Brigham and Women’s will take on a leadership role as the clinical trial site in New England
Boston’s own Brigham and Women’s Hospital will serve as the clinical research site for a Phase 3 trial of Moderna’s highly anticipated coronavirus vaccine, which has already elicited positive immune responses in volunteers of previous trials.
The Phase 3 trial of the coronavirus vaccine, the world’s biggest COVID-19 vaccine study, with 30,000 planned volunteers, got underway on Monday.
“It’s fastest from the time a virus, a pathogen, was identified to the time it actually goes into a Phase 3 trial literally in the history of vaccinology in the U.S. at least and maybe even throughout the world,” said Dr. Anthony Fauci, the nation’s top infectious disease doctor in a Monday webinar with the National Institutes of Health.
The study will enroll participants at a number of locations throughout the United States, with Brigham and Women’s Hospital serving as a clinical research site as part of the COVID-19 Prevention Network, a group funded by the National Institutes of Health.
“This is the first phase 3 trial that will test the effectiveness of a vaccine against COVID-19, and we’ve been working diligently across industry, academia and government to pave a path for launching this trial rapidly and safely,” said Dr. Lindsey Baden, an infectious disease specialist at The Brigham and an expert in vaccine development for viral diseases.
Baden will be the co-principal investigator for the study, which is part of the government’s Operation Warp Speed, which aims to deliver 300 million doses of a safe, effective vaccine for COVID-19 by early 2021.
President Trump said in a Monday press conference, “We’re mass producing all of the most promising vaccine candidates in advance so that on the day one that it’s approved, it’ll be available to the American people immediately,”
The study is designed to evaluate the effectiveness and safety of the vaccine, called mRNA-1273, and its ability to prevent COVID-19 illness.
Participants won’t know if they’re getting the real shot or a dummy version. After two doses, scientists will closely track which group experiences more infections as they go about their daily routines, especially in areas where the virus still is spreading unchecked.
To enroll, volunteers may be any gender, must be at least 18 years old and could be offered payment up to $550. Enrollment is expected to close in January 2021.
The target population for the study are adults whose locations or circumstances put them at higher risk of exposure to COVID-19 and the primary end goal will be the prevention of symptomatic coronavirus.
Every month through fall, the government-funded COVID-19 Prevention Network will roll out a new study of a leading candidate — each one with 30,000 newly recruited volunteers.
Next up in August, the final study of the University of Oxford shot begins, followed by plans to test a candidate from Johnson & Johnson in September and Novavax in October.
Herald wire services contributed to this report.
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