"Docs, Scientists Call on FDA to Delay Approval of COVID Vaccines — Data should be from completed phase III trials, not interim results, group says" by Ryan Basen, Enterprise & Investigative Writer, MedPage Today June 10, 2021 https://www.medpagetoday.com/special-reports/exclusives/93035 ...The group, led by Linda Wastila,
BSPharm, MSPH, PhD, professor of pharmaceutical health services
research at the University of Maryland School of Pharmacy, includes 27
petitioners, including 16 experts outside the U.S., primarily based in
Europe ... asked the FDA to hold off approval until the agency:
- Confirms there is substantial evidence that clinical effectiveness outweighs harms among special populations
- Requires a "thorough" safety analysis of spike proteins produced in situ after vaccine administration, including studies on spike proteins' "full biodistribution, pharmacokinetics, and tissue-specific toxicities"
- Completes vaccine biodistribution studies "from administration site and safety implications of mRNA translation in distant tissues"
- Comprehensively investigates all severe adverse reactions reported after vaccination
- Examines the safety of people taking more than two doses
- Includes gene delivery and therapy experts in its Vaccines and Related Biological Products Advisory Committee
- Enforces "stringent conflict of interest requirements to ensure individuals involved in data analysis and decision making" related to Biologics License Applications lack such conflicts with the vaccine manufacturers
I symbolically add my name to this call to delay approval after witnessing hazards deriving from the vaccine and being unpersuaded by its efficacy in preventing death against variants.
I am strongly against mandatory vaccinations against a virus that was likely engineered and whose fundamental weapon, the spike protein, is elicited by vaccines.
Researchers from the Salk Institute have demonstrated that the spike protein causes vascular damage in the absence of the rest of the virus - doi.org/10.1161/CIRCRESAHA.121.318902
Moreover, the so-called "jab" administration circulates beyond what was represented by the manufacturers with unknown but increasingly alarming "downstream" effects.
See for example https://www.medscape.com/sites/public/covid-19/vaccine-insights/how-concerned-are-you-about-vaccine-related-adverse-events
The fundamental logic of vaccination may not apply here, especially for vulnerable populations, such as YOUNG PEOPLE, who have little to no risk of dying from the virus but are increasingly at risk from blood clots and myocarditis and other life-threatening vaccine-induced complications.
See for example the FDA's recent analysis of cases of heart inflammation in young people (young men especially) and note that these are hospitalizations and subsequent verifications by the FDA, so likely merely the tip of the iceberg:
https://www.fda.gov/media/150054/download - published June 2021
I am terrified by the possibility of ANTIBODY-DEPENDENT ENHANCEMENT EFFECT as I strongly believe, based on the accumulating laboratory and clinical evidence, that this risk increases with every exposure to the spike protein, whether virus or vaccine delivered.
See for example this warning of ADE risks in vaccination:
And the real kicker is that NO SCREENING is occurring before vaccination of people already infected and recovered from COVID-19.
Vaccine adverse outcomes - including death - are likely worsened by previous exposure and recovery from the SARS-CoV-2 virus because of ADE.
Who knows what best practices are for managing vaccine candidacy when no impactful attention is being addressed to the issue and those individuals who raise concerns about effects shamed and/or censored?
I, like most people, want a way out of this pandemic that preserves life and liberty, including self-ownership and free expression.
I also "follow the evidence" and have the capacity to read and understand scientific and clinical evidence.
I am concerned about inadequate independent investigation, transparent analysis and reporting, and call for the end to coercive crisis management by the media and employers.
I believe that we all will need to make accommodations for this horrible new world unleashed by the virus and its mis-management but those accommodations should not be forcibly imposed in ways that are disproportionately hazardous for young people, whose lives should be highly valued because they are our future.
I have the right to speak as a private citizen and as an authority on risk and crisis communication.