WASHINGTON — When it comes to creating and distributing the coronavirus vaccine, the “rule of threes” is vital in both cases, officials said Tuesday at the Trump administration’s Operation Warp Speed Vaccine Summit.
“Why were we so fast? Three main reasons,” said Moncef Slaoui, PhD, chief advisor at Operation Warp Speed, on the administration’s effort to speed up development of COVID-19 vaccines and therapeutics. “The first reason is, we were able to cut the front part of the discovery and development process of a vaccine from years to weeks thanks to the use of platform technologies” that simplified the development of an immune response within the body.
The use of platform technologies enabled vaccine developers to bring vaccines to the clinic “within 2 months of the discovery of the virus,” said Slaoui. “This is where we cut most of the time.”
Operational and Financial Risks
The second factor that allowed Operation Warp Speed to speed up vaccine development “was that we took every operational and financial risk,” he continued. “We planned phase I, II, and III trials in parallel, although of course they didn’t progress in parallel; we only progressed when the FDA said it was safe to progress. We selected hundreds of sites for clinical trials before we knew we could run clinical trials; that cost $1 billion, effectively … We also invested enormous amounts of money to equip and scale up the manufacturing process … That’s how we were able to have millions of doses of vaccines before the vaccines are approved.”
The third reason for the quick results was that “we ran very large trials to assess efficacy,” said Slaoui. “In the context of the pandemic, running a very big trial accelerates the speed with which you run a clinical trial because it allows you to accrue more cases,” and researchers could build up a large database to document the vaccine’s short-term and mid-term safety. “We did not cut corners,” he said.
Gen. Gustave Perna, chief operating officer of Operation Warp Speed and the person who is coordinating the federal government’s vaccine distribution plan, said his strategy has three cornerstones. “First, we went to the CDC experts; we collaborated and partnered with them.” Second, “we went to private industry — why? Private industry knows how to do this. They do it every day; they do it with expertise. We collaborated with them, we took their good ideas and put them into our plan.”
Third, “the key to our success is that it is not our plan that needs to be implemented perfectly — it’s the governors’ plans we want to enable, to empower, to make sure we can execute according to their priorities and guidance,” Perna said. “They know their states, they know their people, and they’re being informed by highly professional medical personnel. Our position is to enable them.” Once a vaccine has received an emergency use authorization, “we’ll start moving the vaccines within 24 hours — throughout the entire United States of America, to 50 states, eight territories, six mega-cities, and five federal agencies.”
“Corners Were Not Cut”
Like Slaoui, Peter Marks, MD, PhD, director of the FDA’s Center for Biologics Evaluation and Research (CBER), emphasized that “corners were not cut” in vaccine development. The vaccine trials “had 30,000 to 45,000 individuals enrolled; that’s a pretty nice size program. That’s giving us a ‘gold standard’ type of clinical trial program that we’d like to see for preventative vaccines.”
“The reason why we’re going through this process at FDA is so that Americans can trust the vaccine they’re going to receive,” Marks continued. By using a transparent process, including public advisory committee meetings, “We hope … people will see nothing’s being hidden, that when we say at FDA they’re safe and effective, we’ve done our best job to make sure they’re safe and effective for all of us to roll up our sleeves and take.”
The summit also featured representatives from CVS and Walgreens, the two large pharmacy chains that are collaborating with the Trump administration to administer vaccines. Rick Gates, Walgreens’ senior vice president for pharmacy and healthcare, addressed the issue of getting vaccine doses to long-term care facilities, noting that his company “will require 800 to 1,000 ‘hub locations’ where we’ll put the Pfizer vaccine to ensure safety. Once the doses are thawed, we have a safe and efficient way to get that ‘last mile’ out to long-term care facilities,” which are each scheduled for two to three vaccination clinics.
Walgreens is working with the facilities “for appropriate space — clean and large enough to ensure social distancing,” he added. “The coronavirus vaccine does present some challenges, but it’s not something we can’t do.”
The Consumer Experience
Jon Roberts, executive vice president and chief operating officer at CVS Health, explained how vaccine distribution would work for people other than nursing home residents. For the Pfizer vaccine, “we’ve identified 1,100 ‘depot stores’ across the country” to get the specially packaged Pfizer vaccine, he said; that vaccine must be stored at a super-cold temperature. “They’ll receive the Pfizer shipper, and you can keep that vaccine in a shipper for 15 days in that container by replenishing the dry ice and then it can be kept at regular refrigerated temperature for another 5 days.”
Meanwhile, “the consumer will go onto the website, pick a store that’s convenient to them, pick a date, and pick a time” to meet with the pharmacist or technician to get the vaccine. After that first appointment is made, the site will immediately schedule the next appointment for the second dose. Patients will get text or email reminders for both appointments. If the patient misses the second appointment, “we’ll make a call to them to make sure they come back in to get the second dose.” Patients will get a card and an email showing that they’ve had the vaccine, Roberts added.
Health and Human Services Secretary Alex Azar moderated a discussion among five governors about their vaccine distribution plans. Louisiana Gov. John Bel Edwards (D) explained that in April, state officials realized “that although African Americans are 32% of our state’s population, at that time 70% of the coronavirus deaths were African Americans. So we created a health equity task force, but we have a head start on these things; every year we do mass vaccination exercises around the flu vaccine, and we specifically target underserved areas to promote flu vaccination.”
This year, Edwards said, “we have been especially successful, with 42% more flu vaccinations than last year … so we’ve been learning lessons about how to get into these communities.”
Texas Gov. Greg Abbott (R) emphasized his state’s lack of a vaccine mandate. “In the state of Texas, people cannot be required to take a vaccine,” he said. “Most people want to and there is such high demand for it, but we want to make sure my fellow Texans know that we know you’re not going to be forced to take a vaccine against your will.” Florida Gov. Ron DeSantis (R) agreed. “This is the first vaccine that has really been politicized,” he said. That’s something people are going to have to deal with … The fact that we’re not threatening to mandate it helps.”
Also at the summit, President Trump signed an executive order to “ensure that Americans have priority access to COVID-19 vaccines developed in the United States or procured by the United States Government” but also stating that once people in the U.S. get the vaccine, “the Secretary of Health and Human Services and the Secretary of State, in coordination with the Administrator of the United States Agency for International Development, the Chief Executive Officer of the United States International Development Finance Corporation, the Chairman and President of the Export-Import Bank of the United States, and the heads of other agencies, shall facilitate international access to United States Government COVID-19 Vaccines for allies, partners, and others, as appropriate and consistent with applicable law.”
Last Updated December 09, 2020