As the world began to understand the gravity of COVID-19 and its devastating effects, we asked, “Will they come up with a vaccine? How will we they get the vaccine to us?” Well, who exactly do we mean when we say they? We know that a global team of scientists has tackled and solved the problem of developing vaccines in record time. The next problem to solve is how to get these vaccines to us and into our arms. We know people are working hard to figure this out but who are they?
Through the kind introduction of a long-time friend of Greenspring’s, I had the opportunity to ask a key player in the distribution of the vaccine about how they are delivering vaccines to the public. Lt. Gen. Giovanni K. Tuck is the former Director for Logistics, Joint Staff, the Pentagon, Arlington, Virginia and the current Deputy Director, Supply, Production & Distribution for the Federal COVID-19 Response, Vaccines & Therapeutics. After you have finished scrolling through his impressive education, assignments, awards and decorations (18 of these alone!), you may feel a little sheepish about how you have spent your free time. That should soon give way to a sense of relief knowing that because they are in charge, we are in good hands.
Lt. Gen. Giovanni K. Tuck was kind enough to answer some questions about vaccine distribution.
- In the history of this country has there ever been an operation like this in terms of size and scope? Is there any previous operation you can compare this to?
From a medical perspective, probably not. But the original concept behind Warp Speed, now known as the Federal Response to COVID-19, was to emulate the Manhattan Project, the crash program to develop an atomic bomb during World War II. Both projects brought scientists, industry experts and government capabilities together to accomplish an urgent goal.
- If we were to peek behind the curtain of vaccine distribution, what does it look like backstage? How many departments of government are involved? How many people are involved? How many pieces of “equipment” (planes, trains, and automobiles) are involved?
It’s honestly harder to find parts of the government that aren’t involved in this operation. It was clear at the start of this effort that no single executive agency would be able to handle the whole process of developing, manufacturing and distributing vaccines for 300 million Americans. So in addition to DOD and DHHS, the two lead agencies, this was a close partnership with each of the states, several major metropolitan areas, and multiple federal agencies responsible for their own populations, such as the Department of State, the Federal Bureau of Prisons, the Indian Health Services, and Veterans Affairs. To ensure security for shipments we worked with the US Marshall Service. Establishing a supply chain for the dry ice and dry ice recharge kits, which are essential to ensuring the viability of the Pfizer vaccine, was a major task that required coordination between the government, the manufacturers, and shipping companies like FedEx and UPS. Really, it’s impossible to describe in just a few sentences all the pieces that went into Operation Warp Speed – it was truly a whole-of-America response.
On any given day, there will typically be thousands of deliveries out the door, totally hundreds of thousands of doses. It is a monumental logistical effort, designed to counter a monumental challenge – the COVID-19 pandemic.
- Can you explain in a “nutshell” the steps involved getting a vaccine from the factory into someone’s arm?
Each vaccine is different, but the process is exceptionally long and complex, and the reason it is complex is to ensure that the vaccines meet the FDA’s standards for safety and efficacy. Before they receive their FDA EUA, each vaccine must successfully conclude stage 3 clinical trials, demonstrate that they generate an immune response, demonstrate efficacy, and of course pass rigorous safety tests.
Part of the reason the operation has been able to accelerate the development of vaccines is that we covered a lot of the financial risk for the manufacturers, letting them move into the production phase even as the clinical trials were in progress. This ‘parallel’ strategy turned what would normally be an unacceptable financial risk for those companies into a viable production strategy.
But the process of creating hundreds of millions of doses requires a huge effort involving the manufacturer, fill/finish facilities, packaging and shipping with appropriate cooling materials like dry ice, and distribution across the country. One of our biggest efforts was working with states to develop an IT system that enabled them to designate locations for us to ship vaccines to every week. It is an immense, extremely difficult problem, but one that I am happy to say has been extraordinarily successful so far.
- What has been the biggest challenge for Operation Warp Speed? What has been the greatest success?
The biggest challenge by far was the last mile of distribution. It’s very easy for us to control all the different variables associated with vaccine delivery when they’re stored in bulk and under our control – things like security, temperature, tracking doses, etc. But when you start to deliver them to the individual hospitals and pharmacies, you go from shipments of tens- or hundreds-of-thousands of doses down to thousands, or in some cases even a hundred doses. That multiplies the challenge of protecting and accounting for all these vaccines by an order of magnitude.
You can imagine a single semi-tractor trailer might be able to carry, without much difficulty, over one hundred-thousand doses of the Pfizer vaccine from their plant in Kalamazoo, Michigan, to a FedEx or UPS distribution site. But there is no single location in the country that gets a hundred-thousand doses – most states don’t even receive that much. So that one shipment on one truck needs to be broken up into dozens or hundreds of smaller shipments, every single one of which requires the same degree of tracking and monitoring, as they make their way to individual pharmacies, hospitals, long-term care facilities, or other locations around the country.
In terms of successes, I think those are readily visible to anyone who watches the news, and especially people who’ve been able to receive a vaccine. Just seven months after Operation Warp Speed was initiated, the FDA granted Emergency Use Authorizations to two of our vaccine candidates, two therapeutic treatments to help people who’ve already contracted COVID-19, and we have several other vaccine candidates in the final stages of applying for FDA EUAs. By summer, we anticipate having more than 600 million vaccines available to the United States – enough for every eligible American who wants one.
- Where can we find accurate and up to date information about how and when we will be able to get the vaccine?
Almost every state has, at this point, a website or call-in system for residents to find out when they are eligible for the vaccine, or to schedule an appointment.
- Will Operation Warp Speed, now the Federal COVID-19 Response, be involved in helping to distribute vaccines internationally?
That is something the Biden Administration will have to consider when they start to address the next phase of combating the COVID-19 pandemic.
- What should we know about Operation Warp Speed, now the Federal COVID-19 Response, that we probably don’t already know?
I would like people to know just how many people are involved across all of the nation, at all levels of government, in science and academia, and in private industry. It’s not just the 100-or-so of us in the core of what was Operation Warp Speed, now the Federal COVID-19 response. It’s tens of thousands of people; a whole-of-America effort to develop a safe and effective vaccine in record time for the American people.
I should also add that the federal response also provides what are known as therapeutics to the states and territories. Therapeutics are treatments like monoclonal antibodies, which can lessen the progression of COVID-19 in patients and in many cases prevent them from requiring hospitalization. As our nation enters some of its grimmest months, and hospitals begin to reach capacity, these therapeutics have the potential to ease the burden on our hospital system.
My thanks to Lt. Gen. Giovanni K. Tuck for his responses and for the work of his team. Hopefully now we know a little more about the work they are doing to help put the pandemic behind us.
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