Feds quietly ban liability for vax makers through Trump's full term as FDA exposes RSV trial harm

The federal government is protecting the manufacturers of COVID-19 and flu vaccines from product liability for another five years, on the cusp of a new administration likely to aggressively look for vaccine injuries and release its hidden books that Just the News went to court to obtain.

Didn't hear about it? That's because the Department of Health and Human Services does not appear to have told the public outside a Dec. 11 Federal Register notice, primarily read by regulated entities, and a generic page buried deep within HHS's website.

Outgoing agency Secretary Xavier Becerra's amendment to the declaration under the Public Readiness and Emergency Preparedness Act for "COVID-19 Medical Countermeasures," enacted 19 months after President Joe Biden formally ended the COVID public health emergency, gives a perfunctory explanation for the liability shield's continuing necessity.

"I have determined there is a credible risk that COVID-19 may in the future constitute such an emergency," says the 27-page notice written in Becerra's voice, dated Dec. 6, much of it rehashing previous amendments and requirements for "covered persons."

"Congress delegated to me the authority to strike the appropriate federal-state balance with respect to Covered Countermeasures through PREP Act Declarations," he also says.

"The 12th Amendment generally extends the protections clarified in the 11th Amendment" from May 2023, which ended some liability provisions and was set to expire Dec. 31, "through 2029," reads the PREP Act questions and answers page. 

The extension also covers COVID therapeutics administered "subcutaneously, intramuscularly, or orally" such as Pfizer's rebound-prone antiviral Paxlovid, whose efficacy Pfizer's own research has questioned.

A section near the notice's end provides for "an additional 12 months of liability protection … to allow for the manufacturer(s) to arrange for disposition of the Covered Countermeasure," implying the shield will last the full decade.

The Dec. 11 notice gives no explanation for the lengthy duration of the extension, three times longer than the previous amendment provided. Published a month after President-elect Donald Trump's victory, it covers the entirety of his pending administration.

One X observer noted interesting timing: Pfizer's combination flu-COVID vaccine was supposed to finish Phase 3 clinical trials last month but failed an important benchmark this summer.

"Pfizer would have to go through the normal licensing and approval process" with the Food and Drug Administration "and possibly lose legal immunity going forward" without this extension, the pseudonymous user wrote.

Posted by the Administration for Strategic Preparedness and Response, the notice is not announced anywhere the general public or media might find it, as far as Just the News could tell. It's not mentioned on HHS's press release page or social media, including Beccera's own.

HHS has yet to answer Just the News queries starting Wednesday morning on how the public could find the notice without directly visiting ASPR's PREP Act page or stumbling across it in the Federal Register.

It was spotted at 1 a.m. Dec. 11 by lawyer Tom Renz, who represents COVID vaccine injury whistleblowers, and that afternoon by the University of Minnesota's Center for Infectious Disease Research and Policy, led by former White House COVID adviser Michael Osterholm.

"We must reverse this nonsense, and more importantly – pass significant reforms to such liability provisions," Rep. Chip Roy, R-Texas, wrote on X. 

"We live in a crime scene," wrote Oregon naturopath Henry Ealy, who with Beaver State lawmakers sought a federal grand jury investigation into COVID statistical manipulation.

Renz suspects the liability shield extension is related to Becerra's presumptive successor Robert F. Kennedy's expected release of information against the vaccines' safety and efficacy and subsequent litigation, assuming the Senate confirms the nation's leading vaccine skeptic.

Trump recently signaled his openness to changing the childhood vaccination schedule under Kennedy's direction. Asked by NBC's "Meet the Press" host Kristen Welker whether he saw a link to autism, Trump said the condition was "almost non-existent" at the turn of the century.

"This last ditch attempt to save big pharma from liability for the chaos they’ve sown in so many lives is likely to be accompanie[d] by other legal maneuvering designed to limit justice," Renz wrote on X.

The American childhood schedule, like American waistlines, is large compared to other countries. University of Southern Denmark global health professor Christine Stabell Benn and Danish-American MIT vaccine-safety researcher Tracy Beth Hoeg host a podcast on the stark differences between the U.S. and Danish schedules.

"The current system for testing, approving and monitoring vaccines is not set up to capture non-specific effects and has serious limitations when it comes to capturing adverse events" following vaccination, their summary of the new episode says.

Advocates for vaccine-injury victims are also raising their profile amid the presumptive ascension of the friendliest HHS secretary they likely could expect.

React19, which lobbies Congress to reform the vaccine-injury compensation system and whose founder is suing Biden administration officials for alleged social media censorship, released a documentary Thursday on Finnish "extreme triathlete" Heiko Sepp.

He was hospitalized with "unbearable chest pain" tied to COVID vaccination three years ago and faces "daily battles" with pain, fainting and "a compromised immune system," it said.

"Meanwhile, the Norwegian health system has turned its back on him, canceling doctors’ appointments and treating him as if he didn't exist," React19 said. "Due to the stigma surrounding post-vaccination health complications, sufferers remain persona non grata."

HHS has not been shy about promoting the latest COVID, flu and RSV vaccines as a precondition for holiday social gatherings, with separate public service announcements for Christmas, Hanukkah and Kwanzaa as well as long-term care facilities.

It's also urging pregnant women approaching delivery to get RSV vaccines to protect their infants, and hosted a webinar last week moderated by its Great Lakes Region director with state and local government public health officials on winter vaccinations.

HHS proclaimed in a post also shared by Assistant Secretary of Health Rachel Levine that any side effects are "usually mild and almost always go away within a few days" and all vaccines are "continually monitored for safety," without noting monitoring varies widely across programs. 

The government also routinely explains away reports in the Vaccine Adverse Events Reporting System, which the public is most apt to use because it's publicly accessible and not limited to reports by healthcare providers and manufacturers.

The post's linked Centers for Disease Control and Prevention page on vaccine side effects also implies parents are threatening the lives of their children and the community by not vaccinating them, without acknowledging the near-zero risk to children from COVID itself and the COVID vaccine's inability to stop infection or transmission.

Yet the CDC itself funded a massive international study that found rates of COVID vaccine "adverse events of special interest" to be much higher than expected, including heart and spinal-cord inflammation, Guillain-Barré syndrome and brain blood clots. It also admitted leaving diagnosis codes off some death certificates credited to COVID vaccines.

The timing of the one-size-fits-all vaccination pressure campaign is particularly bad for RSV vaccines, given that Moderna's mRNA vaccine candidates for RSV could be its death knell.

It got kicked off the Nasdaq 100 on Friday after a three-year stock slide, with Kennedy's nomination prompting another dive Nov. 15, Investor's Business Daily reported.

The final straw may have been the FDA's disclosure Thursday, spotted by BioSpace, that it detected RSV lower respiratory tract infections in infants given Moderna's candidates, explaining why the company paused the trial in July.

"The real story" is that the trial had a placebo group "unlike trials for existing childhood vaccines and shows exactly why a placebo group is critical," vaccine-injury lawyer Aaron Siri wrote on X, wondering if trials for those vaccines would have been halted with placebo groups as well.

Becerra's Dec. 11 notes says without evidence that COVID "continues to cause significant serious illness, morbidity, and mortality during outbreaks," claiming the "risk of domestic cases" – infections regardless of severity – "is high due to ongoing outbreaks that continue domestically and internationally in the year since the PHE for COVID-19 ended."

The U.S. still needs development of and "stockpiling vaccines, therapeutics, devices, and diagnostics for COVID-19" because of this credible threat of emergency, it says.

"COVID-19 is a global challenge that requires a whole-of-nation response" and "there are substantial federal legal and policy issues … in having a uniform interpretation of the PREP Act," whose only exception to immunity is "death or serious physical injury proximately caused by willful misconduct by such covered person."