Temporarily halting a trial to evaluate a vaccine means we are following the rules of safety, noted Maura Abbott, PhD, AOCNP, CPNP, RN, assistant professor of nursing at the Columbia University School of Nursing.
Temporarily halting a trial to evaluate a vaccine means we are following the rules of safety, with regulators and scientists monitoring for every possible adverse effect, noted Maura Abbott, PhD, AOCNP, CPNP, RN, assistant professor of nursing at the Columbia University School of Nursing.
What determines whether a vaccine is inactivated or live?
It just has to do with the mechanism of the action of the vaccine, and so they’re trialing it to see which one will actually end up being the most effective. For instance, with the flu vaccine, there’s 2 ways, right? There’s the mist and there’s the shot. And a couple years ago, the mist was found to be not as active as the shot for a while, and then it was reformulated and for a while then it was equally as effective. So, again, it just really depends on the mechanism of action determined by the scientists who are actually working on it.
In general, most vaccines that we get are inactivated vaccines. That’s generally where we head, but I can’t speak to the final format, and there’s many, many, many, vaccine types being trialed out there.
What does a halting a trial mean for vaccine safety?
When you’re trialing anything, whether it’d be a new vaccine, a new medication, a new medication combination, every single possible side effect that could possibly happen is being monitored by regulators and clinicians and scientists. And everything is documented, whether it be somebody’s eye hurt or they got a rash on their face, or whatever it is. Depending, and no matter the severity, again it’s being graded and it’s watched, and there’s a standard grading system for how severe it is.
And so anytime there’s an adverse event or potentially adverse event related to whatever is being trialed, if it’s serious enough, the vaccine or the medication trial is halted temporarily. The people who are running the study, the overall principal investigators, go back and they check to see if this adverse event is likely related to what was being trialed or is completely unrelated. And then again, they continue to follow it and they investigate to see if there’s any other possible cases like this that may be of less severity to see if this really is related to what’s going on.
So in general, this is actually a good thing because it shows that we’re following the rules of safety. And so the fact that you can restart a trial and keep going generally leads you to believe that everything’s safe and okay. There are clinical trials in which there are adverse events that happen in multiple patients, and then they just don’t start again because then it’s not an okay thing to give to the population. The fact that we’re able to restart and keep going is a good thing because it shows that it really is safe, and we’re going to continue to watch it.