Dr. Jeff Balser, president and CEO, Vanderbilt University Medical Center:
For many months, we’ve been updating you through videos like these on the status of the pandemic. As always, our top priority is to keep everyone safe and healthy, and that includes you.
Our challenges have been many. Taking care of the sickest COVID-19 patients, while finding ways to address the health care needs of ALL of our patients. Using telehealth in new ways to reach patients in their homes. Finding new ways to train and retrain. Taking on new roles. And conducting groundbreaking research under remarkably short timelines.
Your efforts have, and continue, to save countless lives.
Today – even as we’re facing our largest surge of COVID cases at VUMC – comes some encouraging news. At least two COVID-19 vaccines have produced promising results in phase 3 clinical trials. We expect to have two options, one from Moderna and another from Pfizer, both showing remarkable effectiveness based on information from data safety committees, and now under thorough evaluation by the CDC, the FDA, and by independent peer review advisory committees.
While there will very likely be more vaccines to follow, both of these initial vaccines have been made in a new way, using RNA, which has both sped up the development process, and has important safety advantages.
At this point, we expect to begin receiving doses from one or both companies toward the end of December. We don’t have information on the number of doses we may receive, and we are awaiting final guidance from the CDC and the Tennessee Department of Health on how to prioritize doses when the supply is still limited.
It does seem clear that those providing front-line healthcare will be among the first offered vaccination. Over time, we expect to receive larger supplies, so we are already hard at work developing distribution plans for everyone at VUMC, as well as our patients.
Here’s where we need your help.
We know that people across the region trust VUMC, and turn to all of us information. You are very likely already receiving questions from family and friends. We know that people have good questions about the vaccine, and some people 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 latest information on the vaccine. It will feature VUMC’s very own Dr. William Schaffner. A renown infectious disease expert, he’s become one of the nation’s most trusted voices during the pandemic.
Our goal is to give you more information about vaccines in general, and these COVID vaccines in particular, including their safety, and how effective we believe they are.
Today Dr. Schaffner will help guide us through key questions, like “what makes a vaccine work?” “What kind of side effects can we expect?” And “how will a vaccine help us achieve herd immunity?”
Dr. William Schaffner, professor of Preventive Medicine, Health Policy and Infectious Disease:
Thank you, Dr. Balser.
It is my pleasure to be with you today to help inform about the important role vaccines play in keeping us healthy. I have 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 vaccine(s) for COVID-19, it is natural to have questions about them.
It is my hope that at the end of this (video) you will have confidence that a COVID-19 vaccine will be safe and effective. Consider this conversation COVID Vaccine 101.
These are several questions that we are getting daily as people hear more and more about a Covid-19 vaccine and I would like to provide some answers.
1. How can I gain immunity to a virus like COVID-19?
2. What makes a vaccine work?
3. Do we need a vaccine to achieve ‘herd immunity’?
4. How is a vaccine’s effectiveness measured?
5. Will a COVID-19 vaccine be safe since it was created so quickly and what is an EUA?
6. Will a COVID-19 vaccine make me sick?
7. When can I get vaccinated?
You ready? Let’s begin.
How can I gain immunity to a virus like COVID-19?
One way to gain immunity is by catching the virus. Often, once we get an infection, our bodies learn how to protect us from getting sick from the same thing again by making antibodies. We call this protection “immunity."
However, the problem with becoming immune this way is that you may become very sick from the virus. And you also may infect others with the virus, spreading the virus to others making them sick. In the case of the COVID-19 virus, we all have seen how this coronavirus can cause severe illness and even death. We are now seeing thousands of deaths per day in the United States.
The other and better way to gain immunity is with a vaccine. Vaccines safely teach our immune systems 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 just a few of (my favorite examples) of vaccines over our history:
- Thanks to a vaccine, smallpox has been eradicated globally
- A vaccine has caused a 93% reduction in whooping cough cases
- A vaccine has caused a 99% reduction in cases of mumps
- And Polio has been eliminated in the US and most of the world, thanks to a vaccine.
There are many other vaccines and, while very few are 100% effective, they provide significant reduction in the prevalence of the illness so 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.
To slow the spread, we must make it harder for the virus to find new hosts. Social distancing and masking reduce the virus’ opportunities to spread, but these restrictions are not perfect and we have already seen the challenges in getting people to respect these restrictions. A safe and effective vaccine could help end the COVID-19 pandemic.
What makes a vaccine work?
The most important part of a vaccine is called the “antigen” – that’s the part of the vaccine that stimulates our immune system to protect us. Different types of antigens are used to create different types of vaccines. Many vaccines contain antigens made from part of a virus. In the case of COVID-19 vaccines the antigens are only a small piece of the virus, which means they cannot replicate or multiply, and so they cannot cause an infection.
I think it is important that I repeat this statement: the COVID-19 vaccines cannot cause you to get COVID!
When you get a vaccine with the antigen, it 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 are ever exposed to the virus again, your body will make those same antibodies again to reduce the likelihood that the active virus will infect you and make you sick.
Do we need a vaccine to achieve herd immunity?
There has been a lot of discussion about the concept of herd immunity, so I think it is important to understand what herd immunity means. It is based on the idea that a virus is a living thing that (wants) to be able to pass from person to person. If everyone is immune or resistant, then the virus has nowhere to go, and doesn’t spread.
The safest way to become immune is by a vaccine that will protect you from the infection without making you sick from the virus. We could achieve herd immunity after 60-75% of the population is either vaccinated or has been infected with the virus. If we wait for herd immunity to happen without a vaccine, it will take a long time and cause a great deal of unnecessary disease and deaths.
We also must be aware that if we all get vaccinated that will protect people who cannot be vaccinated. For example, children who are too young, or cancer patients who are immunocompromised (have a weak immune system).
So, the quickest way to protect a lot of people becoming ill and dying is by vaccinating as many people as possible.
How is a vaccine’s effectiveness measured?
Initial results of Covid-19 vaccine studies show they are 95% effective. What does 95% effective mean? Let me demonstrate using numbers as an example and not from any particular COVID-19 study.
In a study, a vaccine is given to half. The other half receive a placebo (salt water instead of vaccine). During the study, the participants go about their normal lives. Researchers compare how many people become sick from COVID-19 in each group.
If the vaccine is not effective, researchers would expect the same number of people to become sick from COVID-19 in each group. If the vaccine is effective, there will be a much lower number of people getting sick in the group of people that received the vaccine.
Let’s say, in the placebo group, 100 people became sick from COVID-19 during the study time period. In contrast, the vaccinated group, only 5 people develop the disease. So researchers can say that the vaccine protected 95 people from getting the virus. This means the vaccine is 95% effective.
A vaccine that is 95% effective is extraordinary – similar to the smallpox and polio vaccines. 95% effectiveness is impressive – that’s as good as our best vaccines.
Will a COVID-19 vaccine be safe since it was created so quickly and what is an EUA?
Vaccines can only be given to people in the U.S. with the approval of the Food and Drug Administration (FDA). The FDA has strict guidelines and requirements for vaccine development and approval ensuring 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 may also feel a bit puny for a day after vaccination, with some aches or a 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 have been studying these types of viruses for over 15 years and so we had a head start on vaccine research. In fact, researchers right here at Vanderbilt have 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 is 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 one after the other. The simultaneously, COVID-19 vaccines are being tested in large groups of people the same as with other vaccines. Very careful assessments of safety and effectiveness are made. Using large participant groups also accounts for individual differences. It is important to know that people of all racial, ethnic, and age backgrounds are included in the studies.
So, after all that goes into development, how does the vaccine get approval?
Once a manufacturer completes the required studies, and sees that the studies demonstrate both safety and effectiveness, they will submit detailed scientific data to the FDA about how the vaccine was developed, how it was studied, and how many people were evaluated.
The data are reviewed by an Independent group of experts who review all the data. These are individuals with expertise in virology, biostatistics, ethics, and public health, and who do not work for the pharmaceutical company that is doing the research (or any competing company) or the government. These external experts will provide a recommendation to the FDA on whether they recommend a vaccine for approval or not.
I can assure you, they are both independent and tough. In the case of a COVID-19 vaccine an emergency use authorization (EUA) maybe provided by the FDA. An EUA is a tool to speed up the availability of medical countermeasures, including vaccines, during public health emergencies, such as the current COVID-19 pandemic. For an EUA to be issued for a vaccine, the FDA must Be convinced that the public health threat is very serious and that the vaccine will be an important and safe way to prevent the disease.
Will a COVID-19 vaccine make me sick?
It is likely that you will feel under the weather for a day or two from a COVID-19 vaccine, but it will not make you sick from the virus. When you get the vaccine shot, you should have an immune response to the vaccine.
That response could be anything from feeling tired, to having a fever, body aches, and/or a sore arm. All those reactions are a good thing and a sign your body is developing protection or antibodies and the vaccine is helping you develop immunity. Rest assured that the vaccine does not give you the virus and these reactions are much better than having to fight off the virus by yourself.
I appreciate the opportunity to provide you this important information about vaccines. I am confident that a safe and effective vaccine will soon be available and once I am eligible, I plan to get the vaccine myself.
I offer you the same encouragement that once a vaccine is available you should get vaccinated as well.
Dr. Balser can you provide insight on a question that I am sure is on everyone’s mind before we close.
When will VUMC get a vaccine and when can I get vaccinated?
The scientific community and VUMC are working hard to make sure everyone can get vaccinated as soon as possible. Although we do not have an approved vaccine yet there is a good chance we will have a safe and effective vaccine soon. Demand for a vaccine will be high, and we expect limited amounts at first. It is expected healthcare workers working directly in COVID-19 areas will be the first to be offered the vaccine followed by patients identified in high-risk categories.
Thanks, Bill, for that important information. And for all of your efforts to help our country to better understand COVID-19.
I hope this video today begins to answer your questions, and helps prepare you to answer to questions you are very likely already getting from friends, family, and others in our community.
It’s important to remember – as we begin vaccinating our patients, and ourselves, that a vaccine doesn’t mean the pandemic is over. At least not yet.
We will still need to be vigilant and follow the same basic health recommendations including wearing a mask and following all the safety guidelines until millions of Americans have been vaccinated.
At VUMC, we intend to be prepared to do our part as the vaccine is delivered. Over the coming weeks, we’ll be back with additional videos, with more details about the vaccine, and how we will be making it available to you, and to our patients.
Again, my thanks for all you do to make a difference.
We’ll talk again soon.