What to think about a coming COVID-19 vaccine, with William Schaffner, MD
It has been 6 months since much of the U.S. shut down to stop the spread of COVID-19, and people want to know how the country can move closer to life as it was. As the new school year begins, and another flu season approaches, vaccines have become an important part of the conversation.
Living Beyond Breast Cancer vice president of mission delivery Janine Guglielmino, MA, spoke with William Schaffner, MD, a professor of preventative medicine, about vaccines. They discuss the development of a COVID-19 vaccine, where you should turn for trusted information when one has been approved, and probable limits of a COVID-19 vaccine, especially for people who have compromised immune systems. They also talk about the importance of getting a flu shot this year and making sure adults and children are up to date on their vaccines even while many of us are still working and learning from home.
Watch, listen, or read the transcript below.
William Schaffner, MD
Dr. Schaffner is a professor of preventive medicine in the Department of Health Policy and a professor of medicine in the Division of Infectious Diseases at the Vanderbilt University School of Medicine. He is a member of the COVID-19 Vaccines Work Group of the CDC’s Advisory Committee on Immunization Practices and the COVID-19 Advisory Panel of the National Collegiate Athletic Association and has consulted with Nashville’s Board of Health on COVID policy. Read more.
Janine E. Guglielmino, MA
Vice President, Mission Delivery
Janine oversees the implementation of our programs, publications and research initiatives. In this role, she contributes to the content and design of all core LBBC activities. She leads needs assessments and evaluative activities that ensure the high quality of existing and future programming. Read more.
Janine Guglielmino (00:02):
Hi everyone. My name is Janine Guglielmino and I'm the vice president of mission delivery for Living Beyond Breast Cancer. I want to thank you for being with us today and throughout the pandemic.
Living Beyond Breast Cancer has been bringing you vital information about how to support your physical and emotional health. Today we're going to discuss an important issue, the issue of vaccination and the impact of that in the lives of people with breast cancer. We've been hearing a lot in the news about the rapid development of potential vaccines against SARS-CoV-2, which is the virus that causes the COVID-19 virus that is prompting our pandemic today.
These vaccines are being developed very quickly so they can be available to us as soon as possible. But we know that our community has a lot of questions about the safety of these vaccines, the appropriateness of them for people with a compromised immune system. And how do we know that they're safe when they're being developed so quickly?
We're here today to help answer some of those questions. And we're very fortunate to have with us, Dr. William Schaffner, who is the medical director of the National Foundation for Infectious Diseases. Also, Dr. Schaffner is a professor of preventative medicine and health policy at the Vanderbilt University School of Medicine in Nashville, Tennessee. And to learn more about him, just go to LBBC.ORG and read his full bio. I want to welcome you, Dr. Schaffner, thank you for being with us today,
William Schaffner (01:30):
Janine, it's good to be with you and I look forward to your questions and trying to help answer some of them.
Janine Guglielmino (01:38):
Great. Great. Thank you so much.
We know that there are several large trials going on right now to find a vaccine against the coronavirus. Can you tell us a little bit about how these trials are being conducted and how we can be sure that they're safe?
William Schaffner (01:56):
Sure. So the trials that you referenced Janine are really the end stage of a long scientific process. You start creating a vaccine first in the laboratory, and then you test it in some animals. And then in small groups of people, all volunteers, completely informed. They get the inoculations and we test their blood to see whether the appropriate responses, the protective responses we call them, antibodies are being developed. And we also look for any safety issues, but that happens in relatively small groups of people. We then go to what you've just referenced. The large clinical trials.
30,000 people will be recruited. All volunteers — think about that. Half of them will get the vaccine. The other half will get a placebo, which is an inert substance, all under code. The investigators don't know what they're giving and the recipients don't know what they're receiving all will be revealed at the end of the trial when the code is broken. The trials study two very important aspects. One: effectiveness. Stated simply, does this vaccine work. And the way you do that is very simple. You compare the placebo recipients, the folks who got nothing, with the people who got the vaccine. And of course you would expect that the placebo recipients got a fair enough amount of COVID-19 and the vaccine recipients got very little, and you can see exactly how effective the vaccine was. That's one side of the coin.
The other side of the coin is just as important. And that has to do with safety. Were there any adverse events that occurred? Of course we all know about local adverse events. Oh! It hurts when it goes in. In those phase I and II trials, these vaccines were thought to be “ouchie” vaccines. So everybody is informed about that. Redness, swelling, headache, feeling kind of punky.
Did you get a degree of fever for a day or so after receiving the vaccine? That's all part of normal receiving a vaccine. Some people get those symptoms after getting their flu shot. But the other thing we look for are what we call serious adverse events in a population of 15,000 — half of the 30,000, got the vaccine. Did anything really untoward occur that might be related to the vaccine?
When you give any vaccine to a group of older individuals and then you follow them for a period of time you can expect that some medical events will occur. Of course, some person will get a heart attack for example, but the question is, could that have been related to the vaccine. And then once again, you compare the vaccine recipients with the placebo recipients. So those are the goals of these big trials and we'll see how they work out.
Janine Guglielmino (05:32):
Thanks for that, Dr. Schaffner. So really the structure of these vaccine trials is the same as the kinds of clinical trials that we do in cancer, where there's a phase I, phase II and a phase III. These large trials that are going on right now are the third phase trials where we're looking for effectiveness.
And I would want to point out to our community that there's half of the group getting the COVID-19 vaccine and half getting the placebo and the placebo is the standard because we don't have a vaccine against COVID. It's a little bit different than you'd see in a cancer clinical trial where you're getting a standard activating therapy.
William Schaffner (06:13):
Right. Perfect, Janine. Right.
Janine Guglielmino (06:17):
Thank you, I appreciate that.
These trials, some of them are quite large, fifteen, twenty, thirty thousand people. What is the population of people involved in these trials? Do we know whether there are people with cancer involved in the trials? Are they all healthy individuals who participates in these clinical trials?
William Schaffner (06:37):
These are the first set of clinical trials. We want to know does the vaccine work and is it safe. We can't answer too many questions at the same time. These are trials that are occurring in adults — no pregnant women, no children first time around. And these are people who can range from healthy to having an array of chronic underlying illnesses. It depends a little bit on the trial. People who are actively in chemotherapy or who have recently received it, or who are profoundly immunosuppressed are not in the trials. One trial was just extended to include some people with HIV infection, for example. On the front end, we won't have many people, if any, who are immunocompromised in these trials.
Janine Guglielmino (07:36):
One of the things that that I've heard about in the news media is that when the vaccine, when one of these or several of these vaccines are approved, that they won't be given to the full community immediately, that there'll be some level of prioritization and that it's possible that people who are immune compromised would be the first up to receive the vaccine. Can you talk a little bit about how people can feel safe receiving that vaccine based on who's participated in the clinical trials?
William Schaffner (08:13):
Sure. So you're exactly right. There will be a prioritization scheme because we don't have enough vaccine on day zero to vaccinate everybody. In fact, that prioritization scheme is going to be finalized probably within the next couple of weeks. We anticipate that healthcare workers will probably be first in line; that has generally been the consensus of a number of groups who've looked at this, including focus groups of the general population. They put the healthcare workers who are caring for patients with COVID right in the front of the line.
After that, it gets a little murky. Should we have people who are at increased risk of serious disease, or should there be essential workers who keep the entire society functional? It'll be sorted out. As I like to say, there's no right answer. There's no wrong answer. We just need to get an answer and to communicate it.
Clearly, this is all being done in an ethical fashion and we want to make sure that we're reaching people who are disproportionately affected by this illness who are in minority populations. Now we need to listen very carefully. Once the vaccines are released, who's eligible?
When we expect these vaccines, because they're inactivated vaccines, right? There's no live virus here related to COVID at all. We expect that these vaccines will be recommended for people who are immunocompromised. So we think that that's not going to be a safety issue. The question will be how well do they work in someone who's immunocompromised? You know, a little bit of protection is better than none. Nobody expects these vaccines, even in young healthy people, to be a hundred percent effective. That's something we need to think about. We don't expect them to be a hundred percent effective. We hope they're better than the flu vaccine, but they won't be as effective as measles or tetanus vaccines, for example. So somewhere in there and as is usually the case, if one is immunocompromised, we don't respond as well to the vaccine, but nothing ventured, nothing gained since we expect it to be safe.
My anticipation, my crystal ball says they will be recommended for immunocompromised people, but we just can't tell you how much protection you will get. Don't throw that mask away! Keep wearing the mask, social distancing, all that good stuff will continue even after the vaccine has arrived.
Janine Guglielmino (11:10):
Definitely an important point. And Dr. Schaffner, I want to go back to something that you mentioned that I think is really important and that's causing quite a bit of confusion in our community, which is the difference between an inactivated vaccine and one that's made from a chemical. Can you talk a little bit about the difference between a vaccine made from a live virus and a chemically designed vaccine and what the COVID vaccines, what types are being looked at there?
William Schaffner (11:41):
So let's go back to the more traditional live-virus vaccines. You can take a virus and tame it, and that gets into the body with altered it in the laboratory. So it can't make us sick, but it can fool the body and the body makes protection. That's what we do with the measles, the German measles, rubella, the mumps vaccine, for example,
Janine Guglielmino (12:06):
Essentially it kind of tricks the body into having an immune response and thinking that thinking it's sick and attack it if it recognizes it, right?
William Schaffner (12:14):
Exactly. Now, another way: We can take the whole virus and kill him. And although it's dead, we can inject it. It can't reconstitute itself and make itself alive. And once again, just as you said, Janine, it fools the body and the body makes protection against it. That's not being done with most of the vaccines that are being studied around the world. What's happened is that you take pieces of the vaccine or you take some genetic material from the vaccine, a piece of it and inject that into the body. And then the body — actually, this gets complicated — makes that critical part of the virus and our immune response responds to that.
For example, if you think of the virus, kind of like a sphere with little projections that come out on top of it, those projections originally reminded people of the projections on a crown and that's why this family of viruses was called coronaviruses. Now these projections are very important. Here's the virus, here's the projection. And here's my cell back in my throat, the virus enters. And this is a key that enters into the lock of the cell that lets the virus get into my cell and begin to multiply. This is called the spike protein. And that's the little piece of the virus that we're trying to create antibodies to protect. So it can't get into the cell.
So it's just a little piece of the virus. We don't have to worry that we're going to be injected with the vaccine and get COVID no way.
Janine Guglielmino (14:08):
Okay. That's really helpful. And in general, with people with cancer or who have a compromised immune system, can they take it? Is there a difference in the type of vaccines that they can receive as one safer for them than another?
William Schaffner (14:26):
We'll all have to listen to that very carefully because a number of vaccines are in development at different stages, and it may well be that some are more appropriate, work better, in some populations than others. They may be safer in some populations than others. That's why we do the trials. So we'll all have to be alert to that. Follow the announcements from public health authorities, screen out the politicians, listen to the public health authorities, and including those in your state and in your city — the commissioner of health, the local health department director — they will provide information about who should go where and when to get which vaccines.
Janine Guglielmino (15:23):
Great, thank you, Dr. Schaffner, and one additional follow-up question: Once the vaccines are approved, and then they're given to a general population of people where you can look at people with compromised immune systems and so forth, what's the follow-up process? Is there a phase IV clinical trial that's following people along so that we can get reports? For example, if people with cancer have a different type of reaction to the vaccine how does the industry follow that and make sure the vaccines are safe for a general population of people?
William Schaffner (16:01):
The answer is yes to both of those. And it's not just the industry. As a matter of fact, that becomes a general public health responsibility led by the CDC and state and local health department. We already have in place surveillance systems for our traditional vaccines that monitor their safety and effectiveness constantly. Those systems have all been ginned up. We’re all ready — those of us who are involved in running those systems — in monitoring both the ongoing effectiveness of COVID vaccine, once it starts to be used, and whether any safety issues have cropped up after we start giving it to hundreds of thousands and indeed millions of people. So that's an ongoing phenomenon. That's very, very rigorous and very important. You can be reassured about that.
Janine Guglielmino (16:59):
Great, thanks for responding to that.
We're close to the end of our time together, but I would be remiss if I didn't ask about other vaccines because here in the Northeast, the weather is starting to change, we're getting into the fall and of course flu season is coming. and I wondered if you could speak about the safety and utility of the flu vaccine for people with breast cancer, should they be getting their flu vaccines? Should they go out into the community and get that vaccine this year?
William Schaffner (17:34):
Janine you're close to my heart. I was hoping to do that.
We are anticipating influenza. It will be among us, and of course, will be confused with COVID. They're both respiratory viruses, they're spreading similar ways. Their clinical presentation will confuse me and all the other doctors in the country. As much as we can do to limit the impact of influenza, that will benefit not only ourselves as individuals who get it, but it will take a lot of strain off the healthcare system and also make it less likely that we will spread this virus to others. As I like to say, nobody likes to be a dreaded spreader.
The recommendations about flu vaccine are couldn't be simpler. If you're older than 6 months of age, you should get flu vaccine. Did you hear anything about immunocompromise people with cancers or anything like that? No. No qualifications. This is a safe vaccine. It is not completely effective, but it prevents many illnesses. And even if you get flu, having had the vaccine before, your illness is much less severe. You're less likely to need hospitalization. You're less likely to die. What's wrong with that? We're urging everyone to be vaccinated against influenza this year. It's more important than any other year.
Janine Guglielmino (19:11):
Thank you for that input. It's really important because obviously no one wants to get COVID, but you also don't want to get influenza. If you're going through cancer treatments it can be a very serious illness.
I understand that the National Foundation for Infectious Diseases is doing a campaign right now called Keep up the Rates and I wanted to give you an opportunity to tell our community a little bit about it and where they can find more information.
William Schaffner (19:39):
Surely, thank you very much.
The rates we're talking about are our immunization rates during our lockdown, whether among children or among adults. We began to do telemedicine and our immunization rates have gone down alarmingly, disturbingly. It's very hard for me to immunize my patient through the computer. I haven't figured out how to do that. You have to show up, roll up your sleeves and get your inoculation.
So we're urging everyone, all of the practitioners and all of the patients to raise the rates, get those immunization rates up again. You can be immunized quickly and safely. It's safe to go to that healthcare provider, pharmacist, doctor clinic, wherever you go, make sure you get not only your flu vaccine, but all the other vaccines for which you are indicated. You can find out more information at nfid.org.
Janine Guglielmino (20:43):
All right, well, thank you very much for that, Dr. Schaffner, and thank you for your time today.
And I also want to thank all of you for joining us and encourage you, if you would like to continue the conversation or get more information to visit one of our closed Facebook groups — Breast cancer, support: All ages, all stages and Breast cancer support for young women. And I want to thank you. Stay safe and stay healthy, and we hope to see you soon.