Analysis: Florida Department of Health's Vaccine Guidance

Review of Analysis and Vaccine Guidance Published by the Florida Department of Health: October 7th, 2022

On October 7th, 2022 the State Surgeon General Dr. Joseph A. Ladapo issued “New mRNA COVID-19 Vaccine Guidance” based on an internal non-peer reviewed study.

Per the analysis the claim is that there is an 84% increase in the relative incidence of cardiac-related deaths among males 18-39 years old within 28 days following mRNA vaccination.

The guidance proceeds to make the following additional statements:

• “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.”

• “Males over the age of 60 had a 10% increased risk of cardiac-related death within 28 days of mRNA vaccination.”

This is a point-by-point peer review of this analysis which will include definitions and analysis of methods. In addition, this is an open request for the raw numbers and data used for this analysis such that the scientific community and public can effectively evaluate these claims against prior data and publications.

Due to the lack of supporting evidence provided and the broad claim that may endanger the lives and increase morbidity and mortality among males 18-39 yrs old, it is critical that the supporting numbers be analyzed and reviewed. A government agency issuing broad advisories that directly counter other findings and global recommendations, must provide their supporting data. A similar guidance for “Pediatric COVID-19 Vaccines” in direct opposition of the American Pediatrics Association was released March 8th, 2022 and will be reviewed in a separate analysis and linked to this post when completed.

The Florida State Surgeon General’s advisory and supporting documents in question can currently be found here: Press Release, Advisory, Analysis.

INTRODUCTION

The SARS-CoV-2 virus has killed 82,540 Floridians. Up to 1 in 7 people have significant long-lasting post-acute sequalae SARS-CoV-2 infection (PASC) or “long COVID”. Long COVID is responsible for removing an estimated 4 Million Americans from the workforce. A significant increase in heart attacks and cardiac events post-COVID infection in unvaccinated males over 65 for up to 12 months post-infect has been well documented. In addition, organ damage including kidney, cardiac, lung, both central and peripheral neurological damage have been documented and corroborated by scientific studies performed both in the US and and globally. Vaccinated individuals in the United States and every record-keeping country that has publicly available data are less likely to die, less likely to be hospitalized, and less likely to suffer from extensive long-COVID. Therefore, the recommendation made by the Florida State Health Department against vaccination must be thoroughly reviewed in the context of responsible public health recommendations.

Publication Review and Open Questions:

Over 1 million Americans have died from infection with the SARS-CoV-2 virus. Once vaccines because available, the majority of these deaths have been in the unvaccinated population. Therefore, recommendations to avoid vaccination by elected government officials must be scrutinized at the level of professional scientific review and must hold up to the scrutiny of global scientific and medical community assessment.

Data Sourcing:

In order for proper scientific review to be achieved the patient numbers and methods of medical reporting, must be both reported and traceable through standard reporting methods. As this is a new reported finding methods of data collection must be verifiable by independent parties.

Currently the data from FLSHOTS is not publicly available.

The data that the authors claim to have linked it to is the public database “Merlin”. The Merlin database public dropdown menu does not have: “Heart Attack”, “Myocarditis”, “Cardiac Events”, “Cardiac Disease” listed.

The report does not contain the raw data.

Therefore the data presented in the report is not independently verifiable and the report did not contain the raw data.

False Comparators: If data presented holds up to scientific and medical scrutiny we should all note that this government based health recommendation was based on a comparison of from the data of ‘No COVID’ infection versus ‘Vaccination’ is a significant logical flaw in that COVID infections have been and continue to be widespread. Therefore, this analysis fails to take into account the protective effect of COVID vaccination against cardiac events which has been demonstrated to be significant. The presentation of this data and recommendations of the Florida Department of Health are based on a fallacious argument. If the intent is scientific and medical integrity the reduction in cardiac events post-COVID infection among the vaccinated v. unvaccinated populations would have been presented for risk-assessment completeness.

Analysis Caveats as Stated by the Author(s):

“This study cannot determine the causative nature of a participant’s death. We used death certificate data and not medical records.”

“COVID testing status was unknown for those who did not die of/with COVID.”

“Cardiac-related deaths were ascertained if an ACME code of I3-I52 were on their death certificate, thus, the underlying cause of death may not be cardiac-related.”

“While this method has been used to assess risk of death following COVID-19 vaccination (2) it violates the assumption that an event does not affect subsequent exposure (for mRNA vaccines), which may introduce bias.( 6)”

“Further, it does not consider the multidose vaccination schedule required for mRNA vaccination.”

“Additional studies should be conducted to further understand the risks and benefits of vaccination of males between 25-39. Increased risk in the primary analysis for the 25 - 39 age group was based on a small sample size.”

“Additionally, significant mortality from diagnosed COVID-19 infection occurred among all adult age groups.”

“COVID-19 mortality among asymptomatic or undiagnosed COVID-19 infection is less clear. However, excess overall mortality among 25–44-year-old Americans was significant in a study1 looking at mortality from January 2020-October 2020.”

“Confounding by age may be present in the 60 years or older age group, which may explain the slight elevated risk for cardiac-related deaths following vaccination. This may also explain the increased risk for the entire vaccination analysis group for cardiac-related deaths since this group comprises the vast majority of deaths.”

Immediately after was written:

“Removing those aged 60 years or older yielded non-significant results for cardiac-related deaths following vaccination (RI = 1.15, 95% CI = 0.99 - 1.34), mRNA vaccination (RI = 1.17, 95% CI = 1.00 - 1.37), and males with mRNA vaccination (RI = 1.09, 95% CI = 0.89 - 1.34).”

All confidence intervals stated here are at or below 1 (no effect) in prior caveats stated the sample size is low and confounding factors exist; making these numbers uninterpretable in the context of public health.

Summary: Issuing a government-backed health advisory based on this analysis is both irresponsible and dangerous to public health. Furthermore the Florida State This analysis has no associated authors listed, I would have kept my name off of it too.