Read and report vaccine reactions, harassment and failures.
NVIC If You Vaccinate, Ask 8! downloadable brochure suggests asking eight questions before you make a vaccination decision for yourself, or for your child. If you review these questions before your appointment, you will be better prepared to ask your doctor questions.
To be more fully informed about the vaccine, it is important to read the vaccine manufacturer’s product insert if you are considering Ebola vaccination. Federal law requires drug companies marketing vaccines to include certain kinds of vaccine benefit, risk and use information in product information inserts. The Ebola vaccine package insert is located on the Food and Drug Administration’s website and is also available under NVIC’s Quick Facts.
NVIC provides the public with referenced information on both the disease and vaccine to empower informed decision-making and encourages consumers to further explore these references as vaccine decisions are made.
Other questions that may be useful to discuss with your doctor before getting the Ebola vaccine are:
- If other vaccines in addition to Ebola vaccine are scheduled for me at this office visit, what policy is in place for me to modify the schedule so fewer vaccines are given at once?
- What should I do if I become ill after vaccination?
- What other kinds of reaction symptoms should I call to report after Ebola vaccination?
- If the Ebola vaccine doesn’t protect me, do I have any other options for preventing Ebola virus infection?
In alignment with the informed consent ethic, which has guided the ethical practice of modern medicine, vaccine providers should answer your questions, and/or provide you with resources to learn more. The informed consent ethic, which is recognized globally as a human right, also states that individuals should be able to delay or refuse treatments and interventions without coercion or punishment.
Under federal law, vaccine providers are required to report vaccine adverse events to the federal Vaccine Adverse Event Reporting System (VAERS) that is co-administered by the CDC and FDA. You can learn more about reporting vaccine reactions on NVIC’s reaction reporting webpage and can also directly report vaccine reactions to VAERS.
Vaccine Injury Compensation
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. 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.
Individuals who die or suffer serious harm due to the administration of covered countermeasures, such as vaccines, may be eligible to receive compensation through the Countermeasures Injury Compensation Program (CICP), whether the harm was a result of willful misconduct on the part of the vaccine manufacturer or person administering the vaccine.
HHS has interpreted state and federal 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 Ebola 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.
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. 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.
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.
The CICP and the National Vaccine Injury Compensation Program (VICP) are separate programs managed by HRSA. CICP applies to countermeasures (vaccines and drugs) covered by a PREP Act declaration of a public health emergency, such as those issued for the Ebola virus outbreak in 2016, 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.
Remember, if you choose to vaccinate, always keep a written record of exactly which shots/vaccines you or your child have received, including the manufacturer’s name and vaccine lot number. Write down and describe in detail any serious health problems that develop after vaccination and keep vaccination records in a file you can access easily.
It also is important to be able to recognize a vaccine reaction and seek immediate medical attention if the reaction appears serious, as well as know how to make a vaccine reaction report to federal health officials at the Vaccine Adverse Reporting System (VAERS). NVIC’s Report Vaccine Reactions—It’s the Law webpage can help you file a vaccine reaction report yourself to VAERS if your doctor fails or refuses to make a report.