FDA Blast Florida Surgeon General for Reporting Increase in Adverse Events

The FDA Commissioner Robert Califf and the CDC Director Rochelle Walensky teamed up to issue a strong rebuke to Florida’s Surgeon General Dr. Joseph A. Ladapo for issuing a health alert that his state’s surveillance system reported a major uptick in adverse events in concert with the rollout of the Covid mRNA shots.

“In Florida alone, there was a 1,700% increase in VAERS reports after the release of the COVID-19 vaccine, compared to an increase of 400% in overall vaccine administration for the same time period,” the alert added and provided a graphic.

 

“The reporting of life-threatening conditions increased over 4,400%,” the alert continued. “This is a novel increase and was not seen during the 2009 H1N1 vaccination campaign. There is a need for additional unbiased research to better understand the COVID-19 vaccines’ short- and long-term effects.”

The health alert attached three medical studies that assessed “excess risk” and “increased risk” of adverse events associated with the Covid mRNA shots.

  • According to a study, exit disclaimer iconFraiman J et al, Vaccine. 2022, mRNA COVID-19 vaccines were associated with an excess risk of serious adverse events, including coagulation disorders, acute cardiac injuries, Bell’s palsy, and encephalitis. This risk was 1 in 550 individuals, which is much higher than other vaccines.
  • A second study, exit disclaimer iconSun CLF et al, Sci Rep. 2022, found increased acute cardiac arrests and other acute cardiac events following mRNA COVID-19 vaccination.
  • Additionally, exit disclaimer iconDag Berild J et al, JAMA Netw Open. 2022, assessed the risk of thromboembolic and thrombocytopenic events related to COVID-19 vaccines and found preliminary evidence of increased risk of both coronary disease and cardiovascular disease.

In October, the State Surgeon General recommended against males aged 18 to 39 from receiving the mRNA COVID-19 vaccines.

“The Florida Department of Health (Department) conducted an analysis through a self-controlled case series, which is a technique originally developed to evaluate vaccine safety,” Ladapo announced in a press release.

“This 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,” the announcement stated. “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.”

The FDA and CDC chiefs lashed out at Dr. Ladapo in a joint letter dated on March 10.

“It is the job of public health officials around the country to protect the lives of the populations they serve, particularly the vulnerable,” the co-authors claimed. “Fueling vaccine hesitancy undermines this effort.”

The letter thus lays out that it is the mission of these “public health agencies” to diminish “vaccine hesitancy,” rather than to be upfront and transparent with the American people about the relative risks of Covid vaccination for each individual patient.

The letter does not address the scientific research cited by Dr. Ladapo. It also fails to acknowledge the CDC’s own data that show there is near-universal natural immunity from prior infection in the U.S. population. It also does not recognize that the CDC’s own research shows that natural immunity is superior to vaccinated immunity in many aspects.

However, the FDA and CDC launched into a broadside againt Dr. Ladapo with a polemical defense of Covid vaccination in all cases, regardless of natural immunity or diminished risk due to age.

“The claim that the increase of VAERS reports of life-threatening conditions reported from Florida and elsewhere represents an increase of risk caused by the COVID-19 vaccines is incorrect, misleading and could be harmful to the American public,” the agency heads argued.

“Reports of adverse events to VAERS following vaccination do not mean that a vaccine caused the event,” the co-authors lectured Dr. Ladapo, who is a Harvard-educated doctor. “Adverse events must be compared to background rates in the population.”

The FDA and CDC heads nonetheless acknowledged there are “rare adverse reactions” to specific Covid-19 vaccines, while providing more information about alternative monitoring systems.

“This VAERS review methodology allows for successful identification of rare adverse reactions related to specific COVID-19 vaccines (e.g., Guillain-Barré Syndrome, thrombosis with thrombocytopenia syndrome , and immune thrombocytopenia following use of the Janssen COVID-19 Vaccine or myocarditis, pericarditis and anaphylaxis following use of the Pfizer-BioNTech and Moderna COVID-19 vaccines),” the co-authors wrote.”Information about these adverse reactions is included in the fact sheets for healthcare providers administering vaccine and vaccine recipients and caregivers. FDA and CDC also continue to post summaries of the key safety monitoring findings and present the data publicly at regularly scheduled advisory committee meetings.”

“In addition to VAERS, FDA and CDC utilize complementary active surveillance systems to monitor the safety of COVID-19 vaccines,” the letter added.

“FDA is conducting active surveillance using the Sentinel BEST (Biologics Effectiveness and Safety) System and collaborating with the Center for Medicare and Medicaid Services (CMS) and Department of Veterans Affairs (VA),” the letter continued. “These efforts complement those of CDC’s Vaccine Safety Datalink (VSD) and the v-safe text-based monitoring system for conducting surveillance of adverse events, as well as the Clinical Immunization Safety Assessment (CISA) Project. FDA and CDC are also collaborating with other non-federal partners, including state and local health departments.”

The agency heads then continue to give the same overgeneralized advice on Covid vaccination without acknowledging the disparity in risks between those with natural immunity and those without it, age demographics, and health factors such as obesity. It is the same one-size-fits-all advice that has usurped the role of the states and citizens’ personal physicians.

“Based on available information for the COVID-19 vaccines that are authorized or approved in the United States, the known and potential benefits of these vaccines clearly outweigh their known and potential risks,” the CDC and FDA claim. “Additionally, not only is there no evidence of increased risk of death following mRNA vaccines, but available data have shown quite the opposite: that being up to date on vaccinations saves lives compared to individuals who did not get vaccinated.”

The CDC and FDA then claim that there is a 9.8 fold lower risk of dying from Covid if one is up to date on the latest “boosters.”

“The most recent estimate is that those who are up to date on their vaccination status have a 9.8 fold lower risk of dying from COVID-19 than those who are unvaccinated and 2.4 fold lower risk of dying from Covid-19 than those who were vaccinated but had not received the updated, bivalent vaccine,” the co-authors claim. “Roughly 90% of deaths from COVID-19, as carefully classified by the CDC, in recent months have occurred among those who were not up to date on their vaccines. Furthermore, as stated above, emerging reports indicate a possible reduction in the risk of post-COVID conditions in vaccinated people who survive an infection.”

The FDA and CDC are moving the goalposts by pushing boosters to cover up for the failure of the “vaccines” to stop infection and transmission of the virus. This is a game that would never end, but just-so-happens to benefit Big Pharma’s profits.

The agency heads also fail to acknowledge that the vaccines did not lower excess mortality in many countries around the world.

Nearly three-and-a-half years into a global pandemic, if Covid vaccines were a miracle drug, then all-cause death rates would not remain elevated. Furthermore, Covid vaccination only provides marginal and fleeting benefit to those without natural immunity, while presenting a risk of short-term and long-term side effects.

The FDA and CDC are still stubbornly defending the Covid mRNA shots while attacking anyone who wants to present a more balanced risk assessment. Medical researchers and scientists are attacked as fueling “vaccine hesitancy,” while the state continues to object to reports of adverse events and shields the pharmaceutical companies from liability.

If the Covid mRNA shots are as safe and effective as the FDA and CDC say they are, there is a simple way to prove it: Drop the liability shield.

NOW READ:

The CDC Finally Concedes That Natural Immunity is Superior to Vaccinated Immunity

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OPINION:
This article contains commentary which reflects the author’s opinion.


 

Source: Becker News Rephrased By: InfoArmed

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