KAREN GILLILAND: Welcome. On behalf of the Mayo Clinic School of Continuous Professional Development, I'd like to welcome you to the Mayo Clinic COVID-19 Webinar Series. My name is Karen Gilliland. And I will be your host for today's webinar on supply chain considerations for delivering the COVID-19 vaccine.

This webinar is accredited by the AMA for one credit. There are no relevant disclosures for today's discussion. And we'd like to thank Pfizer for their support of this educational activity.

Before we get started, we'll cover a few points. The first is how to claim credit. If you'd like to claim credit after the webinar, please visit ce.mayo.edu/covid0120. You'll need to log into the site. If it's your first time visiting, you may need to create an account.

After you've done this and logged in, you'll see an access code box. You'll want to type in today's code, which is COVID0120. This will allow you to access the course, complete a short evaluation, and then you'll have the ability to download or save your certificate. This link and code will be dropped into the chat box throughout today's webinar.

The second item is how we'll facilitate questions. You'll see at the bottom of your screen the chat and Q&A function. If you have any questions during this webinar for today's presenters, it's important that you drop them into the Q&A channel rather than the chat box. This will help ensure the panel can see your questions.

There is also a helpful upvote button. So be sure to upvote the questions you would like to see answered. The panel may pause for discussion during certain segments of the webinar. So be sure to submit your questions that are relevant to that topic. If you are experiencing any technical issues during this webinar, please use the chat feature to share so our support team can assist.

Today's learning objectives include discuss reasons for COVID-19 vaccine hesitancy, explore ways the vaccine is allocated and distributed, identify adverse effects from COVID-19 vaccine, and list supply chain considerations. Today, we'd like to introduce our panel moderator, Eric Tichy, Vice Chair, Pharmacy Formulary Mayo Clinic Health System, Assistant Professor of Pharmacy. With that, I'd like to turn things over to Dr. Tichy.

ERIC TICHY: Thank you for the introduction, Karen. We have a diverse group of panelists today that are excited to bring some important information and answer questions to our audience that we know is of international base and domestic as well.

Next slide, please. Our first panelist is Dr. Abinash Virk. Dr. Virk is a consultant in infectious diseases for Mayo Clinic and also an associate professor of medicine. The next panelist is Dr. Michelle Holm, Manager of Pharmaceutical Contract Portfolios, and a member of supply chain management at Mayo Clinic. Dr. Holm is also an assistant professor of pharmacy for Mayo Clinic.

And our final panelist is Dr. Melanie Swift. Dr. Swift is an associate consultant in preventative medicine and assistant professor of medicine for the Mayo Clinic. So our team today will discuss COVID-19 vaccine supply chain considerations. And Dr. Virk will get us started with our content.

ABINASH VIRK: Good morning, I am very excited to be here to share with you a few things about COVID-19 vaccine starting with vaccine hesitancy. In general when we look at vaccine hesitancy, what we find is that majority of the people who are offered vaccines-- and I'm talking in general vaccines whether it's your tetanus booster, or your hepatitis B vaccine, or many others that we commonly use-- most people understand that these have been studied very rigorously. And most people accept them and understand that they're important for the health of the population and health of the individual.

But when we look at hesitancy, well, we find that there are two additional things that we need to think about. One group of people who really want more information, they're hesitant to get it because they need to understand the value of the vaccine. And then there's a second group that we call the anti-vaccine people. They are are people who don't believe in vaccination despite having information about the vaccine, despite being advised about the risks and benefits of these vaccines.

I just want to focus on the group that we call the vaccine hesitant. What we mean by the vaccine hesitant is that it's really a group of people who need more information about the vaccine at the time. And many within this group of vaccine hesitant ultimately do decide to get the vaccine once they have the information that they're really looking for.

And when we talk about specifics of vaccines, what are the things that people look for to help them make decisions whether that vaccine is good for them, or their child, or their family member, or their community? The first and the most important is that they get information from a trusted source. In the United States, we have a committee called Advisory Committee of Immunization Practices. This is an independent committee that is formed of many different scientists. There's representation from American Academy of Pediatrics, OB-GYN, internal medicine, family medicine, and also has representation from the community, so community members can participants in this committee.

The members of this committee use a very rigorous evidence-based evaluation to recommend a vaccine to a particular group of patients. This committee is not biased by the FDA or other people who might have a vested interest in that particular vaccine. So that's really important to understand that there are many bodies, like ACIP, that give recommendations to the country, to the population about vaccines. Their recommendations are really based on rigorous studies that are done looking at the safety and effectiveness of the vaccine. So specifically talking about COVID-19 vaccine, but also talking about many other vaccines.

These studies are done in what we consider randomized double-blinded controlled trials. What does that mean? That means that these vaccines are studied in many volunteers who are-- half of them are given the vaccine of choice that we are trying to study. And the other half are given a placebo, which may be a saline injection or it could be another completely unrelated but previously approved vaccine. And what we want to see in those people is that, did that vaccine actually make a difference in the disease that we're trying to prevent?

And also, we study how many people in both of the arms have any adverse effects. And, is there a higher signal in the vaccine arm or not? These studies are done in very large numbers. And they're blinded to both the researcher as well as the volunteers, so you don't really know whether you got the vaccine or you got the saline, nor does the researcher know so that there is no bias in the results once they're finally reviewed.

There is also a really important component of these randomized controlled trials. And that is that all of these studies have a data safety monitoring board. And this is completely independent from the researchers and the patients. This is a separate board of scientists who get information about the study who do have some knowledge about who was in the vaccine arm and who was in the placebo arm. And if they noticed that there is a problem, meaning that there is more number of bad outcomes of problems going on in the study arm, they can halt the study immediately and not let it go forward. And that continues on a regular basis until the study is completed.

Finally, then we have to ask ourselves, is the vaccine really needed? Do we really need a vaccine? And, do we have alternatives before a situation?

So if we talk about COVID-19, currently there really is no way we are able to stop the pandemic. If we were to be able to stop the pandemic, we would not be talking about a vaccine today. If the pandemic was disappearing, we would not be talking about a vaccine today. But looking at the fact that in the United States, we've had more than 400,000 people who have lost their lives, and we have millions of people worldwide as well who have had the infection, and also many who have lost their lives, we know that at this point a vaccine is going to be needed for us to turn this pandemic around.

And if we don't take the vaccine, what are our alternatives? Our alternatives really are to continue the masking, the social distancing, hand hygiene, which as we all can understand we're all getting tired of. And it is impacting everyone's life. So those are the components of what people are looking for when they are still trying to decide, should I or should I not take the vaccine?

Next slide. So when we look at specifics of COVID-19 vaccine, this has been reviewed by the Advisory Committee of Immunization Practices, as I mentioned. These studies for both the Pfizer and Moderna combined were done in over 70,000 people. This is a very, very large number of people that have been studied. It's not a small number. And the first vaccine of the Moderna went into arms on March 16th, 2020. And so at this point, we have nearly a year's worth of information on these people.

Both the Pfizer as well as the Moderna vaccine are over 94% effective. The Pfizer 95%. And the Moderna 94.1% effective in preventing COVID infection. And both have been shown to prevent severity of COVID infection very significantly.

They were both found to be extremely safe in the trials. They did have some what we call immune-mediated reactions. But these were mild and transient. But there weren't any serious significant side effects in both of these trials.

And thus far in the United States, we have vaccinated over 12 million people. This slide is from last week. We have vaccinated over 12 million people without having any significant serious side effects reported to our reporting system so far.

And then finally, we still have many people having severe complications from COVID-19 currently, meaning that, is there a need? Yes, there is still a need for us to have COVID vaccine available. Otherwise, we will be continuing the masking and social distancing.

There is one caveat. And, I think, this is a very important one that we want to acknowledge and that may be one of the reasons that some people are hesitant to take the vaccine. And the question that's often said or commented to us is that, do you have long-term adverse effect data? And, yes. We don't have that.

The studies, as I mentioned, started in March of 2020. So, yes. We only have about a year's data. But that's still in a large number of people that, I think, we can safely say, we will continue to be monitoring that. And we don't have that yet. But so far, it seems fairly safe.

Next slide. And so finally, the last thing I just wanted to mention was that we really have to develop what we call the community of immunity, meaning that more and more people around us have to be immune so that we can actually stop the transmission of COVID-19. And what the epidemiologists and various experts have evaluated, the current thinking is that at least 70% to 80% of the population has to have immunity against COVID-19 for us to finally get rid of SARS-CoV-2 in the population.

As you can see in this diagram on the right, when you have all these people who are vaccinated or have immunity from prior infection, then the virus doesn't have anywhere to go, except to the ones that don't have immunity. And they are at risk of getting the infection. So if everyone was blue, so to speak, then you wouldn't have a further transmission of COVID-19. I will turn it over now to Dr. Swift.

MELANIE SWIFT: Thank you. So we have vaccines that are safe and effective. And now the hard part, who gets them when the supplies are limited? And, in what order?

So in the United States, the Advisory Committee for Immunization Practices has proposed a phased plan. And like all plans, it's subject to all of the exigencies that can happen in reality. So this slide depicts the ideal plan that was laid out by the ACIP in December, 2020, based upon their forecast of how much vaccine was going to be available when.

At each phase-- 1a, 1b, and 1c-- there's a two-pronged approach to this. One is focusing on the people who are at the greatest risk for morbidity and mortality from COVID. So in Phase 1a, that's long-term care residents who in the United States comprised 40% of COVID deaths in 2020 despite only 6% of the cases. In Phase 1b, it's those oldest bracket of the population 65 and older because of their multifold increased risk of hospitalization and mortality. In Phase 1c, its people age 65 and up and younger people with comorbidities that put them at high risk.

But there's another prong of this plan, which is a strategic plan focused on occupations that are either at increased risk for acquiring COVID, or they are occupations that we need in order to respond to the COVID pandemic, or occupations that we just need in order to keep society functioning. And so in Phase 1a in the United States, that's health care personnel, which is about 21 million people. And this is at the end. We're at the end of that tail right now. We're still working on our health care personnel in the US.

Phase 1b are front-line essential workers. So the box to the right lists some of those industries that are considered essential for society to keep functioning during a pandemic. For people to be able to go to work and be health care workers, they need someone to watch their children, so you see childcare, teachers, et cetera, in there. We need food. We have some essential things. And these front-line workers actually are in close contact with their public or with each other.

And then that distinguishes them from other essential workers, which would be in Phase 1c. And these are the people that are actually out where they could be contracting and spreading COVID in the community. And because they're essential workers, they've got to be at work and they're not able to telework. So our long-term care residents and our cohort of people that are seniors over 75 aren't really the ones that are out spreading COVID in the community. But these front-line workers are a strategic way to-- if we vaccinate them, it's a strategic way to help stop transmission in the communities.

These are still relatively small numbers. When you consider the over 300 million people in the United States, you can see that these buckets are fairly small. And that's in line with what we anticipated in terms of vaccine supply. And as you see when we get down to 1c, the giant bucket there is the people who are under 65 but have high-risk health conditions. And that's because the high-risk conditions for COVID mortality are pretty numerous.

Next slide. So when we think about allocating a scarce resource to this phased approach of people, we have a number of challenges. So the first is who. And we identified that with a national plan, which in the United States, each state then takes that plan and may make adjustments to it.

But then within that, who first? So we have 21 million health care personnel in the United States. And we did not have 21 million doses on day one. So deciding within that who goes first is a challenge.

And then secondly is, how much vaccine do we have? That's an unknown. So we have to take all of these factors into account when we're allocating the vaccine that's been manufactured. So we talked about identifying people who are eligible by their occupation or by personal risk. But that's easier said than done when you're on the ground.

Personal risk if it's based on age is fairly easy to identify in a medical system because we have electronic health records, and we can identify people who are over a certain age, and we can notify them if they can take vaccine when we get to their stage. And medical systems also may have the ability to do reports and identify people that have high-risk health conditions when we get to that phase. But what health care facilities don't know are their patients occupations. This at least in the United States is not routinely incorporated into the medical record anywhere.

Alternatively are public health programs that are vaccinating people in communities. They're not tied to an electronic medical record. And they don't actually have a database of individuals by age or health condition. And they don't have a way to really verify health conditions.

But they can identify occupational groups by reaching out to businesses and government agencies in their communities. And they have the ability to then go on-site or collaborate with those employers to identify occupation. So different vaccine providers have different abilities to identify the eligible people.

So we recommend that wherever possible collaborations and partnerships at the local level be implemented so that you can have some synergy and complement one another. So if you're public health partners can focus on occupational groups that may be more efficient than having your health care system try to do that group. And vice versa for personal risk being more handled by and identified by the health systems.

Then even within that kind of a structure, you still have to subprioritize within these phases. So, for instance, you may have the directive to vaccinate people who are 75 and older or 65 and older, but you don't have enough vaccine to get even a fraction of that group. And what happens from an ethical standpoint when you open vaccine eligibility to a group that is much, much larger and you create a high degree of demand for the amount of vaccine that you have available is that you create inequity. People who are least advantaged, people who are least connected, people who are least able, and willing, and capable of advocating for themselves go to the back of the line.

And what we've seen in the COVID pandemic in the United States are vast health inequities that have been exacerbated over our baseline inequities and disparities in health care with underrepresented minorities suffering, really, the brunt of COVID disease, and morbidity, and mortality. If we don't subprioritize within these phases in some way based on risk, then we end up with a vaccination program for the elite. So I would challenge you to consider this as you start allocating vaccine and determining who goes first within those eligible populations.

And then finally-- and this will lead into Dr. Holm's part of the presentation-- is that we have a lot of uncertainties in this vaccine rollout. And we have to build systems that will allow us to have capacity in the face of this uncertain supply. We don't really know down the road how much vaccine we can expect to be shipped to us at this point in the pandemic more than a week ahead of time.

And so that means constantly being able to shift our capacity-- scale up a clinic if we have a lot of doses coming in. And staff it so that we can schedule people and administer vaccine. And then scale it back down. And then also being sure that you have a reliable supply to get vaccine number 2.

So far in the United States, we have been assured-- and this is born out in our experience here at Mayo so far-- that the second dose of these two-dose series will be shipped to us by the manufacturer for the frozen vaccines when it is time for those second doses to be given. And our state health department has ordered them. And we have reliably received dose 2, earmarked as such. So we have not had to set aside a second dose.

In the future as we get more vaccines available that don't require that frozen storage, like the AstraZeneca vaccine that is now authorized in the UK, like the Johnson & Johnson vaccine that we anticipate will be authorized before very long now, those vaccines are going to be shipped from distributors centrally in the United States and not directly from the manufacturer. So it is important to ensure with your distributor that you will be able to have second doses shipped to you because we don't want to have vaccines sitting around for three to four weeks in refrigerators and freezers at facilities. In order to give the second dose, we want to be able to have enough of a supply certainty that we can go ahead and give all those doses out as first doses and know that the second doses will be coming. But, as you've read internationally, that's certainly a challenge and something we have to continue to be alert for.

And then finally, this uncertainty has to do with how many doses you can extract from a multidose vial. With Pfizer vaccine, it's marketed as having five doses per vial. And with Moderna, it's 10.

And what we found is that we can often extract six doses per vial from the Pfizer vaccine. In fact, about 98% of the time, we can get the sixth dose out. And so that increases your supply by 20% if you're able to do that. And that means being able to scale up your capacity for that additional 20% but not being tied into it so that if you're not able to do that, then you're not turning people away who have scheduled appointments.

And so that's a real challenge. And it calls for building a lot of flexibility into your system. And Dr. Holm will talk more, I'm sure, about the factors that go into this variability of how many doses per vial we can extract as well as the fact that at the end of the day, you're going to have a partially opened vial or more at your vaccination clinic. And you really need a plan in order to be sure you can administer all the vaccine. So with that, let me transition over to Dr. Holm to talk more about pharmacy management and side effects.

MICHELLE HOLM: Thank you, Dr. Swift. Well, as we prepare for the much-anticipated vaccine, we continue to see headline news about the vaccine's high efficacy. And what many people want to know more about is the safety.

So the good news, as Dr. Virk mentioned, is the COVID-19 vaccine has many benefits and very rare adverse effects. As she mentioned, we've seen minimal adverse effects. And that includes 10 million people who have received the actual vaccine and not the placebo to answer one of the questions in the chat.

Therefore, if you have an allergic reaction to the vaccine itself or any component of the vaccine, that is really the only contraindication to receiving the vaccine. So far, we've only really seen allergic reactions primarily in people who have had allergic reactions in the past to medications. So that's been the majority of the people we've seen with the minimal adverse effects that have occurred.

Now secondly, side effects are different than adverse effects. Side effects are common. In fact, they are part of the normal immune response of your body to the vaccine. They can include a headache, injection site pain, muscle pain, fever. And these are all very common a day or two after the vaccine.

Now, a headache or injection site pain may seem inconvenient to experience a day after the vaccine. But compared to the COVID-19 issues, such as pneumonia, blood clots, heart issues, acute kidney injury, this is very, very mild in comparison. Therefore, I strongly encourage you to sign up for the vaccine as soon as you are eligible.

Now, as soon as we reach 70% or herd immunity, we will be able to safely open the economy back up. And none of us will regret not being able to go to a social gathering again. I think we'll all be jumping at the chance for social gatherings rather than complaining that our social calendar is too full after this past year.

And with that, we'll go to the next slide. Thus far two COVID vaccines have been emergency use authorization approved, or an EUA. Now we expect additional vaccines for EUA in the coming months. And we also expect the current vaccines to be FDA approved very soon.

The current vaccines available in the United States include the Pfizer vaccine and the Moderna vaccine. The Pfizer vaccine is given in two doses 21 days apart. And the Moderna vaccine is given two doses 28 days apart.

Now, if you're over the age of 65, be sure to be looking for a notification, as you should be eligible within the next month to receive your vaccine. If you're immunocompromised or have comorbidities, as Dr. Swift mentioned, talk to your local health care system as to when you should be receiving the vaccine. And finally, make sure you're looking at your calendar because once you receive that notification that you're eligible, you want to be sure you're in town 21 to 28 days following that first vaccine administration.

Next slide. So now let's take a look behind the curtain. So for a sneak peek at how our vaccine clinics are able to run so smoothly, I'd like to give you a behind-the-scenes tour on supply chain from their perspective. And to administer these vaccines, ancillary supplies are crucial. And that's not something you may think about when you go in to get a vaccine.

So for us at Mayo Clinic, it was important to procure needed supplies right from the beginning. Many people don't know that needles and syringes have been on short supply since before COVID hit. Therefore, we had to procure essential supplies. And that meant going out to additional manufacturers and distributors that we weren't used to working with to be sure we wouldn't have shortages.

Mayo Clinic's supply chain team is one of the best in the nation. Therefore, our leadership had a pulse on the upcoming shortages before most of us knew that toilet paper would become a hot commodity. That being said, we had to learn quickly that the price and that the supply of items, such as the extra needles and syringes that Dr. Swift mentioned, needed for that sixth dose of the Pfizer vaccine and sometimes able to get the 11th dose of the Moderna vaccine were required.

We also had to reach out for more gloves. Now, gloves aren't required when giving an intramuscular injection. So on top of getting needed supplies, the task force was really put to work on educating staff that the gloves aren't required when giving an intramuscular vaccine and that they're on short supply.

Like the rest of the country, we've learned how to preserve personal protective equipment and how to make an N95 mask last longer. So the next time you see a picture of someone giving you an injection and there's a needle in the picture, a syringe in the picture, and a pair of gloves in the picture, you know the high price tag behind that picture. And that you know that your supply chain is working diligently to be sure that we have the supplies needed that we take for granted each day. Thank you.

ERIC TICHY: Well, thank you, Dr. Virk, Dr. Swift, and Dr. Holm for that really insightful overview of what we are seeing with the vaccine and what we can expect. I already see some questions trickling in. I encourage attendees to hit the Thumbs Up button if they like a particular question.

I also want to set some ground rules. So we would like to make sure that we focus on vaccines that currently have EUA in the US and the UK. And mainly, that's because we want to be able to provide evidence-based responses to any of the questions. Frankly, there's just not enough data available publicly regarding some of the other vaccines. So that's how we're going to focus.

And then we do really want to focus on the vaccine itself-- adverse effects, hesitancy, supply chain challenges, distribution issues. And we're not going to focus on overall COVID questions, as good as those questions might be. That's how we're going to keep things focused.

So I'm going to-- as I see these questions coming in, I do want to ask Dr. Virk a question. She did a nice job of overlaying the risks of the vaccine and some of the safety considerations. Given the information that we have available, as an infectious disease expert, for the population that is eligible to get the vaccine, medically, what would you say is the percentage of people that could get the vaccine? Discounting people that have religious objections or other things, medically, what would be the population that you think could and should get the vaccine?

ABINASH VIRK: Dr. Tichy, I think, that's an excellent question. And the response is that it's really the majority of the population, except for the people who may have had an allergy to what we call polyethylene glycol or polysorbate. These are components within the vaccine.

The vaccine doesn't have any other preservative or any other component, really, other than the mRNA in the Pfizer and the Moderna vaccines. So if people have allergies to PEG and polysorbate or had an allergic reaction to a previous dose of one of these vaccines, then that really leaves us with the rest of the world that could get the vaccine. It would be they are approved to get the vaccine.

In the United States, the emergency use authorization was given to allow anyone 16 years and older to get the vaccine. And there was no group that was considered not eligible for the vaccine other than the allergy issue.

ERIC TICHY: So, really, it's mainly the allergy issue that you would exclude. So we're talking 99% plus people that are in that age cohort should and could get the vaccine.

ABINASH VIRK: Yes, yes. And that does include the pregnant women. And I saw that there were a number of questions about pregnancy.

ERIC TICHY: Yeah. Can you elaborate on that because I do see a number of questions about pregnancy? And that's a legitimate concern. So, how would you advise someone who's got that concern?

ABINASH VIRK: Absolutely, I think, that's a very legitimate question. Historically when studies are done with a new drug or a vaccine, pregnant women are usually excluded. And the reason they're excluded is because we don't want to take any chances with the baby. And we just want to be very protective of that.

However, in this situation when we have a pandemic going, we have number of women who are in reproductive age who might either be pregnant or be working as health care workers and pregnant. And we know that a pregnant woman has a higher risk of adverse effects from COVID-19 and potentially also has impact on the pregnancy itself. But the ACIP, the Advisory Committee on Immunization Practices, really thoughtfully reviewed available data, and also reviewed the consequences of COVID-19 infection in pregnant women, and ultimately recommended that the vaccine should be offered to pregnant women. This was also agreed. American Academy of Pediatrics as well as the OB-GYN society also agreed that pregnant women should get it.

I do want to add one other thing that we-- even though the pregnancy was a contraindication for the Pfizer vaccine, in the Pfizer study after the women had gotten the vaccine, there were 12 women who got pregnant in the vaccine arm and 11 women who got pregnant in the placebo arm. So what that tells us is, number one, that it did not impact fertility because the number of pregnancies was the same in the 20,000 people in both the arms. And, of course, those women are being followed to see if there are going to be any issues or not.

The second thing is that although it has not been published, Pfizer has done studies in animal models, which are required studies for vaccines in terms of impact on reproductive capabilities. And Pfizer did report to ACIP that there was no problems noted in the animal models. So we have at least something to say that the likelihood is low.

And third-- which is, really, another very important component of why it is felt to be safe to give this vaccine to pregnant women despite the lack of that data-- is that mRNA is a very small genetic copy of only one protein of the virus. And this is a very self-destructing small piece of genetic code that essentially disappears a few hours after it gets into the cell. And it does not incorporate into our DNA, so it doesn't have any impact on the baby or on the mother. And it has no impact on the placenta. And so, therefore, it's recommended that it's safe to give to pregnant and breastfeeding mothers.

ERIC TICHY: Thank you for that very thorough answer. Dr. Swift, the next question here is if you have patients that get COVID-19 in between the first and second injection, how are you handling those? What is your recommendation?

MELANIE SWIFT: So this does come up occasionally because people do not have full protection after that first dose of vaccine. And there are people who get it-- have gotten COVID within a few days of getting their vaccine or some time in that interval. When people have not yet had dose 1, we would in the face of the shortage recommend that they wait 90 days before starting the COVID vaccine series just because they have some likely protection for at least 90 days from their infection and we have a shortage of vaccine so other people who are completely vulnerable could take the vaccine instead of people that were recently infected.

It's a little bit of a different question when you've already started the vaccine series. And that's because in the studies, we don't have anybody who was vaccinated between dose 1 and 2 with a window of more than about seven weeks. And they're aiming for either 21 or 28 days. So we don't know what the effectiveness or the impact of that vaccine series would be if it's interrupted by more than 90 days. So that's just an unknown right now.

And so what we're advising is that people who get COVID between the two doses complete their isolation period. They shouldn't go into a vaccination center if they are still on isolation and contagious for COVID. And that could take them past their normally scheduled time frame, which is OK. And then once they're out of isolation and it's time for them to take the vaccine, that they go ahead and take the second dose.

Now, depending upon how resource-constrained the setting is, they may need to push that out a little bit. And that's OK to do. But I wouldn't push it out the full 90 days in the absence of any data on the effectiveness of it. So I would say, as soon as you can depending upon your supply and making sure that you're off of isolation.

ERIC TICHY: Excellent, thank you. I'm going to direct this next one to Dr. Holm. So Dr. Swift addressed how we are relying on those second doses to be shipped. And when they're allocated as specifically second doses, we're holding those. And we're not recommending stockpiling vaccines to ensure second doses because that's going to lead to a trickle of people actually getting the vaccine if everyone at every stage of the supply chain holds back 50% of their doses.

Can you talk to us a little bit about maybe best practices for making sure people show up for their next vaccine? And, how do you ensure high rates of people getting that second dose? What is your guidance?

MICHELLE HOLM: That's a great question, Dr. Tichy. So when you show up for your first vaccine, you're asked, can you show up? Are you available 21 or 28 days from now? And you're asked at that point to say, yes or no. And so showing up for that vaccine is very important for both the supply chain and receiving more vaccine because we have to use the supply we have to get more.

And these supplies are continuously coming from Pfizer and Moderna. So the questions in the chat about, how can we be assured that we're going to get a second dose? They are actually monitoring how much we have and when our second doses are due based on a tracking system that we're using nationwide.

Now, the other reason that it's important for you to show up for your second dose-- and this is really as an individual-- is because to get that full immunity, we're looking at seven days after your second vaccine. So people who have received one dose-- you can't really say that there is solid immunity. And we're not talking about transmission at this point, we're just talking about you getting less severe side effects than you would without the vaccine. So you're looking at seven days after your second vaccine. So if you don't receive your second vaccine on time, you're really delaying the process of feeling better about being safe and not getting severe side effects.

When it comes to transmission, we don't have the study data yet. It is not finalized. So we cannot say that because you are vaccinated, you can't transmit it to someone else. And we are hoping to get that at some point soon.

But, really, to the point of the question of supplies, yes. The manufacturers are sending us second doses. So please don't be afraid that you won't get a second dose if you've gotten your first dose. And it's important for you as an individual to show up on time for that second dose so you can be safer seven days following that second dose as an individual.

ERIC TICHY: And one other best practice that I want to add that I've observed is it's important to make sure that you schedule the patient for that second dose when they get the first dose. So I've found that a process where you get your vaccine and immediately you have someone talking to that person getting them on the schedule, that makes your capture rates a lot easier. And, I think, if someone has an appointment, they're more likely to get that. So that's one observation that I would also add to Dr. Holm's response.

Dr. Virk, you talked a little bit about some of the adverse effects. We have seen reports of anaphylactic reactions and some other reports that have raised some concern. Can you elaborate a little bit more on some of those adverse effects? How often are we seeing anaphylaxis? And even if someone has that reaction, what do they look like six hours, 12 hours, a day or two later?

ABINASH VIRK: Yes. I think I saw the question in the Q&A. So I want to say that when I said that there aren't any serious side effects in the sense that we haven't had any mortality direct related to the Pfizer or the Moderna vaccine, yes, we've had allergic reactions. We've had a spectrum of allergic reactions.

But in the study that was reported by the CDC on January 6th of 1.9 million people that got the Pfizer vaccine, there were only 21 people that had a full on anaphylactic reaction. And that rate is about 11.1 per million. It is a little bit higher than other vaccines. And so, yes. There is some concern that people may have an anaphylactic reaction.

And the thought is that it's primarily driven by the polyethylene glycol or the polysorbate. There is testing for that. And, actually, both of these are fairly common in some of the medications that are used otherwise. So MiraLAX has this. And the GoLYTELY colonoscopy preps have polyethylene glycol. So they're actually fairly common.

So anaphylactic reactions have occurred. There have been milder reactions, allergic reactions that have occurred. In the study that I just mentioned by CDC of the 1.9 million people, there were a total of 128 that had something. So again, fairly low in terms of side effects. These are manageable.

We have-- it's really important to have an emergency medical response team at the site of the vaccination so that if somebody has an anaphylactic reaction, you have a way to manage that right away, to give them epinephrine and Benadryl, and essentially to have them go to the emergency room if needed. All of the patients that we've had-- we've vaccinated over 30,000 people-- we've had about 10 cases of some allergy but not necessarily anaphylaxis. And all of those patients have done well.

I do want to comment on the question that was put in that same question about mortality or deaths associated with Pfizer vaccine. There were some deaths reported from Norway, there was some concern that was related to the Pfizer vaccine. I think it's really important to say that those deaths are being evaluated. They were in extremely older frail people.

Right now as of now, we don't know if there's any direct causal relationship with the Pfizer vaccine and the mortality. At the same time, I do want to tell you that we have-- in the United States, 1.3 million people in long-term care facilities have been vaccinated with the Pfizer or the Moderna vaccine. And there have been no associated deaths from the vaccines.

Yes, we do know that people can have the fatigue, and the headache, and the myalgias. And about 15% of people can have fevers. And in general, that was more common in younger people than older people. So that needs to be considered. Also at the same time at the very older end of patients, there is going to be natural mortality.

ERIC TICHY: Excellent, thank you. Dr. Swift, can you elaborate a little bit on this question that we see a couple of times here related to preventing someone from getting disease versus preventing transmission of disease?

MELANIE SWIFT: Yeah.

ERIC TICHY: And, should we let that slow us down from vaccinating people?

MELANIE SWIFT: Absolutely. So that's a very astute observation. The studies that were used to authorize these vaccines used as their endpoint the development of symptoms that caused the person to get tested and they tested COVID positive. What they did not incorporate because these are very, very, very large studies was routine surveillance for people who might have acquired the virus but never developed symptoms.

We know that COVID is transmissible by people who haven't yet developed symptoms during the couple of days before symptoms start. People are highly contagious during that time. And we also know that people can be asymptomatic for their entire illness and be communicable during that time.

So the question is not just, does the vaccine prevent the clinical manifestation of illness, which we know it does very effectively? The question is, could we assume that it also prevents the acquisition of asymptomatic infection? Or is it more effective in terms of managing symptoms?

So we do have vaccines for adults, like the flu vaccine, that are more effective at preventing the severity of illness than the actual infection itself. And there are good vaccines. And they're important to take. But people can still get flu and transmit flu with the vaccine.

So that's the question we don't know yet on these COVID vaccines for sure is whether or not-- how effective are they? We assume there's some effectiveness. But we don't have a number for it yet of, how effective are they at preventing those asymptomatic cases? So that's why it's still really important if you take the vaccine, that you don't stop your precautions because you could still get exposed to COVID while it's being transmitted in our communities.

And we don't know how protected you are from getting that asymptomatic infection. And if you did, obviously, you wouldn't know it. And if you're not practicing those precautions, you could potentially spread it to others. The biology suggests that it's likely going to be protective against that acquisition as well. But we don't know that for sure.

ERIC TICHY: Dr. Virk, do you want to add anything to that?

ABINASH VIRK: No, I absolutely agree with Dr. Swift. We'll just have to-- we'll learn over the next few months as we go forward with this.

ERIC TICHY: Great. I think we're all optimistic, though, that this is going to be favorable information as we get more data. Well, thank you, doctors, for the information that you provided today. Your insights were extremely helpful. We're coming to the end here. And so I want to bring Karen back in to provide information for followup in CE. So, Karen, if you would, bring this home.

KAREN GILLILAND: Thank you, Dr. Tichy. I'd like to thank our speakers as well as all of you for joining us today to discuss supply chain considerations for delivering the COVID-19 vaccine. If you enjoyed today's discussion, please be sure to check out and register for our upcoming webinars.

If you'd like to claim credit after this webinar, please visit ce.mayo.edu/COVID0120. You'll need to log into the site. If it's your first time visiting, you may need to create an account.