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‘Heartening’ COVID Vaccine News Shared by University of Iowa

University of Iowa Health Care is one of the clinical trial sites for a Pfizer COVID-19 vaccine that's enrolled 44,000 subjects and overnight upgraded its previously announced 90 percent efficacy rate to 95 percent.

by Vanessa Miller, The Gazette, Cedar Rapids, Iowa / November 18, 2020
Nov. 18—IOWA CITY — Despite reaching a new high of 100 COVID-19 patients Wednesday and revealing plans to enter a second phase of its surge plan next week, University Iowa Health Care scientists are sharing hopeful affirmations of vaccines on the horizon showing far better efficacy than expected or hoped.
"This data is better than any of us anticipated," UI Carver College of Medicine Executive Dean and Vaccine Treatment and Evaluation Unit Director Patricia Winokur told Iowa's Board of Regents on Wednesday.
"We were hoping that it would be somewhere around 60 or 70 percent effective," she said. "The fact that it's 95 percent effective is very heartening."
UIHC is serving as one of the clinical trial sites for a Pfizer COVID-19 vaccine that's enrolled 44,000 subjects and overnight upgraded its previously announced 90-percent efficacy rate to 95 percent, according to Winokur.
Describing what that rate means for the prospective vaccine — which has undergone months of testing by giving half enrolled participants a placebo — Winokur said Pfizer has identified 170 COVID-19 infections among its pool of 44,000 research subjects.
About 95 percent of those, 162 specifically, were in the placebo group — meaning they didn't take the vaccine.
"Only eight occurred in the vaccine group," Winokur said, noting Pfizer identified 10 instances of "severe infection" in their study. "Nine of which were in the placebo group. So lots of very promising data — better than we anticipated."
Moderna, in fast pursuit of a similar COVID-19 vaccine, also is reporting 95 percent efficacy among its 30,000 study participants. Now, Winokur said, the companies are following safety protocols — watching for side effects and ensuring the vaccines don't backfire and increase disease severity.
Side effects reported so far are mild and typical — like those that can occur with seasonal flu vaccines, according to Winokur. Results to date show participants ages 18 to 64 reported fever, chills, and fatigue more often than those between 65 and 85. And more reported the short-lived side effects following the second of two required doses.
"The luxury of having participated in this Pfizer vaccine trial is I've seen firsthand how significant these side effects are," Winokur said. "And I will tell you, most people continue to work. Most people have a very abrupt stop of their fatigue, usually after 24 hours, very occasionally lasting 48 hours. They responded very nicely to Tylenol or ibuprofen.

"So it was not anything that was concerning."
Thus Winokur stressed the importance of educating Americans and Iowans on the normalcy of some of these findings and the process scientists and the Food and Drug Administration are taking in churning out a COVID-19 vaccine as fast as safely possible.
"I can't decide whether I like the term 'operation warp speed,'" she said, referencing the federal initiative to create and distribute a vaccine. "Early on, it sounded great. We were all excited to get this vaccine started very quickly. But I think it has backfired a little bit, and it's really established a little bit of suspicion in the public."
Using a graphic showing just how remarkable the COVID-19 vaccine development has been, Winokur explained — for example — the first Dengue outbreak emerged in 1906 and 39 years passed before the first phase of a clinical trial for a vaccine began.
That gap was 27 years for Ebola. But recent work on similar coronavirus' like SARS and MERS paved the way for "warp speed" COVID-19 progress, Winokur said.
"It is because of the scientific discovery that went on, understanding SARS and MERS, that we have been able to make such tremendous progress in understanding the virus that causes COVID-19," she said.
In further arguing the validity and thoroughness of the COVID-19 vaccine development, Winokur said, typical trials distribute experimental vaccines to 1,000 to 3,000 people.
"Think about it. We have 44,000 people that were studied with the Pfizer vaccine, 30,000 people that were studied with Moderna," she said. "That's 30 to 35,000 people that got active vaccine — tenfold above what we normally see in an approval process."
The period of time scientists are waiting to observe side effects extends through the most critical time — when issues, if they do occur, might manifest.
"So we are not really skimping on safety the way a lot of people are worried that we are," she said. "We have huge numbers of people that have been studied."
And, highlighting one more bright spot from recent vaccine work, Winokur said they've shown to be potentially more protective than natural antibodies developed from actually contracting the virus.
"That is a great result, because it suggests that these (antibody) titers may last a little bit longer, and may have more protections, than even the natural infection," she said.
'Very Long Pandemic'
Despite that hopeful outlook, UIHC administrators on Wednesday also reported a stressed staff — strained under the weight of a dragging pandemic that's worsening instead of waning.
After UIHC on Monday reported 85 COVID-19 inpatients, its CEO Suresh Gunasekaran on Wednesday told regents the campus is up to "100 patients in house," a peak, out of its total 850 beds. Before deploying a first phase of its surge plan earlier this month, UIHC had 100 intensive care unit bed.
That total has expanded under the surge plan, and Gunasekaran said to expect another surge phase enacted next week. That could involve another increase in bed capacity, expanded access to its flu-like-illness clinic, and more visitor restrictions.
Limits already in place restrict adult visiting hours to between 1 p.m. and 3 p.m., when it used to be 1 p.m. to 5 p.m. Visitors also can't stay during surgeries or procedures, to avoid loitering.
"These visitor restrictions are not anything that I take pleasure in," Gunasekaran said. "I think it's really important, when you're having these kinds of things happen at the university, to have a visitor. But with the high positivity rate in the community, it just didn't seem safe."
The hospital system has had to reassign employees to manage call, clinic, and inpatient volumes. An email went out Tuesday evening from UIHC's director of advanced practice providers asking the campus' advanced registered nurse practitioners to help in the ICU.
"I have a very important and humble request," wrote Director Maria Lofgren. "During these absolute unprecedented times — we are in desperate need of help for NURSES in our ICUs. I know many of you came into the ARNP role as previous, outstanding ICU nurses."
She reported having contacted the Iowa Board of Nursing to confirm, "You are legally able to work as registered nurses."
UIHC officials confirmed for The Gazette the reassignment, but said no one will take a pay cut if they volunteer to help in a lower-paid position.
In fact, Gunasekaran and Vice President for Medical Affairs Brooks Jackson on Wednesday morning emailed employees to thank them for their efforts and offer a "special lump sum payment of $600 to be paid on December 1 to approximately 11,500 team members."
That, according to the message, includes nurses and caregivers, service employees, maintenance workers, lab technicians, and clerical staff.
The university still is, however, "continuing down the path of having staff give back vacation or take unpaid leave as one of our expenses management activities," according to UIHC Chief Financial Officer Bradley Haws.
With the campus continuing to crowd and take a growing number of COVID-19 patients from more rural maxed-out hospitals and clinics, Gunasekaran urged Iowans to double down on precautions — particularly as the holidays approach.
"It has been a very long pandemic for our staff," he said.
(c)2020 The Gazette (Cedar Rapids, Iowa)
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