What happens to all the other COVID-19 candidates when the first one is approved?
Now we have staff writer John Cohen. He wrote a story this week about an interesting question what happens to all the other covid nineteen vaccine candidates when the first one is approved. Hi John. Hi. Sarah. How are you? I'm good. He could be let's be honest. We're both sick of the pandemic. Yeah. Absolutely. Let me leave my house that my child leave the house. That's all I want to normal. Yeah. Normal. Let's talk about vaccine candidates. How many are in studies now under study now and what does the trial landscape look like at this moment? Know they're forty two in human clinical trials according the WHO list? The World Health Organization doesn't update list that was as of October second in there about two hundred in development. Of, the forty two in clinical trials tanner in the last stage of efficacy trials, the phase three, we're going to be mostly talking about what's going on in the US those numbers reflect worldwide vaccine development that's global. The US has four efficacy studies underway right now, and these are all part of what they like to call warp speed all part of operation more speed. Yeah. Yeah and so they're going through trials going through all the same steps, but that could change once one of them gets. Approval, why would something changed about? You know what's going on with the other CO bids scenes? The concern is that the mediocre might be the enemy of the better or the best the way that we've set things up in the United States the food and Drug Administration has a mechanism called an emergency use authorization. It's received a lot of attention because of hydroxy chloroquine because of rim, Desa there, and because of convalescent plasma and because of diagnostic testing, all of those have used this pathway for. Approval and authorization essentially is short of a full approval and it says, Hey, were in an emergency we only minimal data that gives us an idea of this stuff working and then we'll let it be used widely. So why are we worried about the other possible covid nineteen vaccines? If for example, one gets a UA by November I the FDA has said in a document issued in June that the EU a could be issued for fifty percent efficacy. That's a pretty low standard to begin with. As. Soon, as you authorized the use of one vaccine, first of all, this is an ongoing study because they're going to use data for an e you a most likely from an interim analysis someone of axion efficacy trial is scheduled to take six months. An Independent Safety Monitoring Board looks at the data at certain pre scheduled time points in the case of these efficacy trials they look at. The data early based on what they call? It's are basically the end points of the study. The studies are primarily asking the question. Do they prevent symptomatic disease that the number one question they're asking? So that's an event. If somebody gets a symptomatic disease and these trials are scheduled to have one hundred and fifty events to reach their final conclusions, but they're going to take peaks at the data. At fifty events, a net one, hundred events roughly at fifty events a company. If it had strong evidence that the people in the vaccinated group as opposed to the Placebo group were doing better, they could seek you a based on fifty percent efficacy at that moment they ethically in a quandary because the people who are still in this trial, blindly a receiving either vaccine or placebo ethically you could. Argue you've gotTa Blind and tell the people who are receiving. Placebo. We've got a vaccine that looks good. Do you want to get it? So you've undermined that study from reaching it's real and points of one hundred fifty events What's more? Every other study underway has to let the participants know that the US has issued and ethically you have to give people the option of taking a vaccine. The FDA's blessing. People might walk out a trials who are in trials. If you were staging a new clinical trial, you may well have to compare your vaccine to the one that has received the authorization. Well, it's much easier to prove that something is better than nothing. But what if you have a vaccine that's fifty percent effective and that becomes the competitor not a placebo well. Then, this new vaccine let's say it has sixty two percent efficacy. You're comparing sixty two percent to fifty percent not fifty percent zero. It's really hard to see that small difference or even if they're equivalent, let's say they're both fifty percent. So you need a much larger study and it needs to go on for a longer period of time and it costs a lot more money we. Don't have. It's not likely that people involved in trials for other vaccines or even the people in the placebo arm of the one that does get approved would have access to the sack seen. That's a critical consideration. If supply doesn't meet demand, then we have an easy you were only giving outlets twenty million doses to the top priority people healthcare workers then for the people in other. Clinical trials they have no other option. Then the issue is not this great ethical dilemma, but remember were speeding things up with operation more speed in order to pump out three, hundred, million doses of vaccine from one company by as early as the end of January. So this problem, it's not here today because supply doesn't meet demand, but it sure could be here in late. January and. February march April who knows what we're going to have in terms of efficacy data and who knows what we're going to have in terms of trials in their enrollment. Remember we have a couple of trials that have been stopped because of side effects. When you put a trial on hold that means it's not going to reach its end point for even longer and that's happening right now with two of the warp speed vaccines. In your story, we don't want just one vaccine. There's some good reasons to continue to investigate and to look further afield even after one is approved, can you talk about some of those? For one thing we may need different vaccines for different populations. The elderly we know with influenza, they need a much higher dose because their immune systems don't work as well as they age we may need one that's tailored for pregnant women. Pregnant women are GonNA, tolerate a risk factor much much lower than everyone else. You might need a vaccine that simpler to deliver for some parts of the world that doesn't have a cold chain issue or you need to keep it at. MINUS SEVENTY DEGREES CENTIGRADE. You might need a vaccine that's cheaper for many countries even though it's maybe sixty two percent versus sixty, eight percent effective, it might be a better deal at the end of the day because more people can get it for the amount of money you have on top of all that we want a lot of vaccines because more vaccines means more supply we have an insurance policy of something goes wrong at a manufacturing plant. If a side effect crops up when it goes into wider use, we have this backup of other vaccines. So there are loads of reasons why we want a whole portfolio vaccines ultimately to prove safe effective. That's the. Case that you have to make to participants people who might be involved in trials. Do you think it's going to be effective? Do you think people are gonNA still volunteer to get a vaccine or not vaccine that hasn't been approved? You put your finger on a really important issue and that's who enrolls in a vaccine trial why it's not like you have cancer that's going to kill you and you're enrolling in a trial because you've exhausted all medicines and you're hoping beyond hope that this new treatment will work and Save Your Life. That's a completely different motivation to join a trial. Then a vaccine when you are healthy, you're joining this to prevent something from. Happening so ethically, you can argue that well, that person most of these people are doing it for altruistic reasons the really doing it to help other people and you can ethically approach people in a study and say, Hey, look this one vaccine got EU a based on the early data that it's fifty eight percent effective. We'd like to keep you in this trial and it's a blinded study and we promise at the end of the study is one of the bioethicists I interviewed said we promise at the end we're going to give you the better vaccine, but will you stick with this for a while so that we can figure out if the vaccine that isn't For us is worth pursuing going back to your cancer example. There are cases where a clinical trials is happening the people in the treatment group are doing so well that it's no longer ethical to continue to deny that treatment to the placebo arm. That's not what's happening here. It is a different equation, some ethicists. That, even in a vaccine study, a person has a right to know if they're a participant whether they're receiving a placebo vaccine if there is convincing and compelling evidence that the vaccines working but keep in mind too and this is something that I think a lot of people have a hard time getting their heads around wearing a mask and social distancing goes a long way toward protecting you from this virus maybe even more than fifty percent effective vaccine 'cause then you're walking around. With none of this protection or you're not taking it as seriously exactly and that's called behavioral inhibition. If a vaccine leads to behavioral discipline habituation and people dropped their guard, stop wearing masks stop social distancing they may be putting themselves at more risk even though they have a vaccine in their bodies