U.S. Government Extends Liability Shield for COVID Shot Makers
- by Marco Cáceres
- Published
- Pharma
On Dec. 10, 2024, the U.S. Department of Health and Human Services (HSS) announced it would extend through Dec. 31, 2029 liability protections for pharmaceutical companies that produce COVID-19 biologics. According to Bloomberg Law, the liability shield also protects “health professionals prescribing, dispensing or administering vaccines, including state-licensed pharmacists, pharmacy technicians and pharmacy interns.” The extension takes effect on Jan. 1, 2025.1 2 3 4
Liability Protections Extended for 12th Time
The extension, which is in the form of an amendment to Public Readiness and Emergency Preparedness (PREP) Act passed by Congress after Sept. 11, 2001, the most recent amendment to the PREPA Act, is the 12th of its kind since Jan. 31, 2020 when HSS declared a coronavirus pandemic public health emergency. The PREP Act authorizes the HHS Secretary to provide liability immunity to “certain individuals and entities against any claim of loss caused by, arising out of, relating to, or resulting from the manufacture, distribution, administration, or use of medical countermeasures, except for claims involving “willful misconduct” as defined in the PREP Act.5 6 7
HHS Secretary Xavier Beccera justified the extension based on his view that COVID continues to pose a “credible risk” to public health now and in the future. This, despite the fact that the COVID public health emergency officially ended last year.1 3 4 8 He said:
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. 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-19.3 4
Currently, similar PREP Act liability protections are in effect for medical countermeasures (MCM) against numerous other biological or chemical threats, including “mpox and other orthopox viruses, viral hemorrhagic fevers such as Ebola, nerve agents and insecticides, Zika virus, pandemic flu, anthrax, acute radiation syndrome, and botulinum toxin.”9
The PREP Act was first passed in 2005 to “shield U.S. vaccine makers from liability a vaccine or drug developed in response to a health emergency like a pandemic causes the death or permanent injury of an individual who receives it during pre-licensure clinical trials or after it is released for public use,” noted Barbara Loe Fisher and Rishma Parpia in an article published by The Vaccine Reaction in 2020.7 They added:
[The legislation] was part of a series of “Bioshield” laws created in response to national security fears after 9/11 and subsequent reported weaponized microbe threats, which prompted Congress to encourage pharmaceutical companies to develop anti-bioterrorism vaccines by, in part, eliminating liability for injuries and deaths caused by those vaccines.7
Safety of COVID Shots Being Re-Assessed
The extension of liability protections for COVID-19 biologic coincides with growing calls in the United States for the COVID shots, especially COVID shots using the controversial mRNA technology, to be suspended in order to reassess their safety. A petition introduced earlier this year ER physician and medical researcher Joseph Fraiman, MD states that a “growing body of evidence suggests the widespread rollout of the novel COVID-19 mRNA vaccine products is contributing to an alarming rise in disability and excess deaths.”4 10 11 12 13 14
Dr. Fraiman is the lead author of a study published in the journal Vaccine which re-analyzed the original randomized trials for Pfizer/BioNTech’s and Moderna/NIAID’s COVID biologics and concluded that the rate of serious harm from the shots was one in 800—much higher than previously put forward.10 12 15
Stanford University health researcher Jay Bhattacharya, MD, who has been nominated to be the next director of the National Institutes of Health (NIH), described Fraiman’s study as “probably the most important paper during the pandemic” about COVID biologics.10
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