Until 2019, our bodies’ immune systems had never encountered the novel coronavirus that has wreaked havoc around the world and touched so many lives.

Vaccines teach our immune systems to defend against the disease. At Tanner Health System, we only offer vaccines that have been carefully tested and proven safe.

Vaccine Safety Testing: The Step-by-Step Guide

Since the pandemic started, researchers have worked to make a safe, effective vaccine available as soon as possible.

Here is how the U.S. Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) test and approve new vaccines.

• First, a vaccine manufacturer conducts extensive research in their own laboratories.
• Next, the manufacturer submits their research and a form called an Investigational New Drug application to the FDA. All of this must be done before human clinical trials can begin.
• Then the vaccine goes through three phases of clinical trials, each with varying group sizes.
  1. The first clinical trial uses between 20 and 100 volunteers.
  2. The second uses several hundred volunteers.
  3. The third and final trial uses hundreds or thousands of volunteers.

After clinical trials, a Data Safety Monitoring Board studies the results and advises the vaccine manufacturer on whether the vaccine is safe and effective.

Currently, the FDA’s extensive process helps the United States have the safest vaccine supply in our country’s history. In the case of the COVID-19 vaccines currently approved, the expedited clinical phase meant involving thousands of people of different ages, genders and races to ensure sufficient data on the vaccines’ safety and effectiveness. In other words, we have faith in the vaccine because we know it has been thoroughly tested.

Why are some groups not approved for the vaccine?

Some groups of people — such as children or people with certain medical conditions — were not included in the vaccine’s clinical trials. Since we do not know the effects the COVID-19 vaccine may have on these people, it is recommended that they wait to receive the vaccine.

Women who are pregnant or breastfeeding were not included in the clinical trials, but the CDC states that these women can choose whether they would like to receive a vaccine or not. The American College of Obstetrics and Gynecology (ACOG) recommends pregnant and breastfeeding women receive the vaccine.

Are we monitoring people's health after vaccination?

The CDC and FDA have many groups monitoring vaccine safety. Several of these groups were in place long before the coronavirus outbreak.

For example, the CDC uses the Vaccine Safety Datalink to communicate with a group of integrated healthcare organizations and perform ongoing research about vaccines and side effects. Similarly, the Vaccine Adverse Event Reporting System collects reports from healthcare systems and vaccine manufacturers to report unexpected adverse effects.

Also, the CDC is offering V-safe, a health checker for your smartphone you can use after you receive the vaccine. V-safe uses text messages and surveys directly from the CDC to check in on you after the vaccine or remind you of your next dose.

Check our page for updates on who can receive the vaccine when.