On the latest episode of the WI Law in Action podcast from the UW Law Library, Professor R. Alta Charo, a leading expert in bioethics, discusses the development of COVID-19 treatments and vaccines and the procedural and legal issues that surround them. She explores how vaccine distribution can be expected, how a vaccine gets approved, and how federal, state, and local laws and agencies come into play.
Professor Charo on the role of government in research:
What really made a difference in COVID-19 truly, was the research that wasn’t on COVID-19. It was the basic science research in genomics that made it possible to very, very rapidly understand the genetics of this virus, which was the key to developing some of the most forward-looking kinds of vaccines that we’re now talking about, including the Pfizer, Moderna, and type. So the government’s role is both way behind the scenes in the continued funding of basic research, which has a serendipitous quality. But when it turns out to matter, it’s often profound in its effects, as well as the more practical interventions to provide a financial insurance policy for companies when you want them to invest in something that’s risky, but nonetheless important.
Professor Charo on the vaccine approval process:
So from a regulatory point of view, none of these have actually gotten any kind of approval for use yet. Now, the FDA does have a procedure it can use in moments of acute need, it’s called an emergency use authorization. Companies still have to show the kind of statistically soundproof of safety and effectiveness before they can get an authorization just as if they were going for a regular approval. But there are some things that can be speeded up in terms of the regulatory steps that are taken to go through the process of review and decision making. In addition, these are not vaccines that will have been tested over as long a period of time now, they’ll have looked for several months worth of possible adverse events or side effects. But what might be six months or 12 months after you take the vaccine, by definition we can’t know, we can guess there are lots of good biological hypotheses, but you can’t know. So if you put something on the market under this emergency use authorization, it’s going to be accompanied by special rules about monitoring and follow up.
Professor Charo on testing new COVID vaccines:
The other thing though that’s going to be interesting is that once we have a few vaccines that have actually been authorized, it does get harder and harder to test new vaccines. Because the ethics of research trials suggests that you can’t put people to unreasonable risk. So in order to test a vaccine, you have to have people that are taking the new vaccine and other people that are not. Right now, the people that are not taking the experimental vaccines are getting nothing…. Would it be ethical to have a trial in the future where you have a population that’s truly not vaccinated at all? Or would you now have to run trials where you have the experimental new vaccine versus one of these already authorized vaccines?
Professor Charo on the distribution of the COVID vaccine:
There’s no one way that is necessarily correct. It takes thinking through what your goals are going to be. If what you want to do is simply reduce the sheer number of people who are dying, it’s pretty clear, you would vaccinate first the people who are the oldest and most medically vulnerable. Because while nursing home residents for example, are only about 1% of the population, there are about 6% of the people infected, about 39% of the people who are dying. So if that’s your goal, to keep people alive, you’re going to go ahead and focus on nursing home residents first, first, first. On the other hand, you may want to make sure that society continues functioning. So you may want to focus on people you consider essential. And that’s why you get health care workers and meatpackers and national security people or anybody in the food delivery business and people who are in transportation….
See, you got to really ask what you’re trying to accomplish and model out the effect it has on deaths, on infections, on hospital burden, on the functioning of society and the economy, crucial with schools for example. And then figure out what’s the best balance of these goals. So what’s developing is a bit of a consensus, not perfect, but a bit of a consensus that in the very first stages, it’ll probably be focused on people in the healthcare system who are the most exposed.
Professor Charo on getting vaccinated and achieving widespread immunity:
There’s been a lot of distrust of government agencies in the last year and we have certainly been the victim of the unhappy confluence of a political election season with this pandemic so that everything that’s been done instead has been seen somewhat through a political lens. The election’s over, the particular pressure that November third brought on everybody has been relieved. And it’s time now to really listen hard to what the experts and independent, dispassionate reviewers are telling us about safety and effectiveness and believe them, because we have way too many people who are still saying that they don’t trust the vaccines for some reason. And if we don’t get enough people agreeing to take up the vaccine, we are not going to get the kind of widespread immunity we need to let society truly return to normal someday. We’re going to have a long, awkward period where we’re going to have to be taking vaccines, but still using masks, still using social distancing, because we’re not out of the woods yet. And that’s the worst, most difficult time for public communication. But the first step is for people to actually go ahead and get vaccinated.
R. Alta Charo is the Warren P. Knowles Professor of Law and Bioethics at the University of Wisconsin. To read more of her work, check out her profile on SSRN or the UW Law Repository.