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US government and industry partners will coordinate to bring the most promising COVID-19 vaccine and treatment candidates to clinical trials.
The National Institutes of Health (NIH) and the Foundation for the NIH (FNIH) are bringing together more than a dozen leading biopharmaceutical companies, the Health and Human Services Office of the Assistant Secretary for Preparedness and Response, the Centers for Disease Control and Prevention, FDA, and the European Medicines Agency to develop an international strategy for a coordinated research response to the COVID-19 pandemic, the NIH said in an April 17, 2020 press release. The planned Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) partnership will develop a collaborative framework to prioritize vaccine and drug candidates, streamline clinical trials, coordinate regulatory processes, and leverage assets among all partners to 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 Francis S. Collins, in the press release.
Coordinated by the FNIH, ACTIV government and industry partners will provide infrastructure, subject matter expertise, and funding to bring some of the most promising candidates into clinical trials.
“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 Paul Stoffels, vice-chairman of the executive committee and chief scientific officer, Johnson & Johnson, in the press release.
“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,” added Mikael Dolsten, chief scientific officer and president of Worldwide Research, Development, and Medical at Pfizer, in the press release.
“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, in the press release.
ACTIV will have four fast-track focus areas led by a working group of senior scientists representing government, industry, and academia. These groups will seek to standardize and share preclinical evaluation methods, prioritize and accelerate clinical evaluation of therapeutic candidates with near-term potential, maximize clinical trial capacity and effectiveness, and advance vaccine development. With more than 100 potential preventives and therapeutics for COVID-19 to consider, ACTIV will prioritize candidates and connect clinical trial networks to test new and repurposed candidates quickly and efficiently.
NIH announced in an April 21, 2020 press releasethat an expert panel of US physicians, statisticians, and other experts has developed treatment guidelines for COVID-19, intended for healthcare providers. The Panel said that it recognizes the critical importance of clinical research in generating evidence to address unanswered questions regarding the safety and efficacy of potential treatments for COVID-19, but recognizes that providers are still seeking guidance now. The guidelines consider antivirals, which may target the coronavirus directly, and host modifiers and immune-based therapies, which may influence the immune response to the virus or target the virus. The guidelines are posted online, and NIH noted they will be updated as new authoritative information emerges.