Table of ContentsClose
The quest to develop safe and effective COVID-19 vaccines has involved medical centers from around the world, including University of Iowa Health Care.
Patricia Winokur, MD (88R, 91F), executive dean of the Carver College of Medicine, has been leading the effort at Iowa to enroll study participants and study the safety, tolerability, immunogenicity, and efficacy of two vaccine candidates by Pfizer-BioNTech and Novavax Inc.
The Pfizer vaccine was the first to be distributed widely after receiving emergency use authorization in December 2020, and the Novavax trial is ongoing at Iowa and other sites worldwide.
Even with several approved vaccines touting above-average efficacy, several challenges—including slow distribution; the threat of new, quickly emerging virus variants; and accessibility—continue to serve as roadblocks to curbing the pandemic.
Winokur recently discussed COVID-19 vaccines with Medicine Iowa.
Our Vaccine and Treatment Evaluation Unit has done rapid-paced clinical and vaccine trials before. This has allowed us to develop a system and understand how to bring people in, get them safely enrolled, and maximize our small number of personnel covering the trial. That prior experience was critical, but we pulled together as a team extraordinarily well. We’ve been working long hours: early in the morning, later in the evening, and every weekend.
I knew we were going to need to do vaccine trials, and I was hoping Iowa would be selected to help with the trials. The speed with which they got a product that was ready to be tested was remarkable and quite unexpected.
Usually, we’re starting to work on new pathogens well before they really start spreading and we didn’t have that lead time with COVID-19. However, a study vaccine was created, purified, and ready to be tested in a very short period of time.
Phase 1 and 2 started in April, and they got the results from those, and we were starting phase 3 in July. People had to pass certain milestones in the phase 1 and 2 studies to prove that the doses were reasonable, they had to home in on what they were going to use specifically for phase 3. They had safety requirements to meet, but the ability to ramp that into a 30,000-person trial that quickly is unprecedented.
The ironic thing is all of our pandemic planning was based on unusual strains of influenza, and low and behold the virus that we got was coronavirus. For 15 to 20 years there’s been a remarkable resurgence of interest in vaccines for pandemic preparedness and that’s where all of these new vaccine platforms have been studied along with the use of adjuvants.
Novavax is a more traditional type of vaccine in the sense that you’re vaccinating with a purified protein, but they’re adding adjuvants to the vaccine and we’ve been studying—because of pandemic preparedness and the push to try to figure out a better seasonal flu vaccine—adjuvant technology that really improves response to certain proteins. There has just been so much work that’s gone on behind the scenes that’s been done for preparedness that could be rapidly instituted.
The mRNA vaccines are here to stay. They were remarkably successful, and the speed at which they could prepare these vaccines was a testament to the technology. I think there are modifications that they will be working on to make mRNA vaccines even better. A lot of it is going to be stability—trying to find lipid particles, which encapsulate the mRNA, that are more stable at regular freezer temperatures, not ultra-low freezer temperatures. There will also be work on self-amplifying the antigen production, and that might mean that you could potentially have a one-dose vaccine instead of two doses. They’re also going to be working on ways to home in on exactly the dose that needs to be used.
The other thing we'll be trying to understand is: Can you create multivalent vaccines? With COVID-19 we’re starting to see multiple variants, and we’re going to need to study ways of vaccinating for several variants at once. Remember, we always have three of four different strains of the flu in our seasonal flu vaccines and that’s the same type of thing we’re going to need to be exploring.
And they’re absolutely going to be investigating mRNA vaccines with other pathogens, such as influenza, Ebola, Chikungunya, Zika, and many others.
But the mRNA vaccines are great. We couldn't have asked for better protection in the short term than what we got. To achieve 95% protection is spectacular. What we don’t know and what we’ll be learning is how long that protection lasts.
I think there were a couple things that made this happen fast. One was the technology, and the other was a ton of money. The problem in the future will be that there won’t be this enormous funding provided by the companies and the federal government to bring these vaccines into fruition so quickly. We’ll lose some ground there. But a lot of the improvements in the technologies will be here to stay and we’ve learned a few tricks with the clinical trial that I think are here to stay as well.
That's my guess. As we’re watching these variants, I'm very concerned that we’ll need to have a booster of some sort sooner or later. And there’s a lot of work going on right now to create new boosters. That will be the next set of clinical trials: taking individuals who were in the first trials and then bringing them back and boosting them with a new variant protector. We'll be playing a pretty difficult cat-and-mouse game with the coronavirus evolution until we can get a very broad coverage of vaccines.
Keep in mind that most of the rest of the world is not getting access to vaccines. So, there’s still going to need to be a lot of attention paid to preventing the spread. Even if we could get the U.S. under control, keeping it that way will be hard for a while.
I think it's going to be through the year, easily—if not going into the year after. Remember, we still need to get studies done in younger kids, and those are just starting.
Yes. It takes a while to get manufacturing plants up and to get their first products qualified by the FDA. It’s going to help as the Johnson & Johnson [vaccine] rolls out, and then maybe AstraZeneca and Novavax. That’s why the push to enroll in these later trials is important.
We're not trying to vaccinate just the U.S. To control a pandemic, we must vaccinate the world. Some of these vaccines are cheaper to manufacture and are better suited for other parts of the world where there’s less ability to have freezers that are negative 80 degrees.
Initially, we heard about the 95% efficacy with Pfizer and Moderna, so some people were disappointed at the70% efficacy with some of these newer vaccines. But 70% efficacy still has a tremendous impact on reducing spread and reducing hospitalizations, especially in ICUs. People shouldn’t be focusing so much on “this one is better than the other one.” They should be focusing on “this is really impactful on quelling the whole pandemic.”
Also, people still need to wash their hands, wear masks, and maintain social distancing. There are new variants out there, and these vaccines may not be perfect. You’re also setting an example for all the people who haven’t had the opportunity to get the vaccine.