CORONAVIRUS

University of Iowa seeks volunteers for COVID-19 vaccine trial

Novavax shots don't require ultra cold storage of other two

Syringes of the Pfizer-BioNTech COVID-19 vaccine are seen Dec. 14 at University of Iowa Hospitals and Clinics in Iowa Ci
Syringes of the Pfizer-BioNTech COVID-19 vaccine are seen Dec. 14 at University of Iowa Hospitals and Clinics in Iowa City. UIHC is seeking volunteers to test another COVID-19 vaccine that does not require the ultra cold storage at the Pfizer vaccine. (Andy Abeyta/The Gazette)

IOWA CITY — University of Iowa Health Care is continuing to recruit volunteers to participate in another large COVID-19 vaccine trial as worsening pandemic conditions indicate clear need for more vaccination options according to UIHC Executive Dean Patricia Winokur.

“There’s a lot of information out today that really suggests that we need more vaccines,” Winokur, who directs UIHC’s Vaccine Treatment and Evaluation Unit, told reporters Friday. “We have two emergency use-approved vaccines … But, as everybody can see, we just don’t have enough vaccine to deliver to those that are most in need, and certainly not enough to everybody who wants vaccine.”

With the state and nation still prioritizing health care workers and long-term care facility residents for its limited supply of Pfizer-BioNTech and Moderna vaccines, UIHC on Friday reported 7,630 of its 16,000-some workers have had a first dose and 331 have had both doses needed to achieve 95 percent efficacy.

UIHC — which Friday reported 17 COVID inpatients — has been using its vaccine allotment within seven days of receiving it, even as some states and health care providers have reported lengthy delays in getting their doses into American arms.

The state of Iowa has received 191,675 vaccine doses, according to Friday statistics from the U.S. Centers for Disease Control and Prevention, which reported 74,224 Iowans have received a first dose — about 2 percent of the state’s population.

Beyond the need for greater vaccine quantity, Winokur on Friday told reporters new trials address an international need for greater vaccine diversity.

“There’s a lot of good reasons to try and study multiple types of vaccine,” she said. “We know that there are people that can have allergic reactions to a certain type of vaccine. They may be able to take a different type of vaccine. There are some age populations that respond to one type of vaccine better than another.”

Vaccine trials

The new Novavax trial — UIHC began enrolling volunteers this week — offers a vaccine that does not require extremely cold storage, making it better for large-scale distribution to all corners of the globe.

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“If you look at how this vaccine is stored, it is stored at refrigerated temperatures,” Winokur said. “So if you’re thinking about a vaccine that might be more easily given in a private practitioner’s office, maybe in a country that doesn’t have quite the infrastructure that the United States has, this would be a great vaccine if it turns out to be as effective as the others.”

UIHC served as a trial site for the now Pfizer vaccine and is among multiple sites for the Novavax trial, which aims to enroll 30,000 participants. The UI site began administering shots Monday, with plans to involve 250 participants.

So far, about 25 trial volunteers have received injections at UIHC, which is recruiting men and women over age 18 — particularly those over 65; individuals with medical conditions, like obesity and diabetes, that put them at risk for severe disease; underrepresented populations; and essential workers.

Instead of giving the trial vaccine to just half the participants, with the other half getting a placebo — like the Pfizer and Moderna trials — Winokur said two-thirds of those in this trial will get the actual vaccine. Novavax is opting for that approach in hopes of enticing more participants at a time when actual vaccine is being distributed.

Although many UIHC workers participated in the campus’ Pfizer trial months ago, thousands to date have been prioritized for the authorized vaccine — shrinking that pool of trial prospects. Winokur said some UIHC workers still want to participate in the Novavax investigation.

“I have a few people that actually want to be in this trial, and they have chosen not to get the messenger RNA vaccines,” Winokur said about the Pfizer and Moderna vaccines. “One person is one of our physicians, and his reasoning was that he thought this was a vaccine that was better for the world.”

Timetable

Should the Novavax trial follow the same path as Pfizer and Moderna, Winokur said, Novavax could have enough data to apply for emergency use around March.

While the Pfizer and Moderna vaccines use messenger RNA to generate a recipient’s immune response, this Novavax candidate creates immunity by injecting part of the “outer coat” of the novel coronavirus along with a compound.

“Because the vaccine does not contain the whole virus, it cannot cause COVID-19,” according to UIHC. “This so-called subunit vaccine is the same technology that has been used previously for seasonal flu shots.”

That, Winokur said, might quell some public concern.

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“I think some people might feel more comfortable having that more traditional technology,” she said.

Among the UIHC administrators who received a COVID vaccine dose early on — in hopes of instilling public confidence — Winokur said she’s now had both doses and had few side effects.

“I actually did really well,” she said.

Biden strategy

This week’s instigation of a second UI COVID vaccine trial comes as President-elect Joe Biden on Friday broke from the Trump administration by committing to release nearly every available dose of COVID vaccine instead of holding half to ensure administration of second doses.

When asked about that strategy, Winokur told reporters two doses clearly provide more protection than one. But national experts are weighing whether getting more people partially protected is better than getting fewer people fully protected — and whether doing so could ease some of the pressure on hospital systems.

Before endorsing one method over another, Winokur said she would need to know more about the modeling of vaccine production and distribution and how likely the country is to have second doses available if it uses its full supply now.

“Because that’s the key. If it’s going to still take a long time to get that second dose, then I think that might not be a good strategy,” Winokur said, noting long delays in second doses — well beyond the recommended three or four weeks — could weaken the vaccine’s efficacy.

“If you can get that second dose into people within two to three months, it may be a good decision.”

Volunteers in the Novavax trial will get two doses of vaccine 21 days apart. They’ll be evaluated over eight to 10 visits for safety, effectiveness and side effects — with researchers continuing to follow them for up to two years to see if they develop COVID symptoms.

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For more information, visit https://redcap.link/Novavax, or call (319) 356-4848, or email recruit-vaccine-research@uiowa.edu

Comments: (319) 339-3158; vanessa.miller@thegazette.com

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