2005 PREP Act and 1986 Act Shield Vaccine Manufacturers from Liability
In light of the COVID-19 pandemic, the United States and other countries around the globe have opened the door for accelerated development, testing and fast track licensure of experimental COVID-19 vaccines.
The question many people have is: who will assume product liability when COVID-19 vaccines cause harm to an individual who has been vaccinated?
AstraZeneca Exempted from Liability for COVID-19 Vaccine Injuries & Deaths
AstraZeneca plc, a multinational pharmaceutical and biopharmaceutical company headquartered in Cambridge, England, has been granted product liability protection for the COVID-19 vaccine the company is developing by most countries with which it has made vaccine supply agreements.1
Liability questions have been a central issue in negotiations between AstraZeneca and countries seeking COVID-19 vaccine supply contracts.2
According to a member of AstraZeneca’s senior executive team, Ruud Dober:
“This is a unique situation where we as a company simply cannot take the risk if in four years the vaccine is showing side effects.”
He adds that, “In the contracts we have in place, we are asking for indemnification. For most countries it is acceptable to take that risk on their shoulders because it is in their national interest.”3
AstraZeneca and Emergent BioSolutions have struck an $87 million deal to manufacture two billion doses of the University of Oxford’s adenovirus-based COVID-19 vaccine to supply to the U.S. The manufacturing contract is part of the Operation Warp Speed initiative to develop and rapidly increase production of COVID-19 vaccines before the end of 2020 to make them quickly available to the U.S. population.4
U.S. Congress Shielded Vaccine Makers from Liability for Pandemic Vaccines in 2005
In the U.S., vaccine manufacturers are shielded from liability under the 2005 Public Readiness and Emergency Preparedness (PREP) Act if 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.5 6
The PREP Act 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
After passing the PREP Act in 2005, the next year Congress passed the Pandemic and All Hazards Preparedness Act. That law funded the creation of a public-private business partnership between the federal government and pharmaceutical companies that allowed HHS to provide federal money to drug companies for research and development of new bioterrorism and pandemic vaccines.8
The 2006 Pandemic and All Hazards Preparedness Act also amended the Public Health Service Act to require the Secretary of HHS to lead all federal public health and medical responses to public health emergencies.
HHS Invokes the PREP Act Liability Shield for COVID-19 Vaccines and Drugs
The Secretary of HHS invoked the PREP Act following the Jan. 31, 2020 declaration of a COVID-19 pandemic public health emergency, stating that vaccines and drugs developed to respond to the coronavirus pandemic were covered countermeasures under the 2005 PREP Act.9
The PREP Act authorizes the Secretary of Health and Human Services (HHS) 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.10 11
Under the 2020 coronavirus pandemic public health emergency declaration, “covered persons”—which includes vaccine administrators and manufacturers—are generally immune from legal liability (i.e., they cannot be sued for money damages in civil court) for harm or losses relating to the administration or use of “covered countermeasures” (COVID-19 vaccines and drugs) before or after licensure.
The sole exception to immunity from civil liability under the PREP Act is for death or serious physical injury caused by “willful misconduct,” such as evidence of criminal fraud or gross negligence on the part of a company manufacturing the vaccine or a person who administered the vaccine.
HRSA-Managed Countermeasures Injury Compensation Program (CICP)
Individuals who die or suffer serious harm directly caused by the administration of covered countermeasures, such as vaccines, may be eligible to receive compensation through the Countermeasures Injury Compensation Program,12whether or not the harm was a result of willful misconduct on the part of the vaccine manufacturer or person administering the vaccine.
HHS has interpreted federal and state law to include tort and contract law, as well as claims for loss relating to compliance with local, state, or federal laws, regulations or other legal requirements.
The definition of “loss” under the Act is broad, encompassing both physical and emotional injuries. Although the PREP Act does provide immunity to the pharmaceutical industry from COVID-19 vaccine injury lawsuits, vaccine manufacturers are not immune from injunctive relief or enforcement actions by the U.S. Food and Drug Administration (FDA) or other federal agencies.13
The CICP is administered by employees in HHS’s Health Resources and Services Administration. HRSA is the same agency responsible for administering the federal vaccine injury compensation program (VICP) created by Congress in 1986 under the National Childhood Vaccine Injury Act, which partially shielded vaccine manufacturers from liability for injuries and deaths caused by FDA licensed vaccines that are recommended by the CDC for children and mandated by states for school entry.14
The 1986 Act was later amended to eliminate civil liability from doctors and other vaccine administrators and, in 2011, the U.S. Supreme Court eliminated remaining liability from vaccine manufacturers for defectively designed vaccines.15
HHS regulations govern CICP’s procedures and eligibility determinations. In general, eligible individuals (or their survivors) who suffer death or serious physical injury directly caused by the administration of a covered countermeasure may receive reimbursement for reasonable medical expenses, loss of employment income and survivor benefits in the case of death.
Serious physical injuries under CICP are generally limited to those that warrant hospitalization or result in a significant loss of function or disability. Congress funds CICP awards through emergency appropriations to the Covered Countermeasure Process Fund.16
ACIP Recommendations Will Affect Which Compensation Mechanism Applies to COVID-19 Vaccine Injuries and Deaths
Under HRSA’s management, the CICP and the national Vaccine Injury Compensation Program (VICP) are separate programs. CICP applies to countermeasures (vaccines and drugs) covered by a PREP Act declaration of a public health emergency, such as those issued for the H1N1 “swine flu” influenza pandemic in 2009 and for the Ebola virus outbreak in 2016,17 while the VICP applies to vaccines recommended by the CDC for children and, as of 2016 under the 21st Century Cures Act, vaccines recommended for pregnant women.18
However, if the CDC’s Advisory Committee on Immunization Practices (ACIP) eventually votes to recommend COVID-19 vaccines for children and pregnant women, then it is likely that the VICP will be the primary compensation mechanism used in the U.S. to compensate individuals harmed by COVID-19 vaccines after they are licensed by the FDA.19
The government’s administration of the VICP has long been criticized by families with vaccine injured children for violating the spirit and intent of the 1986 Act, which Congress promised parents in congressional hearings would provide a non-adversarial, expedited, fair and just administrative alternative to a costly, lengthy and emotionally traumatic product liability or malpractice lawsuit in civil court.20 21
Weakening amendments passed by Congress and a series of rule-making changes by HHS and Department of Justice since 1986 have led to a routine denial of two out of three vaccine injury claims, and families often have to wait for years for claims to be adjudicated in the increasingly adversarial U.S. Court of Federal Claims.22 23
Recently, HHS has moved to deny even more awards by eliminating two vaccine injuries—syncope and brachial neuritis—from the Vaccine Injury Table,24 making it more difficult for claimants to receive compensation, which may well affect the number of claims paid for COVID-19 vaccine injuries.
Read the full article at TheVaccineReaction.org.
Comment on this article at VaccineImpact.com.
1 Burger L, Aripaka P. AstraZeneca to be exempt from coronavirus vaccine liability claims in most countries. ReutersJuly 30, 2020.
4 Blankenship K. AstraZeneca, Emergent BioSolutions sign $87M deal to produce U.S. supply of COVID-19 vaccine. Fierce Pharma June 11, 2020.
5 U.S. Centers for Disease Control and Prevention. Public Readiness and Emergency Preparedness Act of 2005 (PREP Act). PREP Act Q&A.
6 Garde D, Branswell H. 6 burning questions Congress could push Covid-19 vaccine makers to answer today. Stat News July 20, 2020.
7 Fisher BL. US Marines and Navy Prepare to Execute Pandemic Plan As Questions Resurface About Coronavirus Origin: After 9/11 Congress Gave More Power to Executive Branch. The Vaccine Reaction Feb. 20, 2020.
8 U.S. Congress. Pandemic and All Hazards Preparedness Act of 2006. (PL109-417).
9 Congressional Research Service. The PREP Act and COVID-19: Limiting Liability for Medical Countermeasures. June 19, 2020.
10 Federal Register. Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19. Mar. 17, 2020.
11 Public Health Emergency. Public Readiness and Emergency Preparedness Act. June 9, 2020.
14 U.S. Department of Health and Human Services. National Vaccine Injury Compensation Program. Health Resources & Services Administration (HRSA).
15 National Vaccine Information Center. NVIC Cites ‘Betrayal’ of U.S. Supreme Court Giving Total Liability Shield to Big Pharma. Businesswire Feb. 23, 2011.
16 See Footnote 11.
18 National Vaccine Information Center. NVIC Calls 21st Century Cures Act a “Wolf in Sheep’s Clothing and Urges Presidential Veto to Protect the Public Health. Businesswire Dec. 8, 2016.
19 King and Spalding. Accelerated COVID-19 Clinical Trials. May 28, 2020.
20 Fisher BL. The Vaccine Injury Compensation Program: A Failed Experiment in Tort Reform. Presentation to Advisory Commission on Childhood Vaccines Nov. 18, 2008.
21 Fisher BL, Williams K, Wrangham TK. Statement by NVIC to GAO on the operation of the Vaccine Injury Compensation Program (VICP) under the 1986 National Childhood Vaccine Injury Act. July 11, 2014.
22 Government Accountability Office. Most Claims Took Multiple Years and Many Were Settled through Negotiation. Nov. 21, 2014.
23 Fisher BL. End Pharma Liability Shield Endangering Public Health and Human Rights. NVIC Newsletter Nov. 8, 2016.
24 Milmore MP. Open letter to the Secretary of HHS and HRSA Administrator Re: HRSA proposed Vaccine Rulemaking Making Dramatic Changes in Scope of the National Vaccine Injury Compensation Program. Apr. 13, 2020.