They seek 60,000 volunteers for Phase 3 of coronavirus vaccine | The NY Journal
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“Having a single vaccine candidate in Phase 3 trials less than a year after a virus was first reported would be a remarkable achievement.”
Health experts say that the vaccine is the best protection option.
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Aurelia Ventura / Impremedia / La Opinion
Recruitment of adult volunteers for a fourth Phase 3 clinical trial evaluating an investigational vaccine against COVID-19 has already started in the United States, as announced this Wednesday by the National Institutes of Health (NHS).
The trial, designed to assess whether the Janssen vaccine COVID-19 under investigation (JNJ-78436725) can prevent symptomatic COVID-19 after a single-dose regimen, it will seek to enroll up to 60,000 volunteers at around 215 clinical research sites, both nationally and internationally.
“Having a single vaccine candidate in Phase 3 trials less than a year after a virus was first reported would be a remarkable achievement. Having four candidates at that stage is extraordinary, “said the secretary of the Department of Health and Human Services (HHS), Alex Azar.
“By creating a portfolio of vaccine candidates, you maximize the chances that we will have substantial supplies of a safe and effective vaccine, and perhaps multiple vaccine options, by January 2021,” he added.
For his part, the director of the National Institute of Allergy and Infectious Diseases (NIAID) and the country’s leading epidemiologist, Anthony S. Fauci, called it an “unprecedented feat” that there are currently four COVID-19 vaccine candidates that are in Phase 3 clinical trials “just over eight months after SARS-CoV-2 was identified.”
This “has been made possible by decades of progress in vaccine technology and a coordinated strategic approach in government, industry and academia,” he added.
The Janssen vaccine candidate is a recombinant vector vaccine that uses a human adenovirus to express the peak protein of the SARS-CoV-2 in cells.
Adenoviruses sith a group of viruses that cause the common cold, however, the adenovirus vector used in the candidate vaccine has been modified so that it can no longer replicate in humans and cause disease.
Janssen uses the same vector in the first dose of his primary booster vaccine regimen against Ebola virus disease that recently received marketing authorization from the European Commission.
Johnson & Johnson’s Janssen pharmaceutical companies developed the investigational vaccine and lead the clinical trial as a regulatory sponsor. Janssen, the NIAID and the Advanced Biomedical Research and Development Authority (BARDA) and the Office of the HHS Assistant Secretary they are funding the trial.
The Phase 3 trial is being carried out in collaboration with Operation Warp Speed (OWS), a multi-agency alliance overseen by HHS and the Department of Defense that aims to accelerate the development, manufacture and distribution of medical measures for COVID-19.
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