'Medical malpractice martial law'? HHS bird-flu 'declaration' spurs fears of liability-free vaccines

HHS rebuts RFK Jr.'s claim that Becerra "just issued a PREP Act declaration for bird flu," but secretary said his update to 2013 declaration will "help facilitate the availability of medical countermeasures," which include vaccines shielded from liability.

Published: July 29, 2024 11:00pm

Should Americans get ready for another whole-of-government campaign to convince everyone – through persuasion, if not mandates – to get vaccinated against a virus new to humans, then expect to struggle to get compensation for vaccine injuries?

That's how independent presidential candidate Robert F. Kennedy Jr., Kentucky GOP Rep. Thomas Massie and some doctors are interpreting Health and Human Services Secretary Xavier Becerra's expansion of an 11-year-old public health emergency to cover all "pandemic influenza A viruses and influenza A viruses with pandemic potential," not just the H7N9 strain from 2013.

Published in the Federal Register on Wednesday, a month after the HHS Administration for Strategic Preparedness and Response (ASPR) released its strategy for H5N1 bird flu and "other potential pandemic influenza viruses," the "Declaration of Emergency Pursuant to the Federal Food, Drug and Cosmetic Act" does not appear to have drawn mainstream media attention.

The declaration says the H7N9 outbreak caused "two separate human case clusters involving over 400 people," with more than 100 deaths, and though "sustained human-to-human transmission was not seen, familial clusters could not be ruled out" and some patients had "treatment-emergent resistance."

It acknowledges that H5N1 animal-to-human transmission has been nearly nonexistent since the species jump was first observed in 1997, but warns that more than half of human cases were fatal and that H5N1 "likely" jumped from cattle this year.

The eight human cases "associated with the dairy cattle outbreak," in Colorado, Michigan and Texas were limited to people with "occupational exposure to infected animals," none produced "severe disease" and H5N1 currently poses a "low" risk to human health, the declaration also says.

But "we cannot be sure" these cases "represent the full spectrum of disease" or that H5N1 will not acquire "a mutation conferring facile mammal-to-mammal transmission," the declaration warns – phrasing that recalls the furin cleavage site within SARS-CoV-2 that supports the lab-leak theory of COVID-19.

The American Medical Association on July 19 issued a "provisional" billing code for H5N8 vaccines awaiting emergency use authorization from the Food and Drug Administration. The American Hospital Association alerted members to the declaration before it was published.

"There have been a total of 11 cases of bird flu in the US since 2022, all mild, most involving just conjunctivitis," with no known "human-to-human" transmission, Kennedy wrote on X that afternoon. "Why would you need this vaccine, unless you expected a much more virulent virus to appear which had mysteriously gained the ability to spread between humans?"

Becerra "just issued a PREP Act declaration for bird flu," Kennedy said, referring to the Public Readiness and Emergency Preparedness Act. "This allows the FDA Commissioner to issue EUAs for bird flu vaccines, with no liability."

Kennedy noted the U.S. government, through ASPR, had already ordered 4.8 million doses of "pre-pandemic vaccine that is well-matched to the H5 of the currently circulating H5N1 strain" from CSL Seqirus, as the company bragged in May. It's the fourth award from the feds to CSL Seqirus pertaining to "sustained highly pathogenic avian influenza (HPAI) activity."

"The PREP Act is medical malpractice martial law, and should be repealed," Massie responded to Kennedy on X. "It supersedes all state tort laws and allows cronies at pharmaceutical and medical device companies to literally get away with murder as long as their victims can’t prove there was malicious intent."

Atossa Therapeutic CEO Steven Quay, who testified at a Senate hearing on COVID origins last month, wrote on X: "Let's keep track of this" given the "non-existent risk benefit analysis" for a vaccine against a bird flu with no documented transmission between humans."

He also wrote: "Follow the money here to see what is happening."

Southern California News Group editorial board member Susan Shelley wrote on X, tagging the House Oversight Committee: "Congressional hearings, before it's too late,"

The publisher owns the Los Angeles Daily News and Orange County Register among other newspapers.

HHS took Kennedy and his allies literally, telling Just the News the July 18 determination – published six days later – "was not under the PREP Act" but rather than FD&C Act. 

"This amendment to the 2013 determination is being done as a part of HHS’ preparedness efforts and no changes have been made in the avian flu public health risk determination," according to a statement credited to an unnamed spokesperson, provided by Spencer Pretecrum in HHS's ASPR communications.

"Additionally, FDA is not currently able to issue emergency use authorizations (EUA) for products for H5N1 because no EUA declaration has been made," the statement reads. FD&C Act Section 564 requires the HHS secretary to make that declaration, after issuing a relevant determination, "for FDA to be able to issue EUAs."

While Wednesday's declaration doesn't mention the PREP Act or vaccines, it says Becerra's order will "help facilitate the availability of medical countermeasures" (MCMs) – a term that explicitly covers vaccines – including through "Emergency Use Instructions" created by the Centers for Disease Control and Prevention for those MCMs.

Becerra amended the COVID countermeasures declaration under the PREP Act in April 2023, a month before the scheduled end of the COVID public health emergency, which "does not automatically terminate PREP Act coverage for countermeasures."

He said the declaration was a "key tool for ensuring that Americans have broad access to critical COVID-19 countermeasures including vaccines, tests, and treatments," and that "much of the health care landscape – including pharmacies – has relied on these flexibilities and liability protections." 

The Countermeasures Injury Compensation Fund, authorized by the PREP Act, covers COVID vaccines issued under EUAs and fully licensed by the FDA. House Select Subcommittee on the Coronavirus Pandemic Chairman Brad Wenstrup, R-Ohio, said at a February hearing that CICP had approved only 11 claims out of 12,000 for COVID vaccines as of January.

Becerra's declaration does not require any data showing a countermeasure's favorable harm-benefit profile, and "possibly" no human testing, for an EUA to be granted, former biowarfare researcher Meryl Nass wrote in her newsletter Thursday

She said the "only justification to vaccinate humans en masse would be a release of a new bird flu strain that has gained two functions simultaneously: virulence for humans, and transmissibility. Gaining both functions at once only happens in labs."

Maine's Board of Licensure in Medicine suspended Nass's license and ordered a neuropsychological evaluation based on her COVID views, some echoed by the CDC, and treatment protocols two years ago.

"Liability protections already in place for the next vaccine roll-out. If you are harmed, you are on your own," AstraZeneca COVID vaccine victim Brianne Dressen wrote on X responding to the HHS declaration. She attended February's House COVID subcommittee hearing and was invoked as an example of the unfairness of CICP.

The Vaccine Injury Compensation Program, which covers vaccines on the childhood schedule, is far friendlier to both victims and their lawyers, with adjudication in real courts, eligibility for attorney's fees and costs, and awards that are magnitudes larger than those issued under CICP.

Vaccine injury group React19 has been lobbying for legislative reform to the compensation programs for two years to help COVID vaccine victims.

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