***URGENT – SUBMISSIONS OF STATEMENT FOR FDA MEETING TO DISCUSS EUA FOR 5 – 11 YEAR OLDS***
DEADLINE – OCTOBER 21st, 2021
***PLEASE FORWARD TO ALL OF YOUR KNOWN CONTACTS (NO RESTRICTIONS ON LOCATION)***
A meeting of the FDA Committee is to be held on Oct. 26th, 2020 to discuss Pfizer-BioNTech’s Emergency Use Authorization (EUA) for administration of their COVID-19 mRNA vaccine to children 5 through 11 years of age.
Responses can be made via: https://www.regulations.gov/document/FDA-2021-N-1088-0001 (please see below for tips as to how to make your response, and you can also view the responses made to date as examples)
WHY ARE WE GENUINELY CONCERNED (nothing to do with ‘anti-vax’)
LISTEN TO THE EXPERTS
Unusual ‘known’ outcomes – MIS-C (specific to children). Pay close attention to the dates of ‘observations’ between March – June, 2020 for this varied and fatal condition for children.
Take this MIS-C knowledge forward, and apply to ‘Two Different Antibody-Dependent Enhancement (ADE) Risks for SARS-CoV-2 Antibodies’ . Check the Summary which states ‘ADE with mast cells likely plays a role in MIS-C for infants and possibly older MIS-C and MIS-A patients.’
Consider the ‘indications’ from observable data.
Listen to the expert (Dr. Ryan Cole) for additional ‘indications’ of concern here.
Due to these significant risk factors, with no existing burden of proof to guarantee the safety of the children (including acceptance of liability), there can be no legitimate and legally obliged informed consent under the practices administered during this vaccine roll out, and as such requires extensive independent laboratory research to qualify these observable concerns, and further no existing burden of proof is offered to indicate benefit outweighing these evidenced risks. Hence precautionary principle and medical ethics demands the prevention of providing this EUA. Additionally, existing research for early treatment is providing evidence of efficacy, whereby burden of proof must be provided stipulating lower risk than these alternative treatments, taking into consideration the afore mentioned risks associated with ADE and MIS-C.
ADVICE IN MAKING YOUR COMMENTS TO THE FDA
Tips for Submitting Effective Comments.
The comment text box will hold 5000 characters which is about 42 lines, and therefore more substantial evidence is recommended to be presented via the ‘Attach Files’ section. This may include any notarised Affidavit from qualified persons from any nation (please take into account that FDA approvals are being utilised as authorisation across all countries recognising FDA pronouncements).
FOLLOW UP
It is recommended that US Citizens also forward your submissions to your Member of Congress, whereby email addresses can be found here.
You can also inform your US Representative.
Other nationalities are encouraged to contact their representatives to determine the processes, permissions and intended authorisations within your domestic territory.
CONCLUDING STATEMENT
It is highly recommended that all submissions to this process be factually based, and where appropriate demanding of the burden of proof, in conjunction with all standard and legally obliged ethics for both medical treatments and medical practitioners. The evidence provided within our statement of concern is not limited to these concerns (Adverse Reaction reporting systems also indicate a significant risk, including deaths at rates never before witnessed nor allowed to extend into such high numbers – please check for yourselves), so we do strongly advise you seek out not only official narratives, but also independent, credible and qualified information such as via the World Council for Health and Early COVID Care.
“Let the little children come to me and do not hinder them, for to such belongs the kingdom of heaven.” Matthew 19
Source material can be found at this site.
