ST. LOUIS (KMOX) - We now know which COVID-19 vaccine candidate is about to be tested at Saint Louis University School of Medicine.
"This is the Moderna vaccine trial," said SLU Care's Dr. Sharon Frey, clinical director of Saint Louis University's Center for Vaccine Development. "Earlier studies of this vaccine looked really good for the development of an immune response that looks like it might be protective. I do want to say that the reason we are testing this vaccine is because we do not know if it works or not. So that is the question we are trying to figure out with this large efficacy trial."
Dr. Frey says 30,000 volunteers are being sought for this Phase 3 trial at approximately 89 sites nationwide, including several hundred for the SLU trial. Volunteers should be 18 years of age or older and who are at risk for developing COVID-19.
Dr. Frey says that means people who are out and about in the community, or with children who are exposed to the disease, or in the workplace with other people. Elderly people over age 65 are especially needed, says Dr. Frey. As are younger people with co-morbidities -- like heart and lung disease. She says she hopes the final volunteer pool will be representative of the whole region.
She expects the registration process to be completed within 8 weeks.
Participants will receive either the vaccine or a placebo -- given in two injections -- one on day one, and then the second 28 days later. Each individual enrolled will be involved in the study for 25 months. Volunteers will be compensated for their time.
"People will be followed very closely after each of the vaccinations and then for a period of two years," said Dr. Frey. "While like all vaccines, there are possible side effects, and we'll be closely monitoring for any side effects, but so far no one has had a serious adverse effect from the vaccine in the two previous phases of this trial.
"You cannot develop COVID-19 from being in this study and receiving this vaccine. This vaccine does not have any live virus in it and we do not expose you to coronavirus. If a person becomes exposed to coronavirus, and develops COVID-19, they do that because of their own behavior -- either at home, at the workplace or out in public. We do want people to understand we do not know if this vaccine works and people should do what they would normally do to protect themselves -- such as wearing a mask and practicing social distancing. We know that people don't always do that because they might be in a hurry or they were just with their friends and they think that they are safe, but that's how people become infected."
"mRNA is the instruction manual that allows the body to make the spike protein -- which is the small piece of the virus that causes an immune response," said Dr. Frey. "It is also the same part of the virus to which neutralizing antibodies are made. This is an absolutely new platform for making vaccines. They are no vaccines on the market made from mRNA -- however mRNA has been used to test other vaccines. One of the things that's nice about mRNA is that it is very easy to produce and can be mass produced quickly -- providing millions of vaccines to individuals."
For more info on the trial -- or to volunteer -- log onto vaccine.slu.edu and complete the questionnaire or call 314-977-6333 or 1-866-410-6333.