The Trump administration on Wednesday outlined a strategy to deliver safe and effective COVID-19 vaccine doses to the American people as quickly as possible, for free.
In a report to Congress and a separate “playbook” for states, the Department of Health and Human Services, in conjunction with the Department of Defense and the Centers for Disease Control and Prevention (CDC) laid out detailed vaccination distribution plans for states, tribal, territorial and local public health programs.
The playbook warned that states have never needed a pandemic response plan that is this complex.
“Significant additional planning is needed to operationalize a vaccination response to COVID-19, which is much larger in scope and complexity than seasonal influenza or other previous outbreak-related vaccination responses,” the agencies said.
Health officials noted that the plan is flexible, because some variables won’t be known until a vaccine is authorized or approved by the Food and Drug Administration (FDA), such as populations for whom a given vaccine is most appropriate, distribution and storage requirements, dosage requirements and other variables.
“We’re dealing in a world of great uncertainty,” Paul Mango, deputy chief of staff for policy at HHS, said during a call with reporters. “We don’t know the timing of when we’ll have a vaccine, we don’t know the quantities, we don’t know the efficacy of those vaccines … so this is a really, quite extraordinary, logistically complex undertaking.”
But, Mango said, “we are prepared for all of those uncertainties.”
In addition, the initial doses of the vaccine will be free of charge for patients. The administration’s Provider Relief Fund contains over a billion dollars of taxpayer money that will be used to reimburse providers for uninsured patients.
Officials said they are working to iron out some “complications” with Medicare, but the worst-case scenario is Medicare beneficiaries will have to pay $3.50 out of pocket.
The detailed assessment comes amid growing skepticism from the public about the politicization of the administration’s entire vaccination plan.
President Trump has routinely said a vaccine will be available before the November election, and the public and some experts have expressed concern that health agencies will rush the authorization to aid his reelection chances.
Health officials have been working hard to reassure the public that a vaccine will only come to market when it’s ready.
“We are working closely with our state and local public health partners … to ensure that Americans can receive the vaccine as soon as possible and vaccinate with confidence,” HHS Secretary Alex Azar said in a statement Wednesday. “Americans should know that the vaccine development process is being driven completely by science and the data.”
The Trump administration’s Operation Warp Speed is aimed at developing and delivering a COVID-19 vaccine to the public in record time through contracts with seven different drugmakers. While some of the leading vaccine candidates have moved into large phase three trials, it’s still not clear if any of the vaccines sponsored by the administration will be successful.
The federal government has contracted with McKesson, the country’s largest drug distribution company, to ensure states will receive vaccines as quickly as possible.
The administration is anticipating the FDA will grant the initial vaccine an emergency authorization, which requires less data than a complete approval. The goal of Operation Warp Speed is to have vaccines moving to administration sites within 24 hours after an emergency authorization.
Initially, there may be a limited supply of vaccines available, and the focus will be on protecting health workers, other essential employees and people in vulnerable groups.