COVID-19 Vaccines: NIAID Creates Clinical Trials Network As Vaccine Trials Nationwide Facing Problems Getting Volunteers Or Patients To Enroll
Source: COVID-19 Vaccines Jul 10, 2020 4 years, 4 months, 4 days, 1 hour, 34 minutes ago
COVID-19 Vaccines: The U.S.National Institute of Allergy & Infectious Diseases (NIAID
) has founded a new clinical trials network focused on enrolling volunteers in clinical trials for COVID-19 vaccines and monoclonal antibodies.
Various media have recently reported that sponsor companies are struggling to enroll patients in clinical trials for COVID-19 vaccines, essentially competing against each other.
One of the possible reasons for this could be the extremely fast phase that vaccines are being developed, jumpstarting rapidly coupled with a lot of safety issues and proper testing in animal models being bypassed, are making lots of individuals lose confidence in these vaccines.
Francis Collins, director of the U.S. National Institutes of Health, the umbrella organization for NIAID told Thailand Medical News, “We not only have to find the number of volunteers, but they need to be in an area where the virus is currently spreading, otherwise you learn nothing about the effectiveness of the vaccine. It is a big task, and it means pulling together all of the clinical trial capacity that we can.”
COVPN or COVID-19 Prevention Trials Network, the new network, merged four existing NIAID-funded clinical trials networks. They are the HIV Vaccine Trials Network (HVTN), which is located in Seattle; the HIV Prevention Trials Network (HPTN), based in Durham, North Carolina; the Infectious Diseases Clinical Research Consortium (IDCRC), headquartered in Atlanta; and the AIDS Clinical Trials Group, based in Los Angeles.
Besides still running clinical trials for HIV vaccine and prevention and also other infectious diseases, each of those networks will be adding on the new COVID-19 activities.
Alex Azar, secretary of the U.S. Department of Health and Human Services (HHS) said, “Establishing a unified clinical trial network is a key element of President Trump’s Operation Warp Speed, which aims to deliver substantial quantities of a safe, effective vaccine by January 2021. Starting this summer, this new network will leverage existing infrastructure and engage communities to secure the thousands of volunteers needed for late-stage clinical trials of promising vaccines.”
The newly revamped network’s vaccine testing will be led by Dr Larry Corey of the Fred Hutchinson Cancer Research Center in Seattle and Dr Kathleen M. Neuzil of the University of Maryland School of Medicine.
Dr Myron S. Cohen of the University of North Carolina, Chapel Hill and Dr David S. Stephens of Emory University in Atlanta will head the network’s monoclonal antibody clinical testing.
The HIV Vaccine Trials Network or HVTN is located at the Fred Hutchinson Cancer Research Center and will act as the new COVPN’s operational center.
COVID-19 Prevention Trials Network or COVPN is “functional unit” of Operation Warp Speed, which is President Trump’s program to speed efforts to have a usable and safe vaccine against COVID-19 by January 2021. The network will rely on a harmonized vaccine protocol developed by the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) public-priv
ate partnership. This protocol allows researcher to analyze data from multiple vaccine trials. It is expected to run more than 100 clinical trial locations across the U.S. and internationally.
Dr Anthony S. Fauci, director of NIAID said, “Having a safe and effective medical countermeasure to prevent COVID-19 would enable us to not only save lives but also help end the global pandemic. Centralizing our clinical research efforts into a single trials network will expand the resources and expertise needed to efficiently identify safe and effective vaccines and other prevention strategies against COVID-19.”
The initial Phase III trial that COVPN is expected to run is for Moderna and NIAID’s mRNA-1273 vaccine, which is generally viewed as the leader in vaccine development for COVID-19.
Moderna indicated
on June 11, it had finalized the Phase III clinical trial structure for mRNA-1273 with plans to begin the trial in 30,000 participants in July. On July 2, there were indications that Moderna was making changes to the trial structure with the start date being pushed back. Despite the changes, Moderna’s chief executive officer Stephane Bancel told
media “we have always said July. And I confirm July.”
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