by Brenda Baletti, Ph.D., Childrens Health Defense:
Public health authorities have taken a series of actions in recent weeks to facilitate the possible future distribution of bird flu testing and vaccines, even as the CDC maintains the current public health risk from bird flu is low.
The U.S. Department of Health and Human Services (HHS) this month issued a declaration of emergency, announcing that some flu viruses — including H5N1 bird flu — could cause a pandemic and threaten national security.
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The announcement by HHS Secretary Xavier Becerra amended a 2013 section of the Federal Food, Drug, and Cosmetic (FD&C) Act, which allows the agency to extend the availability of medical countermeasures to pandemic influenza A viruses, including the currently circulating H5N1 strain of bird flu.
Prior to the amendment, the declaration covered only the previous H7N9 strain of bird flu.
The announcement specified that current circumstances justify the emergency use authorization (EUA) of in vitro diagnostics such as RT-PCR tests to detect bird flu and other pandemic influenza A viruses.
“This paves the way for more EUA vaccines, devices and products to possibly be effective against these new and unknown viruses,” attorney Ray Flores told The Defender.
He added:
“Just as EUA PCR tests exaggerated the COVID-19 pandemic, the detection of avian influenza and influenza A viruses with pandemic potential via unlicensed PCR tests is destined to justify lockdowns, masking, invasive nasal swabs, and wide-scale vaccination with experimental mRNA technology.
“The stage is set for RT-PCR tests to take the pivotal role of determining false positives with amped up cycle thresholds designed to declare asymptomatic, otherwise healthy people to be infected — just like last time.”
Under the FD&C Act, HHS can take steps to facilitate countermeasures only after the secretary of either the U.S. Department of Homeland Security, U.S. Department of Defense or HHS determines there is an emergency or potential for an emergency involving a chemical, biological, radiological or nuclear agent that may threaten the national or health security of U.S. citizens.
After that determination, the HHS secretary can declare that existing circumstances justify an EUA that would allow the FDA to authorize previously unlicensed drugs or vaccines or previously unapproved uses of licensed drugs.
The amendment covers animal or human flu viruses — circulating in wild birds, humans, or domestic animals — that may infect humans, may have caused pandemics in the past or may mutate to cause a pandemic in humans for which they have no prior immunity.
Becerra said in the amendment that the bird flu viruses may pose a public health threat, despite acknowledging that it “may initially only be occasionally transmitted to or between humans.” However, he added that bird flu viruses may “have the potential to become highly transmissible in humans and can cause significant morbidity and mortality.”
The currently circulating H5N1 virus is one in a series of bird flu viruses that pose such a threat, although the virus is not easily transmissible to humans and none of the human cases reported to the Centers for Disease Control and Prevention (CDC) involved severe disease, the announcement said.
“We cannot be sure,” Becerra said, that the mild cases associated with dairy cattle represent the full spectrum of the disease, “nor can we be assured that the virus will not mutate to cause more severe disease and/or to become more transmissible.”
The CDC reports the current public health risk is low and that surveillance shows “no indicators of unusual influenza activity in people, including avian influenza A(H5).”
There have been a total of 14 reported human cases since 2022, according to the agency. Four occurred after exposure to dairy cows, 10 after exposure to poultry and none have been serious.
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