The ‘10ng’ DNA safety limit for vaccines is a fallacy

The 10 ng safety limit for residual DNA in vaccines has jumped 1,000-fold over the decades. An investigation reveals the global standard is built on assumptions—not robust evidence.

International drug regulators have set a safety threshold that allows up to 10 nanograms (ng) of residual DNA per vaccine dose—a trace amount they claim poses no risk to human health.

It was originally 1,000 times lower—at just 10 picograms (pg) but over the decades, that threshold quietly increased without fanfare or public scrutiny.

Regulators insist that the 10 ng limit is supported by sound science. But is it?

I set out to investigate what evidence—if any—supported this dramatic shift. When I asked the American, European and Australian drug regulators for human data to justify the 10 ng threshold, none could provide any.

The European Medicines Agency (EMA) responded that there is “no fixed limit” of residual DNA and that “higher amounts of DNA can be accepted if the DNA is sufficiently fragmented.”

The US Food and Drug Administration (FDA) initially agreed to respond but, after multiple delays, stated: “We have nothing further to share.”

Australia’s Therapeutic Goods Administration (TGA) also failed to produce any human data supporting the limit.

Rather than citing clinical studies, regulators pointed to the “millions of doses” administered without obvious harm.

So, despite the glaring absence of human safety data, the 10 ng threshold has become the global standard.