COVID-19 vaccine development updates

Watch infectious disease specialist, Patricia Winokur, MD, discuss progress on finding a vaccine for COVID-19 and how the clinical trials at UI Health Care are going.

You can also read an edited transcript of the video to get the highlights quickly. Answers were condensed from Winokur’s unscripted responses to the questions asked in the Facebook Live broadcast.

Are there any updates on the COVID-19 vaccine development?

A little over a month ago, there were about five or six vaccines that were in late-stage testing, and that number has gone up to 11. We’re starting to see the results of the first vaccines that entered into these late stage trials, and it looks good.

In the blood studies, it looks like antibodies are being developed, and we’re starting to get a sense of the safety of the vaccines.

Here at the University of Iowa we’re doing the Pfizer vaccine study. This is a messenger RNA vaccine and, so far, I think this study is the one that’s in the lead. They’ve enrolled about 37,000 people around the world and about 70 percent of them have gotten their second dose, so we’re getting a lot of data.

As you’ve probably heard, the company has set points when they stop the data collection. They analyze the data and decide whether the vaccine has shown enough protection from COVID-19 to get FDA approval for use. They’re in the stage now of doing one of their data cuts.

What have the results of the vaccine trials been so far?

In almost all of these studies, half the people get the active vaccine and half the people get saline (basically, this is salt water), or what we call a placebo. We have been blinded to what our subjects get, but I can tell you that we are seeing some reactions.

Sore arm is very common with this vaccine, and that’s also true with the published data. We’ve seen some people that have felt fatigued, a little flu-like, which is not uncommon with many vaccines. I would say the numbers of people with those reactions are a little higher than some vaccines but also, it’s similar to vaccines that we have studied and that have been FDA approved.  For example, the Shingrix shingles vaccine has similar symptoms. So far, nothing has been worrisome enough to stop the Pfizer trial.

There’s another trial, Moderna, which is also a messenger RNA vaccine. It’s the second in line right now, and they’ve enrolled about 30,000 people. They, too, have been seeing the same reactions of sore arm and some feverishness, but nothing that stopped that trial, either. So, these are promising results.

Are these reactions to the vaccine similar to those that may result from a flu shot?

Yes, they are similar. What we’ve seen is a little bit more reactogenic than what I’ve seen with flu vaccines. The sore arm is a little more intense and the flu-like feeling is a little more intense than I’ve seen with the flu vaccine. But Tylenol and Ibuprofen work like a charm, and most people feel back to normal within hours.

Is it possible that we could have more than one vaccine available to use at some point?

I actually think we’re going to have several vaccines that will get approved, which is a good thing. Eventually we’ll have the ability to compare them and see if one is better than the other in creating antibodies or protecting for a longer period of time.

There are other studies that are getting ready to roll out. They will be very different vaccine platforms that are actually much more traditional and much more like how we make vaccines for flu.

The Novovex study is getting very close to starting around the country. This is a vaccine that they purify the spike protein and add a compound to it to kind of rev up the immune system a little bit. That’s very similar to vaccines that we’ve had approved for many years.

How will researchers and our government measure whether a vaccine is safe and effective?

How confident are you that it will be safe and effective?

Safety is measured in every step of every trial. Remember, with all of these trials we start with a very small number of people that are enrolled and we follow them almost every two to three days. We follow laboratory studies, we follow their symptoms, we have them write down diaries of whether they have a temperature. It’s only after we’ve proven safety in that small number of people that we start moving into these larger numbers of people.

But even as we get into these large numbers of people, we are very carefully following all the symptoms that they’re experiencing, such as whether they’ve had to go to the emergency room or their doctor.

Those are the things that help us understand whether these vaccines are in fact safe, and we’re very carefully documenting any change in health, even if it’s something they had before but it’s gotten worse.

We get these very extensive lists of illnesses that develop in our subjects. Most of them are probably just run-of-the-mill things, like going out to eat and getting an upset stomach.

But we do occasionally get events that are more serious – someone had to go to the emergency room or developed something that looks more concerning. Those will then get worked up very carefully to understand if there’s another underlying illness that did just happen to occur during that same time point, or maybe it’s something that we think is associated with a vaccine.

That’s certainly what happened with the Oxford vaccine, the AstraZeneca vaccine. They had one person that they thought developed a new neurologic symptom. In that case, they thought that perhaps they actually had underlying multiple sclerosis that was undiagnosed at the time of entry. But then a second person developed an illness that was consistent with transverse myelitis.

They chose to put a very significant pause on that trial. Europe paused, they reviewed those two incidents, and they were willing to continue. The U.S. tends to be a little bit more rigorous in our drug approvals, and the fact that we have continued that pause shows you that we’re pretty attuned to watching for safety.

When a vaccine is approved, would you get it?

I absolutely would, but I think there are a couple reasons why I would. Sure, I would love to protect myself, that would be something that I would expect this vaccine to do and that’s certainly what we’re going to be proving. But I also think it’s really important because I am around patients who are at high risk. If I can prevent them from getting COVID-19, that’s really important.

I also have an elderly parent. I need to protect my mother and others in the community, so there’s a humanitarian reason for taking the vaccine, too. I take that responsibility very seriously.

When will the COVID-19 vaccine be approved and available?

The FDA actually increased their safety requirements and their follow-up for these studies in October. I think it was in response to a lot of the concerns that people have, and because of that, I think it’s going to take just a little bit longer to get to the end points that the companies need to achieve before they can have the data for the FDA to review.

I would say November or December would be when they will get the data to the FDA and they will scrutinize it carefully. There will be independent scientists that will scrutinize this data very carefully, and that will only be after that very intense review that they will think about approving it.

Why have we been able to work on this vaccine so quickly?

One of the things that we’ve had going for the past decade is a lot of interest in developing these more novel platforms for vaccines that allow us to create them faster. A lot of the thanks goes to the fact that we’re using cancer vaccines as a very promising therapy for helping control metastatic spread of cancer.

Because there’s been so much work over the past decade on creating these platforms of vaccines, we’ve been able to get the right proteins into these vaccine platforms to get them tested. There were a lot of tests that have been done in humans for these platforms to show that they’re safe.

The other thing that’s really helpful is the work that some of our scientists here on campus did with SARS and MERS. They were starting to understand what proteins are in these viruses that are very similar to the coronavirus that is now spreading across the globe. They found the most important proteins that stimulated an immune response, and because of that work, we were able to pick the right proteins and put them into these vaccine platforms.

So, a lot of the thanks goes to some very attentive scientists that have been working diligently for many, many years. That’s great insight, and I think it’s also important to note that this is kind of what happens when we have a global pandemic. The whole world is searching for this vaccine, so it’s not just a handful of researchers doing this work. It’s really kind of all-hands-on-deck right now.

A pandemic is a different kind of world view of science, and we know here on campus, all around the country and the world scientists have put aside their other research to really try and understand this coronavirus. They’re trying to understand the immune responses and other things that are causing some of the serious illness. That’s been exciting, and it is why we’re pushing the vaccine development so quickly.

A pandemic is a special time We have a need to get this vaccine out so people can start getting back to their normal lives, which I think most people would like to do sooner rather than later.

What is in the vaccine that the University of Iowa is studying?

The vaccine that we’re studying here at the university is called a messenger RNA vaccine. It’s really kind of the process our body uses naturally to make proteins.

If you remember your molecular biology, our genes have DNA. Our body then takes bits of that DNA and created what we call messenger RNA, and then your body takes that and turns it into proteins. Those are the proteins that make up cells and all the components of the body.

So, they skipped the DNA step, created the messenger RNA step, and then they depend on your body to create the protein. All we have to do is get that messenger RNA into the cell and then the cell creates its own proteins and displays those proteins the way it naturally would in an infection.

Will this be a one-time vaccination?

Most of the vaccines that are being studied now require two doses, and most of them are three to four weeks apart. So, to get fully protected you need to get two doses of the vaccine, but we do not know how long these vaccines will last.

From the studies that we can see in the literature, the good news is the vaccines are stimulating an antibody response. The quantity of antibodies produced is actually better than what we’re seeing in people who recover from coronavirus, it’s about three to four times better.

I know a lot of people are worried that they see these people getting coronavirus twice.   The hope is that the vaccines may actually be better than natural infections at preventing second infections, but my guess is they’re not going to be good for the rest of your life. I think that you will probably need to get a second dose in a year or two years, something like that.

That’s just another reason why herd immunity won’t be possible with COVID-19 until we have a vaccination. Getting it from a friend or family may not be as effective as the vaccine.

I think it’s really a combination. When you’ve looked at the numbers of people that have actually contracted COVID-19, so far in most areas it’s less than 10 percent of the population. There is a long way to go from 10 percent of the population to probably what we need, which is 60 to 75 percent of the population to have antibodies. You need something that gets a lot more people covered, and I think the vaccine will be safer than getting coronavirus.

That’s another important thing to think about when you’re thinking about safety, because the vaccine obviously has to be safer than the disease itself, otherwise it’s not a good vaccine. I think with how many people have gotten devastatingly ill from coronavirus, we have a lot of opportunity to protect people in a much safer way than allowing just continued spread of coronavirus.

Why has the Pfizer trial expanded the number of participants to include children?

The expansion had a couple reasons. One is they added HIV patients because a vaccine could be given in some countries that have very high rates of HIV. They included 16- and 17-year-olds first, because we starting to think that we need to cover children, as well. Just recently they added 12- to 15-year-olds.

They’re starting to get the vaccine studied in children so that we have the data to know that it will be safe. We always test all of our drugs on adults first and prove safety before we think about moving it into children. We would not have expanded if we didn’t have a really good safety database.

Once the vaccine is approved, who decides who will be eligible to receive the vaccine first?

Do we think younger and healthier people might have to wait while other more vulnerable populations get the vaccine?

There are several groups that have been working on these strategies. In the United States, we have a group that helps create our immunization policies, it’s called ACIP (Advisory Committee on Immunization Practices). But also, the National Academy of Medicine, which is a group of very talented scientists, have also weighed in on what they think is the best and most ethical way of distributing this scarce resource.

The first group that they are going to cover are essential workers. That’ll include those that are in the emergency room, paramedics, fire, those individuals are out in the community a lot or they’re in a health care setting where they’re really critical for taking care of the COVID-19 patients.

They will also expand into some of the essential workers that are running some of our city services that we need. The elderly will be one of the next groups just because this is a group that has a high risk of serious illness. We do have a lot of data now that’s being published about the 65-and-older population, and they too are generating a very good antibody response to these vaccines.

Then as you go down it will be expanded to more of the general population and healthy population.

What is at stake over the next few months?

Why is taking safety precautions still so important?

Well, I don’t think we’re going to have the vaccine for a few months. We’re starting to get into winter, it’s a time when we’re going to see more respiratory illness and we’re already seeing it in Iowa and around the country.

But remember, once that vaccine is approved, we aren’t going to have enough doses to really spread around all populations right away. You’re going to perhaps protect the hospital workers and the paramedics and the fire department, but that’s only a very small sliver of the population. There’s still a lot of opportunity to transmit coronavirus from person to person.

A lot of people don’t think we’re going to have really large quantities of vaccine until late spring to early summer 2021, so we have to go ahead and continue the best prevention that we can which is masks, hand washing, and social distancing.

It’s imperative, and this is going to be really hard to do over the holidays but it’s really important. We just can’t keep spreading this person to person. It’s harming too many people.

Is it more important than ever to get the flu vaccine?

It is more important than ever to get the flu vaccine for a couple reasons.

One, we know that people can get dual infections, so there will be people that could get coronavirus and influenza. That’s going to be devastating, and both of them are life-threatening diseases.

The other reason is a lot of the testing that we do uses the same reagents that we need to use to test for coronavirus. We may run out of the testing materials, we may run out of masks, all the things that we do to protect people from spreading the disease in the hospital.

We may run out of hospital beds. We’re already getting to a point where we’re very worried about hospital beds again. We’re seeing in states that were doing fine a few months ago are at a critical stage now. If we can do anything to try and reduce that burden on the hospitals, that’s going to be really important.

Get your flu shot as soon as possible, continue to wear masks, practice good hand hygiene, social distance when we can, avoid closed spaces.

As the weather gets colder, we’re all going to need to keep that top of mind, enclosed spaces are really not a great place to be with others. That’s unfortunately the case, and I know people are getting tired of social distancing. They want to go out and see their friends, but now is the time to be even more diligent.

Is there anything else you want people to know and keep top of mind?

Trust the science and the process of watching the safety. This is not going to be compromised in this vaccine. The scientists are going to keep going and watching all the things that we need to watch and ensure that these vaccines are as safe as they can be.

We will continue to learn more once these vaccines are approved and out in the general public, like any other drug. They’re going to be watching for new safety events and if something needs to stop, we’ll stop.

Please remember to wash your hands often with soap and water or use hand sanitizer, wear a face mask and keep a safe distance from others when in public, and make sure to take care of your physical and mental health.