Would you volunteer to be infected with COVID-19 to help develop a vaccine?
Reps. Bill Foster, D-Ill., and Donna Shalala, D-Fla., are urging the FDA to take more risks — including infecting young and healthy volunteers— to quickly develop a COVID-19 vaccine.
If you are young and healthy, would you volunteer to be infected with COVID-19 to help quickly develop a vaccine? With the pandemic sweeping the globe, it’s a reasonable question to be asking.
A group of 35 lawmakers, led by Reps. Bill Foster, D-Ill., and Donna Shalala, D-Fla., are urging the Food and Drug Administration to take more risks — including infecting humans — to shrink the time it takes to develop and approve a vaccine.
“We are trying to give the FDA political cover to be somewhat more aggressive on the rapid rollout of vaccines than they would under normal circumstances,” Foster told the Chicago Sun-Times on Tuesday.
The “typical” approval time for vaccines of normal diseases is 18 months to several years.Foster told me testing a COVID-19 vaccine using infected humans could cut that time to two or three months.
Foster, a physicist, and Shalala, who served as Health and Human Services Secretary under former President Bill Clinton, laid out the case for rethinking the risk/benefit ratio involved in COVID-19 human drug testing in a letter to HHS Secretary Alex Azar and FDA Commissioner Stephen Hahn.
They want the FDA to embrace “expedited procedures for testing, approval and use of COVID-19 vaccines.”
The pandemic, Foster and Shalala said in their letter, means a reevaluation of the “essential tradeoff” of having new drugs quickly — even if “the effectiveness and side effects” are “not fully known at the time of deployment.”
In normal times, infecting human subjects to develop a drug is controversial, and while it has been done, it is rare. The Foster/Shalala letter is intended to let the FDA know that Congress — or at least 35 House members — will have their back.
The 35 included two Republicans and a total of five Illinois Democrats: Foster, Sean Casten, Danny Davis, Bobby Rush and Jesus “Chuy” Garcia.
“We write to assure you that Congress understands that a more risk-tolerant development process is likely appropriate in the case of a COVID-19 vaccine,” the letter said.
They suggest running two vaccine trials in parallel: One, the time consuming traditional way, not involving infecting anyone while at the same time “deliberately infecting volunteers.” Some infected volunteers would receive a vaccine; others a placebos.
“We urge you to consider these and other options, provided they proceed with the principle of informed consent of truly voluntary subjects and backed by the best available science.”
Any volunteer would head into a test knowing there is no widely accepted cure for COVID-19. “There is no zero risk path here,” Foster told me. Still, “Anytime any new drug is approved there’s a risk.”
The discussion of infecting humans is done in the context that COVID-19 “is a fire burning through the developed world right now and very soon the developing world,” Foster said. “...So the benefits of getting a vaccine approve early is enormous.”
An article in the April 3 edition of “Science” considered the ethics of using human volunteers to speed a vaccine.
Seema Shah, a bioethicist at Northwestern University, noted her “misgivings” in the article and said they could be addressed if “the volunteers were people already ‘trained to take on these risks,’ like health care workers.”
She added, “If we’re going to say we’re making an exception to the standard way we do things, then we really have to get that right.”
Foster, from Naperville, who represents the 11th Congressional District, said young and healthy volunteers would be recruited because they would have a “low probability of dying” in a controlled testing situation. Also, “You can get the right racial mixture so you can actually resolve some of these issues, why is it African-Americans are dying at a much higher rate.”
The volunteers would have “state of the art medical care” if they got sick.
Said Foster, “It’s very much like the military, asking for volunteers for a very dangerous mission.” The COVID-19 vaccine volunteers “will be heroes to humanity and they will be responsible for saving thousands and maybe millions of lives.”