Right now, six vaccines for COVID-19 are in development as part of Operation Warp Speed, said the program's chief operating officer. Once one or more of those vaccines proves both effective and safe, their fast and efficient distribution will require knowing where every dose is at all times.
When planning for the distribution of a COVID-19 vaccine, Army Gen. Gustave F. Perna said he kept four tenets in mind. The first of those, he said, is visibility and control.
"We need to know where every vial was, whether it was in the factory, or it was on a truck, or it had been distributed down to an administration site; we must have 100% accountability of all vaccines every day," said Perna, who spoke Oct. 27 to the Heritage Foundation in Washington.
Also key to effective distribution efforts, he said, is tracking the uptake of vaccine — how many people are actually taking it. The primary reason for that, he said, is that of the six vaccines in development, five require two doses. It'll be important that everybody who takes a first dose gets the correct second dose when they come back for it.
Uptake tracking is also important, he said, because the amount of vaccine being distributed will dramatically increase shortly after the first doses become available.
"Initially, there will be tens of millions of doses available," he said, but beginning in January, the number of doses will quickly ramp up to hundreds of millions. "It'll be essential that we maintain the right flow of vaccine to the American people."
A third tenant of vaccine distribution, he said, is knowing where the vaccine is going.
"We must make sure that we have traceability of the vaccine, and that we know where the vaccine is going at all times," he said. "It'll be a hot commodity, of course, and we need it to get to the places where it will be distributed based on state priorities and requirements in accordance with the safety and effectiveness of the vaccine."
Finally, he said, OWS wants to make sure that the entirety of the American population is covered, including all of the continental U.S. and every island, as well as to those Americans serving overseas at military bases and diplomatic locations.
Perna also said COVID-19 vaccine distribution, both initially and into the foreseeable future, will differ from other types of vaccine distribution efforts in that a COVID-19 vaccine will be "pushed" out to the American population, rather than "pulled." For influenza vaccines, for instance, distribution happens when hospitals and pharmacies order it from manufacturers — that's a "pull" model.
With the COVID-19 vaccine, the U.S. government has already paid for the vaccine. It will be sent out where it's needed without individual administration sites needing to ask for it.
"We are going to allocate equitably vaccine doses to all of America simultaneously," Perna said. "As doses become available, we're pushing down and out to the United States of America."
Doing the impossible
It wasn't until May that Operation Warp Speed stood up. It's a partnership between the Defense Department and the Department of Health and Human Services. One of the program's goals is to find a vaccine for COVID-19 before the end of the year and to quickly get that vaccine out to Americans by January 2021.
Most vaccines take years to develop, but OWS embarked on an effort to develop and distribute one in just nine months. Dr. Matthew Hepburn, head of vaccine development for Operation Warp Speed, says many people ask him how that's possible.
"The simple question is, how can you achieve the impossible? How can you take a vaccine development process that typically can take five years, eight years, 10 years, and truncate that into the timelines of Operation Warp Speed?"
One of the ways that's been possible, so far, Hepburn said, is modern vaccine technology.
"I think it's very helpful to point out the efforts that have gone on for decades in terms of developing vaccines," he said. "We stand on the shoulders of giants — of the people that worked on polio, measles, the smallpox eradication campaign."
Before OWS started, he said, there had already been great progress in terms of how to accelerate vaccine development. There had already been investments by HHS and the National Institutes of Health, he said. And DOD is also working on ways to make vaccines more quickly.
"Now. I feel like they're really paying off," he said. "That's how we're in phase III clinical trials now ... because of those investments and those technologies that were started in the spring that are now really paying off both for their ability to be developed quickly and prove that they work in animal models, but also that they can be manufactured at a very large scale."
Another angle making OWS successful in achieving its goal, Hepburn said, is the manufacturing process. For the COVID-19 vaccine, manufacturing of the vaccine candidates is happening while they are still being evaluated for effectiveness. For vaccines candidates that prove ineffective, the already manufactured doses will be disposed of. But for those that are proven to work, millions of doses will be ready to go immediately.
"We've run these processes in parallel, and really made investments where large amounts of vaccines are being made much sooner," Hepburn said. "By those investments, we're able to have millions of doses available much sooner than we ever would."
Large, diverse, safe clinical trials are also playing a role in OWS's effectiveness, Hepburn said. Clinical trials for the vaccine candidates involve some 30,000 individuals each, and safety has been a priority, he said.
Two manufacturers, for instance, had their trials put on a "safety pause." While those pauses have been lifted, he said, they demonstrate the level of commitment to both a safe and effective vaccine, Hepburn said.
"We are following the highest ethical standards to ensure that these vaccines are safe, and that those clinical trials are conducted to the highest regulatory and ethical standards, as well," Hepburn said.
The clinical trials themselves are also large, involving 30,000 volunteers. Typically, he said, such a trial might involve 5,000 or 8,000 persons. The increase means better results.
"We want to gather as much safety information as we possibly can," he said. "And we also want to know if they work. With the more people you enroll, the sooner you're going to be able to evaluate the effectiveness."
Finally, Hepburn said, teamwork among multiple agencies and industry has helped OWS be effective in vaccine development.
"The way we fight the virus is really getting the best from all of us," he said, adding that this includes extraordinary cooperation among DOD, HHS and the private sector. "I've seen some of the best teamwork that I've ever been a part of as part of Operation Warp Speed — and it is the essential fourth ingredient on how we achieve the impossible."