There’s a new crack in the facade after Florida’s surgeon general, Dr. Joseph Ladapo, issued bold new guidance on Friday recommending against vaccinating males aged 18 to 39 with mRNA COVID-19 vaccines.
Florida’s Department of Health conducted an analysis through a self-controlled case series, a technique originally developed to evaluate vaccine safety, to study the mortality risk following mRNA COVID-19 vaccination.
The analysis found an 84% increase in the relative incidence of cardiac-related death among males 18-39 years old within 28 days following mRNA vaccination with Pfizer and Moderna’s COVID-19 vaccines.
“Based on currently available data, patients should be informed of the possible cardiac complications that can arise after receiving an mRNA COVID-19 vaccine,” according to new guidance issued by Ladapo. “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 [18 to 39] age group.”
Non-mRNA vaccines were not found to have these increased risks; however, Johnson & Johnson’s shot can cause fatal blood clotting disorders and Guillain-Barré syndrome — a rare disorder where the body’s immune system attacks the nerves causing muscle weakness and paralysis.
“Studying the safety and efficacy of any medications, including vaccines, is an important component of public health,” said Ladapo. “Far less attention has been paid to safety and the concerns of many individuals have been dismissed — these are important findings that should be communicated to Floridians.”
In the analysis, the self-controlled case series (SCCS) method to evaluate death as the outcome was used. The SCCS method utilizes within-person comparisons to estimate the temporal association between a transient exposure and an acute event. It then estimates relative incidence by comparing incidence during a defined high-risk period following exposure with incidence during a control period.
Data from Florida’s reportable disease repository, state health online tracking system and death records data from vital statistics were linked.
Florida residents aged 18 years or older who died within 25 weeks of receiving a COVID-19 vaccine since the beginning of the Dec. 15, 2020 roll-out were included. Individuals were excluded if they had a documented COVID-19 infection, experienced a COVID-19
associated death, received a booster shot or received their last COVID-19 vaccination after December 8, 2021, to ensure each individual had the 25-week follow-up period to experience the event of interest.
Researchers looked at the 28-day risk period following COVID-19 vaccination to assess natural all-cause deaths (excluding homicides, suicides and accidents) and cardiac-related deaths.
The study end date for both analyses was June 1, 2022, to allow for deaths to be registered.
In the 28 days following vaccination, no increased risk was observed for all-cause deaths, but a statistically significant increase in cardiac-related deaths was detected for the entire study population — and was highest for age groups 25 to 39 and those aged 60 or older.
Males aged 60 and older had a 10% increased risk of cardiac-related death within 28 days of
mRNA vaccination. Males who received a non-mRNA vaccine had a significantly lower risk.
Floridians are encouraged to discuss all the potential benefits and risks of receiving mRNA COVID-19 vaccines with their healthcare provider, but “the State Surgeon General now recommends against the COVID-19 mRNA vaccines for males ages 18-39 years old,” guidance states.
Florida’s Health Department continues to stand by its “Guidance for Pediatric COVID-19 Vaccines” issued in March 2022, which recommends against COVID-19 vaccination of healthy children and adolescents 5 years old to 17 years old. This now includes recommendations against COVID-19 vaccination for infants and children under 5 years old, recently authorized under Emergency Use Authorization.