Some clinical trials for potential COVID-19 vaccines are going well—but don’t expect a vaccine any time this year, says an infectious disease specialist with Detroit’s Henry Ford Health System.
Dr. Allison Weinmann is involved in phase three clinical trials for Moderna's mRNA-1273 Coronavirus Efficacy (COVE) vaccine study. Henry Ford is participating in the national study, which has recruited 30,000 volunteers to receive either the vaccine or a placebo, and monitor the results for both safety and efficacy.
In an online town hall hosted by the Detroit Regional Chamber this week, Weinmann said that vaccine, and others currently in development, are showing tentative promise. But she said that even if the trials run smoothly, it’s very unlikely researchers will have all the data they need for U.S. Food and Drug Administration approval by the end of this year.
“I would anticipate by next year sometime. That’s what most experts are thinking,” Weinmann said.
“There’s been a lot of talk about it being by November first . I don’t think anybody in the scientific community really thinks we’re going to have good data by then.”
There are multiple constraining factors in vaccine development, Weinmann said. Not only does any vaccine need to prove it induces a robust immune system response to the virus, it needs to prove it can do so for “multiple populations”—regardless of age, race, or other factors.
Then there’s the fact that at least some people in the trials need to be exposed to the virus to validate its protective effect. But with COVID-19 prevalence levels in places like Michigan now fairly low, that’s harder to do. “Which is great news for our patients and our community, but actually conversely kind of impacts how quickly you can get results for a vaccine trial,” Weinmann said.
One clinical trial for a vaccine produced by drugmaker AstraZeneca was recently halted temporarily, when one trial subject became ill. While it’s currently unclear whether that was caused by the vaccine, Weinmann said that pause is actually an important indicator that pharmaceutical companies and researchers involved in the hunt for a COVID-19 vaccine are committed to not rushing the process. She said winning over public trust in that process is as key as the vaccine hunt itself.
“I think there’s a strong lack of public confidence in the process right now,” Weinmann said. “Which is a shame, because when we get a vaccine, hopefully it will be a very good one, even if it’s one that needs to be repeated annually.”
But despite those constraints, Weinmann is hopeful that 2021 will be “the golden year” where one or more vaccines is approved, and starts being widely distributed. She said the vaccine development process usually takes at least three years, so that in itself would be an incredible feat.
“This has been really an amazing national collaboration, to come up with so many vaccine candidates so quickly,” Weinmann said. "It really is unprecedented.”
In the meantime, Weinmann said infectious disease researchers and public health officials are concerned about a possible resurgence of COVID-19 in the fall and winter, especially as it coincides with the traditional flu season. She said that’s concerning on a number of levels: there could be inadequate hospital bed space if the two viruses converge, and it’s unclear what the flu might do to people suffering long-term health effects from COVID-19. She urges everyone to get a flu shot this year.
Weinmann warned that even if it seems like the pandemic is abating, it's not; people need to remain on guard, and continue taking steps such as wearing masks in public, washing their hands, and social distancing.
“COVID is out there. It has not disappeared,” she said. “Just because our prevalence is down, people should really not feel falsely reassured. It is out there, and we have a huge number of vulnerable citizens.”
There are three COVID-19 vaccine clinical trials in Michigan. Besides the Moderna trial at Henry Ford, the University of Michigan is conducting trials with AstraZeneca, and the Michigan Center for Medical Research is testing a vaccine in conjunction with Pfizer/BioNTech.
Editor's note: Henry Ford Health System is one of Michigan Radio's corporate sponsors.