a group of people who haven't. You could compare the outcomes of people in the two groups with the vaccine's effect on infections and side effects. There is no control in a case series design. Each individual is compared to a later control period in a fixed window of time.

The study needs to only include people who experience a vaccine side effect and a specific intervention. The timing of the health event in relation to the intervention is examined to see if people are more likely to experience the event soon after the intervention compared with a later control period. It's possible that the intervention was involved in the event.

A case-series design was used in a 2004 study in the New England Journal of Medicine to see if people were more likely to have a stroke or heart attack after getting a vaccine. The study found that acute infections increased the risk of stroke and heart attack.