the first phase 3 trial of a coronavirus vaccine It started this week, with plans to enroll 30,000 volunteers by the time it ends, and more phase 3 trials are likely to start soon. While we all look forward to a safe and effective vaccine as soon as possible, the only way to find out if it’s safe and effective is for the volunteers to try it.
Vaccine trials in humans, such as drug trials, come in three phases. In the first two, the researchers calculate the proper dose, make sure that the side effects are not too severe, and of course that the vaccine elicits an immune response. The third phase is “the definitive trial”, medical scientist John Cooke he told us. It involves a large number of volunteers receiving the experimental vaccine or a placebo; This is how we found out if the vaccine really works in the real world.
What if you are a volunteer?
The first step is to complete an evaluation questionnaire that will help researchers determine if you are the type of volunteer they are looking for. Each study has its own eligibility criteria based on things like age and health history. You can see the criteria for the judgment of Moderna here in your entry at ClinicalTrials.gov.
The Coronavirus Prevention Network maintains a registry of volunteers for vaccine and antibody trials across the country, and You can sign up here.
The trial enrollment and participation process will involve visits to the research center, generally plus or minus 10 visits over the course of a year or two. These visits may include physical exams, blood draws, and injections or infusions. Volunteers are paid for their time. The Coronavirus Prevention Network does not give a specific amount, as payment varies by study and location, but payments for long-term studies can be in the hundreds of dollars.
When you sign up for a research study, whether it’s for a vaccine or anything else, the study will be explained to you, with a clear discussion of the risks and benefits, and you will be able to ask questions. You can always say no or withdraw from the study at any time.
Will people be exposed to the virus as part of the test?
They won’t give you the virus. Studies that intentionally infect people are called challenge studies, and they are not currently considered for COVID-19 vaccine trials.
However, the idea of a vaccine trial is to see if it protects you against the virus. Studies aim to accept only people who I do not have I still had COVID-19; then they will wait to see if you understand it or not.
Is this a good opportunity or a risky one?
It is potentially both. If you’re lucky, it could end up in the arm of the trial receiving the actual vaccine (instead of the placebo) and the vaccine might work. Congratulations!
But you can get the vaccine, and the vaccine may turn out to have harmful side effects. On the plus side, that’s information researchers should know, and perhaps their experience will lead to a harmful vaccine being phased out, or a better understanding of who might be harmed by the vaccine on rare occasions and why.
Or maybe you will get the placebo. There’s no way to know. You can also get the vaccine, and it turns out that the vaccine does not protect you. You definitely shouldn’t act like you’re protected just because you’re participating in a vaccine trial.
Testing a new vaccine is an inherently risky proposition, and that’s the main reason for trials, so a treatment can be tried first on people who know what they agree with and who are under close observation, rather than implementing it to all before the risks and benefits are well understood.
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