The Trump administration on Wednesday released its plans for distributing coronavirus vaccines once the Food and Drug Administration (FDA) approves their use, with the goal of providing more than 100 million doses at no cost to patients by January 2021.
Federal officials from Operation Warp Speed, the government's vaccine development task force, said on a call with reporters Wednesday that vaccine distribution will be set in motion "within 24 hours" of the FDA authorizing a vaccine, different versions of which are being developed by major drug manufacturers. The strategy released by the Department of Health and Human Services (HHS) details plans to provide enough doses so that everyone who wants to be vaccinated can be, said Robert Redfield, director of the Centers for Disease Control and Prevention.
The government has spent billions of dollars to secure millions of doses of potential vaccines, and "no American will be charged for either the COVID-19 vaccine or its distribution," HHS said. The department is also developing plans under recent legislation to ensure that "no one will be charged any out–of-pocket expenses for the administration of the vaccine either."
The "potential phased structure" for distribution relies on cooperation between public and private entities. The relationship hinges on a shared database of vaccination history for all Americans opting to receive the coronavirus vaccine.
It is likely that any vaccine will require two doses, administered about a month apart, in order to be effective. Officials noted that the time lapse will inevitably force some people to be vaccinated at two different locations, therefore requiring all vaccination centers to be in communication with each other through a shared database.
Combining existing vaccination databases from states and private pharmacies is the next hurdle, according to officials. "The databases exist. The hard part is getting the databases to talk to each other," said Lieutenant General Paul Ostrowski, who oversees logistics for Operation Warp Speed.
The first phase of distribution — after FDA approval — has the goal of "maximizing vaccine acceptance and public health protection while minimizing waste and inefficiency." The initial supply for the vaccine will be limited. "Final decisions about prioritization" have yet to be made, according to the strategy document, but federal officials have begun developing plans "specific to focused populations" most in need of a vaccine.
"As the volume of available vaccine increases, distribution will expand, increasing access to the larger population," reads the phase two outline. "When larger quantities of vaccine become available, there will be two simultaneous objectives: 1) to provide widespread access to vaccination and achieve coverage across the United States population and 2) to ensure high uptake in target populations, particularly those who are at high risk for severe outcomes from COVID-19."
Phase three acknowledges that initial vaccine distribution may not be widespread enough to stamp out the virus. According to HHS, "if the risk of COVID-19 persists such that there remains a public health need for an ongoing vaccination program," the vaccine will ultimately be made "universally available and integrated into routine vaccination programs, run by both public and private partners."
Redfield noted that the framework is not final, and will be updated as more information is known. He called planning for distribution a a "critical next step" in order to "restore our normal way of life."
"CDC is drawing on its years of planning and cooperation with state and local public health partners to ensure a safe, effective, and life-saving COVID-19 vaccine is ready to be distributed following FDA approval," Redfield said in a press release. "CDC will play a vital role in deciding, based on input from experts and stakeholders, how initial, limited vaccine doses will be allocated and distributed while reliably producing more than 100 million doses by January 2021."
According to HHS, the process for distributing the vaccine "will be adjusted based on experience from COVID-19, real-time data on the virus and its impact on populations, performance of each vaccine, and the ongoing needs of the essential workforce."