NIH and Biopharmas Partner to Speed COVID-19 Vaccine and Treatment Options

The NIH and the Foundation for the NIH (FNIH) are bringing more than a dozen leading biopharmaceutical companies together with governmental agencies to coordinate the research response to the COVID-19 pandemic. The planned Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) partnership will develop a framework for prioritizing vaccine and drug candidates, streamlining clinical trials, coordinating regulatory processes and/or leveraging assets among the partners to rapidly respond to the COVID-19 and future pandemics.

The following biopharmas are participating in this effort along with the CDC, the FDA, the EMA and the HHS Office of the Assistant Secretary for Preparedness and Response:

AbbVie Amgen AstraZeneca Bristol Myers Squibb Evotec GlaxoSmithKline Johnson & Johnson KSQ Therapeutics

Eli Lilly and Company Merck & Co., Inc. Novartis Pfizer Roche Sanofi Takeda Vir Biotechnology

Coordinated by the FNIH, ACTIV will provide infrastructure, subject matter expertise and/or funding (both new and in-kind) to identify, prioritize and facilitate the entry of some of the most promising candidates into clinical trials. Industry partners also will make available certain prioritized compounds, some of which have already cleared various phases of development, and associated data to support research related to COVID-19.  The partnership is being developed with input from a steering committee managed by the FNIH which includes leaders from NIH, FDA and the R&D organizations of the companies.

The research community is currently striving to sift through more than 100 potential preventives and therapeutics for COVID-19. ACTIV will aim to provide guidance which can be used to prioritize the plethora of vaccine and therapeutic candidates in development and connect clinical trial networks to test new and repurposed candidates quickly and efficiently.

“Using the most advanced clinical trial methods to rapidly test multiple interventions will help get the answers we need as soon as possible to expedite potential prevention and treatment approaches to fight COVID-19,” said FDA Commissioner Stephen M. Hahn, M.D. “Collaboration is a critical ingredient for success and the FDA will continue to use every tool possible under our Coronavirus Treatment Acceleration Program to speed the development of safe and effective medical countermeasures.” (Source: NIH Website, 17 April, 2020)