Monopoly: US builds coronavirus strains for potential human challenge trials

Chicago (Reuters)-US government scientists have begun working on a new strain of coronavirus that can be used in human challenge trials of vaccines. This is a controversial issue in which healthy volunteers are vaccinated and then intentionally infected with the virus. Reuters learned.

This work is preliminary and such trials do not replace large Phase 3 trials such as the ongoing trials in the United States testing Moderna Inc’s COVID-19 vaccine. There is none(MRNA.O) And Pfizer Inc (PFE.N), a statement emailed to Reuters by the National Institute of Allergy and Infectious Diseases (NIAID), which is part of the National Institutes of Health.

US authorities organizing the fight against the pandemic are under pressure from 1 Day Sooner and other advocates who see the Challenge Trial as a way to speed up testing of the COVID-19 vaccine. Most vaccine trials rely on inadvertent infections, which can take a long time to develop.

AstraZeneca (AZN.L) And Johnson & Johnson (JNJ.N), they will consider human challenge trials to test the COVID-19 vaccine as needed.

“When a human challenge study is needed to fully evaluate a candidate vaccine or treatment for SARS-CoV-2, NIAID will begin investigating the technical and ethical considerations of conducting a human challenge study. did.”

This includes efforts to produce suitable SARS-CoV-2 strains, develop clinical protocols and identify the resources needed to conduct such studies.

In order to control the virus, a small challenge study is carried out in a small separation unit. Large-scale challenge studies of around 100 people will take place in multiple locations, requiring months of preparation to coordinate the study.

Such tests are usually done when the virus is not widely distributed, but not for COVID-19. Many scientists consider the new human challenge of the coronavirus unethical because there is no “first aid” for the sick.

J&J Global Vaccine Chief Johan Van Hoof earlier this week in an interview with Reuters said preparations for such trials are underway around the world and the company is following them.

Van Hoff provides such an option as a test when the virus is no longer widely available, but only if ethical issues are resolved and effective treatments are available. Said to proceed.

Dr. Anna Durbin, a vaccine researcher at Johns Hopkins Bloomberg School of Public Health who conducted the Darth Challenge study, takes 9-12 months to set up a Human Challenge trial and another 6 months to coordinate the overall test. I estimate. Multiple test sites.

NIAID continues to prioritize field trials to evaluate SARS-CoV-2 vaccine candidates, but has opened up the possibility of challenging future generation vaccine or treatment trials.

Dr Dan Barouch, a vaccine researcher at Harvard’s Beth Israel Deaconess Medical Center in Boston, who assisted in the design and implementation of J&J’s COVID-19 vaccine in animal studies, is a manufacturer planning a human challenge study. Said I don’t know about.

“In a raging pandemic situation, you don’t need it. Just try it and you’ll get real results,” he said.

In addition, Dr. Catherine Neuzil of the University of Maryland School of Medicine said she was a co-leader of the Coronavirus Vaccine Prevention Network, which was founded by NIAID and is testing the COVID-19 vaccine.

“In a 20-year-old challenge study, I don’t think this vaccine will help prevent hospitalization of the elderly, patients with chronic kidney disease,” she said.

Report by Julie Steinheysen. Additional report by Francesco Gualatio in Brussels. Edited by Peter Henderson and Leslie Adler

Our criteria:Thomson Reuters Trust Principles.

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