Is it time for the FDA or CDC to issue a warning about the Pfizer/BioNTech COVID-19 vaccine for the safety and health of children?

A look at previous FDA or CDC product warnings for the safety and health of children for comparison begs the question

Many of us might recall the FDA press release in February 2022 warning “Consumers Not to Use Certain Powdered Infant Formula Produced in Abbott Nutrition’s Facility” because of an additional reported death:

“Cronobacter infection may have been a contributing cause of death for this patient. In total, this investigation includes four reports of Cronobacter sakazakii infections in infants (three from FDA complaints and one from a CDC case finding) and one complaint of a Salmonella Newport infection in an infant. All five (four Cronobacter infections and one Salmonella Newport infection) illnesses resulted in hospitalization and Cronobacter may have contributed to death in two patients.”

Source: https://www.fda.gov/news-events/press-announcements/fda-warns-consumers-not-use-certain-powdered-infant-formula-produced-abbott-nutritions-facility

The news release states that Abbott initiated a voluntary recall of the infant powder formulas manufactured at one plant as a result of these reported deaths and illnesses.

Also in June 1982, the CDC released the announcement about the “Surgeon General's Advisory on the Use of Salicylates and Reye Syndrome” which warned of the use of salicylates such as aspirin for children exhibiting influenza and chickenpox symptoms.

“The Centers for Disease Control (CDC) estimates that 600-1,200 cases occur each year in the United States, most in persons between the ages of 5 and 16 years.”

Source: https://www.cdc.gov/mmwr/preview/mmwrhtml/00001108.htm

This adverse effect of a commonly used medicine of adults, but not recommended for children exemplifies that notion that:

Children are not just small versions of adults, nor should they be assumed to be or treated as such.

Surgical eye centers and providers of LASIK know this fact to be true, as this procedure for sight correction is not even available for children; the FDA has not approved it for children. The FDA rightly recognizes that children’s eyes are still developing and their eyesight will continue to change. Some eye centers view 25-40 years old as the best age to have the procedure done.

Source: https://www.hodgeseyecare.com/what-is-the-best-age-to-get-lasik/blog

Given the adverse reaction reports submitted to Vaccine Adverse Event Reporting System (VAERS) up through the current date, one might expect a similar FDA or CDC issued warning for the Pfizer/BioNTech COVID-19 vaccine as well.

If one searches the online Coronavirus Adverse Vaccine Event (CAVE) search tool using the following parameters:

The tool returns a table of the results with an accompanying word cloud using the reported symptoms:

Source: https://vaccines.shinyapps.io/cave/

Moreover, a summary of serious adverse reactions found from the Open VAERs tool for COVID-19 vaccine data for children age 5 -17 shows the following statistics:

Source: https://openvaers.com/covid-data/child-summaries

In December 2021, the CDC’s COVID-19 Task Force uses this very dataset to present on adverse events among children ages 5–11 years after COVID-19 vaccination, acknowledging the important information that the VAERs tool collects.

Source: https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2021-12-16/05-COVID-Su-508.pdf

Yet, no such warning about the COVID-19 vaccince appears to have been released by the FDA or CDC, nor has Pfizer or BioNTech issued a voluntary recall.

A multitude of questions arise:

• What criteria does the FDA or CDC use for issuing warnings?

• What is the minimum outcome of a product’s adverse effects that justifies a voluntary recall by Pfizer or BioNTech?

Lastly, is it only up to common citizenry to question whether a warning should be issued by the FDA or CDC, or is there some more effectual entity that should be called upon?

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Featured video: “A Call to Europe: The Future of Our Children is at Stake”

“Call for a European moratorium on health restrictions: the future of our children is at stake.

In the framework of the citizens' rally in Brussels organised on 23 January by Europeans United International, Children's Health Defense Europe organised a press conference with several speakers concerned by the current policy turn and the future that awaits our young generations, who have been constantly side-lined since the beginning of the crisis.”

https://tube.childrenshealthdefense.eu/w/iHAgarqxu3aQivQBusXYjP?start=8m30s

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For more information on CAVE or additional research using the CAVE tool, check out the following substack: