Emergency Use Authorization Without Emergency And Science – What Has Happened To FDA

If one carefully reads the recently released FDA guidance/amendments (link), it should be clear that the vaccines lack scientific support for their relevance and need. The FDA has become an unprofessional and non-scientific organization.  

From the guidance, “Today, the U.S. Food and Drug Administration amended the emergency use authorizations (EUAs) of the Moderna and Pfizer-BioNTech COVID-19 bivalent mRNA vaccines to simplify the vaccination schedule for most individuals. This action includes authorizing the current bivalent vaccines (original and omicron BA.4/BA.5 strains) to be used for all doses administered to individuals 6 months of age and older, including for an additional dose or doses for certain populations. The monovalent Moderna and Pfizer-BioNTech COVID-19 vaccines are no longer authorized for use in the United States.”

If the vaccines had been safe and effective, as claimed, their use would have changed from “authorized” to “approved.” Unfortunately, it is not the case. The vaccines’ fakeness was predicted, by the author, at the beginning of the pandemic, before their introduction, stating,

Therefore, a fake vaccine will most likely be developed to satisfy the regulatory wish and calm down the created public hysteria and fear. Unfortunately, such vaccines, if developed and administered, will undoubtedly create potentially dangerous side effects, without any presumed benefits, by interfering with the body’s immune system and other related physiological processes.” (link)

Therefore, indirectly, FDA acknowledges that the vaccines did not work, hence discontinued, without disclosing the safety and efficacy data from clinical trials, which was expected soon, as reported earlier [“estimated study completion date” of Jan. 31, 2023,” see link here and here].

However, a bigger mystery is why they have suggested an alternative version of the vaccine without any supported clinical trial or testing when in their view pandemic is over and most people are showing immunity against the virus and its variants.

Furthermore, the FDA announcement states, “Most UNVACCINATED individuals MAY RECEIVE a single dose of a bivalent vaccine, rather than multiple doses of the original monovalent mRNA vaccines.” So it appears that the vaccine is not recommended or mandated but a suggestion. That is interesting.

It could be argued that FDA realizes that the new suggested version also does not have the needed safety and efficacy support; hence, its vaccine recommendation could only be implemented with the EUA. Therefore, the FDA AMENDS the EUA, rationalizing EUA without the emergency (link). It is bizarre! How can they claim to be a science-based organization caring for the public’s health? 

Unfortunately, this change/update has to be made because the usual standards for product approval for the vaccines/drugs could not be met.

Certainly, it would further damage the FDA and the medical profession’s already significantly lost credibility as an unbiased evaluator of medicines. FDA seems to have placed itself in a difficult position, perhaps more accurately, on its deathbed with a few remaining gasps for air.

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