Late Thursday afternoon, the FDA’s vaccine advisory panel voted 17 to 4, with one abstention, to recommend the agency grant emergency use authorization for Pfizer’s COVID-19 vaccine to be administered to people 16 and older. The FDA almost always follows the panel’s recommendations, and the emergency use authorization is expected to happen quickly.
The four members who voted against approval expressed concerns that there was not enough data regarding the effects of the vaccine on 16- and 17-year-olds, and suggested restricting the vaccine to those 18 or older.
The Iowa Department of Public Health’s interim director Kelly Garcia said last week the state expected to receive its first shipment of the Pfizer vaccine during the week of Dec. 13. Plans call for the front-line healthcare workers, as well as long-term care facility residents and their immediate caregivers, to be the first to receive the vaccine.
University of Iowa Hospitals and Clinics CEO Suresh Gunasekaran told reporters on Wednesday that UIHC will be prepared to start vaccinating some of its employees next week, but it isn’t yet clear how many doses of the vaccine UIHC will receive.
“We think, for next week, the number will probably be close to 1,000 doses,” Gunasekaran said. “And we have 18,000 workers.”
Healthcare workers engaged in direct patient care will be prioritized for the vaccine, he said.
During her news conference on Wednesday, Gov. Kim Reynolds said that if the state receives the Pfizer vaccine as expected next week, vaccinations for long-term care residents and caregivers should begin on Dec. 28.
As welcome as the Pfizer vaccine is, the White House Coronavirus Task Force warned in its latest report that the vaccine can’t solve the problem of the ongoing surge of COVID-19.
“The current vaccine implementation will not substantially reduce viral spread, hospitalizations, or fatalities until the 100 million Americans with comorbidities can be fully immunized, which will take until the late spring,” the report stated. “Behavioral change and aggressive mitigation policies are the only widespread prevention tools that we have to address this winter surge.”
More than a quarter of a million Iowans have now tested positive for COVID-19. At 10 a.m. on Thursday morning, the Iowa Department of Public Health reported another 2,246 cases of the virus were confirmed during the previous 24 hours. Those cases, which include 80 residents of Johnson County and 79 residents of Linn County, pushed the total number of the state’s residents who have tested positive since March 8 to 251,028.
The reported number of deaths from COVID-19 also remained high on Thursday, with IDPH disclosing another 99 Iowans had died from the virus. Among the deceased were three residents of Johnson County and four residents of Linn County. The state’s COVID-19 death toll stood at 3,120 on Thursday morning.
According to IDPH, there were ongoing outbreaks of the virus at 141 long-term care facilities on Thursday, and 863 patients in Iowa hospitals have tested positive. One hundred and twenty-four of those hospitalized patients were admitted during the preceding 24 hours, and 189 of them were being treated in intensive care units.
Shortly after 5 p.m. on Thursday, Gov. Reynolds’ office sent out a press release about what the governor called the “FDA approval for the Pfizer vaccine,” which Reynolds said is “great news for the state of Iowa and the entire country.” Although that approval is expected soon, it hasn’t happened yet. Today’s event was just the vote of the advisory panel, which is made up of experts from outside the FDA.
As FDA Administrator Dr. Stephen Hahn pointed out on Twitter around the same time Reynolds’ office sent out the press release, the decision regarding emergency use authorization now moves to the FDA’s staff.
FDA staff feel the responsibility to move as quickly as possible. However, they know they must carry out their mandate to protect the public health & ensure any authorized vaccine meets our rigorous safety and effectiveness standards that the American people have come to expect.
— Dr. Stephen M. Hahn (@SteveFDA) December 10, 2020