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US NIH chief details framework for historic COVID-19 drugs, vaccines venture

The U.S. National Institutes of Health pulled 18 biopharmaceutical companies together in record time for a historic public-private venture of scope and scale never before seen, the agency's chief said.

The driver: COVID-19, the disease caused by the novel coronavirus.

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National Institutes of Health Director Francis Collins

Source: AP Photo

Other such collaborations between governments and industry have taken years to put together, Francis Collins wrote in the Journal of the American Medical Association, in an article he co-authored with Paul Stoffels, chief scientific officer at Johnson & Johnson, the world's biggest publicly traded healthcare company.

The Accelerating COVID-19 Therapeutic Interventions and Vaccines, or ACTIV, initiative for COVID-19 products was launched April 17, just two weeks after leaders from the NIH and other U.S. and European government agencies met with academic experts and multiple research and development heads from industry, Collins and Stoffels said. ACTIV had 16 drug and vaccine manufacturers at that time.

Collins and Stoffels noted that by comparison, the NIH's Accelerating Medicines Partnership, or AMP, took two years to go from concept to launch. The AMP public-private collaboration with a dozen companies is aimed at speeding and lowering the costs of developing drugs and diagnostics aimed at Alzheimer's disease, type 2 diabetes, rheumatoid arthritis, lupus and Parkinson's disease.

Collins and Stoffels are co-chairing ACTIV's partnership leadership group, whose members include Anthony Fauci, director of the NIH's National Institute of Allergy and Infectious Diseases; Janet Woodcock, director of the U.S. Food and Drug Administration's Center for Drug Evaluation and Research; Gary Gibbons, director of the NIH's National Heart, Lung, and Blood Institute; Mikael Dolsten, chief scientific officer at Pfizer Inc.; and William Pao, head of pharma research and early development at Roche Holding AG.

"Aside from the unquestionable urgency and enormous public health need posed by the COVID-19 pandemic, one key factor that helped to speed the formation of this partnership was having the U.S. and European government regulatory agencies directly involved from the outset," Collins and Stoffels said.

ACTIV and the NIH's "Shark Tank"-like Rapid Acceleration of Diagnostics competition are part of a larger initiative known as Operation Warp Speed.

Shared goals

The ACTIV partners not only shared the goal of achieving success in record time; they also "embraced the spirit" of former U.S. President Harry S. Truman's philosophy that much can be accomplished "if you do not care who gets the credit," Collins and Stoffels wrote.

"Such an unprecedented partnership will be necessary to mount an effective and sustained response in these unprecedented times," they said.

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Paul Stoffels, chief scientific officer at Johnson & Johnson
Source: Johnson & Johnson

ACTIV also has four working groups: preclinical, therapeutics clinical, clinical trial capacity and vaccines.

The therapeutics clinical group has narrowed its list to 170 candidates with established safety profiles, Collins and Stoffels said.

On May 6, the group presented its first list of repurposed drugs recommended for inclusion in ACTIV's master protocol for adaptive clinical studies. Such trials allow for prospectively planned modifications to one or more aspects of the study design based on accumulating data from participants.

The clinical trial capacity group has also identified 44 study networks for potential inclusion in COVID-19 trials, the NIH leader and the J&J scientist said.

In addition, that group has developed two survey instruments to assess the capabilities and capacities of those networks and a matrix to guide the deployment of innovative solutions throughout the trial life cycle.

Vaccines

ACTIV's vaccine workgroup is charged with identifying biomarkers to speed authorization or approval of candidates and to provide evidence to address safety concerns, such as immune enhancement, meaning that instead of the vaccine protecting against the disease, it could make it worse.

One company that has partnered with Fauci's agency at the NIH, Moderna Inc., is not part of ACTIV.

The NIH did not respond to repeated questions about why Moderna has opted against joining the multicompany ACTIV collaboration when the small biotech has had a longstanding partnership with the U.S. government and is actively pursuing a vaccine with the agency.

On May 18, Moderna reported early results of its phase 1 trial with NIH, which showed the vaccine candidate had COVID-19 antibodies in all 45 participants. The Moderna-NIH vaccine candidate also produced neutralizing antibodies against COVID-19 in eight of the healthy volunteers, the company said.

The NIH and Moderna started work on their vaccine candidate, known as mRNA-1273, in January. The agency and the company launched the phase 1 trial in mid-March — "record speed" for a vaccine trial, Fauci said at that time.

Moderna said it anticipates starting its phase 2 trial shortly and expects to begin a phase 3 study in July.

Collins and Stoffels said ACTIV is seeking to have vaccine candidates from the collaboration ready to enter clinical trials by July 1.

J&J has already said it plans to enter phase 1 human testing by September.

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