Vaccine Hope on the Horizon

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Brian: Brian Lehrer on WNYC, and for the week ending yesterday, November 9th, an average of 947 Americans died each day of COVID-19. One month ago, the week ending October 9th, an average of 719 Americans died per day. That's 947 last week compared with 719 a month ago, that means around 230 more people every day are dying of COVID in this country than one month ago.

If that's the number per day, it means more than 6,500 people died of COVID in this country last week. For the local record, an average of 10 people a day died of the disease in Connecticut last week, 12 people a day in New Jersey, 22 people a day in New York.

There was some good news yesterday, which almost all of you have heard, no doubt, early data from Pfizer shows that a vaccine the company has been working on is more than 90% effective in the trial so far. There is, however, some fine print, including the fact that this vaccine wouldn't be available for a number of weeks or months, even to begin with.

Joe Biden announced his first COVID measures yesterday. Another White House outbreak is underway too with Chief of Staff, Mark Meadows and HUD secretary, Ben Carson, the latest to announce positive tests, and Mayor de Blasio and Governor Cuomo can't agree on how serious the COVID situation is in New York. What else is new? Those two can't agree.

Let's try to make sense of all this. With us is Dr. Uzma Syed, MD infectious disease specialist and chair of the COVID Task Force at Good Samaritan Hospital on Long Island. Hi Dr. Syed, welcome back to WNYC.

Uzma: Hi, Brian. Thank you so much for having me back, pleasure to be with you.

Brian: First, the numbers on the increases in deaths that I just gave plus the 130,000 new cases reported yesterday, a record, put those numbers into context. What do they tell us about the trajectory in America right now?

Uzma: I think it's really important to highlight the current situation and how we're in a really alarming state right now, nationally and globally. We've been very fortunate in New York, up until now we've had a nice summer reprieve, but none of this is unexpected. It took us roughly a little over a week, about 10 days to get from 9 million to 10 million cases and our cases are going up at a rather alarming rate nationally and what follows behind those cases are hospitalizations and deaths.

We are going to be very quickly approaching the 250,000 lives loss mark, which is really troubling even despite all of the ray of hope and the advances that we've made, we still are at a position where we do not have any therapeutic that's 100% curative nor do we have a vaccine right now that's available as a preventative measure. I think the things that Americans need to remember is that we have to use the tools in our shed that we know that work.

All of those measures to really prevent infection, simple things such as masks wearing and making sure that you're not in environments that promote virus transmission, crowded, indoor gatherings, and as we're moving into the winter, these numbers are just going to continue to grow exponentially and it's really troublesome already what's happening throughout the country and far worse is just on the horizon.

Brian: Joe Biden gave his first post-election COVID address yesterday. Is it clear to you what would actually change on January 20th in terms of COVID policy?

Uzma: I think the most important thing that we really need, that we needed yesterday that we need right this moment and going forward, we really need a national plan. We need an effort for all of us to be on the same page to really work hard to combat this virus.

We cannot keep losing more and more lives every day. This is very serious. It's getting worse by the minute and until we have things that will really help us get a control of this, we need a really good national effort with leaders in science that I know he's already put together a good strong team, so we need this to really be in effect and right away.

Brian: I keep looking to Europe to compare the United States who regular listeners to the show will know that who the summer, while cases were increasing in the United States and deaths were increasing in the United States, deaths as well as cases, I would go on pretty much once a week and give the United States numbers with those like 700 deaths a day on average and then look at Italy four, look at the UK eight, look at France three deaths a day.

It's not that way anymore. They're over 400 deaths a day in Italy now. Oh, my goodness, and they don't have Donald Trump. What does that tell us about how difficult it is to get this under control, whether you're going the Trump way or the Biden way?

Uzma: I think it's really clear and we've known this from early on, we've been following this from very early on and we are right behind Europe from the start of this. I think one thing that's very clear is so much of this virus and control of this virus is really dependent on our behavior and I think the second that things get a little bit better, we sort get this false sense of security.

There's many, many different variables to this, whether it be pandemic, fatigue, or just the social isolation and people just want to get back to normal and you let your guard down and the virus has not gone away and it just finds its way back into the community with increasing transmission and we get into the situation where we are at right now, where they're at and unfortunately we are right behind them and so a lot of this is dependent on our behavior and the things that we can do to really control this.

Brian: Now to the good news, when a lot of people saw that Pfizer's COVID vaccine was more than 90% effective in the recent trials, there were sighs of relief. There were reasons to feel encouraged. How does the company know that the vaccine is 90% effective? Are you encouraged? I don't know what 90% effective means.

Uzma: That's a great question. As somebody who's on the front lines, who unfortunately still is having to stare death in the face with patients losing their lives daily, even though we are more than eight months into this pandemic, I will take any ray of hope and silver lining that's out there and really be cautiously optimistic as Dr. Fauci likes to say in our industry.

There's data that is released, right now we just have a press release, and so we're going by the information that we're told, but we really are awaiting all of the data, all the information that backs this and more data that needs to be collected as this study is ongoing to really look at the variables and to see, everything that's behind this, to look at, "Is this in fact effective in all age groups? Does this prevent severe illness or not?"

Basically, initially, the goal for this trial was to-- The interim analysis wanted to look at 32 case reports of coronavirus, but then they decided to extend it to a minimum of 62 cases. By the time they started gathering that information and back and forth with the FDA, they in fact had reported that they had 94 confirmed cases.

What that really means is that the clinical trial is really looking at patients that have gotten the vaccine and patients that have not and what they're doing is they're having symptomatic reporting after most people are aware at this point that it's a two-series vaccine, there's a prime and then there's a boost three weeks later and then approximately seven days after that, they want to see if there has been, in fact, development of illness in placebo versus patients that have actually gotten the vaccine.

Now, these patients are not necessarily being challenged because we have so much community transmission within the United States and within the world, it's just a matter of symptomatic reporting of new cases. To the best of my knowledge there isn't surveillance, PCR testing, being done of all these patients. What we're looking at is that 94 numbers, the confirmed cases by symptoms, but in fact, that number could actually even be higher because we already know that there are people that don't develop symptoms with COVID-19.

What they found was that it's 90% efficacious in producing neutralizing antibodies to prevent symptoms of infection. So that's a lot higher than what we had in mind going into this. Usually, the benchmark if you look at influenza vaccines and just from the FDA standards, they were just looking at a 50% confidence interval, and having this higher number is really helpful because that tells us that if you look at the entire population of the United States previously, if we had a lower efficacious vaccine, then you would need much more of the population to be vaccinated.

With this level of effectiveness, you can really get about 60% of the population vaccinated to get that number really below one. That's our goal, to really break that cycle of transmission.

Brian: In a clinical trial of vaccines like this, wouldn't they test all the subjects once a week or something to catch the asymptomatic?

Uzma: It really depends on the design of the trial. Each trial is very different and many trials have very different parameters that are set up to look at the placebo and the people that are actually receiving the vaccine. They look at symptom development, side effects, adverse effects, again, most of which we don't have information on. We do know that for the most part that the vaccine has been well tolerated from this press report that we have. There haven't been serious adverse events reported, unlike some of the other trials that had been paused previously in the United States and globally, AstraZeneca being one of them.

From this press release, we haven't heard that, but we need that information. We really need a lot more information before we can make definitive, good statements about this, but this is what it is. It's a press release and at least it's some positive information and we will be cautiously optimistic while we're waiting for the rest of the data to be available.

Brian: We're talking about COVID news with Dr. Uzma Syed, infectious disease specialist and chair of the COVID Task Force at Good Samaritan Hospital on Long Island. As you can hear, she knows a lot about the vaccine trial. If you have a question about that, you can call in or some of the other COVID stories that we have been in and we'll be talking about. 646-435-7280. 646-435-7280.

I think we have a call coming in that relates to the possible reluctance that people might have, some people might have to taking a vaccine once it is available. Let's see what Lisa in Forest Hills has to say. Hi, Lisa you're on WNYC.

Lisa: Hi, thank you so much for taking my call. Yes, I'm very skeptical though I want to be cooperative. I'm just curious. Considering that there is long-term side effects that could be severe after getting COVID, would those same side effects be potential for getting the COVID vaccine?

Brian: In other words, if the vaccine-- and maybe this is a myth you need to bust, Dr. Syed, but people think of a vaccine probably wrongly in most cases as giving you a low dose of the actual disease so you develop immunity to it, and therefore, you're at risk of side effects. Is that a myth you on a bust?

Uzma: This is a great question. Hi, Lisa. Thank you much for joining us today. A lot of misinformation spreads very rapidly about vaccines, has been going on for a long time now, and especially right now given this pandemic that we're in. We really need to work hard on getting the accurate information out there. Just simply starting from something like the influenza vaccine, people are often very skeptical to get that vaccine because they claim that they got influenza from the vaccine, when, in fact, it's a killed vaccine and you can't actually acquire the actual virus from the vaccine.

What usually happens is people are incubating or harboring the virus around that time of year when they get vaccinated. It's just coincidental that they may get sick with influenza, or they might just have some of the mild side effects that people have from any vaccinations, which could be a low-grade temperature, a little bit body aches, but those things usually self-resolve.

With respect to these novel vaccines that are being developed, a lot of them are on new platforms that we've never ever used before that have never been FDA approved. I think that's why we do these clinical trials is to study them extensively to make sure that they are safe, to make sure that they are effective.

These patients need to be followed long after even if the FDA grants approval after the data is available and transparent and we see that it has been safe and effective, whichever candidate the FDA does grant approval to, those patients still need to be followed because we are not going to know the long-term effects until all those patients are followed and if there are any adverse effects, any side effects that are in fact reported.

That being said, I think so far, the data is showing that people are tolerating the vaccine and we just have to keep moving forward with that to make sure that we are continuing to collect data to have all the information that we need to know about the full side effect profile of any vaccine.

Brian: Jules in the West Village, you're on WNYC. Another vaccine question I think. Hi, Jules?

Jules: Hi. Last night on Brian William's MSNBC program, Laurie Garrett, the infectious disease specialist journalist, reported that based on the information so far, the Pfizer vaccine has only been shown to provide immunity for seven days.

Brian: Is that your understanding, Dr. Syed? I hadn't heard that before. I didn't see that segment last night.

Uzma: The data that they have right now, this is the prelim data that they have in one month out, basically, because as we know, the patients require a primary vaccination, then a booster vaccine three weeks later, and then seven days after that is when they are looking at if patients are developing disease or not. They're continuing with this because the FDA wants all the information at two months out and longer as I mentioned before.

For us, the main question, the million-dollar question still remains, if we do have a vaccine that's safe and effective, how long does that immunity last? We don't know. These are the things that are still yet to be answered. Only time will tell and we need to continue the science and we need to continue these really good studies with evidence-based medicine to really have the answers.

Brian: Let's say there is a vaccine that really is 90% effective. Can an individual know if it worked for them?

Uzma: There's a lot of variables in that, again, because the trials are being done as a randomized double-blinded study where you don't know if you got the placebo or the vaccine. That's how they're able to study it. For the general population, eventually, there's going to be lots of different variables that are going to go into seeing whether or not the person who's received the vaccine is having a positive effect of protection from the vaccine, and usually, that's symptomatic course, if the patient develops any symptoms of COVID-19 or if at some point, they get tested and they show whether or not they have developed antibodies.

That's also in question whether or not patients who have previously had COVID-19 or not would be candidates for vaccine studies and things of that nature. There are a lot of different variables in that, seeing if it's protective and if it's beneficial. That's why these vaccine trials have to be very, very diverse. That data, we still don't have on the profile of the age characteristics of the people in this study especially the newly reported data and the press release that we have, the underlying medical conditions.

We know that these trials have been really aimed at being more diverse. Globally, I think they had over 40% diversity in their enrollment and nationally, I think it was about 30%, but we need all the nitty-gritty information and all the data to know.

Brian: At the level of an individual, once there's an approved vaccine and it's being widely distributed, and one gets the vaccine, can they go back and get an antibody test if that's the right measure and based on the results of that or something else, say, "Oh, well, okay. Now, I can go have indoor dining again. Now, I can go back to the office again. Now, I can see my grandchildren again," or anything like that?

Uzma: I think that's the whole goal of the vaccination is to provide protection for people. If this does continue on this path, our hope right now is that by the time the vaccinations are rolled out, again, it's a tiered basis that the National Academy of Science Engineering and Medicine has developed, a phased-out approach for vaccine delivery. By the time the general population does get vaccinated, the real test will be in this fall of 2021 when we would expect more coronavirus transmission SARS-CoV-2 transmission rather in the community because, again, that's what we expect in the seasons when people move indoors.

For somebody who's been vaccinated, the test will be, do they acquire the infection or not? Again, with time, we'll know exactly how long that immunity is. The best way to know that is by having exposure and not developing disease. Those are the best ways that we can see and that's exactly what these trials really focus on.

Brian: Janine in Manhattan, you're on WNYC with infectious disease specialist, Dr. Uzma Syed. Hi, Janine?

Janine: Hi. Thank you so much for bringing up this really great point. Here's my question. The Trump administration has eased FDA parameters and testing standards for specifically the COVID-19 vaccine. I have two quick questions or shortcutting the approval-

Brian: Process.

Janine: -standards. Number one is, are there reliable sources to read specifics on these vaccine trials? Like what were the number of people in trial? What were the age groups? What's the length of time that they call long-term effects that they're following pre-site effects, that kind of thing.

The second question is, specifically for the COVID-19 vaccines, because they're making this relaxed FDA requirement to get approval. Is there a requirement of the companies participating in this specific vaccine that the companies that are participating be required to continue following the participants in the trial after their initial results or after their approval, since it's a speeded-up process? Those are my two questions.

Brian: Thank you. Doctor.

Uzma: Those are great questions. I'm going to see if I can answer both of them. The main thing that I want to get across-- Thank you so much for that wonderful question, is that there's been a lot of scrutiny, obviously, because there's so much politicization of science, unfortunately. What I want you to know though, is that these vaccine companies, actually nine of them, had signed a pledge to really uphold high ethical standards and not seek premature government approval for the COVID-19 vaccine.

This way, they wanted to really garner that trust in the public, to know that everything that they're doing is by the book and that they're not going to prematurely try to push through a candidate that may not meet all the requirements. That being said, they also ended up going a step further and releasing basically the blueprints of their vaccines, which usually most companies will not do because these are, as you can see, referred to as secret ingredients, but they wanted to be transparent with the entire process.

Science is always a certain way where you have certain criteria that has to be met for whether it's a therapeutic or whether it's a vaccine, has to meet certain criteria to really make it through approval and before that happens, all of that data has to be available.

Again, right now, all we have is a press release, but that doesn't mean the FDA is not giving this E-way right now, emergency use authorization based on that, that data has to all be available for the general public to really see and to know and have complete transparency.

I think a lot of these vaccine companies, the nine ones, especially that have signed this pledge, are really working hard to make sure that there is transparency because again, the goal of this is to find a vaccine that is safe and effective, but also have trust from the public so that these vaccines are accepted and that people are getting vaccinated because there's no point of having a vaccine that's effective if nobody's willing to take it.

Brian: [crosstalk] Oh, and what was the second question? Janine, go ahead. Do you want to reframe your second question?

Janine: Me to reframe it?

Brian: Yes.

Brian: Okay. Basically, this is a novel or a new virus that we don't actually know the lifecycle of, how long a person retains immunity if they catch it et cetera, et cetera, even how long they retain immunity if they get a vaccine that does work.

One of the important things and my understanding is that's why it takes so long traditionally to have vaccines approved is because you're looking for what's the one-year, three-year, five-year effects of whatever virus you're studying and what is this effect of vaccine? That's nothing that you can shortcut. Is there some requirements specifically for the CoV-2 vaccines that the companies continue to follow their participants beyond the initial studies that got them the final stage three approval?

Brian: Janine, obviously, paying attention. Dr. Syed.

Uzma: Absolutely. Usually, we talk about studies up until phase three, but there's also phase four, which is what happens after any candidate has been authorized or approved for administration. We have systems in place. We have the vaccine adverse event reporting system, we have the vaccine safety data book. There's also a new app that's been developed for texting, for monitoring of active surveillance of people that have received the vaccine. I believe it's called Be Safe, and that's looking at surveillance after vaccination one week out, two weeks out, and then it's done for about six weeks and then further down the line.

All of these patients that are receiving vaccines absolutely have to be followed and a lot of that is going to require a combined effort from the public. First of all, people that are eventually going to receive the COVID-19 vaccine, they need a booster so we need to make sure that people are compliant with going to get that second vaccine, and then they need to be compliant with reporting any symptoms or any side effects to their physicians who then are then responsible to reporting it to the national agencies.

There's a system in place and it's been that way for all vaccinations and it certainly will continue to be that way for the novel vaccines, but we are going to have to study this and monitor for a while because it's a new virus and it's a new vaccine that's being developed and we have to follow patients farther out to know what's happening and to know specifically about how long even the immunity lasts.

Brian: This is WNYC FM HDN (AM) New York, WNJT-FM 88.1, Trenton, WNJP 88.5, Sussex, WNJY 89.3, Net Kong and WNJO 90.3, Toms River. We are in New York and New Jersey public radio. A few more minutes left with Dr. Uzma Syed, infectious disease specialist and chair of the COVID Task Force at Good Samaritan Hospital on Long Island.

It looks like we have a participant in one of these trials calling in, not the Pfizer trial, but the one by Moderna. Let's see what Burl on the Upper Westside has to say. Burl, you're on WNYC.

Burl: Hi. Yes, I've been very impressed with the whole process. I'm afraid I got the placebo since I had no reaction to the two shots, but they are rigorous and I had the shots early September, early October and then the end of October, I went in, and each time they've taken my blood and a series of questions and there's an app on my phone that I have to respond to, and going forward, I think I'm not going to have any in-office visits for the next many several months. I don't know, but there's an app on my phone that I'm going to have to respond to. I don't know if it's going to be every week. There's a whole series of questions that I have to answer.

I think I'm impressed with how careful they are being. Other than I'm sort of sorry, I didn't actually get the vaccine I'm afraid unless sometimes there's no reaction, but yes, any questions that you have?

Brian: Dr. Syed any questions from you for her?

Uzma: Yes, that's wonderful. I'm so happy to hear that. Thank you first and foremost for participating because none of this would be possible without volunteers, without people really stepping up for a good cause because the only way that we're going to know if these work is by having people enroll in these trials. So I want to thank you so much for participating, taking the first step.

I'm really happy to hear that it's been a smooth process for you and I hope that that gives people more comfort to know that and that people need to know, even though this data was released, that doesn't mean that it's over. We still need to study [crosstalk] as many, many, many more people, so I really encourage people of all walks of life to really think about participating in these trials because that's the only way we're going to know in the age groups, in the children, and pregnant women, we need more data to know exactly where we're heading and the rate that the country is going out with COVID-19 and unfortunately mortality, the sooner the more data that we have, the better it is for all of us.

Brian: Do they ever tell people like Burl whether they got the vaccine or got the placebo?

Uzma: No. While you're in the clinical trial, no, that information, it's kept blinded for that reason for--

Brian: Later, is there a point past which?

Uzma: Eventually when the trials are over, it depends on the actual clinical trial, but most participants have said that they are inclined just as our wonderful listener here has been saying that they believe that they didn't get the actual vaccine because they didn't have any adverse events such as soreness or aches, the general usual symptoms that you have from vaccinations. Again, these are all novel vaccine, so we're going to have to wait to see the actual data that's reported on them and their side effect profile to know.

Brian: Oh, should we do one more of these? Because now we're getting a call from somebody who's in the Pfizer vaccine trial and of course that's the one that's in the news. Arlene in Fairhaven, you're on WNYC. Arlene, thanks so much for calling in.

Arlene: Hi, Brian, thank you. Yes, very much like the lady who was just talking about the Moderna of studies, very similar. I've had two shots. I also think I got the placebo because I didn't have any effect, but maybe there are just is no effect for some people, but it's very rigorous. You go in, they give you a whole medical rundown before you get your first shot or they give you a COVID test at the time, they take blood.

The same thing happens three weeks later. In the interim, there's an app where you report every week, if you're having any symptoms, you have an at-home COVID test that they give you in case you think you have it where you overnight it to them immediately. There's someone you call, a doctor in their study if you are admitted to a hospital for COVID or if your doctor says you have COVID. They're on top of it.

What I'm looking forward to is apparently once there's an FDA approval, they will let you know if you are in the placebo group, because of course at that point you would want to know, so you could get the actual vaccine, but it seems extremely professional.

Brian: Arlene, thank you so much for that report from your side.

Uzma: I'm so happy you brought that up, actually, Arlene, because that's something that I want people to know as well, that may be enrolled in these clinical trials, because there is this fear we don't really know which one of these vaccine candidates will eventually get the FDA approval. Hopefully, it will be more than one so that we have enough supply to vaccinate the population of the US, but I think it's important for people to know those people that may have received placebo.

Ethically, you are always given the option of continuing with the trial, if you want, or opting out. Obviously, any treatment that's rendered effective and safe, and that could prevent any illness has to be offered to every person. I think that's a really good point to bring up that people- I don't want people to shy away from participating in the trials by thinking that they may not actually get the vaccine. When the vaccine is FDA approved, it will be made available to everyone.

Brian: Last thing, and thanks for staying over our originally scheduled time because this has been so interesting for people, I think. It's an equity question. Remember back in February and March, when it seemed like the only people with access to COVID testing were the rich and famous? How will public health officials ensure that the same thing doesn't happen with vaccines?

Uzma: That's a great question. Honestly, that is something that really needs to be focused on because we already know that there's many challenges with these vaccines, whether it be this one specifically. We know that there's, I think, three of the four candidates right now that are in phase three in the US, have these requirements of deep freezing. That becomes very challenging, it's not very easy. Your usual CVS pharmacy, for example, may not have the capabilities of storing these vaccines and having it readily available.

There really has to be a joint effort from the federal government, private entities, from HHS, Department of Defense, CDC, state health departments, local partners, community partners, it has to be a very elaborate, collaborative effort to ensure that the people who are most vulnerable, most susceptible are in fact able to get the vaccine.

Again, the ACIP and the National Academies of Science Engineering Medicine has developed a framework for equitable allocation of the COVID-19 vaccines. There's a stratification based on risk of acquiring infection, morbidity, and mortality, negative social impact, and how easily you are able to transmit the disease. Then they've categorized this and stratified it into people that would receive the vaccine in which order.

It's going to be a very complicated effort, but it needs to be that way to ensure that there is in fact equity in this and that people do have access, the people that need the vaccine are having access, are able to get the vaccinations, and at no cost. I know that there's a lot of talk about that as well.

Brian: Dr. Uzma Syed, infectious disease specialist, and chair of the COVID Task Force at Good Samaritan hospital on Long Island. Thanks for so much great information, we really appreciate it.

Uzma: Thank you so much for having me.

 

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