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.
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.
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.
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.