Doctors alarmed as FDA suggests ’emergency use’ of COVID-19 vaccine, bypassing trials

Epidemiologists and vaccine experts are alarmed by Food and Drug Administration Commissioner Stephen Hahn’s recent assertion that he will consider approving a coronavirus vaccine before the completion of late-stage clinical trials.

The FDA commissioner can issue a so-called emergency use authorization (EUA) on his own if he determines the benefits of rushing the vaccine into production outweigh the risks, but several vaccine experts told Yahoo News they are deeply concerned by the idea. No vaccine has ever been approved on an EUA basis, said Dr. Peter Hotez, a top vaccine expert, except once to overcome unusual technicalities on a military anthrax vaccine.

“We don’t do EUAs for vaccines,” Hotez said. “It’s a lesser review, it’s a lower-quality review, and when you’re talking about vaccinating a large chunk of the American population that’s not acceptable.”

On Aug. 23, President Trump called a press conference to announce an EUA for convalescent plasma to treat COVID-19, which was controversial in its own right, but the people who might receive it are already sick; vaccines by definition are given to healthy people. In that light, it is vital that clinical trials be allowed to run their course, especially given the novel approaches some labs are employing in their coronavirus vaccine efforts, said Hotez, a professor of pediatrics and the dean of the School of Tropical Medicine at Baylor College of Medicine.

Hotez said he is troubled by the mixed messages coming from the Department of Health and Human Services, which oversees the FDA and the Centers for Disease Control and Prevention and has led the coronavirus response. The president’s Operation Warp Speed effort to find a vaccine by the end of the year has further confused the public, Hotez said, since there has been little to no communication about what is happening behind the scenes.

“This has created a vacuum that’s allowed the anti-vaccine lobby to fill, and we have a very aggressive anti-vaccine lobby in the United States,” Hotez said. He said that since the anti-vaccine forces have criticized vaccines as unsafe and as the byproducts of a rushed and “conspiratorial” process, it is risky to even consider — much less publicly discuss — cutting corners in the race to approval.

In an interview with the Financial Times over the weekend, Hahn insisted that if he determines a vaccine is safe enough for an EUA, it will be a “science, medicine, data decision. This is not going to be a political decision.” 

Administration officials first signaled they were willing to consider authorization for a coronavirus vaccine without completing trials over the summer. The Financial Times reported in late July that in a meeting with House Speaker Nancy Pelosi, Treasury Secretary Steven Mnuchin and White House chief of staff Mark Meadows suggested emergency use authorization for a vaccine without completing trials.

Dr. Paul Offit, the co-inventor of the rotavirus vaccine and a pediatrician at Children’s Hospital of Philadelphia, said he worries Hahn is being pressured by the administration, particularly in the wake of the FDA approval of hydroxychloroquine and convalescent plasma as treatments for coronavirus infection without adequate evidence they work and are safe. 

“There was never a controlled study [of convalescent plasma] so that’s the second example of something that has not been shown to work that has now been approved by the FDA under EUA, and you have the president standing up there saying, ‘This is a breakthrough therapy,’ which it’s not,” Offit said. “I think people can reasonably worry [about political pressure] now. … You see the FDA making decisions that you don’t think it would normally make so why is that?”

“You do get the sense [Hahn’s] being pressured,” Offit added. “You do get the sense that he serves at the behest of the president instead of at the behest of the American public. You do get that feeling. I hope I’m wrong.”

13 PHOTOSCoronavirus vaccine trial in SeattleSee GalleryCoronavirus vaccine trial in SeattleA pharmacist gives Jennifer Haller, left, the first shot in the first-stage safety study clinical trial of a potential vaccine for COVID-19, the disease caused by the new coronavirus, Monday, March 16, 2020, at the Kaiser Permanente Washington Health Research Institute in Seattle. (AP Photo/Ted S. Warren)Jennifer Haller poses for a photo in the living room of her home, Monday, March 16, 2020, in Seattle. Earlier in the day, Haller was the first person to receive a shot of a potential vaccine for COVID-19, the disease caused by the new coronavirus, at the start of the first-stage safety study clinical trial of the vaccine at the Kaiser Permanente Washington Health Research Institute in Seattle. (AP Photo/Ted S. Warren)Pharmacist Michael Witte opens a package taken from a freezer that contains the potential vaccine for COVID-19, the disease caused by the new coronavirus, on the first day of a first-stage safety study clinical trial of the vaccine, Monday, March 16, 2020, at the Kaiser Permanente Washington Health Research Institute in Seattle. (AP Photo/Ted S. Warren)Pharmacist Michael Witte, left, gives Rebecca Sirull, right, a shot in the first-stage safety study clinical trial of a potential vaccine for COVID-19, the disease caused by the new coronavirus, Monday, March 16, 2020, at the Kaiser Permanente Washington Health Research Institute in Seattle. Sirull is the third patient to receive the shot in the study. (AP Photo/Ted S. Warren)Jennifer Haller is reflected in a mirror as she waits in an exam room before she was given a shot in the first-stage safety study clinical trial of a potential coronavirus vaccine, Monday, March 16, 2020, at the Kaiser Permanente Washington Health Research Institute in Seattle. Haller was the first person to receive the shot in the study. (AP Photo/Ted S. Warren)Pharmacist Michael Witte, left, gives Neal Browning, right, a shot in the first-stage safety study clinical trial of a potential vaccine for COVID-19, the disease caused by the new coronavirus Monday, March 16, 2020, at the Kaiser Permanente Washington Health Research Institute in Seattle. Browning is the second patient to receive the shot in the study. (AP Photo/Ted S. Warren)The first clinical trials to find a coronavirus vaccine have begun at a hospital in Seattle. A total of 45 men and women have volunteered to be injected. Unlike most vaccines, these COVID-19 vaccines have not been tested on mice, and will go directly to humans due to the urgent need for the drug. Lisa Guerrero spoke with Neal Browning, one of the men who is participating in the trial. He explained what he has to go through as part of this brave new experiment.The first clinical trials to find a coronavirus vaccine have begun at a hospital in Seattle. A total of 45 men and women have volunteered to be injected. Unlike most vaccines, these COVID-19 vaccines have not been tested on mice, and will go directly to humans due to the urgent need for the drug. Lisa Guerrero spoke with Neal Browning, one of the men who is participating in the trial. He explained what he has to go through as part of this brave new experiment.Pharmacist Michael Witte, left, gives Rebecca Sirull, right, a shot in the first-stage safety study clinical trial of a potential vaccine for the coronavirus, Monday, March 16, 2020, at the Kaiser Permanente Washington Health Research Institute in Seattle. Sirull is the third patient to receive the shot in the study. (AP Photo/Ted S. Warren)Dr. Lisa Jackson, a senior investigator at the Kaiser Permanente Washington Health Research Institute, poses for a photo, Sunday, March 15, 2020, in Seattle. Jackson is leading the first-stage safety study clinical trial of a potential vaccine for COVID-19, the disease caused by the new coronavirus, which was given to the first volunteer in the study by injection, Monday, March 16 in Seattle. (AP Photo/Ted S. Warren)Dr. Lisa Jackson, a senior investigator at the Kaiser Permanente Washington Health Research Institute, works in her office with an image of COVID-19 taped to her door, Sunday, March 15, 2020, in Seattle. Jackson is leading the first-stage safety study clinical trial of a potential vaccine for COVID-19, the disease caused by the new coronavirus, which was given to the first volunteer in the study by injection, Monday, March 16.(AP Photo/Ted S. Warren)Rebecca Sirull, center, poses for a photo with her roommates, Anna Thomas, left, and Madeleine Busch, Monday, March 16, 2020, at the home they share in Seattle. Earlier in the day, Sirull was the third person to receive a shot of a potential vaccine for the COVID-19 coronavirus at the start of the first-stage safety study clinical trial of the vaccine at the Kaiser Permanente Washington Health Research Institute in Seattle. (AP Photo/Ted S. Warren)Rebecca Sirull works on her laptop, Monday, March 16, 2020, at her home in Seattle. Earlier in the day, Sirull, an editorial coordinator for the Institute for Health Metrics and Evaluation, was the third person to receive a shot of a potential vaccine for the COVID-19 coronavirus at the start of the first-stage safety study clinical trial of the vaccine at the Kaiser Permanente Washington Health Research Institute in Seattle. (AP Photo/Ted S. Warren)Up Next

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Offit recalled that just a couple of days before a vital meeting to discuss an EUA for convalescent plasma, Trump publicly criticized the FDA for being staffed by the “deep state.” Shortly after that, Offit said, Hahn flew back to Washington from Colorado to meet with the president to make sure [Trump] was “OK with what’s going on.”

Offit said that because all of the vaccines now being tested are being developed with novel strategies that have never been used commercially before, it is that much more critical to collect data in large-scale trials before the vaccine is “put out there to a group that is going to [initially] consist of mostly healthy [essential workers] who are unlikely to die from this virus” even if they did contract it.

All of the vaccine experts Yahoo News spoke with also worried that the public will be wary of a vaccine that is perceived as having been rushed into production for political reasons.

“I think there are physicians in practice and public health authorities who would express a lot of skepticism about the decision [to approve a vaccine on an EUA, which would imperil the whole concept of distributing the vaccine,” said Dr. William Schaffner, an infectious disease specialist at the Vanderbilt University Medical Center. “If the vaccine is widely distributed, you can actually reduce the transmission of the virus — and if many people withhold themselves from the vaccine and don’t get it because they’re nervous about this whole process … we will not be able to substantially diminish the transmission of this virus in our communities.”

Dr. George Rutherford, an epidemiologist at the University of California, San Francisco, said there have been devastating side effects to vaccines in the past that have not surfaced until after clinical trials have finished. 

For example, one of the early rotavirus vaccines was found to cause a rare but serious side effect called intussusception, which leads to a telescoping of the intestines, Rutherford said. A surgical emergency in children, intussusception occurred in about 1 in 100,000 patients. Rutherford said this side effect wasn’t seen until after trials were completed “so that’s something that’s racking around in everybody’s minds about rare side effects.”

“Sometimes the side effects are so rare that they don’t show up until 100,000 people have gotten it,” Rutherford said. “I think that’s the sort of stuff that we really have to be careful about.”

News reports have suggested that Trump is hoping to pull off an “October surprise” with an early vaccine release. Rutherford said the prospect of that terrifies him. 

“This whole October surprise thing is just chilling — to think that somebody would try and game this like that,” Rutherford said. 

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