The Trump administration announced its strategy Wednesday for distributing any eventual COVID-19 vaccine, which requires states and localities to submit plans to the Centers for Disease Control and Prevention by Oct. 16.
The 11-page overview and 57-page playbook developed by the departments of Health and Human Services and Defense are intended to assist state, tribal, territorial and other local public health programs. HHS broke down the process into first communicating with local officials to promote the vaccine, distributing it, ensuring the reliability of the supply chain, and monitoring the vaccine's administration.
Ensuring that consumers get vaccines in a timely and correct way will be a major test for the administration, which has struggled to meet several challenges throughout the coronavirus pandemic.
For most of the potential vaccines, individuals can expect to receive two doses separated by 21 or 28 days.
The COVID-19 vaccine is expected to be distributed swiftly after an emergency use authorization or Biologics License Application approval by the Food and Drug Administration.
During a call with reporters Wednesday, federal officials said that 24 hours after a EUA or BLA, vaccines will move to administration sites and will be distributed by the health care distribution and technology company McKesson. Before that, the American Society for Investigative Pathology is expected to offer McKesson recommendations on distribution.
The rollout involves three phases for different populations, with vaccines likely integrated into routine care run by public and private programs in the final phase.
CDC Director Robert Redfield told reporters that initially there may be a limited vaccine supply, and that distribution would focus on frontline health care workers first, followed by other essential workers and those at highest risk for illness such as older people.
“CDC’s goal and that of the U.S. government is to have enough COVID-19 vaccines for all people in the United States who wish to be vaccinated,” he said.
Redfield cautioned that it’s still unclear what it will take for herd immunity to be achieved so that the virus is contained.
“Scientifically for COVID-19, we don't know exactly what the level of immunity would be required to interrupt sustained transmission or what you would call herd immunity,” Redfield said. “Clearly, the objective of having a biological safe and efficacious vaccine is to be able to vaccinate the American public with the goal of achieving immunity to the point that there is no longer sustained transmission of this virus.”
Paul A. Ostrowski, the deputy chief of supply, production and distribution for the administration's vaccine and therapeutics effort known as Operation Warp Speed, said data monitoring will be a key challenge.
“We have to be able to tell the person that we vaccinated when it is time to come back in for the second shot, the second vaccination,” he said. “We also have to make sure they have the right vaccination injected on the second dose.”
A Pfizer vaccine, for example, would not be interchangeable with a different one manufactured by Moderna.
“The databases exist. The hard part is getting the databases to talk to one another,” Ostrowski said. “The individual databases talk today; what we’re in the process of doing is allowing those different databases to talk together through a data link that we’re developing and testing as we speak.”
The administration expects the vaccine will be free for most individuals, either through a provider relief fund reimbursement for the uninsured, through private plans or Medicaid. Details are still being worked out for Medicare fee-for-service coverage.
HHS officials said in a worst-case scenario it would be $3.50 out of consumers' pockets, and that the government is working to eliminate that.
A top Senate Democrat called the plan incomplete. Patty Murray, the top Democrat on the appropriations subcommittee that funds HHS and a member of the Senate Health, Education, Labor and Pensions Committee, said the plan is "a long-overdue step forward, but there is still more to do."
"It’s clear that this is still not the kind of comprehensive, end-to-end national plan I’ve called for and that we desperately need," she said. "We are still missing important details on research and review, like what standards FDA will use to authorize a vaccine for emergency use … how we make sure disparities are addressed in clinical trials, and manufacturing, like how we address supply chain issues and avoid bottlenecks. And we still need more details on addressing disparities."
Harald Schmidt, a University of Pennsylvania medical ethicist and researcher in vaccination, raised concerns about a lack of specificity in the plan's prioritization of Black communities.
"In defining further the exact locations to which vaccines will ultimately be shipped, it is imperative that planners consider how they will incorporate the important recent proposal by the [National Academies of Sciences, Engineering, and Medicine] to prioritize worse-off population groups, particularly African-American communities," he said, adding there doesn't seem to be further guidance as to how to use CDC tools that the academy proposed using for that purpose.
Andrew Siddons contributed to this report.