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What questions should I ask my doctor about COVID-19 vaccines?


questions

As of February 27, 2021, three experimental COVID-19 vaccines had been granted an Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) to release the vaccines for use in the U.S.1 2 3

NVIC If You Vaccinate, Ask 8! Webpage downloadable brochure suggests asking eight questions before you make a vaccination decision for yourself, or for your loved one. If you review these questions before your appointment, you will be better prepared to ask your doctor questions. Also make sure that the nurse or doctor gives you the relevant COVID-19 Vaccine Fact Sheet for the vaccine you are considering well ahead of time to allow you to review it before you or your loved one gets vaccinated. Copies of Fact Sheet for each vaccine are also available on the FDA's website and there is a link to the Fact Sheet on NVIC's “Quick Facts” at the top of this page.

The U.S. Centers for Disease Control and Prevention (CDC) has not published a Vaccine Information Statement (VIS) as of February 28, 2021. To be more fully informed about the COVID-19 vaccine, reading the FDA Fact Sheet, that can be obtained from a vaccine provider, is recommended prior to vaccination.

NVIC provides the public with referenced information on diseases and vaccines to empower informed decision-making and encourages consumers to further explore these references as vaccine decisions are made.

Additional questions to ask

Other questions that may be useful to discuss with your doctor before getting the COVID-19 vaccine are: 

  • What should I do if my child or I become ill after vaccination?
  • What other kinds of reaction symptoms should I call to report after COVID-19 vaccination?
  • If the coronavirus vaccine doesn’t protect me or my child, do we have any other options for preventing coronavirus 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.4

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.5 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 for COVID-19 EUA Vaccines

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.6 7 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.8

The Secretary of Health and Human Services (HHS) invoked the PREP Act following the January 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 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.

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),12 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 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

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 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

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

Under the National Childhood Vaccine Injury Act of 1986, doctors and all vaccine providers are legally required to give you vaccine benefit and risk information before vaccination; record serious health problems following vaccination in the permanent medical record; keep a permanent record of all vaccines given, including the manufacturer’s name and lot number; and report serious health problems, injuries and deaths that follow vaccination to VAERS.

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.

IMPORTANT NOTE: NVIC encourages you to become fully informed about covid-19 and the covid-19 vaccine by reading all sections in the Table of Contents, which contain many links and resources such as the manufacturer product information inserts, and to speak with one or more trusted health care professionals before making a vaccination decision for yourself or your child. This information is for educational purposes only and is not intended as medical advice.

« Return to Vaccines & Diseases Table of Contents

References

1 U.S. Food and Drug Administration. Pfizer-BioNTech COVID-19 Vaccine. Dec. 11, 2020.

2 U.S. Food and Drug Administration. Moderna COVID-19 Vaccine. Feb. 3, 2021.

3 U.S. Food and Drug Administration. FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine. Press Release. Feb. 27, 2021.

4 Fisher BL. From Nuremberg to California: Why Informed Consent Matters in the 21st Century. National Vaccine Information Center Oct. 24, 2017.

5 Government Publishing Office. 42 U.S.C. §§ 300aa-25.Recording and reporting of information. 2016 edition.

6 U.S Department. of Health & Human Services -Public Health Emergency. Public Readiness and Emergency Preparedness Act of 2005 (PREP Act). PREP Act Q&A. Feb. 11, 2021.

7 Garde D., Branswell H. 6 burning questions Congress could push Covid-19 vaccine makers to answer todayStat News July 20, 2020.

8 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.

9 Congressional Research Service. The PREP Act and COVID-19: Limiting Liability for Medical Countermeasures. Dec. 21, 2020.

10 Federal Register. Declaration Under the Public Readiness and Emergency Preparedness Act for Medical Countermeasures Against COVID-19. Mar. 17, 2020.

11 U.S Department. of Health & Human Services - Public Health Emergency. Public Readiness and Emergency Preparedness Act. Feb. 11, 2021.

12 U.S Department. of Health & Human Services - Public Health Emergency. Public Readiness and Emergency Preparedness Act. Feb. 11, 2021.

13 U.S Department. of Health & Human Services - Public Health Emergency. Public Readiness and Emergency Preparedness Act. Feb. 11, 2021.

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 U.S. Department of Health & Human Services - Public Health Emergency. Public Readiness and Emergency Preparedness Act. Feb. 11, 2021.

17 U.S. Department of Health & Human Services - Public Health Emergency. Public Readiness and Emergency Preparedness Act. Feb. 11, 2021.

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 HealthBusinesswire Dec. 8, 2016.

19 King and Spalding. Accelerated Covid-19 Vaccine Clinical Trials. May 28, 2020.


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