The FDA Should Have Been Ready for the Vaccine Information Shared by Florida’s Surgeon General


On October 7, Florida’s Surgeon General Joseph Ladapo shared a report from his agency on COVID-19-mRNA vaccines. The vaccine was given to men aged 18 to 39. This increased the risk of death from cardiac causes.

The analysis revealed that the relative risk of death from cardiac disease among men aged 18 to 39 within 28 days after mRNA vaccination increased by 84%. The high global immunity to COVID-19 means that vaccination may be more beneficial than the abnormally high rate of cardiac-related deaths among this age group. These increased risks were not seen in non-mRNA vaccines.

These findings led Ladapo to recommend that males between the ages of 18 and 39 not be vaccinated with mRNA COVID-19. He also stated that men over 60 were at 10% higher risk of death from cardiac complications within 28 days after mRNA vaccination. Floridians were encouraged to talk with their doctor about the possible risks and benefits of the vaccine.

Ladapo shared the link with the analysis and new guidance to communicate the results.

Twitter temporarily blocked the tweet, stating that “Our current misleading information policy covers: synthetic and manipulated media, COVID-19 and civic integrity.” Twitter restored the tweet on Sunday morning.

It’s a shame that Twitter decided to censor the tweet, even though the FDA had already acknowledged the dangers of cardiac disease in men below 40 years old a year prior. The FDA’s Vaccine and Related Biological Products Advisory Committee met on Sept. 17, 2021 to discuss approval of a booster dose for mRNA vaccines. Doran Fink M.D. is the deputy director of clinical services at the FDA’s Division of Vaccines and Related Products Applications. She provided insight into myocarditis frequency.

The Vaccine Adverse Event Reporting System’s (VAERS), reported the highest rate for young men aged 16-17 years. The incidence rate for the United States was approximately 1:5,000 according to US health claims data, which is better than VAERS. This was mainly due to the second doses of mRNA vaccine. Florida advised against the COVID-19 vaccine being given to healthy children in March 2022.

The cardiac risk to older adolescents was not the only topic discussed. Dr. Arnold Monto was the acting chair of the committee and asked Fink if it was possible for him to tell when myocarditis has stopped being a problem. Fink’s full answer is a prelude for the Florida findings (emphasis mine).

Social media won’t censor what the FDA is saying, even if it contradicts Florida. This endorsement is attached to the YouTube video of the hearing.

Fink refers to the risk-benefit analysis as the essential assessment that every healthcare provider must undergo before offering therapy. This is the basis of informed consent to which all patients have access before they accept treatment. This is exactly what Florida’s new guidance calls for. The treatment cannot be worse than the disease, as President Donald Trump once stated. This was once a major consideration in medicine.

Over a year ago, the FDA had information on cardiac risks in men aged 40 and under. The guidance should have been issued by the FDA recommending that this age group be vaccinated at a halt. Fink also noted that no data was available on the risk of developing cardiac complications after the third dose. This should have been alarming considering the majority of cases of heart disease occurred after the second dose. There was much controversy surrounding the recommendation of boosters. Two FDA vaccine experts who were critical of the decision resigned prior to the announcement, reportedly due to political interference by the White House.

Ladapo shared distressing data. It shouldn’t have been surprising, however, after the FDA’s findings which were supported by Israeli data. Kaiser Permanente Northwest published a preprint study that showed that the FDA data had significantly underestimated the risk of side effects from cardiac vaccines. The researchers used the cohort of patients aged between 12 and 39 to study the effects of the cardiac vaccine side effects. They followed them for 30 days following the second dose.

Their study revealed cases of cardiac side effects that were not covered by data in the Vaccine Safety Database. This database is used by the vaccine advisory boards for FDA and CDC. A more thorough analysis revealed that cardiac complications were a possibility in 1 in 1860 males aged 18-24 and 1 per 2650 boys 12-17.

Ladapo’s “experts” should have known that fatal cardiac events could be possible, considering the rate of such events documented in literature. The FDA experts discussed last September the need to assess levels of troponin. This is a marker for myocarditis. Sub-clinical cases, which could lead to heart damage, were also discussed by the committee.

Ladapo addressed his critics after the restoration of his announcement tweet and pointed out their errors. He corrected their incorrect assumptions regarding the study design and data that his department had access. Ladapo pointed out that even though the sample size was only half what it was, the signal would still have value. He then takes aim at the “experts”.

He was funny enough to add a wink emoticon. Dr. Ladapo is very clear about his intentions and deserves credit for sharing information that is against the Florida narrative, even though it could help keep Florida residents healthy.

This data suggests that there is a partial explanation to the alarming rise in deaths among Americans of working age, as reported by the insurance industry. It is now up to vaccine manufacturers and public health officials to prove that Sudden Adult Death Syndrome (SADS) is not related with mRNA vaccines. It may also be an answer to the shocking number of athletes who have died while competing. It was, according to Johns Hopkins University’s Marty Makary.

FDA’s refusal to anonymize, summarize and report on autopsies relating to VAERS-related deaths only raises suspicion. Just recently, the CDC was forced to release data from V-Safe. This is enough to make one wonder if these agencies care more about politics than public health.

The post The FDA Should Have Been Ready for the Vaccine Information Shared by Florida’s Surgeon General appeared first on Conservative Research Group.


Please enter your comment!
Please enter your name here