Q&A: Implications of stopping and restarting COVID-19 vaccine trials
Earlier this month, phase 3 trials for AstraZeneca’s COVID-19 vaccine candidate were halted due to a suspected serious adverse reaction in a participant from the United Kingdom. The trials have since resumed in the U.K.
Healio spoke with Paul A. Offit, MD, director of the Vaccine Education Center at Children’s Hospital of Philadelphia, about the logistics behind stopping and restarting a vaccine trial and what it could mean for attitudes about a COVID-19 vaccine when one is available. – by Caitlyn Stulpin
Q: Who decides when to stop and restart vaccine trials?
A: Usually the data safety monitoring board and then they report that to the regulatory agency and then the regulatory agency decides when to restart.
Q: Is it good news on some level that the AstraZeneca trials were stopped? Does it show that they are being careful?
A: Yes, I think they stopped it because they wanted to take a closer look at that patient and take a closer look at all the participants in the trial to make sure that there's nothing similar that has been seen in anybody else. It's good. You want people to be very careful about safety issues. So, that's a good thing.
Q: What do delays like this usually mean for a trial? Can we expect that it will delay when the vaccine will be available?
A: I think that's fair. As far as I know, the FDA here in the United States still has that program on delay. I don't know if they started back up again. So there obviously seems to be some differences between the U.K. regulators and the U.S. or FDA regulators in terms of what criteria they use to restart those trials.
Q: Do you expect that situations like this will have an impact on people's feelings about getting a COVID-19 vaccine when one is available?
A: I don't think so. I just don't think people pay that much attention to this, frankly. I think that they're generally nervous about how quickly this is being developed. I think they're generally nervous about trusting the administration regarding scientific issues, given that there seems to have been a clear politicization of various scientific issues. So, I think that makes people nervous. But I think once the data are clear and we can all see what the data are, we can see to what extent it's effective, on how many people it's been tested in, and how safe it is based on how many people it's been tested on. Who's been in those trials? In other words, was I represented at trial? If I'm over 65, or I'm African American, or I'm Latinx, I'm obese am I represented in those trials? I think once that information gets out there, that's what people will pay attention to.
AstraZeneca. COVID-19 vaccine AZD1222 clinical trials resumed in the UK. https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2020/covid-19-vaccine-azd1222-clinical-trials-resumed-in-the-uk.html. Accessed September 22, 2020.
AstraZeneca. Statement on AstraZeneca Oxford SARS-CoV-2 vaccine, AZD1222, COVID-19 vaccine trials temporarily pause. https://www.astrazeneca.com/content/astraz/media-centre/press-releases/2020/statement-on-astrazeneca-oxford-sars-cov-2-vaccine-azd1222-covid-19-vaccine-trials-temporary-pause.html. Accessed September 22, 2020.