From A to Vaccine

Scientists study the structure of germs, and how they cause disease, to identify potential ways of creating an effective vaccine. Before any research trials involving people, vaccines are studied in a laboratory to determine how best they should be administered and to ensure they are effective and safe. If enough research supports the vaccine candidate, it can move into clinical trials involving people.

These clinical trials are tightly regulated by the U.S. Food & Drug Administration (FDA) to ensure the process is safe and leads to an effective vaccine. There are typically three phases of clinical trials:

Phase I

Involves a small group (usually less than 100) of volunteers. The purpose of the study is to determine if the vaccine is safe, figure out the best dose, and look for any serious side effects.

Phase II

Involves a larger group (usually a few hundred) of volunteers and focuses on the immune response to the vaccine, while also continuing to ensure the vaccine is safe and side effects are minor.

Phase III

Involves a large (usually several thousand) group of volunteers who are randomly selected to either receive the vaccine or an alternative “control” medication such as a placebo or a different type of vaccine that is already approved. In this phase, people who receive the vaccine are compared to those who do not, to better determine if the vaccine is effective as well as safe.

Once clinical trials are complete, the FDA reviews all of the results to ensure the vaccine is safe, effective, and any potential side effects are outweighed by the benefits of receiving the vaccine prior to approval.

While the COVID-19 vaccines currently under development are following the same clinical trial structure required of all vaccines, efforts at the local, state and national levels have made significant contributions to accelerate the timeline from research to distribution. It is important to note this acceleration refers to areas of funding, resources, production and distribution only. There have been no shortcuts when it comes to safety protocols and clinical trials.