The national effort to accelerate the development, manufacturing and distribution of a COVID-19 vaccine, called "Operation Warp Speed," will hasten the delivery of that vaccine by conducting steps concurrently that normally would be conducted sequentially, senior administration officials said.
Operation Warp Speed is a partnership among components of the Department of Health and Human Services, as well as the Defense Department.
Speaking on background during a conference call June 16, officials said that when creating a vaccine, things such as development, clinical trials and manufacturing typically would occur one after the other. In some cases, officials said, Operation Warp Speed will do them at the same time.
"We expect to be producing large quantities of vaccines while the clinical trials are still underway," one official said. "That is, when safety and efficacy have been demonstrated, there isn't a day's delay due to manufacturing ramp-up timelines. We will still complete all of the necessary clinical trials to determine safety and efficacy."
Another senior administration official said that the manufacturing capacity for three to five selected candidates will be advanced while those vaccine candidates are still in development.
"That capacity will be used for whatever vaccine is eventually successful, regardless of which firms have developed their capacity," that official said.
Private-sector drug companies would not develop a drug in such a fashion, the first official said, due to the financial risk. But for a COVID-19 vaccine, the official added, Operation Warp Speed and the federal government — not private companies — will be assuming the risk.
"The return on this investment to our country in terms of lives saved and economic confidence is far greater than that of any single vaccine developer," an official said. "So while we'll be lowering the financial risk for these companies, we will not be lowering any standards of development, safety and efficacy."
While the timeline is speeding up, the science will not be compromised, the official said, nor will the safety of the American public, adding that Operation Warp Speed hopes to have a vaccine by January.
So far, the effort has yielded 14 vaccine candidates from more than 100 that are in development. Some of those are in clinical trials now.
Those 14 will be further narrowed down to seven candidates, and the most promising of those will get further testing and clinical trials.
Operation Warp Speed has also been working with multiple companies to quickly manufacture a vaccine and to develop solutions for the distribution of that vaccine once it is ready. This includes tools such as pre-filled syringes, vials and containers.
Vaccine development is already proceeding at a record-setting pace, the second official said. He also discussed vaccine distribution.
"A tiered approach will be used for this vaccine distribution," he said. "This approach will be based on the methodology that has been used for pandemic influenza planning for decades, as well as what we've learned from the first wave of the COVID-19 pandemic."
In a tiered system, he said, the elderly, those with preexisting conditions and people performing essential services would be given higher tiers.
OWS is a partnership between the Defense Department and the Department of Health and Human Services. Specific DHS components involved include the Centers for Disease Control and Prevention, the Food and Drug Administration, the National Institutes of Health and the Biomedical Advanced Research and Development Authority.