What Questions Should I Ask My Doctor About the Smallpox and Monkeypox Vaccine?

Updated August 13, 2022


NVIC’s If You Vaccinate, Ask 8! Webpage 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. Also, make sure that the nurse or doctor gives you the relevant Vaccine Information Statement (VIS) for the vaccine or vaccines you are considering well ahead of time to allow you to review it before you or your child gets vaccinated. Copies of VIS for each vaccine are also available on the CDC's website and there is a link to the VIS for vaccines on NVIC's “Quick Facts” at the top of this page.

Due to the brevity of information provided in the VIS, NVIC suggests that consumers also read the vaccine manufacturer product insert that can be obtained from your doctor or public health clinic. Because federal law requires drug companies marketing vaccines to include certain kinds of vaccine benefit, risk and use information in product information inserts, they represent additional information that may not be available on the CDC Smallpox/Monkeypox VIS or FDA Medical Guide for vaccination with ACAM2000. Smallpox vaccine package inserts are located on the Food and Drug Administration’s website.

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

  • If other vaccines in addition to smallpox vaccine are scheduled for me or for my child at this office visit, does your policy provide me the flexibility of spreading these vaccines out over time, rather than receiving the recommended vaccines all at one time?
  • 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 smallpox vaccination?
  • If the smallpox vaccine doesn’t protect me or my child, do we have any other options for preventing smallpox infection?

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 bioterrorism attack 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.1 2 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.3

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.4

The U.S Department of Health and Human Services (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 smallpox 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.5

The CICP is administered by employees in HHS’s Health Resources and Services Administration (HRSA). 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.6 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.7

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.8

The CICP and the National Vaccine Injury Compensation Program (VICP) are separate programs managed by HRSA. The 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, the Ebola virus outbreak in 2016,9 and the 2019 outbreak of SARS-CoV-2/COVID-19 (cite please). The VICP applies to vaccines routinely recommended by the CDC for children and, as of 2016 under the 21st Century Cures Act, vaccines recommended for pregnant women.10

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 (CDC’s VIS); 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 the federal vaccine adverse event reporting system (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 to 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 smallpox and the smallpox 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. This information is for educational purposes only and is not intended as medical advice.


References:

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