At least 5 years of safety data, please

Post #1180

When FDA examined gene therapy (GT) products, the safest group were those based on adeno-associated virus (AAV) vectors:

This led to a recommendation on Long Term Follow-up (LTFU) safety monitoring for this safest group of gene therapy products which lasts up to 5 years, though products that are less safe need 15 years of safety monitoring:

The FDA is admittedly aware of latent cancer arising years after gene therapy:

So the required Long Term Follow-up (LTFU) safety data cannot be measured in mere months, and it is required to be measured in “years”:

But when writing about the spike protein that your body makes after you get injected with mRNA shots, the FDA implies that it is safe:

Given how Nic Hulscher reported on spike protein being found in the body almost two years after mRNA shots, how can the FDA know that spike protein does not cause disease, when its own documents reveal that the safest gene therapy products should be studied for 5 years before they are pronounced as safe?

It appears that FDA is engaged in a “performatory contradiction” — laying out how things should proceed regarding safety monitoring, but then going against its own advice. Because of the unknown safety of mRNA shots for children, Denmark, Iceland, Portugal, and Sweden do not recommend them (at all) for those under age 18:

[click to enlarge]

But, disturbingly, the USA is continuing to recommend them for children as young as 6 months old:

And this is continuing even though there are officially only 2 months of safety data on children:

If spike protein can be found in the body almost 2 years later, then gathering safety data for 2 months in kids is next-to-useless in uncovering the true safety profile of these experimental gene therapies. The USA should be like Denmark, Iceland, Portugal, and Sweden and not recommend them (at all) for those under age 18.

Only adults who are old enough to make choices for themselves should be allowed to gamble with their long-term health by taking experimental injections.

Reference

[for the safest gene therapies, FDA recommends 5 years of safety monitoring] — https://www.fda.gov/media/113768/download

[FDA claims to know that spike protein is safe, even with only 2 months of data (on kids)] — https://www.fda.gov/vaccines-blood-biologics/consumers-biologics/vaccines-children-guide-parents-and-caregivers

[4 nations in Europe do not recommend COVID shots for any children] — https://vaccine-schedule.ecdc.europa.eu/Scheduler/ByDisease?SelectedDiseaseId=52&SelectedCountryIdByDisease=-1

[In the USA, COVID shots are still on the childhood vaccine schedule] — https://www.cdc.gov/vaccines/hcp/imz-schedules/child-adolescent-age.html

[FDA got safety data on kids for 2 months] — https://www.mayoclinic.org/diseases-conditions/coronavirus/in-depth/covid-19-vaccines-for-kids/art-20513332