The new Pfizer vaccine has clearly met the success criteria and is a “homerun,” according to an expert who spoke during Tuesday morning’s news conference at the University of Kansas Health System.
Dr. Gregory Poland, a vaccinologist and the founding director of the Mayo Clinic’s Vaccine Research Group, said the trials for the vaccine measured efficacy seven days after giving the second dose and found an efficacy rate of 95 percent. The estimate did not vary by age , gender, race and comorbidities, which is why he called it a “homerun,” he said.
The emergency use authorization for the Pfizer vaccine is likely to be approved on Thursday by the FDA, he said, and if it is, it will be possible to start vaccinations on Friday. Front-line health care workers and nursing home residents are on the list to receive the first vaccines.
While efficacy is easy to measure, safety is different, Dr. Poland said. They now have two to three months of safety data after the second dose was given to trial participants, he said. From 95 to 100 percent of any serious vaccine reactions generally occur within six weeks of receiving a vaccine, he said. He doesn’t expect different safety results because of the time interval of the studies.
He said the main differences of the Pfizer and Moderna vaccines were in storage and logistics. The Moderna vaccine needs to be kept at minus 20 degrees, refrigerated up to 30 days and at room temperature for no more than 12 hours, he said. That’s different from Pfizer’s vaccine, which is stored at minus 75 (or minus 104 Fahrenheit), kept refrigerated only for five days, and at room temperature only a maximum of two hours.
“That does induce a logistical and administrative burden on people as they are trying to receive, store and administer this vaccine, particularly in any sort of mass administration,” he said.
Dr. Dana Hawkinson, medical director of infection prevention and control for the KU Health System, said they have plenty of space for the vaccine at the health system, and could store up to 300,000 doses should they deliver that many.
It was recently reported that the United States ordered its first tranche of vaccines and didn’t order the second tranche, which is now going to different countries, Dr. Steve Stites, chief medical officer at KU Health System, said.
Dr. Poland said that was puzzling, and that Pfizer production capacity in January will increase. Instead of 100 million doses by the end of the year, Pfizer is talking 40 to 50 million, and this is a two-dose vaccine, Dr. Poland said.
Dr. Poland said to achieve herd immunity, the population would need to be about 70 percent vaccinated. The 95 percent rate means 5 percent of the people who get the vaccine will not be protected.
The idea of herd immunity through trying to get COVID-19 has been called unethical by Dr. Anthony Fauci, one of the leaders of the White House Coronavirus Task Force, and even Sweden has now rejected the possibility of reaching herd immunity that way, Dr. Poland said. They suffered enormous numbers of deaths compared to surrounding countries and have now rescinded their earlier policy.
For the most part, efficacy studies have involved individuals who wore masks, washed hands and were safely distanced from others, he said. The efficacy of the vaccine among people who don’t observe these measures, he said, was not known.
Dr. Poland said if a very large proportion of the population can get vaccinated, from 70 to 90 percent, they can get back to some degree of normalcy rapidly. But the paradox of the people not following masking and distancing is they are going to lose many more people than they need to, and the pandemic will last many more months longer than it needed to.
The best estimate is one out of 700 Americans will have died of this virus by the first quarter of 2021, Dr. Poland said, “and yet we can’t be inconvenienced with wearing a piece of cloth over our faces?”
He urged people not to be misled by those who are not scientists. It is not political, religious or economic, he said, but it is a medical issue.
On Tuesday morning, KU Health System reported an increased number of COVID-19 inpatients. There were 94 active COVID-19 cases in the hospital, up from 82 on Monday, according to Dr. Hawkinson. There were 52 patients in the intensive care unit, an increase from 47 on Monday, and 25 of the ICU patients were on ventilators, a decrease from 28 on Monday. There were another 62 patients still in the hospital and out of the acute infection phase, up from 59 on Monday, for a total of 156 COVID-19 patients, an increase from 141 on Monday.
HaysMed in Hays, Kansas, reported a total 28 COVID-19 inpatients, an increase from 25 on Monday. Twenty-four were active patients and four were in the recovery phase.
The KU doctors’ news conference is online at https://www.facebook.com/kuhospital/videos/186807629820339.