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How we know the vaccine is safe

Having a safe and effective vaccine is the top priority. The manufacturers must present the study data that shows the vaccine is safe and that it works before it is approved for general populations. This data is closely reviewed by several scientific groups at the Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC). The CDC Advisory Committee on Immunization Practices (ACIP) and other groups look at available information about a vaccine and make informed decisions about the risks and benefits of using it. MDH is committed to making vaccines available that we are confident are safe and effective.

Who is in the vaccine studies

Pregnant people and children

The first vaccine studies are usually done with groups that are at highest risk for the disease, or who will get very sick if they get the disease. Then the studies are expanded to other groups such as pregnant people and people who are immunocompromised (cannot easily fight off a disease). For COVID-19 vaccine, studies focused on non-pregnant adults ages 18 years and older at first (16 years and older for Pfizer). Vaccine manufacturers have started expanding to pregnant people and some children as they get more data from the first part of their studies.

Diverse and underserved communities

The COVID-19 vaccine clinical trials include people from diverse communities. It is important for these studies to have equitably more people from racially and ethnically diverse backgrounds. This way they have enough information to be confident that the vaccine is safe and works for these groups. It's especially important that COVID-19 vaccine trials include people from diverse communities, because these communities have been severely impacted by the disease and could greatly benefit from getting vaccinated.

Making a safe and effective vaccine

This handout explains how the COVID-19 vaccine processes and timelines were made more efficient compared to other vaccine development.

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