To respond to the generational public health crisis caused by the global COVID-19 pandemic, a swift, coordinated effort across many sectors of society is necessary, say National Institutes of Health (NIH) Director Francis S. Collins, M.D., Ph.D., and Johnson & Johnson Vice Chairman of the Executive Committee and Chief Scientific Officer Paul Stoffels, M.D.
In a Viewpoint published in JAMA, Drs. Collins and Stoffels outline the innovative efforts of Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV), a public-private initiative organized by NIH and the Foundation for the NIH. ACTIV’s partners, which include at least 18 leading biopharmaceutical companies, multiple U.S. federal agencies, and the European Medicines Agency, are developing an international strategy for an integrated research response to COVID-19.
Noting that never has a public-private biomedical research effort of this scope and scale come together with such speed and determination, Drs. Collins and Stoffels describe how ACTIV has established a collaborative framework to prioritize therapeutic and vaccine candidates; to streamline human clinical trials and tap into existing trial networks; and to coordinate regulatory processes and leverage assets among all partners. The authors point out that ACTIV’s industry partners have taken unprecedented steps to support a prioritization of therapeutic and vaccine candidates, no matter who has developed them, and have indicated willingness to contribute their respective clinical trial capacities, irrespective of the agent to be studied.
ACTIV has established four working groups, each with one co-chair from NIH and one from industry. They are:
· The Preclinical Working Group. Charged with standardizing and sharing preclinical evaluation resources and methods, and with accelerating testing of candidate therapies and vaccines to support entry into clinical trials.
· The Therapeutics Clinical Working Group. Charged with prioritizing and accelerating clinical evaluation of a long list of therapeutic candidates for COVID-19 with near-term potential.
· The Clinical Trial Capacity Working Group. Charged with assembling and coordinating existing networks of clinical trials to increase efficiency and build capacity to test potential therapies and vaccines for COVID-19.
· The Vaccines Working Group. Charged with accelerating evaluation of vaccine candidates to enable rapid authorization or approval.
