Emergency Approval Of First COVID-19 Vaccine Could Complicate Search For The Best One

Speaker 1: 00:00 San Diego reaches the sad milestone of more than 1000 COVID deaths. Speaker 2: 00:05 I think we've all become a little numb, uh, as this, this number just keeps going up and up. Speaker 1: 00:11 I'm Maureen Cavenaugh with Mark Sauer. This is KPBS mid-day edition With vaccine approval, getting closer and closer. We'll hear why new COVID vaccine trials are still moving forward. Speaker 3: 00:31 It would be nearly impossible for one pharmaceutical company to generate enough doses of vaccine to vaccinate the U S let alone the world Speaker 1: 00:40 And a preview of tonight's KPBS community conversation on keeping our democracy that's ahead. On mid day edition, Speaker 1: 01:02 San Diego has now lost a thousand people to COVID-19 the profiles of the COVID victims. Show them to be our neighbors, friends, or tragically, our family members. Some are people who died too soon, often in their forties and fifties, others had their last years taken from them by this cruel and incurable disease. It was only about nine months ago that the first San Diego resident to die of COVID-19 made headlines. Now with more than a thousand dead, we're left to wonder how many more will be lost before the virus is controlled. Joining me is San Diego union Tribune health reporter, Paul Sisson, and Paul. Welcome. Thank you for having me. It may have seemed unbelievable back in March when we heard about the first death that we'd finally reached this point, remind us how San Diego received news of that first COVID victim. Speaker 2: 01:57 And going back in time, as you may recall, the first death happened on March 22nd. Uh, it was a man in his seventies who actually didn't die in San Diego County. He actually died in a Santa Clara hospital and, uh, there was, you know, a whole big debate after that about whether, whether that deaths should count for San Diego or not. And, uh, and so that's how we started out with, uh, with our first death, uh, San Diego County resident, who actually wasn't here when he died. Speaker 1: 02:24 And it made headlines at the time. It's been a long time since, since a COVID death made headlines, Speaker 2: 02:30 Right? I mean, you know, we've, we've, uh, certainly been covering the desk. Everybody has a in, in the media and people have still been paying attention, but it just hasn't quite, I think we've all become a little numb, uh, as this, this number just keeps going up and up. I think we, uh, you know, have just become used to the, this a hundred after a hundred, after a hundred more deaths associated with, with the novel coronavirus. Speaker 1: 02:54 Now, back in the summertime, it looked like things were slowing down a little bit. Have, uh, the, has the actual death rate in the County slowed? Speaker 2: 03:03 Yes, it does look like it has, uh, you know, we did a month by month analysis yesterday. And, uh, I, I think that the most deadly month that we've had so far was still back in July. Uh, and we haven't had quite as many in recent months as we were having. Uh, I was talking to, uh, some folks at the hospital association, uh, you know, about why that is and, and really the thought that there are two main reasons. The first being that overall, the, the people who are getting infected with this virus are younger, maybe in their twenties, maybe in their thirties, uh, more often than they were in the, in the early going. Uh, and as we know this, uh, this disease is significantly more deadly. Uh, the older you are. Uh, and then the second main reason is that they've gotten better over time at treating patients, uh, who get into severe respiratory distress and end up hospitalized. Uh, we've seen the overall length of hospital hospital stay cut roughly in half. Speaker 1: 04:01 Do we know the person who actually was the 1000th victim in San Diego? Speaker 2: 04:06 Uh, we don't quite know. Um, that's, that's a situation that is a little confusing for people. Uh, you know, it can take days or even weeks in some cases for them to issue death certificates after people die. Uh, they might do a little investigation to determine what the exact cause of death actually was when they look at the medical records that were associated with each person. Uh, and so the County does not tell the public about COVID related deaths until it has a, uh, an actual death certificate and, uh, you know, receives an actual death certificate. Uh, and so it is always the case that when we hear about new deaths, they actually happened sometime in the past. And so, uh, the thousands of deaths death on the county's list at the moment actually is a man who died back on November 24th. Uh, and so it is probably going to be the case that, uh, as we move forward in time, we will see some more deaths that actually occurred before that date. So the thousands death will probably change a few more times before it, uh, you know, it's far enough in the past that, that we aren't getting any more deaths that precede, that Speaker 1: 05:12 We often talk about COVID deaths in terms of statistics by age or ethnicity. But the union Tribune has over the months profile the life stories of many San Diego ones who died from COVID. Why did the paper start doing that? Speaker 2: 05:27 You know, we just really wanted to put a human face on these numbers. Um, you know, like I said, uh, you see these numbers go up and up and you can become a little numb to it. And you can forget, uh, I suppose that these are human beings who each have their own life story and who, who deserve to have some acknowledgement of, you know, who they were and how they died. And, uh, and, uh, you know, these are our neighbors, these are our family members, and we just kind of felt like they really deserved some sort of, yeah, the Speaker 1: 05:58 Stories you told us about the lives of the people we've lost are social workers, single mothers, teachers, Naval officers, athletes, and many, many elderly people who died without family or friends in attendance. Can you share maybe one or two of those stories with us? Speaker 2: 06:17 You know, our, one of our, uh, great writers, Gary WARF has really been doing a lot of these for us at one that struck me. It was a, it was a woman named Blanca Ramirez, who he just recently wrote about Blanca was an Imperial beach resident and her daughter, uh, Brianna Romo told us about her. Uh, she died on September 7th at age 55, uh, after a contract and COVID 19 in July. And, uh, we, we learned that she actually had an auto-immune disease disease called lupus, uh, that really, uh, contributed to her susceptibility to this virus. And it just kind of brought home for me that, you know, this, this is our society's duty to protect these folks who have these conditions that they can't control. Uh, and so, you know, that that really definitely hit home with me. Speaker 1: 07:09 Now you've covered San Diego, hospitals and healthcare workers throughout the pandemic. I'm wondering how has this high death toll affected those people who are closest to the patients? Speaker 2: 07:20 You know, it started with them being very nervous. Uh, you know, the folks that I've talked to anyway about going home to their families and protecting their families and being able to be able to understand whether or not they could actually trust the protective gear that they wear when they're working at the bedside with people. And, you know, I think over time, generally folks tell me that they've come to trust their gear and they've come to trust that it works. And they were, they were a little less nervous about going home at the end of the shift, as long as they take the right precautions, but it's just a grind to keep seeing these types of, uh, of medical consequences for people day after day, week after week, month after month. I talked to a lot of executives recently, and a lot of our, um, local, uh, health systems who say that they are just really afraid that they're critical workers to people on the front lines, the respiratory therapists, the, uh, critical care nurses, uh, you know, those types of folks, uh, who have their hands on patients are just getting burnt out with the, they've just been doing this for so many months in a row. Speaker 2: 08:21 Now that, you know, just as this new wave arrives, uh, they're just, they're just getting burnt out. So that, that is a scary thing to think about, right? Speaker 1: 08:29 You talk about the new wave, uh, our numbers of newly diagnosed COVID patients are now extremely high over a thousand a day. Have you heard any estimates on how high the death toll could reach in San Diego? Speaker 2: 08:43 You know, I really haven't the local public health department and, and state, and, uh, in, in even the wider reaching, uh, national resources really don't seem to want to go there. Uh, it, it feels a little bit like they just don't, uh, don't see a lot of, um, a lot of margin in, in talking about that. It's something that's just so grim, but certainly, you know, we, we can expect the rate of death to increase as we see the rate of infection increase, even if, even if this is a less deadly than it was, we're just seeing so many more infections than we were a few months ago that we certainly can expect the overall number of deaths to increase. Speaker 1: 09:23 I've been speaking with San Diego union Tribune, health reporter, Paul and Paul. Thank you. Thank you, California is expected to receive a limited 327,000 doses of an emergency authorized COVID-19 vaccine. Pfizer could be the first one approved later this month, but KPBS health reporter Taran mento tells us that first vaccine can complicate the search for the best vaccine. Speaker 4: 09:57 It's a lot of paperwork to be a human test subject, and there's hands multiple forms to volunteer. Christian Bremer's. The papers are the final steps before Ramers joins an experimental COVID-19 vaccine study with Yonson pharmaceuticals. The company is part of Johnson and Johnson. Would you allow us to get that over the nurses, disposable gown Russell's each time she explains what Ramers is signing after a few pages Ramers needs a new pen. He also answers a series of questions that has the nurse scribbling down to what is your ethnicity, Speaker 5: 10:32 Hispanic? Speaker 4: 10:33 The process to join a COVID-19 vaccine trial is not only lengthy, but also invasive. I would have to ask them a confidential questions in a followup interview. Ramers a community clinic. Physician says he endured it all to help fight the pandemic and skepticism around a vaccine, Speaker 5: 10:50 A lot of suspicion and fear. And that's based in historical Speaker 1: 10:54 Injustices, really from biomedical research. And so, um, you know, Speaker 5: 10:58 Really take a proactive stance against that Speaker 4: 11:01 Personal gain is uncertain. Ramers doesn't know whether he received the vaccine or a placebo researchers don't know either it's called a double blind and protects the integrity of the study, but volunteers can drop out at any point and researchers worry. The first emergency approved vaccine may give them just the right Speaker 5: 11:19 Something people should know about. Clinical trials is it's always the participants, uh, uh, rights to pull out of the trial. If they want to Speaker 4: 11:26 Actors like Ramers would be prioritized to receive an emergency approved Speaker 5: 11:30 Vaccine. And so that's a key consideration for me is that if I have, uh, the ability to get a vaccine that's approved and I, I get in line because I'm a healthcare provider, you always have the ability to pull out of the vaccine. Speaker 4: 11:41 UC San Diego health, Susan Little is overseeing the local trial for Yonson as well as for AstraZeneca. They require enrolling hundreds to thousands of volunteers, Speaker 1: 11:49 AstraZeneca study. We're hoping to put closer to 750 and Speaker 6: 11:54 The, uh, Yonson study. We're quite a bit ambitious. We're trying to put 2000, yeah. Speaker 4: 11:58 Plus tens of thousands of others elsewhere, but she's worried another vaccine receiving emergency use approval could push some people out that would jeopardize long-term data collection needed to produce multiple vaccines. Speaker 6: 12:11 It would be nearly impossible for one pharmaceutical company to generate enough doses of vaccine to vaccinate the U S let alone the world. Speaker 4: 12:20 And she says many volunteers may not even be eligible for the initial doses that will likely be in short supply, even among priority groups. But she also says COVID is a public health emergency that demands an urgent response Speaker 6: 12:32 With the epidemic raging the way it is. We need vaccines as fast as possible for as many people as possible. So we're in a very difficult catch 22 position here. Speaker 4: 12:41 Little says she's already planning how to talk to participants once the first emergency authorization is granted, which could be later this month, Speaker 6: 12:48 We might advise our participants that really, if you were to wait until February, you could evaluate this vaccine study that you're on. Seeing if it was bad. Speaker 4: 13:01 Johnson's is a one dose vaccine while Pfizer's requires two injections, FDA guidelines say it does not consider an emergency approved vaccine as a reason to tell participants if they received a placebo, but a leading bioethicist from NYU says, participants have a right to know under such circumstances. Raymer says he hopes he's in the vaccine arm of the Anson trial. Speaker 1: 13:23 Um, and so, you know, fingers crossed that it was the vaccine, but that's the idea of going in is that you have to be willing to take a placebo Speaker 4: 13:31 Still. He plans to review data from an emergency proof vaccine before making up his mind, but Yonson told KPBS they'll notify participants about eligibility for an emergency approved vaccine. The company said volunteers can use that info to continue as is or seek to be on blind. Speaker 1: 13:48 Joining me is KPBS health reporter, Taran, mento, and Taran. Welcome. Thanks Maureen. Hi. Hi. Now your report focuses on people who are involved in ongoing clinical trials here in San Diego for a COVID-19 vaccine from Johnson and Johnson. But that is obviously not the first vaccine that's coming out. So why do we need more than one vaccine? Speaker 4: 14:11 Right. We know that an FDA advisory committee is going to review an application from Pfizer for emergency use, and then shortly after that, it should be Moderna. Um, and the short answer is just the volume of needed doses. You know, Susan Little is leading some of the local trials at UC San Diego, and she pointed out that just one company can't manufacture all the doses that would eventually be needed. So multiple producers would get us closer to the mass quantities. We'll need not just here in the U S but worldwide. Speaker 1: 14:42 Yeah. Well, I'm going to ask the other question then. Why not just concentrate on producing huge volumes of those vaccines and let other trials go if indeed Pfizer and Madrona vaccine are as effective as they say they are, Speaker 4: 14:58 Right. You know, but each vaccine is slightly different. So Madonna and Pfizer are using messenger RNA. It's not the actual virus. It just kind of communicates to your body how to respond to the virus. So it produces that defense that hopefully it remembers when it comes in contact with the virus and initial data shows that, you know, for at least the two months after you get your final dose, it does remember and can Mount a response to the virus. Um, but we haven't used an RNA vaccine before, you know, so how long does it lasts beyond that two months? Um, you know, early data does say that that's the period, but we can't determine if it lasts longer until we give it the time to see those longer results. We got to keep studying it, but we want to take multiple approaches at the same time as we continue to wait for that time to pass. You know, and another thing is that Pfizer and Madrona vaccines are two dose. And as I mentioned in the story Yonson, which is the pharmaceutical company with Johnson and Johnson is one dose. It's easier to give people one dose then making sure they come back three to four weeks later for that second dose. And we could see that, you know, some people of certain demographics may respond better to one type of vaccine, um, than, than the other. So the greater variety of options that we have, the better we can meet the public's needs. Speaker 1: 16:10 Okay. So we keep hearing about 20 million doses of a vaccine potentially ready to go by the end of this year. But when it breaks down to how much San Diego might get you do the math, and it might only be enough for about 12,000 people here, you did an interview with San Diego's public health officials, how are they getting ready to prioritize who gets the vaccine? Speaker 4: 16:32 Right? And so our friends at UT San Diego did some of the math that you just mentioned, um, in, in, in my interview, um, with, uh, health and human services agency, director, Nick [inaudible] and County public health officer, dr. Wilma, and, you know, they said that they're looking at state and federal guidance or these playbooks that the state has put out in CDC has put out. It has a long list of critical populations that they should identify in the County and provide an estimate of how many in our region. Um, you know, we know that an advisory group, um, just recommended healthcare workers and long-term care facility residents be a part of the first phase, which is, which is known as one a, you know, the second half is known as one B, which could be people with two or more underlying conditions in older people, you know, in dr. Speaker 4: 17:14 Wooten said, when you look at those two phases together, one a and one B that represents about 75% of our county's population. And I did talk to dr. Wooten before the CDC made that detailed recommendation about longterm care facility residents. So it may be slightly more or less than 75% under those guidelines, um, which still need to be formally approved by the CDC director. But that gives you an idea just of how many people really are considered priority. So the County is talking about half. They have to prioritize the priorities, identify subsets when within these groups, I mean, just with healthcare workers, are we talking only about doctors or nurses, only ICU nurses only, ER, doctors, only those in hospitals. So they're identifying all those different possibilities now and where they are so they can distributed appropriately based on whatever volume of doses happen to come our way. Um, the governor said we should get about 327,000 doses. And the math that UT did shows it could vaccinate 12,000 people in San Diego, but I'm not certain if it'll just be distributed by priority population volume, the state guidelines did say they're also looking at areas that have a high burden of disease, and that may shift their response with vaccine distribution. Speaker 1: 18:25 Okay. Here's a practical question. If, if you are among one of the first in line for an emergency authorized vaccine, where do you get it? I mean, you probably don't go to your local drug store, right. Speaker 4: 18:38 To preface all of this, I should say, like there's a lot, we don't know. I'm sure the public is just tired of hearing that response. That there's a lot, we don't really know. So we're just planning for a variety of situations, but, you know, eventually the vaccine should be at a pharmacy. The Vettel federal government has said they made agreements with pharmacy chains, you know, but early on, it'll probably go directly to the locations where these priority populations are. If they have the storage abilities to keep it as cold as it needs to be. So hospitals skilled nursing facilities, and these providers are working with our County to apply to the state and onto the CDC to get certain allocations and director [inaudible]. And, you know, he, again, director of the county's health and human services agency, so that the overall plan is to use, you know, the medical facilities that already serve as, uh, sites for other vaccinations, but its habitat as we continue to expand and more people, um, you know, could be approved to get the vaccine. You know, there'll be at public health centers, perhaps even at one day pop-up sites like they have for, for flu shots. Um, and even at, maybe at COVID testing sites, um, because the County is providing some flu shots at COVID testing sites. Um, so the resources are all in one location. And so, uh, director [inaudible] dr. Wilson said the testing sites have been in locations that are accessible for hard to reach populations. So they, they want to build on that. Speaker 1: 19:57 Now both the Pfizer and the modern vaccines, uh, they are of course at the head of the line for authorization, both of those need double doses as, as you mentioned to be effective. So how do San Diego public health officials prepare to handle that? Speaker 4: 20:13 The key tool that they pointed to was the San Diego immunization registry it documents who gets, which vaccines. And it's usually used for childhood immunization schedules, but they said it'll be mandatory for COVID-19 vaccines. So that helps with making sure facilities are following up with the right people for that second dose. And when we do have multiple vaccines confirming that people are getting the second dose of the correct one. So if you got Pfizer first, you need to get Pfizer second. Um, and you can't get, you know, Pfizer and then Madonna, cause we just don't have the research showing if, if that would work. Um, but you know, director meshy and, and dr. Budin both said that they'll have to get people in tour and the first place because of skepticism around the, you know, the production of the vaccine. So they're working with community groups and leaders, including in our communities of color and refugee populations to make sure that the message isn't just coming from health officials, but people that they may actually know on a personal level and, and have a better trusting relationship with. Speaker 4: 21:13 And for people who actually got a vaccine in the clinical trial, is there a risk involved in getting another vaccine? That's a good question, because we don't have the data. We haven't looked at that scenario. We just don't have the data to actually know. And that's um, so, you know, maybe later on further studies, we'll, we'll be looking into that issue, but right now we know that Pfizer first and second dose, 95% efficacy and, uh, very minimal side effects. You know, like I said, in my story, something equivalent to, you know, what you may see after, um, a flu shot, you know, Madonna, same thing. So like we haven't tested what happens if you get a Pfizer shot and then I'm a Dharna shot. Um, what happens if you get, you know, the Yonson shot and that got to go back and get them a dare, a shot, we just don't know yet. Speaker 4: 22:00 And so, um, that's not recommended at all that you do that. So we would have to continue to study that. And, um, but focus on what the research already is telling us, you know, Tara and their headlines just today. Some people getting the Pfizer or the modern of vaccines, some of them come down with slight flu symptoms like aches and fevers. And why would that happen? You know, it it's we've, we people see this with a flu shot people sometimes after they get a flu shot, just the way that their body reacts, the way that their body is preparing to Mount its response. If it was being introduced into the, you know, fully blown virus, um, they sometimes have to take a day off of work and, and recuperate before, um, you know, after they get it. And so in a way, you know, seeing these moderate side effects could be a sign that the body is appropriately, uh, responding to the vaccine and that it's, it's triggering that reaction to prepare your body, to defend the full-blown virus. I've been speaking with KPBS health reporter, Taran, mento, and Taren. Thank you. A pleasure, Maureen. Speaker 7: 23:07 We are excited about a special event. KPBS is producing online tonight, along with the national conflict resolution center. It's the latest in our series of community conversations, the topic for this post election panel discussion, which I'm moderating is timely and critical, keeping our democracy. What now I'll be questioning three San Diego political scientists and inviting your questions and online participation as well. Joining me now for a preview of our discussion is one of our panelists. Gina Goss is a professor of political science at UC San Diego. Welcome to midday edition. Thank you. I'm glad to be here. Multiple issues and trends arose during the 2020 election, which are still affecting our democracy. Let's start with the black lives matter movement manifested in massive protests here in San Diego and in cities across this nation this year, how important was that movement in the election? Speaker 6: 24:03 Black lives matter was a very important in the 2020 election. It didn't start this year. It's started, uh, it was founded years ago and re reactions of police brutality and lots of different locations. But this year it was really important, especially during the pandemic and especially in light of, uh, new videos and, uh, stories of police shootings throughout the country. And in San Diego, it helped a lot of people to express their concerns and also organize and really be in community with people to talk about how issues were affecting them, and also think about ways to get politics politicians to represent their issues. So I think it framed a lot of people's understanding of how to think about politics and how to think about what this election meant to them in 2020. Speaker 7: 24:49 And in what ways does the treatment of black Americans and other people of color affect our democracy? It must be profound. Speaker 6: 24:57 Yeah, it really is. When we think about democracy, democracy is supposed to represent everyone equally. And when you have people within a society who are consistently being victimized consistently not being the winners in every democracy, it's not just an indictment on the way that those people are treated, but it's an indictment on our democracy as a whole, if an entire populations of people aren't actively being able to participate in the democracy itself, isn't doing what it's supposed to be doing. Speaker 7: 25:25 And in your view, what needs to happen to make our democracy, what it aspires to be a country where we, the people means everyone, Speaker 6: 25:33 Part of it is really living up to that value of what we, the people means. And recognizing that democracy isn't just for certain populations. It isn't just for individuals, but it's for everyone. And, uh, for us to live up to that really requires us to understand that to be American is a very diverse concept. That's just not about, uh, kind of what we might understand as American, which typically tends to be associated with whiteness, but it also represents other groups who have been born and raised in this country, but even those who have come and naturalize into citizenship and, and those who typically we may not think of as American, uh, including black populations who we've talked about, even in this conversation as being, uh, unlikely to win representation, uh, or, uh, be received justice as victims of crimes, or even as perpetrators or crimes. Speaker 7: 26:28 Now it's been said, often an Americans are divided. That's maybe one thing we can all agree on. We see events through different lenses, facts, and they're seen as facts by millions sciences dismissed and lies and disinformation, including from the president of the United States, swirl around us daily. Why do you think this is happening and what can be done about it? Speaker 6: 26:47 I think a lot of it is just distrust in other people. We don't trust the people who are telling us things and we don't trust the way they think of ourselves. Uh, we don't trust that people believe that we're able to understand politics. So when people are telling us that you don't understand things, it makes them less likely to listen to those people as authorities. Right? So a lot of it is, uh, based, I think in a lot of hurt and pain and a lot of distrust and miscommunication and misperceptions of people, we don't understand because they're not active participants. Uh, they're not the people we interact with on a daily basis. So when we hear information from them, we discredit it. Especially if that information, isn't something that aligns with conclusions that we really understand or things though the way we think about society in the world Speaker 7: 27:39 And how can we get to where we at least agree on what our goals are as a country? Speaker 6: 27:44 A lot of that I think is respect and trust. Uh, it, I don't know if it necessarily requires us to start by trying to agree on facts. I think it starts by as learning to respect each other and understand where we're coming from. We entered into these conversations when we get there, we can start understanding or believing the things that people say to us because we believe their intentions to be true and honest in respect. Speaker 7: 28:08 I want to let listeners know, I'll explain in a minute how you can join our event online tonight, but a final question for now how big a threat to our democracy does this font of misinformation, the outright lies and false stories present. Speaker 6: 28:21 It's a huge threat to democracy. Like I said before, democracy requires us to not only be invested in our own rights and liberties being represented, but those of other people, but if we don't acknowledge other people respect their right to be participants in a democracy, then the entire institution is threatened and crippled and we can't make the necessary decisions to move forward. As a, as a country, Speaker 7: 28:45 I've been speaking with Latina Goss assistant professor of political science at UC San Diego. Thanks very much. Thank you for having me. It was great to be here. Our panel discussion and interactive session begins online at six to see evening, to be a part of it. Join us through KPBS, his Facebook page or our YouTube account. You can find links at kpbs.org/events. Community conversations is a partnership of KPBS and the national conflict resolution center made possible by Rady children's hospital, auxiliary and California state university, San Marcos.