Questions and Answers About COVID-19 Vaccine Clinical Trials
Are the vaccine trials being rushed? Are they safe? Two Michigan Medicine researchers weigh in.
As researchers around the globe work to develop a vaccine for COVID-19, they are depending on volunteers of all backgrounds to sign up for clinical trials. Anna Lok, M.D., assistant dean for clinical research and Njira Lugogo, M.D., medical director of the Michigan Clinical Research Unit, answered several common questions about the COVID-19 vaccine clinical trials during a recent livestream. Here are a few highlights, edited for length and clarity:
Lok: We know that everyone is eager to have the COVID vaccines and would have liked to have those vaccines yesterday. However, there is commitment from the sponsors and makers of the vaccines, as well as the FDA, that we’re not going to rush. We want to expedite the trials and get it done as quickly as possible, but we have to make sure there’s safety data that these vaccines work before they will be approved. The manufacturers basically said we’re not going to release those vaccines until we’re sure that they are safe and effective.
Lok: This is anybody’s guess because the trials are still on going and we expect the first trials will have results maybe late October, but more likely it’s going to be November. It depends on whether the vaccine results are exactly as expected or whether they need additional analysis and additional testing. So the earliest would likely be late October/early November if everything goes well. When those results come in the FDA has to review to make sure they agree with the interpretation of those results. What we do know is all these manufactures are geared up to mass produce in collaboration with the federal government. So once we know they are good and the FDA gives the greenlight, it’s not going to take months to produce them because all of the machinery is going to be in place and will be cranking up.
Lugogo: That’s a frequently asked question and a good question. Almost all clinical trials, particularly those related to COVID, have been reviewed by the FDA and approved prior initiation of the trial. They have a lot of oversight boards in place to catch any safety signals or events that may occur and they have the processes to pause the trial if anything unusual happens. Also, as investigators we’re responsible for making sure our first priority is the safety of our participants and we are required to report any unusual events that occur so we can protect all the participants in a trial across the whole world and all the sites.
I think it’s something that a lot of people are concerned about, but it’s a way to contribute towards discovering new treatments that will revolutionize how we manage patients, and there are a lot of safety nets in place to make sure that patients are protected and that’s always our first priority. And we’re always open about the risks, discussing the potential benefits while we do the informed consent process, and we are always open to addressing any concerns that people have as they go along. But we will be monitoring all participants in the COVID trials quite closely. They will be getting in touch with us if they have any type of symptoms, be they symptoms of COVID or any other concerns.
Lugogo: It’s quite important because we know unfortunately from the data we have that African American and people from Latinx backgrounds are having more poor outcomes when they get COVID-19. So those populations are at higher risk of more severe disease and of dying if they contract COVID 19. So we want to make sure we include people who are at higher risk because part of the whole point of a Phase III trial is to see if someone develops COVID after getting the vaccine and will the vaccine prevent them from getting very severe disease.
Also, we need to make sure there are no genetic or other factors predisposing people to developing more sever disease that may change the way they respond to the vaccine. And also, at the end of the day the vaccine will be given to everybody. And if we didn’t study people from different backgrounds and detect any issues that occur in a controlled setting, then what will happen when we start vaccinating everybody with a vaccine that wasn’t studied in that population? So it’d really quite important to make sure the vaccine is safe in a controlled setting for all kinds of people—age, gender, racial background, BMI, obese people, thin people—and all over the spectrum so that we have confidence when we start vaccinating everyone.