CHICAGO, Aug 14 (Reuters) - U.S. government scientists have begun efforts to manufacture a strain of the novel coronavirus that could be used in human challenge trials of vaccines, a controversial type of study in which healthy volunteers would be vaccinated and then intentionally infected with the virus, Reuters has learned.
The work is preliminary and such trials would not replace large-scale, Phase 3 trials such as those now under way in the United States testing experimental COVID-19 vaccines from Moderna Inc and Pfizer Inc, according to a statement emailed to Reuters by the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health.
U.S. officials organizing the fight against the pandemic have been under pressure from advocacy groups such as 1 Day Sooner and others that see challenge trials as a way to speed up tests of a COVID-19 vaccine. Most vaccine trials rely on inadvertent infection, which can take time to occur.
Some drugmakers, including AstraZeneca and Johnson & Johnson, have said they would consider human challenge trials to test COVID-19 vaccines if needed.
"Should there be a need for human challenge studies to fully assess candidate vaccines or therapeutics for SARS-CoV-2, NIAID has begun investigations of the technical and ethical considerations of conducting human challenge studies," the agency statement said.
That includes efforts to manufacture a suitable SARS-CoV-2 strain, draft a clinical protocol and identify resources that would be required to conduct such studies.
Small challenge studies would be done in small isolation units to control the virus. Larger challenge studies involving 100 people or so would have to be done in multiple locations, adding months of preparations to coordinate the studies.
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Coronavirus vaccine trial in Seattle
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Coronavirus vaccine trial in Seattle
A 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)
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Such trials are typically done when a virus is not widely circulating, which is not the case with COVID-19. Many scientists consider human challenge trials of the novel coronavirus unethical because there are no "rescue therapies" for those who fall ill.
Earlier this week, Johan Van Hoof, global vaccines chief for J&J, said in an interview with Reuters that the preparations for such trials are under way across the world, and the company is following those preparations.
Van Hoof said such trials would offer a testing option in case the virus stops circulating widely, but the company would only move forward with such trials if the ethical issues are resolved and an effective treatment is available.
Dr. Anna Durbin, a vaccine researcher at the Johns Hopkins Bloomberg School of Public Health, who has run a dozen challenge studies, estimates it could take nine to 12 months to set up a human challenge trial, and another six months to coordinate testing across multiple testing sites.
NIAID said it is continuing to prioritize field trials to evaluate SARS-CoV-2 vaccine candidates, but it opened the possibility to challenge trials for future generations of vaccines or treatments.
Dr. Dan Barouch, a vaccine researcher at Harvard's Beth Israel Deaconess Medical Center in Boston, who helped design and conduct animal studies on J&J's COVID-19 vaccine, said he is not aware of any manufacturers planning human challenge studies.
"In the setting of a pandemic that is raging, you don't need it. You just do a trial and get a real result," he said.
Moreover, vaccine trials would have to be done in healthy young people, said University of Maryland School of Medicine's Dr. Kathleen Neuzil, co-leader of the Coronavirus Vaccine Prevention Network, which was formed by NIAID and is testing COVID-19 vaccines.
"A 20-year-old in a challenge study isn't really going to give us the answer of will this vaccine keep an older person, someone with chronic kidney disease, from ending up in the hospital," she said. (Reporting by Julie Steenhuysen; Additional reporting by Francesco Guarascio in Brussels; editing by Peter Henderson and Leslie Adler)
