Scientists, doctors, and public heath experts are expressing serious concerns following a Sunday interview in which the head of the U.S. Food and Drug Administration said he was willing to bypass the normal approval process to authorize deployment of a Covid-19 vaccine before stringent safety testing is completed.
FDA Commissioner Stephen Hahn told the Financial Times on Sunday that his agency was prepared to approve a vaccine before Phase 3 clinical trials were complete, if government officials believe the benefits of doing so outweighed the risks.
“It is up to the sponsor [vaccine developer] to apply for authorization or approval, and we make an adjudication of their application,” Hahn told the UK-based business paper. “If they do that before the end of Phase 3, we may find that appropriate, we will make a determination.”
Hahn insisted that the government’s decision would not be influenced by election year political pressure.
“This is going to be a science, medicine, data decision,” he said.
Many public health experts, however, expressed skepticism about Hahn’s claims.
“We absolutely cannot tolerate or accept an emergency authorization for any Covid-19 vaccine without reliable safety and efficacy data from Phase 3 clinical trials,” Dr. Angela Rasmussen, a virologist at Columbia University in New York, tweeted on Sunday.
“Circumventing clinical trials by issuing an EUA [emergency authorization]… would place huge numbers of people at risk for massive potential harm,” she wrote.
“It makes a mockery of the very serious protections put in place to conduct clinical research ethically,” Rasmussen added.
Writing in The Lancet last week, a group of medical experts acknowledged the need for “efficient, speedy, and reliable evaluation of many candidate vaccines against Covid-19.” However, they warned that “political and economic pressures for rapid introduction of a… vaccine could lead to widespread deployment of a vaccine that is really only weakly effective… perhaps because of a misleadingly promising result from an underpowered trial.”
“Deployment of a weakly effective vaccine could actually worsen the Covid-19 pandemic if authorities wrongly assume it causes a substantial reduction in risk, or if vaccinated individuals wrongly believe they are immune,” the experts added.
Hahn insisted that the potential benefits outweighed the dangers, justifying the emergency authorization.
“Our emergency use authorization is not the same as a full approval,” he told FT. “The legal, medical, and scientific standard for that is the benefit outweighs the risk in a public health emergency.”
Numerous experts pointed to last week’s announcement by President Donald Trump that the FDA had issued an Emergency Use Authorization for blood plasma treatment of Covid-19 after the president, Hahn and Health and Human Services (HHS) Secretary Alex Azar claimed the treatment reduced deaths from the disease by 35%. It did not, and Hahn was subsequently forced to apologize amid stinging criticism from experts.
“I can’t remember a mistake by the FDA or the commissioner as serious as this one,” Dr. Eric Topol of the Scripps Translational Science Institute in La Jolla, California told NPR after Hahn’s false claim.
“You saw the FDA be bullied by the president of the United States into approving something that they didn’t want approved earlier, because he wanted them to do that,” Dr. Paul Offit, director of the Vaccine Education Center at Children’s Hospital in Philadelphia, said in an August 24 interview with the Journal of the American Medical Association.
Both China and Russia have approved vaccines before completing Phase 3 trials, drawing criticism from Dr. Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, who has questioned whether the Russian vaccine—which President Vladimir Putin claims his own daughter has received—is safe or effective.
The FDA has come under increasing pressure in recent weeks as Trump seeks to roll out a vaccine before the November 3 presidential election. To that end, HHS in June announced Operation Warp Speed, a public-private initiative headed by a former pharmaceutical executive, which the agency said “aims to deliver 300 million doses of a safe, effective vaccine for Covid-19 by January 2021.”
On Friday, HHS Deputy Secretary Paul Mango said the government is “very pleased” with vaccine progress. “We feel we are absolutely on track—if not a little bit ahead—in terms of our overall objective,” he added.
Trump has frequently been at odds with the FDA, which he has baselessly attacked as part of a “deep state” conspiracy.
“The deep state, or whoever, over at the FDA is making it very difficult for drug companies to get people in order to test the vaccines and therapeutics,” the president tweeted on August 22. “Obviously, they are hoping to delay the answer until after November 3.”
Pharmaceutical companies are currently manufacturing three of six vaccine candidates funded by Operation Warp Speed. Two of the six potential vaccines are currently in Phase 3 trials, according to the U.S. Department of Defense.
According to an August CNN poll, fully 40% of Americans do not want to receive a coronavirus vaccine when it becomes available, even if it is free and convenient. This, experts say, could hinder efforts to control the Covid-19 outbreak by preventing herd immunity. One Harvard Medical School professor said that establishing an independent panel might increase public trust in any potential vaccine.
“I’m hearing this from my peers, from doctors and nurses; they’re not anti-vaxxers,” Dr. Kathryn Stephenson told CNN. “They’re pro-vaccine. They vaccinated their own children. But they are skeptical about this vaccine.”
The number of total worldwide coronavirus cases topped 25 million on Sunday, with more than 6 million confirmed cases in the United States. More than 840,000 people around the world have died from the virus, with 183,000—or more than 1 in 5—of those deaths occurring in the U.S.
Numerous states including Iowa, North Dakota, and South Dakota—where hundreds of thousands of motorcycle enthusiasts gathered this month for the annual Sturgis Rally—are reporting a record number of new cases.