FDA Abandons Informed Consent After “Emergency Use” Approval Of J&J Coronavirus Vaccine, SKIPPING Large-scale Safety Testing

FDA abandons informed consent after “emergency use” approval of J&J coronavirus vaccine, which SKIPPED large-scale safety testing

Johnson and Johnson’s single dose coronavirus vaccine was recently granted “emergency use” approval by the Food and Drug Administration (FDA). This means J&J skipped large scale safety testing for their experimental biologic. To make matters worse, all previous attempts to create a safe and effective coronavirus vaccine (SARS and MERS) have failed and caused pathogenic priming. What makes this fast-tracked biologic any different? The short and long-term effects of the vaccine have not been observed or evaluated. The vaccine has only been studied for efficacy up until 28 days, post vaccination. In that short time, researchers found the vaccine to be 85 percent efficacious for preventing serious illness. The efficacy rate would plummet even further if more time was used to evaluate whether recipients became seriously ill. The vaccine wasn’t studied outside 28 days, most likely because the issue of pathogenic priming would result in more serious illness, hospitalization and death.

Informed consent suspended, as medical authorities push untested vaccine

Because the vaccine was given “emergency” use approval, informed consent is officially suspended for this biologic, as medical authorities abandon medical principles and push it forward into people’s arms. No one will adequately warn patients of the inherent risks of this experimental biologic. Instead, the vaccines are marketed up front as treating an “emergency” – as if healthy vaccine recipients are in some kind of imminent danger. This is a bold-faced lie for most age groups, because there are efficacious treatments and there is a low mortality rate for people younger than 65. Moreover, if there was more emphasis on what can be done to boost the immune system of individuals, then the theory of needing a perfect savior of a vaccine would be moot. And just to be clear, the concept of a perfect vaccine won’t ever exist for coronaviruses, due to the ever-evolving nature of this virus type.

Janet Woodcock, acting FDA commissioner said the authorization of the J&J vaccine is crucial in the fight against a pandemic, even though the virus has changed significantly over the past year, succumbing to the natural phenomenon of virus mutation and host adaptation. Nevertheless, Woodcock promoted the vaccine as “the best medical prevention method for covid-19,” even though reliable treatments are available, including convalescent plasma, a time-honored approach for facing emerging infectious diseases. Plasma donations harness antibodies from the survivors of an infectious disease to help vulnerable people recover and gain immunity.

FDA forces doctors to abandon their Hippocratic Oath

The J&J vaccine will quickly become the more popular option for covid vaccination, for it is recommended as a one-dose vaccine, unlike the Moderna and Pfizer inoculations, which require a minimum two-shot protocol. The J&J vaccine is designed like a traditional biologic, using an attenuated virus, grown in animal and aborted fetal cell lines. The Moderna and Pfizer experiments are based on a new type technology that inserts instructions into cells, forcing the body to create spike proteins from the coronavirus. The nano-particles in these vaccines must be preserved at extremely low temperatures or they will degrade. The J&J vaccine, on the other hand, introduces a foreign coronavirus antigen into the body, along with an adjuvant and other chemicals that are meant to augment an immune response. These biologics typically take 10-15 years to develop, and only 23 percent of vaccines ever make it through this tedious and time-consuming scientific process. The J&J vaccine was pushed through the large-scale safety studies, bypassing years of scientific research and evaluation.

By releasing this biologic without proper safety testing, the FDA is forfeiting informed consent and forcing medical authorities, doctors and nurses to go against their Hippocratic oath.