CHICAGO, Aug 14 (Reuters) – U.S. government scientists have begun efforts to create a strain of the new coronavirus that could be used in human challenge tests on 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 on a large scale, Phase 3 studies such as those currently testing in the United States experimental COVID-19 vaccines from Moderna Inc and Pfizer Inc, according to a statement by email sent 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 who see challenge trials as a way to speed up tests of a COVID-19 vaccine. Most vaccine studies rely on inadvertent infection, which can take time to prevent.
Some drugmakers, including AstraZeneca and Johnson & Johnson, have said they would consider human challenge testing to test COVID-19 vaccines as needed.
“Should human challenge studies be required to fully evaluate candidate vaccines or therapies for SARS-CoV-2, NIAID has begun researching the technical and ethical considerations of conducting human challenge studies,” he said. statement of the agency.
This includes efforts to produce an appropriate SARS-CoV-2 strain, establish a clinical protocol, and identify resources needed 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 at multiple locations, adding months of preparation to coordinate the studies.
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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. the Kaiser Permanente Washington Health Research Institute in Seattle. (AP Photo / Ted S. Warren)
Pharmacist Michael Witte opens a package taken from a freezer containing the potential vaccine for COVID-19, the disease caused by the new coronavirus, on the first day of a clinical trial for a first-stage safety study of the vaccine, Monday 16 March 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 at 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 being shot in the clinical trial of the first-stage safety study 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 at 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 vaccine for coronavirus have begun in a Seattle hospital. A total of 45 men and women underwent voluntary injection. 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 medicine. Lisa Guerrero spoke with Neal Browning, one of the men doing the test. He explained what he has to go through as part of this brave new experiment.
The first clinical trials to find a vaccine for coronavirus have begun in a Seattle hospital. A total of 45 men and women underwent voluntary injection. 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 medicine. Lisa Guerrero spoke with Neal Browning, one of the men doing the test. 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 at 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 researcher at the Kaiser Permanente Washington Health Research Institute, poses for a photo, Sunday, March 15, 2020, in Seattle. Jackson is leading the clinical trial of the first-stage safety study 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 researcher at the Kaiser Permanente Washington Health Research Institute, is working in her office with a picture of COVID-19 carpets on her door, Sunday, March 15, 2020, in Seattle. Jackson is leading the clinical trial for first-stage safety study 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 16th. (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 house 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 is working 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 tests are typically performed when a virus is not circulating widely, which is not the case with COVID-19. Many scientists consider trials of human challenge from the novel coronavirus unethical because there are no “rescue therapies” for those who fall ill.
Earlier this week, Johan Van Hoof, global vacciner for J&J, said in an interview with Reuters that the preparations for such trials are all over the world, and the company is following those preparations.
Van Hoof said such trials offer a test option in case the virus stops circulating, but the company would only proceed with such trials if the ethical issues are resolved and effective treatment is available.
Dr. Anna Durbin, a fax researcher at the Johns Hopkins Bloomberg School of Public Health, who has conducted a dozen challenge studies, estimates that it can take nine to 12 months to set up a human challenge test, and another six months. to coordinate tests across multiple test sites.
NIAID said it is continuing to prioritize field studies to evaluate SARS-CoV-2 vaccine candidates, but it opened up the possibility of challenging tears 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 was unaware of manufacturers planning human challenge studies. .
“In setting up a pandemic that rages, you don’t have to. You just do a trial and get a real result,” he said.
In addition, vaccine tests should be done in healthy young people, said Dr. Kathleen Neuzil, University of Maryland School of Medicine, co-leader of the Coronavirus Vaccine Prevention Network, which was formed by NIAID and tests COVID-19 vaccines.
“A 20-year-old in a challenge study will not actually give us the answer to this vaccine that an elderly person, one with chronic kidney injection, ends up in the hospital,” she said. (Report by Julie Steenhuysen; Additional Reporting by Francesco Guarascio in Brussels; Edited by Peter Henderson and Leslie Adler)
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