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

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Although initial doses of an emergency approved vaccine are expected to be limited to certain groups, experts are concerned participants in other ongoing vaccine trials may drop out to seek what regulators first OK.

Speaker 1: 00:00 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 2: 00:21 It's a lot of paperwork to be a human test subject and nurse hands, multiple forms to volunteer Christian dreamers. 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

Speaker 3: 00:39 You allow us to get that early?

Speaker 2: 00:41 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 3: 00:56 Hispanic?

Speaker 2: 00:57 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 3: 01:14 There's a lot of suspicion and fear, and that's based in historical

Speaker 4: 01:18 Injustices, really from biomedical research. And so, um,

Speaker 3: 01:22 Really take a proactive stance against that

Speaker 2: 01:25 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 reason

Speaker 3: 01:43 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 2: 01:51 Doctors like Ramers would be prioritized to receive an emergency approved vaccine.

Speaker 3: 01:55 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 that I get in line, because I'm a healthcare provider, you always have the ability to pull out of the vaccine.

Speaker 2: 02:05 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 4: 02:14 AstraZeneca study. We're hoping to put closer to 750 and the Yansen study. We're quite a bit ambitious. We're trying to put 2000 on

Speaker 2: 02:22 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 4: 02:35 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 2: 02:44 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 4: 02:56 With the epidemic raging the way it is. We vaccines as fast as possible for as many people as possible. So we're in a very difficult catch 22 position, right?

Speaker 2: 03:06 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 4: 03:12 We might advise our participants that really, if you were to wait until February, you could evaluate this vaccine study that you're on to see if it was

Speaker 2: 03:24 Better. 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 4: 03:47 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 for the sake of the science.

Speaker 2: 03:55 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.

Speaker 1: 04:12 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 2: 04:35 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: 05:07 Yeah. Well, I'm going to ask the other question then. Why not just concentrate on producing huge volumes of those vaccines and let these other trials go if indeed Pfizer and modern a vaccine are as effective as they say they are, right?

Speaker 2: 05:23 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. And, but we haven't used an RNA vaccine before, you know, so how long does it last 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 maternal vaccines are to 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: 06:34 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 2: 06:57 Right? And so our friends at UT San Diego did some of the math that you just mentioned, um, in, in my interview, um, with, uh, health and human services, agency, director, Nick meshy own, and a County public health officer, dr. Wilma Wooten, you know, they said that they're looking at state and federal guidance. They're 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, of how many in our region. Um, you know, we know that an advisory group, um, just recommended health care 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 2: 07:38 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 long-term 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 it then 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 distribute it 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. Um, 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: 08:50 Okay. Here's a practical question. If, if you are among one of the first in line, an emergency authorized vaccine, where do you get it? I mean, you probably don't go to your local drug store, right,

Speaker 2: 09:02 Right. To preface all 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 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 meshy on, you know, he, again, director of the county's health and human services agency. So the overall plan is to use, you know, the medical facilities that already serve as, uh, sites for other vaccinations.

Speaker 2: 09:51 But on top of that, 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 meshy on and 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: 10:21 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 for that?

Speaker 2: 10:37 So 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 that would work. Um, but you know, director Mesha and, and dr. And both said that they'll have to get people in tour in 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, 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 have a better trusting relationship with.

Speaker 1: 11:37 And for people who actually got a vaccine in the clinical trial, is there a risk involved in getting another vaccine?

Speaker 2: 11:45 That's a good question, because we don't have the data we haven't looked at. Um, 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 what you may see after a flu shot, you know, Madonna, same thing. So like, we haven't tested what happens if you get a Pfizer shot and then a Madonna shot, um, what happens if you get, you know, the Yonson shot and then out to go back and get them a Derna shot. We just don't know yet. 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,

Speaker 1: 12:33 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?

Speaker 2: 12:47 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 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 responding to the vaccine and that it's, it's triggering that reaction to prepare your body, to defend the full blown virus.

Speaker 1: 13:22 I've been speaking with KPBS health reporter, Taren, mento, and Terran. Thank you.

Speaker 5: 13:26 My pleasure, Maureen.

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Maureen Cavanaugh and Jade Hindmon host KPBS Midday Edition, a daily radio news magazine keeping San Diego in the know on everything from politics to the arts.