The implications of not regulating vaccines

https://link.springer.com/article/10.1007/s40264-023-01295-3

“The current framework for testing and regulating vaccines was established before the realization that vaccines, in addition to their effect against the vaccine-specific disease, may also have “non-specific effects” affecting the risk of unrelated diseases. Accumulating evidence from epidemiological studies shows that vaccines in some situations can affect all-cause mortality and morbidity in ways that are not explained by the prevention of the vaccine-targeted disease. Live attenuated vaccines have sometimes been associated with decreases in mortality and morbidity that are greater than anticipated. In contrast, some non-live vaccines have in certain contexts been associated with increases in all-cause mortality and morbidity.” (The covid shot is a non-live vaccine just FYI.)

“The current clinical testing and approval process is built on the following generally accepted concepts. During a phase I trial, small groups of healthy volunteers receive the candidate vaccine. In phase II, the vaccine is given to individuals with characteristics matching those for whom the new vaccine is intended. In phase III, the vaccine is given to thousands of participants in a randomized and blinded manner, with both an intervention and a control group, testing for efficacy and safety. Efficacy is typically the primary objective; safety is most commonly a secondary objective. Efficacy is typically assessed by comparing the vaccinated and the control groups with respect to the occurrence of the vaccine-specific disease and/or correlates of protection against the clinical disease. No standardized protocols exist for how phase III trials should collect data on safety, but there are some guidelines”. Here is where the train derailed in the covid vaccine. We do not have clinical studies. We had a phase I trial that we already know from Pfizer data had serious safety concerns. We failed to do a phase 3 trial because we unblinded the study. We gave everyone the vaccine and lost the control group to compare ANY data against. The roughly 25% of the population who is unvaccinated is essentially the rogue control group at this point. Many are off the grid with healthcare at this point, and it is very difficult to even compare their health data to those who were covid injected. When you couple that fact with the fact that healthcare goes to great lengths to avoid attributing adverse events to the covid injection, we have a royal mess going on.

“Rare AEs typically do not manifest in the clinical trial programs, and even if they do, there are usually too few cases to draw conclusions of causality. For example, if a vaccine caused a serious adverse reaction in 1 in 10,000 cases, it would take a study with 30,000 subjects to have a 95% chance of detecting even one case. Therefore, after a vaccine has come on the market, there is a reporting system where vaccine providers and the public can report health problems (“post-licensure safety surveillance”). If there is doubt about the real-life effectiveness and safety of a vaccine, regulators can also require that a phase IV trial, a post-authorization safety study, be carried out. This framework has worked well to deliver numerous new vaccines to the market; vaccines that were effective against the specific disease the vaccine was to target and for which we have reasonable assurance that the vaccine is not associated with frequent serious events that would shift the benefit/risk balance.”

“However, it is now evident that vaccines may affect the risk of other diseases in ways that were not foreseen when the current framework was established. Here, we propose that a new framework for testing, approving, and regulating vaccines is needed. This framework includes an assessment of vaccine effects on infections other than the target infection, and on overall health (such as all-cause mortality, all-cause hospitalization, or all-cause consultation rates).”

Here is a table of the current protocol, with the recommendations for a new vaccine surveilllance protocol:

This was published in April 2023. I wonder what sparked this paper to be written and the new protocols to be suggested? Of course they do not name the mRNA dart, but one would have to hypothesize that is a big contributor here. My vote is get rid of every vaccine and scrap this entire charade.