A Vaccine Primer Toolkit

Learn About The Safety of Vaccines

Table of Contents

GHW’s Vaccine Primer






06. Are Vaccines Monitored?






The benefits of vaccination

NCNW and its Good Health WINs partners have chosen to begin our work with vaccines because of how they have fundamentally changed our lives. Prior to the development of immunizations, thousands of children in the U.S. died before the age of 5. Thanks to vaccines, the Centers for Disease Control and Prevention (CDC) estimate that vaccination of children born between 1994 and 2018 in the U.S. will prevent 936,000 deaths and 419 million illnesses.

The benefits of vaccination extend well beyond those who receive them. If someone is vaccinated, that means they cannot contract and pass along a dangerous disease. By stopping transmission, they can be a part of protecting their loved ones, community, and people they may never even know who are particularly vulnerable to infections.

Vaccines are only effective, however, if people receive them. In this tool kit you will learn about how vaccines work, how they are tested for safety and efficacy, and how people can get vaccines for themselves and their families.

The Side Effects of Vaccines –
How High is the Risk?


The different types of vaccines

Vaccines are made up of parts of viruses or bacteria that are altered or weakened so that they only cause an imitation of the disease and not the disease itself. There are several types of vaccines:

  • Live, attenuated vaccines like MMR (measles, mumps, rubella), chickenpox and flu nasal spray (LAIV) vaccines weaken the living viruses in the vaccine so they cannot cause disease in people. Since these types of vaccines are the closest to natural infections, they are very effective, but not everyone can get them. For example, people with weakened immune systems like those undergoing chemotherapy, can’t get live vaccines.
  • Toxoid vaccines prevent diseases caused by bacteria that produce toxins (poisons) in the body. Like in live, attenuated vaccines, the toxins are weakened so they cannot cause illness. Weakened toxins are called toxoids. For example, DTaP and Tdap vaccines contains diphtheria and tetanus toxoids, in addition to protection against pertussis (also known as whooping cough).
  • Inactivated vaccines (like many of the flu shots), the viruses are inactivated (killed) when making the vaccine. By killing the viruses, the vaccines produce immune responses, but cannot cause the disease itself. Examples of inactivated vaccines include hepatitis A, influenza (shot only), polio (shot only) and rabies.
  • Subunit vaccines use only a part of the virus or bacteria is included in the vaccine instead of the full germ. Because these vaccines contain only the essential antigens and not all the other molecules that make up the germ, they cannot cause illness. The pertussis (whooping cough) component of the DTaP vaccine is an example of a subunit vaccine.
  • Conjugate vaccines use part of the sugar-like coating of bacteria called polysaccharides. However, because young children don’t make a very good immune response to the sugar coating alone, the coating is linked (conjugated) to a harmless protein. This protein carries the sugar-like coating of the bacteria to certain cells in the immune system to which it would not have access on its own. Then, if the bacteria enters the body, the antibodies will recognize the sugar coating and keep the bacteria from causing disease. Although many conjugate vaccines were developed because of the need to protect infants and young children with immature immune systems, conjugate vaccines are recommended for all ages. Examples of conjugate vaccines include Hib, hepatitis B, HPV, DTaP, shingles, pneumococcal (PCV13) and meningococcal (MenACY).
  • mRNA vaccines, like some COVID-19 vaccines, teach our cells how to make a protein – or a piece of a protein – that triggers an immune response (antibodies) in our bodies. These antibodies then protect us from future infections, such as COVID-19. Our body’s cells break down and get rid of the mRNA soon after it is finished using the instructions on how to make a protein that triggers our body’s immune response.
  • Viral vector vaccines, such as the COVID-19 vaccine created by Johnson & Johnson (Janseen) and the Ebola vaccine, use a modified, harmless version of a different virus (the vector) to help trigger our body’s immune system to begin producing antibodies that will help protect against a particular disease.


The process of each vaccine

The process for each vaccine is different depending on what type of vaccine it is. The manufacturing facilities, however, must all meet strict government standard for safety and cleanliness, called good manufacturing processes, or GMPs. Vaccine manufacturers conduct dozens, and sometimes hundreds, of tests a day to ensure the facilities are clean of any possible contaminants. The Food and Drug Administration (FDA), World Health Organization (WHO) and other health authorities from around the globe will make unannounced visits to inspect manufacturing facilities.
The Journey of Your Child’s Vaccine


Safety and Effectiveness

Vaccines are one of the most thoroughly tested medical products available in the U.S. Before a vaccine can be considered for approval by the FDA, a vaccine manufacturer must show it is safe and effective through clinical trials. Developing a new vaccine begins with exploratory stage and pre-clinical stage before advancing to three stages of clinical trials. The FDA then examines these studies and determines whether a vaccine is safe, effective, and ready to be licensed for use. The FDA only licenses vaccines that have data that shows that the vaccines’ benefits outweigh the potential risks. If there is any question about the data, or any holes in the data, the FDA will request further studies before approving the vaccine.


Additional Hurdles

Vaccines go through an additional hurdle after FDA approval, before most health care providers will recommend the vaccine to their patients. The Advisory Committee on Immunization Practices, or ACIP, is a panel of independent experts who review the science submitted to FDA and determine whether, and to whom, the vaccine should be recommended. The CDC then publishes these recommendations in their publication called Morbidity and Mortality Weekly Report (MMWR). Once recommendations are published in MMWR, medical professional societies such as the American Academy of Pediatrics (AAP) and American Academy of Family Physicians (AAFP) will share the new vaccine recommendations with doctors across the country. Without an ACIP recommendation for routine use, a vaccine will not be given to many people.

06. Are Vaccines Monitored?

Safety & Effectiveness After Approval

There are several systems in place to continue monitoring vaccines for their safety and effectiveness after they are approved by the FDA. Three of the key systems are:

  • VAERS, or the Vaccine Adverse Event Reporting System, collects adverse event reports, but it relies on individuals to report injuries and is therefore not meant to form a
    comprehensive database of possible vaccine side effects.
  • VSD, or the Vaccine Safety Datalink, has been a continuing collaboration since 1990 between the CDC’s Immunization Safety Office and eight health care organizations across the country. This network conducts studies based on questions or concerns raised from the medical literature and reports to VAERS. In addition, when new vaccines are recommended, or if changes are made in how a vaccine is recommended, VSD will monitor the safety of these vaccines and recommendations.
  • CISA, or the Clinical Immunization Safety Assessment Project, began in 2001 to better understand individual risk for adverse events following immunization. CISA addresses vaccine safety issues, conducts high quality clinical research and assesses complex clinical adverse events following vaccination.


Vaccines aren’t just for children anymore

Vaccines aren’t just for children anymore. Children of all ages, including preteens and teens, as well as adults and pregnant people are recommended for certain vaccines.

  • Children & Teens: Children can be protected from more infectious diseases than ever before. You can look at the CDC’s recommended vaccination schedules to learn more about the vaccines infants, children and teenagers should receive.
  • Adults: Adults may need to receive vaccines depending on their age, whether they have any other health conditions such as asthma or heart disease, and what they do for a living. The CDC has an online quiz to help adults learn which vaccines they may need.
  • Pregnant People: All pregnant people should receive a Tdap (tetanus-diphtheria-pertussis) vaccine during every pregnancy as well as a flu vaccine if they are pregnant during the Fall and Winter months. These vaccines not only protect pregnant people, but the baby when it’s born thanks to antibodies from their mothers. You can learn more about these vaccines and their safety on our partner’s, Vaccinate Your Family’s, website.

To learn more about all of the diseases that vaccines can prevent, check out Vaccinate Your Family’s website.


Insured or Not Insured

People in the U.S. either have private health insurance, public health insurance (meaning Medicare, Medicaid or, in the case of children, CHIP), or are not insured at all. While there are some safety nets in place to guarantee access to vaccines, they still have many holes.

  • Private Health Insurance: The Affordable Care Act required all private health insurance plans to cover vaccines at no charge to patients, including those for both children as well as adults. However, some plans were “grandfathered,” meaning employers only had to cover vaccines when they started a new insurance plan, and some have yet to begin a new plan. This means some people with private health insurance still have to pay a copay or other fee to receive vaccines for themselves, their spouses or their children.
  • Medicare: Medicare covers flu and pneumococcal vaccines at no cost to patients. Any other adult vaccine may or may not be covered depending on whether the Medicare recipient has a Part D plan and on how that plan covers vaccines.
  • Medicaid: We do not yet have universal coverage for vaccines under Medicaid. Each state’s plans are different and may or may not cover vaccines for adults and for pregnant people at no cost.
  • CHIP: Each state has a CHIP, or Children’s Health Insurance Plan. CHIP provides health coverage to children whose families meet certain income requirements. Those requirements differ by state. Not all children who are covered by CHIP have coverage for vaccines.
  • Vaccines for Children: Luckily, there is a program called Vaccines for Children, or VFC. VFC was created by Congress in the 1990s to ensure no child was denied a vaccine because their families couldn’t afford it. As a result, vaccination rates among children have risen to an all time high.


Vaccine Injury

Serious vaccine injuries are very rare, but they do happen. Because people are receiving vaccines in good faith, to protect themselves and others, the federal government setup a special court in the late 1980s called the Vaccine Injury Compensation Program, or VICP, to help people who have been seriously injured by vaccines. It has a lower burden of proof than civil court and was designed to move more quickly. Further, lawyers representing the injured are paid for their time regardless of whether they win, which incentivizes lawyers to take up vaccine cases.

Since the program’s inception over 30 years ago, it has paid over $4 billion in compensation and legal fees. That means about one in every 1 million people vaccinated has been compensated.

The program is not funded by taxpayers, but by an excise tax on each vaccine administered. It also does not prevent someone from filing a civil lawsuit. If a person’s case is not decided within 240 days of filing, or if they do not like the ruling of this special court, they can choose to move their claim to civil court.


Toolkits and Other Educational Resources

• The CDC has developed A Guide for Community Partners which includes Best Practices for CBOs/FBOs. •Resources for Faith-based and Community Organizations Fighting COVID-19
highlights a variety of ways that FBOs and CBOs can access federal funding or otherwise engage in partnerships with government.

•The Ad Council has developed community-specific toolkits for Black, Hispanic/Latino, faith, public health, and employer communities with messaging tips, FAQs and other resources to help organizations increase confidence in COVID-19 vaccines. Included within these resources are videos, study guides, event templates and more.

• Questions & Answers About COVID-19 Vaccines | The Ad Council (getvaccineanswers.org) • Toolkit for Black Communities | Ad Council COVID-19 Initiative (blackcommunityvaccinetoolkit.org) • Toolkit for Faith Communities | Ad Council COVID-19 Initiative (faithcommunityvaccinetoolkit.org) • Toolkit for Hispanic Communities | Ad Council COVID-19 Initiative

• Groups such as Choose Health Life and Urban Strategies have developed educational resources.

COVID-19 Community Corps

Would you like to join the COVID-19 Community Corps? As a member, you’ll receive timely, accurate information to share with your family, friends, and neighbors. By encouraging them to get vaccinated, you’ll help protect them – and allow all of us to safely gather together again.

As a Corps member, you’ll get resources to help you build vaccine confidence in your community, including:

• Fact sheets on vaccine safety, tips on how to talk with friends and family about the importance of vaccination, and hints for planning and attending community events

• Social media content to share with your followers

• Regular email updates with the latest vaccine news and resources to share
You can sign up here: https://wecandothis.hhs.gov/covidcommunitycorps. We hope you will join.

Ensuring Equity on COVID-19 Vaccinations

As stated by the CDC, “Health equity is when all members of society enjoy a fair and just opportunity to be healthy as possible.” COVID-19 vaccinations present an important opportunity to ensure that all members of society can be as healthy as possible.

• Racial Equity Guidebook developed on behalf of Black Coalition against COVID-19 addresses equitable vaccine use in the community, including through faith-based and community partnerships.

• Made to Save is national grassroots effort to ensure communities hardest hit by the pandemic have equitable access to the COVID-19 vaccines and accurate, timely information. Check out how to partner with them and join their training on 4/27 at 7pm ET – “Talking to Friends and Family about the COVID-19 Vaccines” – RSVP

• Faith4Vaccines is an inclusive, multifaith movement comprised of local and national religious leaders, as well as medical professionals, who are working together to identify and resolve current gaps in vaccine mobilization, outreach, and uptake.

• FEMA document on protecting civil rights during disasters, including during COVID-19: https://www.fema.gov/sites/default/files/documents/fema_civil-rights_bulletin_03-04-2021.pdf

Engaging Vaccinating Organizations

•If your community is interested in supporting state and local vaccine programs, use the CDC’s locator to determine local vaccine efforts, contact your state or local health department or state Association of Immunization Manager (AIM) to find out when, where, and how vaccines are being made available in your community. Also, check in with your local Community Health Center, which may have received funding to increase vaccine access.

• You can also contact pharmacies like those within Walmart and Rite Aid sites who presented on the webinar. You can also find pharmacies participating in the Federal Retail Pharmacy program here.

• More information about State health officials can be found at the Association of State and Territorial Health Officials (ASTHO).

• More information about Local health officials can be found at National Association of County and City Health Officials (NACCHO).

• Learn more about Community Health Centers at the National Association of Community Health Centers.

Getting Involved with Vaccine Efforts
• The Association of Immunization Managers (AIM) released a two-page overview How Can Faith Leaders Help End the COVID-19 Pandemic? Support the COVID-19 vaccination effort.

• The National Forum on COVID-19 Vaccine has a variety of materials and resources supporting equitable vaccine engagement and community-based partnerships, including information on:
• Equitable Vaccine Implementation,
• Engaging Community-Based Organizations to be Vaccination Partners, and
• Increasing Vaccine Confidence through Communication and Community Engagement.

•FEMA has also developed a guidebook communities can consider in setting up vaccination centers of all sizes. – Community Vaccination Centers Playbook | FEMA.gov.

Additional Resources
• Health Equity Task Force – The Office of Minority Health (hhs.gov)

• Coronavirus Disease 2019 (COVID-19) | CDC

• Coronavirus (COVID-19) Response | FEMA.gov

• Partner Coordination Efforts to Strengthen Infection Prevention and Control Practices •Public Health and Faith Community Partnerships: Model Practices to Increase Influenza Prevention Among Hard-to-Reach Populations

• Mobilizing for Action through Planning and Partnerships (MAPP)

• Engaging with Community- and Faith-Based Organizations in Public Health Emergencies

GHW’s acknowledges All In: Partnering with Faith and Community in COVID-19 Vaccination Efforts for their additional vaccine resources



Choose a Location

● CDC: Centers for Disease Control and Prevention
● FDA: Food and Drug Association
● WHO: World Health Organization
● ACIP: Advisory Committee on Immunization Practices
● AAP: American Academy of Pediatrics
● AAFP: American Academy of Family Physicians
● ACP: American College of Physicians
● AMA: American Medical Association
● ACOG: American College of Obstetricians and Gynecologists
● MMWR: Morbidity and Mortality Weekly Report
● VAERS: Vaccine Adverse Event Reporting System
● VSD: Vaccine Safety Datalink
● CISA: Clinical Immunization Safety Assessment Project
● VFC: Vaccines for Children program
● CHIP: Children’s Health Insurance Plan
● VICP: Vaccine Injury Compensation Program