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IOWA CITY - University of Iowa Health Care is expanding its role in the global effort to find vaccines against COVID-19 by beginning to enroll volunteers for another trial.
Of the two vaccines already approved for emergency use in the United States, UIHC served as a trial site for the Pfizer-BioNTech option - enrolling 250 participants for the double-blind study that vaccinated half its volunteers.
The new trial in which UIHC is participating is for a Novavax vaccine similar in some ways to the Pfizer and Moderna vaccines already being deployed. But it has differences, too, according to UIHC Executive Dean Patricia Winokur, who directs the campus' Vaccine Treatment and Evaluation Unit.
'The Novavax is a product that is a much more traditional vaccine,” she said. 'The technology that we're using is very similar to some of the flu vaccines that have been approved in the United States.”
The product doesn't use any of the virus itself but rather - like others COVID-19 vaccines already on the market or under development - targets the novel coronavirus' spike protein with messenger RNA.
'Your body creates that spike protein,” Winokur said, explaining the vaccine delivers 'the instruction manual for making that protein.”
'This is the more traditional vaccine where a manufacturing plant produces the spike protein.”
Q: What are other similarities and differences between this trial vaccine and the Pfizer and Moderna products?
A: The Novavax will need two doses, like the others. And they'll come three weeks apart - like the Pfizer vaccine.
'The side effect profile might be a little lower,” Winokur said.
Q: What sort of volunteers is UIHC looking to recruit for this trial, and how many?
A: The UI portion of the trial again will aim for 250 participants ages 18 and up. Researchers, according to Winokur, are specifically interested in recruiting people at higher risk for severe COVID-19 infection; underrepresented populations; and front-line workers.
'I would say this study is pushing more of a 65 and older crowd, and also really wanting those that have high-risk conditions,” she said.
Q: How many total participants is Novavax looking to recruit and how can people volunteer to participate at the UIHC site?
A: The company wants 30,000 total volunteers, and Winokur said her team is looking for people who don't have priority yet but could benefit from vaccination. Having just started recruiting, UIHC hasn't started Novavax trial vaccinations.
Anyone interested in participating can send an email to email@example.com or call (319) 356-4848.
Q: How could this vaccine change the vaccination landscape internationally - if approved?
A: 'This one is going to be a really important trial for those that are interested in understanding how we can vaccinate the world,” Winokur said. 'Because this vaccine is only going to be needed to be stored at refrigerated temperature. This is going to be a much more appropriate vaccine for small practices; if you're getting into other countries that don't have the structure that the U.S. has.
'The other thing that they're saying is that we need a lot of different vaccine platforms because we do think that there are going to be certain populations that respond better to one type of vaccine than another,” she said. 'They also might have different safety profiles for different populations.”
Q: How many vaccine doses has UIHC received so far - of the Pfizer and Moderna products?
A: UIHC received 1,500 Moderna vaccine doses earlier this week and has received two shipments of 975 doses of the Pfizer vaccine - although the campus did get some extra doses in those deliveries, as was reported nationally.
'We were able to extend that a little bit just because there was extra dosing in the vials,” Winokur said. 'So I think that by the time we finished our allotments between Pfizer and Moderna, we were going to have somewhere around 3,900 people vaccinated.”
Q: Do you know how many UIHC employees have deferred the vaccine - after being offered - so far?
A: A UIHC survey showed about 7 percent of its employees were differing.
'But a lot of those already had COVID,” Winokur said. 'So it is a very high uptake in our population.”
Q: Has UIHC been testing employees it has been vaccinating to see whether they currently have COVID-19 or whether they have had it - like through an antibody test?
A: 'We are not testing them,” she said. 'If they have known history of COVID infection within the past 90 days, we're telling them to wait until after 90 days to get vaccinated.”
Q: In trials, researchers found vaccine to be more effective than antibodies a person's system develops after infection, is that correct?
A: 'In the study, the titers that are generated in the blood are actually three or four times higher than those from natural infection,” Winokur said.
Q: What are your thoughts about the variant strain of the coronavirus in the United Kingdom? Are you concerned it might be more transmissible?
A: 'It is part of the normal virus life,” Winokur said. 'This happens with all viruses … They mutate eventually over time. Some viruses mutate faster than others. Coronaviruses are in between. They're not as fast as flu, but they're faster than other types of viruses. So I am not surprised at this.
'Is it going to change things?” she asked. 'I think we have so much infection right now in the United States that I don't think it's going to change things, particularly.”
Q: Do you think the vaccines we're using now will be just as effective against this variant?
A: 'I do think that this vaccine is going to be effective for those mutations that they're seeing,” she said. 'One of the nice things about the vaccine is it's displaying the entire spike protein, so you can develop antibodies to different parts of it. So there are 17 mutations in the spike protein in the UK variant. But they are going to be distributed, and you're going to have opportunities to develop antibodies.”
Q: What percentage of the population will need to get vaccinated to establish herd immunity?
A: Modeling studies have shown Iowa could impact death and intensive care unit admission at 50 percent vaccination, Winokur said.
'But to start to really squelch transmission, we're going to need closer to 70 percent of the population vaccinated,” she said.
Q: Have you 'unblinded” any participants who enrolled in the UI site for the Pfizer trial? If so, how many?
A: UI Health Care has unblinded 133 subjects in health care or long-term care facilities, and 66 of those were 'eligible to be crossed over,” meaning they got the placebo in the trial and can now get the vaccine.
Q: What are your thoughts on the recently-approved rapid tests expected to become available at drugstores in the near future?
A: 'They're going to have a high false positive and a false negative rate,” Winokur said. 'And so oftentimes with these rapid tests, if it's positive, we believe it. If it's negative, and the symptoms are consistent with COVID-19, we ask them to get a PCR test, which is a more accurate test.”
Q: Do you have any idea when the vaccine will be available to the general public, and whether UIHC will be involved in distribution?
A: 'We don't have any information on that right now just because the numbers of doses are so limited,” Winokur said, noting UIHC is taking direction on how to use its doses now from state and local public health officials.
Q: Are companies doing research yet on vaccine efficacy and safety for children and pregnant women?
A: 'The studies are being designed right now, and I know Pfizer is starting to solicit interest of sites for doing pregnant women … that's one of their priority populations,” she said. 'But there are no studies that have been started.”
Q: My last question comes from my 7-year-old. If Santa is magic, why couldn't he just vaccinate everyone for Christmas?
A: He's very busy right now, she said.
'But that's going to be his next project.”
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