FDA Meeting About injecting the whole population of babies 6 months and older with gene Therapy products
Making public comment in the federal registrar
I encourage you to comment on the upcoming FDA Vaccines and Related Biological Products Advisory Committee meetings. The Meeting on June 14th and 15th is about expanding the Moderna and Pfizer EUAs to include ages 6months and up.
Comment on the matter is open until 11:59pm ET on June 13th.
Why comment? well it is an opportunity to notify the FDA of any concerns that you may have about the matter. Even if the conclusions are already forgone as is intended by the White House and CDC, the importance of commenting is to document things in the formal record. This formal record could be used in court latter if there are any legal challenges since it is part of the official records surrounding a regulatory decision. Also, silence bespeaks consent. Now is the time to speak your mind.
I think that if you have an opinion on the subject of injecting modified MRNA gene therapies into 6 month old population wide, you should post comment on the federal registrar for the meeting on June 14th and 15th by clicking on this link:
Formal Comment to FDA
Initially I had tried to obtain the meeting materials from the FDA so that I could read the packages of information submitted to the FDA by Pfizer and Moderna and make a comment accordingly.
However the FDA informed me that the materials would not be published until June 10th.
All public comments after June7th at 11:59pm ET will be added to the federal docket as part of the official record but will not be forwarded to the committee for consideration in the hearing. It was important for me to review the data, but more important to write an initial comment about the lack of transparency in this process and the politicization of this process.
I may make another comment latter in the week and will update.
This was my submission last night, word for word. Feel free to cut and paste and reuse any part that helps.
Comment tracking number: l43-lk7e-fix5
I am a certified Pediatric Nurse Practitioner in Primary Care. I am concerned about the lack of Transparency in the approval process for these vaccines. The Data packages for the vaccines under consideration have not been shared in a timely manner, and I can not review them before the deadline to have comments submitted for the committee. This is very disappointing- and illegally undermines the transparency of this process and the ability of the public to make comments on these important meetings. I have requested from the panel the materials to review for my comment and received word that they would be made available on June 10th. This withholding of data limits my ability to make timely comments in a meaningful way because the committee refuses to publish the materials within the time frame of its public comment deadlines for comments to be forwarded to committee members.
This meeting should be delayed so that the materials can be considered for public comment that is submitted to the committee.
The FDA exists to protect the public from industries. The purpose of this committee is to recommend the FDA on how to protect the public. Yet one can see from White House press releases, and CDC guidelines, the decision to purchase 10 million doses of the vaccines in question for our youngest population and the ordering of those vaccines has already been undertaken, creating enormous pressure that biases the decisions of this committee in its recommendations and the FDA that it advises in its authorizations. While I am sure that you are aware of these political pressures, I have attached references below.
https://www.cdc.gov/vaccines/covid-19/downloads/Pediatric-Planning-Guide.pdf?wpisrc=nl_health202
(PDFs included as attached documents)
As a pediatric Nurse Practitioner I can order the vaccines for these young children before the advisory panel meeting takes place. In this political setting it is ridiculous to assume that there is consideration of safety at play in this panel or in the FDA when it comes to COVID19 vaccines. Taken into the context of the withholding of public data until after the initial comment period closes, these actions are a farce at over site and appear complicit with defrauding the American People.
I would like to remind the members of this committee of their obligation to first Do No Harm. Also, for a product of massive vaccinations to be ethical, it must be very very safe and it must have an overall positive health impact. Abundant evidence shows that COVID poses nearly zero risk to this age group, meaning that the vaccination of children in this age group is unlikely to have any impact. I am sure that the Number needed to vaccinate to save one life, even based on the pharmaceutical research which is unlikely to reflect actual real world experience towards efficacy will be very very high for this population.
A Johns Hopkins study monitoring 48,000 children diagnosed with COVID showed a zero mortality rate in children under 18 without commodities.
A study in Nature demonstrated that children under 18 with no commodities have virtually no risk of death.
Data from England and Wales, published by the UK Office of National Statistics on January 17, 2022, revealed that throughout 2020 and 2021, only one child under the age of 5, without commodities, died from COVID in the two countries, whose total population is 60 million.
A large study conducted in Germany showed zero deaths for children 5-11 and a case fatality rate of three out of a million in children without commodities.
Another study in Nature from April 2021, suggests children’s bodies clear the virus more easily than adults.
A study published in December in Nature demonstrated how children efficiently mount effective, robust and sustained immune responses to COVID.
As we are becoming more and more aware of a lack of efficacy of MRNA Vaccines at stopping Infections and Spreads and Stopping Deaths There is no emergency for this population, the vaccines can not stop the spread, so there should be no emergency use authorization for these vaccines for this population.
The vaccines have some potential harms that have not been studied. It is the obligation of this panel to recommend against any authorization of these products for young children. I am concerned about a possibly Fraudulent effort to sell these products that are potentially harmful to the American Public in the form of the utilization of false claims both of safety that have not and could not possibly have been demonstrated and of efficacy that only are backed by ever narrowing the definition of what is efficacious. The decision to push these not yet proven to be safe products on infants may result in totally preventable deaths and injuries.
-Anthony Luczak, APRN,CPNP,PMHS
link to make your Formal Comment
Thanks to James Roguski for his really outstanding work. I did use his wording when citing the studies, about the approaching zero risk for children in the age groups being considered. Check out his substack which has another template letter and more information on this and the other upcoming meetings@ jamesrogusky.substack.com