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What are emergency use vaccines and what compensation is available when they cause injury?


Emergency Use Authorization (EUA) vaccines are biological products that the FDA has authorized for emergency use during a public health emergency. Under federal law1 2 EUA status may be granted to approved, licensed and unapproved products.

HRSA Guidance on COVID-19 EUA Vaccines. Correspondence received by NVIC on August 26, 2021 from the U.S. Health Resources & Services Administration (HRSA), which administers both the federal Vaccine Injury Compensation Program (VICP) and the Countermeasures Injury Compensation Program (CICP), states:

"Your question relates to which Program provides coverage, the CICP or the Vaccine Injury Compensation Program (VICP), for injuries alleged to have been caused by the newly licensed Pfizer COVID-19 vaccine.

As noted, the COVID-19 vaccines currently authorized through Food and Drug Administration (FDA) Emergency Use Authorizations or approved by the FDA are covered countermeasures under the Public Readiness and Emergency Preparedness Act and, therefore, individuals who allege injury as a result of the administration or use of such vaccines are eligible to apply for benefits under the CICP. Full FDA approval of the Pfizer COVID-19 vaccine does not remove its coverage from the CICP or provide coverage under the VICP."

As of September 1, 2021, all vaccines developed for COVID-19 have been granted EUA status by the FDA and are recognized as "countermeasures". Compensation of vaccine injuries while a vaccine maintains an EUA status will be processed by the CICP. Prior to COVID-19 vaccines, the Anthrax vaccine was authorized under the EUA in 2005.3

During an Advisory Committee on Immunization Practices (ACIP) meeting held  August 30, 2021, CDC representatives cautioned vaccine providers that while booster doses are under consideration for the general population, they have not been recommended. Further, CDC representatives stated that doses of COVID-19 vaccines administered off label (outside of FDA/CDC/ACIP recommendations): 

  • may not be covered under the PREP Act as a countermeasure and vaccine providers may not have immunity from claims;
  • those injured may not be eligible for compensation via the CICP;
  • may not be reimbursed to providers by payers; and 
  • are a violation of the CDC provider agreement and may impact the ability of the provider to be a part of the provider program.

FDA Informing & Right of Refusal by Recipients of EUA Products. The FDA's website states that individuals receiving EUA vaccines must be informed that they have the right to accept or refuse the vaccine, and be made aware of any alternative product. The FDA also states that this information is typically included in the patient “fact sheet” posted on the FDA’s  website.4 Federal law governing EUA vaccines provides that vaccine recipients must be informed of the following information: 5

  • the vaccine is authorized for emergency use;
  • the significant known and potential risks and benefits of use;
  • the extent to which risks and benefits are unknown;
  • the option to accept or refuse the vaccine, and the consequences of refusal, if any; and
  • available alternatives to the vaccine, and their risks and benefits.

Unlike federal law that requires vaccine providers to inform adults, parents and guardians of the risks and benefits associated with routine childhood vaccines prior to vaccination, federal law governing EUA vaccines is silent on who is responsible for providing this information to EUA vaccine recipients and when it must be provided.

COVID-19 vaccine fact sheets are available on the FDA website for recipients and providers. Provider fact sheets contain more information on clinical trial data, safety data, adverse events and how they are reported. 

Seniors and the Disabled. For information on the consequences of vaccine refusal by the disabled and/or their guardians, those receiving Medicaid, Medicare or other agency benefits, and in settings such as assisted living and long-term care and skilled nursing facilities it is advisable to consult with professionals experienced with this type of law. Below are some resources to consider:

  • Elder and Special Needs Law Attorneys: Attorneys that have expertise in addressing legal issues such has estate planning, long-term care, and coverage by Medicare and Medicaid as it relates to seniors and the disabled. Attorneys with this specialty may also be able to advise on the consequences of refusing an EUA vaccine. The National Academy of Elder Law Attorneys and the National Elder Law Foundation are national organizations that can provide basic information on this area of law and provide state level information on locating an elder law attorney;.
  • Long-Term Care Ombudsman Program: Every state has a long-term care ombudsman who assists residents living in nursing homes, assisted living facilities and other similar care facilities. These individuals help residents work through issues and understand their rights. The Administration for Community Living provides basic information about this type of ombudsman and your rights in these settings. You may also find the ombudsman in your state by visiting The National Consumer Voice for Quality Long-Term Care’s

EUA Vaccines - Military Exemptions. When the Secretary of Defense requests or requires a member of the military to take a new investigative drug or drug unapproved for its applied purpose, such as an EUA vaccine, the Secretary of Defense must provide the military member with the following information:

  • Clear notice that the drug is an investigational new or unapproved for its applied use.
  • Why the investigational new drug or unapproved drug for its applied use is being given.
  • Any possible known side effects of the investigational new drug or drug unapproved for its applied use including any potential interactions with other administered drugs.
  • Any other information the Secretary of Health and Human Services requires to be disclosed.

The Secretary must also give the health care providers who will be administering the investigational new drug or drug unapproved for its intended use with the following information:

  • Any possible known side effects of the investigational new drug or drug unapproved for its applied use including any potential interactions with other administered drugs.
  • Any other information that the Secretary of Health and Human Services requires to be disclosed.

When the use of the investigational new drug, or drug unapproved for its applied purpose, is given due a member of the military participating in a particular military operation, the requirement that the military member give consent prior to receiving the drug may be waived by the President, if the President concludes in writing that obtaining consent is not in the interests of National Security. The Secretary of Defense may also request that the President remove the prior consent requirement for an investigational new drug or drug unapproved for its applied purpose.6

For more information on vaccines and exemptions as they pertain to military personnel and their families, please visit NVIC’s Military Personnel Vaccine Concerns FAQ. For information on adult and employee vaccine mandates, please visit NVIC’s Adult and Employee Vaccine Mandate FAQ.

Reporting Vaccine Reactions. Vaccines are pharmaceutical products that carry risks that can be greater for some than for others. Some vaccines can cause side effects, symptoms and adverse reactions more often than other vaccines. ALL serious health problems, which develop after vaccination, should be reported to the federal health authorities at VAERS. NVIC acts as a watchdog on VAERS and encourages consumers to also report vaccine reactions to NVIC's Vaccine Reaction Registry, which has been available since 1982. NVIC  also hosts MedAlerts, an online service that allows the public to easily search the federal VAERS database. To learn more about vaccine reactions and how to report them, visit our Vaccine Reaction FAQ.

Vaccine Injury Compensation – EUA Vaccines. Vaccine injuries that occur as a result of an EUA vaccine may be compensated through the Countermeasures Injury Compensation Program (CICP), which differs from the federal Vaccine Injury Compensation Program (VICP). The differences between these compensation programs can be found on the Health and Human Services website (HRSA). For example, CICP is a payer of last resort, has no judicial appeals process, attorney’s fees are not covered, and the U.S. Health and Human Services decide compensation petitions unlike the VICP.7 These differences make it more difficult to receive compensation from the CICP.

As of October 1, 2020, only 39 of the 446 injury claims covered by the CICP, only 39 of were eligible for compensation, with 29 of those claims receiving compensation totalling over $6 million. Ten of the 39 claims received no compensation at all, due to the injured party not having any qualifying compensable expenses or losses.8 Only seven percent of vaccine injury claims have been compensated by the CICP compared to 34 percent of claims compensated by the VICP.8

NVIC does not provide legal advice. We encourage the public to obtain legal advice to further understand and protect their rights and to be informed of any course of action available that may be taken to remedy any violation of these rights.

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References

1FDA. Emergency Use Authorization for Vaccines Explained: What is an Emergency Use Authorization? Accessed Dec. 3, 2020. FDA Revised Nov. 20, 2020.  

2 Office of the Law Revision Counsel – United States Code. 21 U.S. Code 360bbb-3- Authorization of medical products for the use in emergencies. Viewed Dec. 10, 2020.

3 FDA. Anthrax Vaccine Adsorbed (AVA) EUA – Archived Information. Current as of Dec. 4, 2020.

4 FDA. Emergency Use Authorization for Vaccines Explained: How will vaccine recipients be informed about the benefits and risks of any vaccine that receives an EUA? Accessed Dec. 3, 2020. FDA Revised Nov. 20, 2020.  

5 Office of the Law Revision Counsel – United States Code. 21 U.S. Code 360bbb-3- Authorization of medical products for the use in emergencies. Viewed Dec. 10, 2020.

6 Office of the Law Revision Counsel – United States Code 10 USC 1107: Notice of use of an investigational new drug or a drug unapproved for its applied use. Viewed Dec. 22, 2020.

7 HRSA. Comparison of Countermeasures Injury Compensation Program (CICP) to the National Vaccine Injury Program (VICP). HRSA Revised November 2020.

8 HRSA. ACCV Presentation – Overview of The Countermeasures Injury Compensation Program. Dec. 3, 2020.

9 HRSA. Data & Statistics. Dec. 1, 2020.
 


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