The US National Institutes of Health has formed a partnership among multiple federal agencies and pharmaceutical companies to speed the response to the COVID-19 pandemic.
Called the Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) partnership, the group’s goal is to break down traditional barriers between companies and the federal government to get safe, effective treatments and vaccines to the public as quickly as possible.
“There was unanimous agreement that the time has come to put aside any of the obstacles that might normally get in the way of such a public-private partnership,” NIH director Francis Collins says.
The partnership had its first meeting on April 3. Out of that meeting came four areas of focus, Collins says.
European Medicines Agency
US Centers for Disease Control and Prevention
US Food and Drug Administration
US Health and Human Services Office of the Assistant Secretary for Preparedness and Response
US National Institutes of Health
Foundation for the National Institutes of Health
Bristol Myers Squibb
Eli Lilly and Company
Johnson & Johnson
Merck & Co.
NOTE: As of April 17, 2020
Preclinical drugs: Find a systematic way to identify and quickly screen potential drugs against COVID-19 then prioritize them for development on the basis of likely safety and effectiveness.
Repurposing drugs: Inventory existing therapeutics and prioritize for clinical trials those most likely to be successful against COVID-19. Also design and launch master clinical trial protocols for all candidates to streamline the drug-testing process.
Clinical trial capacity: Connect existing clinical trial networks—including those for HIV, cancer, and vaccine evaluation—to expedite COVID-19 trials and identify capacity across different populations and disease stages.
Vaccine development: Share insights about immune responses to vaccines, establish common protocols and endpoints that signal protective immunity against SAR-CoV-2—the virus that causes COVID-19—and streamline discussions with regulators.
ACTIV is being led by the Foundation for the National Institutes of Health, an NIH-associated nonprofit that has led other public-private partnerships to tackle health challenges like diabetes and mosquito-borne diseases.
Work between government agencies and companies can often be complicated by intellectual property issues, but those have been largely put aside in an attempt to speed up the process, says David Wholley, senior vice president of research partnerships at the NIH foundation, who is leading ACTIV. Wholley and Collins spoke at an April 17 press briefing.
“These people, their families, and their businesses have all been highly impacted, like all of us. That has led to much less of an emphasis on proprietary positions than you may have seen in the past,” he says. “The overall goal is to save lives.”
Collins says pharmaceutical company heads have told him that they are willing to turn over their clinical-trial networks to another company’s drug if it is the most promising against COVID-19, something he’s never heard before. “That tells you just how dedicated the whole group is to finding an answer,” he says.
Right now, this is an informal coalition—any company who wanted to join was included in the partnership, Collins says. For now, ACTIV is still willing to add new companies, although Collins says that soon the effort will have gone too far for newcomers to catch up.
One of ACTIV’s most important roles will be setting the scientific criteria to screen promising drug candidates or therapeutics and push the top contenders through preclinical and clinical trials quickly.
“Of the more than 100 candidates that are out there, frankly, quite a lot of those are not going to be very well supported. And there may be some diamonds in the rough,” Collins says. “Instead of just throwing them at a dartboard, we really want to get the best expertise to help us out.”
That ranking may happen in categories, he says, such as small molecules that have a known mechanism of action likely to work against the virus or immune therapies to tamp down an overactive immune system.
Several other coalitions have also formed around COVID-19, including one from the Bill & Melinda Gates Foundation. Collins says NIH is supportive of those initiatives and hopes they can work together to avoid duplicating efforts. Many of the ACTIV members are also in those groups.
That’s also true of international endeavors. ACTIV plans to watch and learn from trials worldwide, including those in the United Kingdom and Europe and another multisite trial led by the World Health Organization. For ACTIV, though, “most of the focus right now is on what we can do in the United States,” Collins says.
NIH has not specified how much money it will spend, Collins says. A lot depends on what trials it identifies and whether there will be an industry or another federal partner who could cover some of the costs.
When the world gets a vaccine that’s safe, effective, and can be manufactured in large numbers of doses, it “will be a very happy moment indeed for this crisis,” Collins says. “So we will spare nothing in trying to get there. But I’m not ready yet to say exactly what the group’s going to come up with.”
Right now, the group is very focused on the current COVID-19 crisis, Collins says, but he can imagine that the work they do could be useful for a future pandemic. That could include everything from new drug targets to different approaches to regulatory science. But they won’t compromise on collecting the data that is needed.
“If we want to get these to the point of FDA [Food and Drug Administration] approval, it will have to meet a very high standard of safety and efficacy,” Collins says. “We would not want to run a trial that didn’t achieve that.”
This story was revised on April 23, 2020, to clarify that Francis Collins and David Wholley spoke at a press briefing.