COVID-19 Vaccine 101

Hi there, For several months we’ve been updating you thru videos like these on the status of the pandemic. As always our top priority is to stay everyone safe and healthy which includes you. Our challenges are many, taking care of the sickest COVID-19 patients while finding ways to deal with the healthcare needs of all of our patients. Using telehealth and new ways to succeed in patients in their homes, finding new ways to coach and retrain. taking over new roles and conducting groundbreaking research under remarkably short timelines. Your efforts have and still save countless lives. Today, whilst we’re facing our latest surge of COVID-19 cases at VUMC, come some encouraging news. a minimum of two COVID-19 vaccines has produced promising leads to phase three clinical trials. We expect to possess two options: one from Modern a and another from Pfizer both showing remarkable effectiveness supported information from data safety committees and now under thorough evaluation by the CDC, the FDA, and by independent per review advisory committees.

While there’ll be very likely more vaccines to follow both of those initial vaccines are made during a new way, using RNA which has both sped up the event process and has important safety advantages. At now, we expect to start receiving doses from one or both companies toward the top of December. We’re awaiting final guidance from the CDC and therefore the Tennessee department of health on the way to prioritize doses when the availability remains limited. It does seem clear that those providing frontline health care are going to be among the primarily offered vaccination. Over time we expect to receive larger supplies, so we are already hard at work developing distribution plans for everybody at VUMC also like our patients. Here’s where we’d like your help. we all know that folks across the region trust VUMC and switch to all or any folks for information. you’re very likely already receiving questions from family and friends. we all know that folks have good questions on the vaccine and a few even have skepticism given these are unprecedented and unfamiliar circumstances.

You probably have questions yourself. That’s why we are beginning a special series of videos to share the newest information on the vaccine. it’ll feature VUMC’s very own Dr. William Schaffer. A renowned communicable disease expert. He’s become one of the nation’s most trusted voices during the pandemic. Our goal is to offer you more information about vaccines generally land these COVID vaccines especially including their safety and the way effective we believe they’re. Today Dr. Schaffer will help us through questions like what makes a vaccine work? What sorts of side effects can we expect? and the way will the vaccine help us achieve herd immunity? Bill. — many thanks, Dr. Balser. It’s my pleasure to be with you today to assist inform you about the important role vaccines play to keep us healthy. I’ve devoted my professional career to the study and understanding of infectious diseases that affect our everyday lives. COVID-19 certainly has had a profound impact on our world over the last year, and as we move towards having vaccines for COVID-19 it’s natural to possess questions on them.

However, the problem with becoming immune this way is of course, that you may become very sick from the virus and you also may spread the virus infecting others and making them sick. In the case of COVID-19, we all have seen how this Coronavirus can cause really severe illness and even death, and indeed we’re now seeing thousands of deaths per day in the United States. Now the other and better way to gain immunity is with a vaccine. Vaccines safely teach our immune systems on how to recognize specific infections before they infect us and make us sick. In response to the vaccine, our immune systems will also make antibodies. Those same antibodies protect us from the real virus. Vaccines have drastically reduced disease around the world. Here are a few of my favorite examples of vaccines over our history. Thanks to a vaccine, smallpox that really dreaded infection has been eradicated from the entire globe. A vaccine has caused a 93% reduction in whooping cough cases, we don’t see those on our pediatric wards anymore.

A vaccine has caused a 99% reduction in cases of mumps. And polio — polio has been eliminated in the United States, eliminated and now over most of the world, thanks to a vaccine. There are many other vaccines and while very few are a hundred percent effective, they do provide a significant reduction in the prevalence of the illness so that we can go about our normal lives with little disruption. This lack of immunity is why the COVID-19 virus has caused so much disruption. It spreads quickly through communities because the virus is completely new to humans. Since none of us are immune to the virus it has no trouble finding new people to infect. So to slow the spread, we must make it harder for the virus to find new humans to infect. We do this by social distancing and masking. They reduce the viruses’ opportunities to spread but these restrictions, they’re not perfect, and we’ve already seen the challenges in getting everyone to respect these restrictions.

A safe and effective vaccine could really help end the COVID-19 pandemic. Question two, what makes a vaccine work? The most important part of a vaccine is called the antigen. That’s the part of the vaccine that actually stimulates our immune system to protect us. Different types of antigens are created by scientists to create different types of vaccines, and many vaccines contain antigens made from just a part of a virus. In the case of COVID-19 vaccines, the antigens are only a very small piece of the virus which means they cannot replicate, they cannot multiply and if they can’t multiply, they cannot cause an infection. I think this is so important that I’ll repeat this statement. The COVID-19 vaccines cannot cause you to get COVID, no fear. Now, when you get a vaccine with the antigen, the antigen stimulates your immune system to produce antibodies against the virus, and these antibodies, build your immunity. Once your body develops these antibodies, it remembers them.

So if you’re ever, ever exposed to the virus again, your body will quickly make these same antibodies again to reduce the likelihood that the active virus will infect you and make you sick. You’ll be protected. Question three, do we need a vaccine to achieve herd immunity? You know, there’s been a lot of discussion about this concept of herd immunity so I think it’s important to understand what this herd immunity really means. It’s based on the idea that a virus is a living thing that really wants to be able to spread from person to person. Now, if everyone is immune or resistant then the virus has nowhere to go and it can’t spread. The safest way to become immune is via a vaccine that will protect you from the infection. We could achieve herd immunity after 60 to 75% of the population is either vaccinated or has been infected with the virus.

Now, if we wait for the herd to immunity to happen without a vaccine, first of all, it will take a long time, and of course, it will cause a great deal of unnecessary disease and deaths. We also should be aware that if we all get vaccinated that also will protect people who cannot be vaccinated. For example, children who are too young or cancer patients who are immunocompromised, that is they have a weakened immune system. If all the rest of us get vaccinated it will provide what we call a cocoon of protection around those too frail to be vaccinated. Fourth question, how is the effectiveness of a vaccine actually measured? The initial results of the corvid-19 vaccine studies show they are 95% effective. So what does that 95%effective really mean? Let me demonstrate by using some numbers as an example and they’re not from any particular COVID-19 study.

In this hypothetical study, a vaccine is given to half the volunteers. The other half receives a placebo, saltwater instead of a vaccine all under code. During the study, the participants, these volunteers go about their normal lives. The investigators compare how many people became sick from COVID-19 in each group, in the placebo group, and in the vaccine group. Say in the placebo group a hundred people became sick from COVID 19 during the study period. In contrast, in the vaccinated group, only five people developed the disease. So researchers would say that the vaccine actually protected 95 people in the vaccine group from getting the virus. This means the vaccine is 95% effective. A vaccine that’s 95%effective is extraordinary, similar to smallpox and polio vaccines.

Fifth question, will aCOVID-19 vaccine be safe since it was created so quickly, and what’s this thing called a EUA? Vaccines can only be given to people in the United States with the approval of the food and drug administration, the FDA. The FDA has strict guidelines and requirements for vaccine development and approval. This ensures that a vaccine is proven to be both safe and effective. Here are some important points about ensuring a safe vaccine is developed and approved. Safety means that studies of the vaccine have shown it to cause minimal harm. Of course, like all vaccines, it can cause a sore arm where the vaccine was injected or a mild fever. A few persons indeed may also feel a bit puny for a day after vaccination with some aches or headache. That’s actually your immune system working with the vaccine. Like other vaccines you have received, we anticipate these side effects. However, these vaccines have not caused serious illness or death.

Even though COVID-19 is a new virus, scientists actually have been studying these types of viruses for over 15 years, and so we’ve had a head start on vaccine research. In fact, researchers right here at Vanderbilt has been at the forefront of Coronavirus vaccine development over the past decade. The COVID-19 vaccines are being developed through the same oversight phases as a typical vaccine. It’s just that the severity of the pandemic has accelerated the speed of the process. Some steps are being completed at the same time simultaneously instead of sequentially one after the other. The COVID-19 vaccines are being tested in large groups of people, the same as with other vaccines, and very careful assessments of safety and effectiveness are made. Using large volunteer groups also counts for individual differences. It’s important to know that people of all racial, ethnic, and age backgrounds are included in the studies.

So in any case that goes into development, how does the vaccine actually get approval? Once the manufacturer completes the specified studies and sees that the studies demonstrate both safety and effectiveness they’ll submit all of the detailed scientific data to the FDA about how the vaccine was developed, how it had been studied, and the way many of us were evaluated. the info is then reviewed by an independent group of experts. These are individuals expertly in virology, biostatistics, ethics, and public health and who don’t work for the drug company that’s doing the research or for the other competing company, and that they also don’t work for the govt. These are external experts and that they will provide are commendation to the FDA on whether or not they recommend a vaccine for approval or not. I can assure you, they’re both independent and hard. within the case of a COVID-19 vaccine, an emergency use authorization, there’s that EUA could also be provided by the FDA. During public health emergencies like the present COVID-19pandemic, a EUA may be a tool to hurry up the supply of medical countermeasures including vaccines. For a EUA to be issued for a vaccine, the FDA must be convinced that the general public health threat is extremely serious, obviously, it is, which the vaccine is going to be crucial and safe thanks to preventing the disease.

Question six will a COVID-19vaccine make me sick? It’s likely that you simply will feel under the weather for each day or two from a COVID-19 vaccine, but it’ll not cause you to sick from the virus. once you get the vaccine shot, you ought to have an immune reaction to the vaccine. That response might be anything from feeling tired to having a fever, body aches, and or a sore arm. of these reactions are literally an honest thing and a symbol that your body is developing protection, those antibodies, which the vaccine helps you develop immunity. Rest assured that the vaccine doesn’t offer you the virus, and these reactions are far better than having to repel the virus all by yourself. I appreciate the chance to supply you with this important information about COVID vaccines. I’m confident that a secure and effective vaccine will soon be available, and once I’m eligible, I decide to get the vaccine myself. I provide you with an equivalent encouragement that when the vaccine is out there, you ought to get vaccinated also, Dr. Balser? — Thanks Dr. Schaffner for that important information, and for all of your efforts to assist our country to raised understand COVID-19.

I hope this video today begins to answer your questions and helps prepare you to answer questions you’re very likely already getting from friends, family, et al. in our community. it is vital to recollect as we start vaccinating our patients and ourselves that a vaccine doesn’t mean the pandemic is over, a minimum of not yet. we’ll still get to be vigilant and follow equivalent basic health

recommendations including wearing a mask and following all the security guidelines until many Americans are vaccinated. At VUMC we shall be prepared to try to do our part because the vaccine is delivered. Over the approaching weeks, we’ll be back with additional videos, with more details about the vaccine and the way we’ll be making it available to you and to our patients. Again, my thanks for all you are doing to form a difference. We’ll talk again soon.