July 9, 2020
The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, has established a new clinical trials network that aims to enroll thousands of volunteers in large-scale clinical trials testing a variety of investigational vaccines and monoclonal antibodies intended to protect people from COVID-19. The COVID-19 Prevention Trials Network was established by merging four existing NIAID-funded clinical trials networks: the HIV Vaccine Trials Network, based in Seattle; the HIV Prevention Trials Network, based in Durham, NC; the Infectious Diseases Clinical Research Consortium, based in Atlanta; and the AIDS Clinical Trials Group, based in Los Angeles. These networks will continue to perform clinical trials for HIV vaccine and prevention and other infectious diseases in addition to their new COVID roles.
Meanwhile, the U.S. Department of Health and Human Services (HHS) and Department of Defense (DoD) announced a $1.6 billion agreement with Novavax, Inc. of Gaithersburg, MD, to demonstrate commercial-scale manufacturing of the company’s COVID-19 investigational vaccine. By funding this manufacturing effort, the federal government will own the 100 million doses of investigational vaccine expected to result from the demonstration projects. The doses would become available for use in clinical trials or, if the U.S. Food and Drug Administration (FDA) grants Emergency Use Authorization or licenses the investigational vaccine, the federal government could distribute the doses as part of a COVID-19 vaccination campaign.
HHS and DOD have also reached an agreement with Regeneron, Inc. of Tarrytown, NY, to demonstrate commercial-scale manufacturing of the company’s COVID-19 investigational anti-viral antibody treatment, REGN-COV2. By funding this manufacturing effort, the federal government will own the doses expected to result from the demonstration project – between 70,000 and 300,000 doses – with the initial doses ready as early as end of summer and completed this fall. If the U.S. FDA grants Emergency Use Authorization or approves the treatment, the federal government would allocate these doses to treat COVID-19 patients.