Guest post by Michael Nevradakis, Ph.D.

This is the 12th extension of the liability shield for COVID-19 countermeasures since January 2020, when HHS declared a public health emergency under the Public Readiness and Emergency Preparedness Act, or PREP Act.

The U.S. Department of Health and Human Services (HHS) extended liability protection to COVID-19 vaccine makers and those administering the shots through Dec. 31, 2029. The extension takes effect Jan. 1, 2025.

HHS Secretary Xavier Beccera said the extension is needed because COVID-19 poses a “credible risk” to public health now and in the future.

“I have determined that the spread of SARS-CoV-2 or a virus mutating therefrom and the resulting disease COVID-19 constitutes a credible risk of a future public health emergency,” Beccera said in the announcement.

“Development of and stockpiling vaccines, therapeutics, devices, and diagnostics for COVID-19 continues to be needed for U.S. preparedness against the credible threat of a public health emergency due to outbreaks of COVID-19,” Beccera added.

Kim Mack Rosenberg, general counsel for Children’s Health Defense (CHD), called the last-minute move by the Biden administration “very concerning” because it protects industry and the government and “allows for largely unfettered product development.”

This is the 12th extension of the liability shield for COVID-19 countermeasures since January 2020, when HHS declared a public health emergency under the Public Readiness and Emergency Preparedness Act (PREP Act).

The act provides legal immunity to “covered persons” who manufacture or administer countermeasures during a public health emergency, including vaccine makers, manufacturers of masks and other personal protective equipment, and physicians, nurses and pharmacists who administer vaccines covered under the act.

Although the Biden administration ended its COVID-19 public health emergency in May 2023, the public health emergency HHS declared in January 2020 under the PREP Act remains in effect.

The extension comes amid growing calls for the vaccines to be paused or pulled from the market, based on reports of vaccine-related deaths and injuries.

‘Purely to protect themselves from litigation’

CHD CEO Mary Holland accused the outgoing Biden administration of “attempting to tie the hands of the incoming administration in its treatment of emergencies and pandemics. This is not the way elections and transfer of power are supposed to work.”

Ray Flores, senior outside counsel for CHD, told The Defender it’s “no surprise at all” that HHS extended the liability shield.

“This is something I’ve been warning of — a once-in-a-lifetime pandemic that they want to last the rest of our lives,” Flores said. “It is preposterous that HHS extended PREP Act protections based on a no-longer-existing threat. The only threat is a loss of air-tight liability that leaves the vast majority of victims out of luck.”

Dr. Joel Wallskog, a Wisconsin orthopedic surgeon who no longer practices due to injuries he sustained from the Moderna COVID-19 vaccine, told The Defender the extension “is disappointing.”

“The news is not surprising given the corruption of the current leadership of public health agencies,” said Wallskog, co-chairman of React19, a nonprofit representing vaccine injury victims. “This decision has nothing to do with a COVID-19 ‘threat.’ This is purely to protect themselves from litigation and to prevent Americans injured by the COVID-19 vaccines from fair and just compensation.”

Dr. Danice Hertz, a retired gastroenterologist who was “horribly injured” by the COVID-19 vaccine, told The Defender the extension is “inappropriate and unethical.”

“To argue that a more serious COVID-related public health emergency might develop in the future is a weak excuse for continuing a less-than-effective and potentially dangerous medical product,” Hertz said.

Wayne Rohde, author of “The Vaccine Court: The Dark Truth of America’s Vaccine Injury Compensation Program” and “The Vaccine Court 2.0,” told The Defender Big Pharma likely influenced the decision to extend the liability shield.

“There is no credible threat,” Rohde said. “Pharma made this decision and Beccera did their bidding. This was a political decision.”

Flores noted that Beccera “has unfettered authority to declare, determine the scope, extend, and end” an HHS public health emergency, adding that “no court can review” these declarations.

Others welcomed the news of the extension — and called for liability protections to be made permanent. In a press release, Michael D. Hogue, executive vice president and CEO of the American Pharmacists Association (AphA), said, “Today’s necessary actions by HHS will continue to save lives and lower health care costs.”

“APhA applauds HHS for extending these federal authorities until legislation is passed by the U.S. Congress to make them permanent,” Hogue said.

Reacting to these statements, Rohde said AphA was lobbying the White House heavily for the last year. “Retail pharmacies are having trouble staying open and they needed this declaration to keep the lights on.”

“Since there are recently manufactured vaccines that expire in 2027, this emergency protection had to continue,” Flores said.

‘Slap in the face’ to vaccine-injured

According to Bloomberg Law, “The announcement comes as people working in the vaccine injury space have called for Covid-19 vaccines to be covered under the HHS’ Vaccine Injury Compensation Program” or VICP.

VICP handles injury claims for 16 vaccines on the childhood vaccination schedule — but not vaccines covered under the PREP Act. Claims for the latter category are instead filed with the Countermeasures Injury Compensation Program (CICP).

CICP has been criticized for the narrow range of relief it offers victims. The program allows people to claim compensation only for unreimbursed medical expenses, lost wages up to $50,000 and death. At a congressional hearing in February, CICP’s slow pace of resolving vaccine injury claims came under scrutiny.

As of Nov. 1, 13,520 COVID-19 claims had been filed with CICP. Of these, 65 were determined to be eligible for compensation — but only 18 had been compensated. A total of 3,373 claims were denied, while 10,082 were “pending review or in review.”

The average payout of the 18 compensated claims is $24,513.93. However, this figure includes a payout of $370,376 offered to a single victim — the maximum amount allowed under the program. All other payouts totaled a combined $70,874.78 — an average of $4,169.10 per claim.

Of the compensated claims, 15 involved cases of myocarditis or myopericarditis, with one claim each for diagnoses of anaphylaxis, syncope and Guillain-Barré syndrome.

“There is supposed to be a safety net for those injured from these countermeasures. This ‘safety net’ is the CICP, which is a dismal failure,” Wallskog said. “It has a 98% rejection rate. Its budget for 2025 is $10 million — $9 million for administrative costs and $1 million for injuries.”

According to Rohde, there are nearly 800 petitions filed in the CICP alleging death as the result of the COVID-19 vaccine. “We have only seen one award for death since 2021.”

Hertz, who previously told The Defender a claim she filed with CICP never received a response, said there are “extensive reports of serious complications and deaths resulting from the COVID vaccines. These reports have gone largely ignored.”

“Extending the PREP Act is a slap in the face to the many injured by the COVID vaccines who have nowhere to turn for help or support,” Hertz said.

Wallskog suggested that the “only emergency they are extending is the COVID vaccine injury crisis plaguing Americans.”

‘Urgent need’ to overhaul COVID vaccine injury compensation program

The obstacles faced by vaccine injury victims who have sought to file claims with CICP have led to calls for its overhaul, for COVID-19 vaccines to be brought under the auspices of VICP or for vaccine makers’ liability shield to be stripped altogether.

Legislation introduced in Congress in March, the Let Injured Americans Be Legally Empowered Act (LIABLE Act), would “allow Americans who took vaccines that were misleadingly promoted and forced onto many Americans via federal mandates to pursue civil litigation for their injuries.”

However, the bill has since languished in the U.S. House of Representatives.

“The backlog of petitions in the CICP illustrates the extreme urgent need by Congress and incoming secretary of HHS to allow all COVID vaccine injury petitions, including those dismissed, to be refiled in the VICP immediately,” Rohde said.

Flores said it’s unlikely the COVID-19 vaccines will ever be moved to the VICP. “The ‘Vaccine court’ would be flooded with claims.” Flores said the 75-cent excise tax currently charged for vaccines covered under VICP to fund the program, “would need to be increased at least a thousand-fold.”

Will Trump administration rescind the extension?

Could the new administration rescind the extension, or the PREP Act entirely? Some experts say this is possible. Last month, President-elect Donald Trump nominated Robert F. Kennedy Jr., founder and former chairman of CHD, to lead HHS. Confirmation hearings in the Senate are expected to begin in January 2025.

“I hope and trust that the new administration will review this decision and make necessary changes,” Holland said.

“The incoming secretary of HHS can rescind this declaration, announce that he is moving the COVID-19 vaccine into the VICP and address the need for existing petitioners in the CICP to refile in the VICP,” Rohde said.

For this to occur though, Rohde said Congress will need to enact a similar tax on the COVID-19 vaccines. Federal staff that would process COVID-19 vaccine injury claims under VICP “will need to expand … to meet that demand.”

Wallskog called for the PREP Act to be rescinded. “I believe strongly that the PREP Act should be dissolved. We at React19 will work aggressively with the new administration to eliminate the act.”

For Flores though, such an outcome is unlikely. He said:

“Congress cannot rescind the PREP Act without the U.S. running the risk of liability to these manufacturers. The Pfizer and Moderna contracts guarantee that these manufacturers are protected by the PREP Act.

“If the emergency ends, then vaccines already in distribution, if administered, could trigger manufacturer liability. To avoid a breach of contract, the solution is simple: Leave manufacturer immunity in place and take away immunity for all other covered persons. Then, the products will just sit there — or be administered at the formerly covered person’s own risk.”

Lawsuits challenging the PREP Act, including in Vermont and North Carolina, may “do more to chip away at PREP itself,” Flores said — as might a case in Utah challenging a COVID-19 vaccine manufacturer based on a breach-of-contract claim.

“PREP permits mRNA to make a plaything of our immune systems,” Flores said. “It only ensures one thing: more victims whose lives will be destroyed.”

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