NIH Launches Partnership to Speed COVID-19 Vaccine, Treatments
NIH and the Foundation for the NIH are bringing together more than a dozen leading biopharmaceutical companies, the HHS Office of the Assistant Secretary for Preparedness and Response, the Centers for Disease Control and Prevention, the Food and Drug Administration and the European Medicines Agency to develop an international strategy for a coordinated research response to the COVID-19 pandemic.
The planned Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) partnership will develop a collaborative framework for prioritizing vaccine and drug candidates, streamlining clinical trials, coordinating regulatory processes and/or leveraging assets among all partners to rapidly respond to the COVID-19 and future pandemics.
“We need to bring the full power of the biomedical research enterprise to bear on this crisis,” said NIH director Dr. Francis Collins. “Now is the time to come together with unassailable objectivity to swiftly advance the development of the most promising vaccine and therapeutic candidates that can help end the COVID-19 global pandemic.”
At a virtual town hall meeting on Apr. 24, Collins said such partnerships “usually take 1 to 1½ years to organize. This time we did it in about a week and a half, which is a reflection of the urgency of the challenge we are facing.”
Coordinated by FNIH, ACTIV government and industry partners 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 FNIH that includes leaders from NIH, FDA and the research and development organizations of the companies.
“COVID-19 is the most significant global health challenge of our lifetime, and it will take all of us working together as a global community to put an end to this pandemic,” said Dr. Paul Stoffels, vice chairman of the executive committee and chief scientific officer, Johnson & Johnson. “We will need to harness the best ideas from multiple stakeholders, including governments, regulatory authorities, academia, NGOs and industry to stop COVID-19.”
“Battling the COVID-19 pandemic is far too great a challenge for any one company or institution to solve alone,” adds Dr. Mikael Dolsten, chief scientific officer and president, worldwide research, development and medical, Pfizer. “We are seeing an unprecedented level of collaboration across the innovation ecosystem to address this global health crisis, and this potentially powerful NIH initiative may allow us to further accelerate the delivery of much-needed therapies to patients around the world.”
The research community is currently sifting through more than 100 potential preventives and therapeutics for COVID-19. ACTIV will aim to provide guidance that can be used to prioritize the range 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 Dr. Stephen Hahn. “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.”
ACTIV will have 4 working groups uniting the efforts of some 70 experts.
“This powerful public-private partnership will focus and expedite R&D activities required to combat COVID-19,” said Dr. Maria Freire, FNIH president and executive director. “Working in lockstep, the public and private sectors will maximize the chances of success and provide a roadmap to pre-emptively manage future threats.”