What we know about the Trump administration’s vaccine accelerator

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Erin McCallister Senior Manager, Health Research Institute, PwC US May 28, 2020

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The Trump administration announced its first investment in Operation Warp Speed, an effort to accelerate the development, manufacture and distribution of vaccines against the SARS-CoV-2 virus, which causes COVID-19. While details are emerging about the program, questions remain around the selection process and the design and execution of the confirmatory trials.

On May 15, HHS announced the leadership and top-line details of Operation Warp Speed. The program will be co-led by Moncef Slaoui, who will serve as chief adviser, and Gen. Gustave Perna, who will be COO. Slaoui is the former chairman of global R&D and vaccines at a global pharmaceutical company; Perna is charge of US Army Materiel Command, which oversees the Army’s global supply chain, installation and readiness.The project will include leaders from the FDA, the CDC, the National Institutes of Health (NIH), the Biomedical Advanced Research and Development Authority (BARDA) and the departments of Defense, Veterans Affairs, Agriculture and Energy.

The group’s goal is to produce and deliver 300 million vaccines by January via public-private partnerships. The effort has at least $10 billion from the CARES Act, including $6.5 billion allocated to BARDA and $3 billion to the NIH.

On May 21, Operation Warp Speed announced its first collaboration with a pharmaceutical company, which will receive funding from BARDA to support clinical studies, manufacturing and process development for its vaccine candidate. 

HHS said that the funding would allow the candidate to begin Phase III studies “this summer with approximately 30,000 volunteers in the US.”

A vaccine from Moderna that is being developed in partnership with the NIH is expected to start Phase III trials in July. The company received an award of up to $483 million from BARDA in April to fund development and manufacture scale-up of its mRNA vaccine candidate.

In an interview with Reuters, NIH Director Francis Collins said Operation Warp Speed may try to run the two Phase III trials of vaccine candidates “side-by-side,” but with a single control arm. These types of trials, known as platform studies, use master protocols and have been endorsed by the FDA and the World Health Organization (WHO).

Operation Warp Speed aims to winnow a list of 14 undisclosed candidates to about eight that would advance to Phase III. The selection criteria for which candidates the White House would move forward have not been disclosed.

Collins said the candidates would need to finish early safety testing, typically done in Phases I and II, “by this summer to make it into the bigger trials.”

HRI Impact analysis

As the federal government attempts to fast-track vaccines, questions remain about how to assess the safety and efficacy of the candidates and allocate them on a global scale.

vaccine developed for the Ebola virus was approved based on a Phase III trial conducted during the 2014-16 outbreak in Guinea in which individuals known to have been in contact with an Ebola-positive patient were given the vaccine either immediately or on a delayed schedule.

For COVID-19, the WHO has designed the Solidarity trial, a platform study that seeks to enroll adults in locations considered at high risk for exposure to SARS-CoV-2. The WHO has started to organize sites for the trial, which has drawn interest from over 100 countries as of April 30.

The FDA is collaborating with other regulators via the International Coalition of Medicines Regulatory Authorities to map out uniform data requirements for COVID-19 trials. The group met on May 14 and endorsed the use of master protocols for vaccine trials. The discussion was moderated by Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research and a member of Operation Warp Speed.

Additionally, CDC’s Advisory Committee on Immunization Practices (ACIP) will meet on June 24 to discuss COVID-19 vaccine products in development, the safety and immunogenicity of the candidates, and next steps. ACIP makes recommendations on the safe use of vaccines in the civilian population.

While Operation Warp Speed is aimed at ramping up US supply of a COVID-19 vaccine, the WHO as well as other not-for-profits have similar global projects underway, seeking equitable distribution of vaccines. 

However, an analysis by HRI found that there could be other challenges in the supply chain to distribute a vaccine if one is found to be safe and effective.

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Contact us

Trine K. Tsouderos

HRI Regulatory Center Leader, PwC US

Tel: +1 (312) 241 3824

Crystal Yednak

Senior Manager, Health Research Institute, PwC US

Erin McCallister

Senior Manager, Health Research Institute, PwC US

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