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IOWA CITY - Following Monday's news that a Pfizer coronavirus vaccine under development has proved - upon an early analysis - more than 90 percent effective in preventing COVID-19 in participants, University of Iowa doctors involved in the trial confirmed that's high and above expectations.
'Ninety percent is really good,” Pat Winokur, UI College of Medicine executive dean and principal investigator on the UI portion of the Pfizer vaccine trial, told reporters Monday.
'Influenza, for example - a vaccine that most of us, especially in health care, take every year - has a vaccine efficacy of 50 to 70 percent. So this is much better than that,” she said. 'We were worried … we had hoped there would be at least 50 to 70 percent.”
To see a 90-percent effective rate among the tens of thousands of participants in the trials globally is 'wonderful,” Winokur said.
'Absolutely I will be in line to get that vaccine if I'm priority,” she said.
UI Chief Pharmacy Officer Mike Brownlee, who is codirecting UIHC's vaccine distribution planning, agreed.
'That's a very high percentage, and I was very encouraged to see that,” he said. 'So I'll be in line as well.”
Pfizer and collaborator BioNTech announced the early findings from its COVID-19 vaccine trial Monday morning, raising the possibility some distribution could begin in the coming months to high-risk and high-priority populations.
To be sure, Monday's announcement doesn't mean for certain that a vaccine of that potency is imminent. This interim analysis, from an independent data monitoring board, looked at only a relatively small sample.
The study is continuing and Pfizer cautioned that the protection rate might change as more COVID-19 cases are added to the calculations.
Brownlee cautioned that widespread distribution of any vaccine remains many months off while coronavirus concerns remain urgent - with Iowa breaking records in infections and hospitalizations.
He urged Iowans to continue to wear masks, social distance, avoid gatherings and wash hands frequently.
The promising early findings from the vaccine trial raise the likelihood the world will at some point have an effective tool for mitigating COVID-19 infections.
'The fact that it's that high does mean that it will start to have an impact on truncating that curve and flattening the curve faster,” Winokur said. 'So that was one of the really powerful things about seeing that 90 percent.”
The Pfizer trial entered its third phase in late July, when the UI joined the effort to enroll some of the more than 40,000 total participants. The UIHC portion has involved about 270 individuals - half getting active vaccine and another half getting placebo.
'The case split between vaccinated individuals and those who received the placebo indicates a vaccine efficacy rate above 90 percent, at seven days after the second dose,” according to a Pfizer statement. 'This means that protection is achieved 28 days after the initiation of the vaccination, which consists of a two-dose schedule.”
Winokur confirmed UIHC's portion of the study did involve some positive COVID-19 cases, but she doesn't know how many - her team was 'blind” to that information. And she stressed research remains ongoing, as trial participants must be followed for safety-related concerns, side effects and efficacy issues for two years.
Pfizer and BioNTech estimated two months of safety data is required by the Food and Drug Administration for potential 'emergency use authorization.” Once the data goes to the FDA, external reviewers will assess it - a process taking two to three weeks, according to Winokur.
'So sometime in December would be when we would be expecting the earliest approval from the FDA for emergency use authorization,” she said. 'Then you'd have to start delivering the vaccine and go into all the difficult decisions. … Who's going to get the vaccine? How they're going to store it? Who's going to get priority for delivery?”
Brownlee said the UIHC vaccine distribution team began meeting more than a month ago to discuss the complex issues involved in distribution - and one of the first things they did was acquire four freezers to store both the Pfizer vaccine, which has to be stored between minus 60 to minus 80 degrees Celsius, and another Moderna candidate vaccine, which can be stored at minus 20 degrees.
'So actually Monday of last week we received all four of the freezers that we had ordered to store the vaccines, so we're prepared to store both types of vaccine when and if they're approved by the FDA,” Brownlee said.
Those freezers provide capacity to store hundreds of thousands of vaccine doses, he said.
The Iowa Department of Public Health is granting authority over vaccine distribution prioritization to local public health departments. So Brownlee said UIHC is working with Johnson County Public Health 'as we look forward into the future with what prioritization might look like.”
In that front-line workers are expected to be among the priorities, he said, 'We do know that health care workers will be at the top of the list from a vaccine perspective.”
Brownlee said he can't say how many doses of the vaccine the entire state of Iowa would receive. And he noted UIHC won't have any advantage in receiving more because of its involvement in the trial.
'The advantage is that we've got experts here that have been able to contribute to the vaccine trials - like Dr. Winokur - and we're very fortunate to have that kind of expertise here on campus to help us with our planning,” he said.
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The Associated Press contributed.