WHAT WAS CLAIMED
The US FDA has admitted unvaccinated people are at risk from people "shedding" COVID-19 mRNA vaccines.
OUR VERDICT
False. The FDA has not admitted this, and experts say there's no mechanism for this to occur.
AAP FACTCHECK - The US drug regulator has not admitted that "shedding" from COVID-19 mRNA vaccines causes side effects to unvaccinated people, despite claims on social media.
The US Food and Drug Administration (FDA) and an expert say there's no plausible mechanism by which such vaccines could do what's being claimed.
Facebook posts make the claim, stating: "The Food and Drug Administration (FDA) has admitted that unvaccinated people are at risk of Covid mRNA 'vaccine' side effects, such as cancer and sudden death, due to 'shedding' from those who received the injections."
This text matches the first line of an article by Slay News, a website AAP FactCheck has debunked numerous times, with many posts also including a link to this piece.
The Slay News article alleges that the FDA made the "admission" in a 2015 report.
But this is not true.
The FDA report does not mention mRNA vaccines, or discuss vaccines at all.
It does discuss "shedding", but not in relation to vaccines or any COVID-19 treatments.
The FDA document gives guidance to drug developers on how to conduct studies on shedding in the development of virus or bacteria-based gene therapy and 'oncolytic products'.
AAP FactCheck has previously debunked claims that mRNA vaccines for COVID-19 are "gene therapy" as have Reuters Fact Check, The Associated Press and Australia's Gene Technology Regulator, as they cannot modify the body's genes.
'Oncolytic products' contain replicating viruses or dividing bacteria designed to attack cancer cells, the FDA document says.
In this context, the document says (page one), shedding would be the release of those products from treated to untreated individuals, which could happen through faeces or urine, saliva, or wounds in the skin.
However, the FDA confirmed that the two US-licensed COVID-19 vaccines, made by Pfizer and Moderna, do not produce a virus capable of replicating.
The FDA said it was unaware of "biologically plausible mechanisms" for these vaccines to cause shedding, the official told AAP FactCheck.
Vaccine shedding typically refers to the release of vaccine components outside the body, according to the US Centers for Disease Control and Prevention (CDC), which can "only occur when a vaccine contains a live weakened version of the virus".
However, it's well-established that mRNA vaccines do not contain live virus.
The Children's Hospital of Philadelphia website states that mRNA vaccines contain a single gene from the virus that causes COVID-19, which instructs cells to create a protein, but no other virus proteins are created, "so whole virus particles are never present".
A Nebraska Medicine article also said that shedding can't happen without a live vaccine, and mRNA vaccines "are not live vaccines and do not replicate".
Gigi Gronvall, an immune system and vaccine expert at the Johns Hopkins Center for Health Security, said there was "no plausible mechanism" for shedding to occur from such vaccines.
"If there were shedding — if immunity could be shared, which it can't for this vaccine — we would see much fewer deaths among the unvaccinated," Professor Gronvall told AAP FactCheck.
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