Click on one of the headings below to see the information from a specific lecture.
Information shared in conjunction with the Urgent and Critical Lecture Series lecture, Pandemic Update: Vaccines, Testing, and Treatments, November 17, 2020.
Shared by Raymond Yung, Chief, Division of Geriatrics and Director of the Geriatrics Center and Institute of Gerontology.
I hope this message finds you safe and well. You may have heard a lot recently about the race to develop a COVID-19 vaccine. There are actually several different kinds of COVID-19 vaccines that are being developed. The University of Michigan is now involved in testing two of these candidate vaccines and we wanted to give you some general information about how these vaccines are developed and tested. We have also included two links below that explain the trials and the different kinds of COVID-19 vaccines and how they work.
From Ensuring the Safety of Vaccines in the United States, January 2018:
Vaccine development begins in the laboratory before any tests in animals or humans are done. If laboratory tests show that a vaccine has potential, it is usually tested in animals. If a vaccine is safe in animals, and studies suggest that it will be safe in people, clinical trials with volunteers are next.
Typically, there are three phases of clinical trials. Vaccines that are being developed for children are first tested in adults. FDA sets guidelines for the three phases of clinical trials to ensure the safety of the volunteers.
Phase 1 clinical trials focus on safety and include 20–100 healthy volunteers. In Phase 1, scientists begin to learn how the size of the dose may be related to side effects. If possible at this early stage, scientists also try to learn how effective the vaccine may be.
If no serious side effects are found in Phase 1, next is Phase 2, which involves several hundred volunteers. This phase includes studies that may provide additional information on common short-term side effects and how the size of the dose relates to immune response.
In Phase 3 studies, hundreds or thousands of volunteers participate. Vaccinated people are compared with people who have received a placebo or another vaccine so researchers can learn more about the test vaccine’s safety and effectiveness and identify common side effects.
Clinical trials are conducted according to plans that FDA reviews to ensure the highest scientific and ethical standards. The results of the clinical trials are a part of FDA’s evaluation to assess the safety and effectiveness of each vaccine. In addition to evaluating the results of the clinical trials, FDA scientists and medical professionals carefully evaluate a wide range of information including results of studies on the vaccine’s physical, chemical, and biological properties, as well as how it is manufactured, to ensure that it can be made consistently safe, pure, and potent.
