Amid increasing claims about the impossibility of meeting President Trump’s January 2021 timeline for delivering a safe and effective coronavirus vaccine to more than 325 million people in the United States, senior administration officials briefed journalists on the “record-setting pace” of vaccine development and the “simultaneous” scaling tracks planned.
“The timelines are being modified, but it’s important to note that the science is not,” a senior administration official said Tuesday on a joint Department of Health and Human Services and Department of Defense press briefing about the progress of what the president dubbed “Operation Warp Speed.”
Traditionally, the official said, development, manufacturing, and distribution occur sequentially.
“The key unique characteristic of OWS is that these elements are occurring simultaneously,” the official said.
Officials closely involved in the joint effort, which held a kickoff ceremony on May 15 at the White House, described a timeline for developing a vaccine that actually began when China shared the viral sequence with the National Institutes of Health on Jan. 10.
As a result of the early start, 14 candidates have already been chosen from a field of more than 100.
“The three to five selected candidates most promising will be advanced while they are still in development rather than scaled after approval or authorization,” another senior administration official said.
The Food and Drug Administration will review clinical data as it comes in, rather than wait until all trials are complete.
The two officials emphasized that while the “vagaries of science” prevent a guarantee that a vaccine will be ready by the end of the year, simultaneous development and scaling not possible in the private sector will give the government approach a head start.
The U.S. government will pay the cost of vaccines to those otherwise unable to pay, officials said, and discussions with insurance providers have indicated that they intend to provide coronavirus vaccines “with zero co-pay.”
Officials expect that up to 40 million people will have strong enough antibodies not to require a vaccine and that enough of the American public will be vaccinated by the “height of flu season” in 2021.
Billions invested
The CARES Act authorized nearly $10 billion to develop a coronavirus vaccine and countermeasures that are funding the project.
Among the lead candidates and related investments are $456 million to support phase 1 clinical trials for a vaccine by Johnson & Johnson; $483 million available for Moderna’s vaccine, which began phase 1 trials March 16; and $1.2 billion to support a candidate by AstraZeneca and the University of Oxford.
The agreement supporting the AstraZeneca/Oxford University vaccine candidate calls for at least 300 million doses of the vaccine for the U.S., with the first available as early as October 2020 and phase 3 clinical studies beginning this summer.
“Our priorities are very clear. Let’s take care of Americans first,” an official said.
While clearly impressed with the team in place, one administration official with decades of U.S. Army infectious disease research and delivery experience promised a “24/7” commitment to meet the goals but refrained from promising delivery by the target date.
“We cannot promise a hundred percent chance of success,” he said. “What we can tell Americans is that we’ve taken every possible step to maximize the probability of success and shorten the timelines to getting safe and effective vaccines and therapeutics.”
At the May 15 White House ceremony with HHS Secretary Alex Azar, Defense Secretary Mark Esper told the president, “We will get the job done,” shedding any doubt about the importance of the mission and the logistical capacity of the Pentagon, a point that was stressed at Tuesday’s briefing.
“The DoD is uniquely capable of meeting the logistical needs of Operation Warp Speed and its involvement in supply production and development on a faster distribution than otherwise possible,” said an administration official.
Hefty investments in manufacturing capacity to make the vaccine at scale include March 30, April 16, and May 21 agreements with Johnson & Johnson, Moderna, and AstraZeneca for the U.S. government to invest in manufacturing capabilities in exchange for amortized pricing.
A June 1 investment of $628 million with Emergent BioSolutions was meant to increase domestic manufacturing and capacity for vaccine and therapeutics.
Officials said the U.S. government is also buying rights and licensing technology related to the investments and development.
The in-person and telephone briefing described a tiered system that will be designed to get vaccines to the most vulnerable first, including the elderly, those with pre-existing conditions, and those performing essential functions, such as national security.
