At a time when coronavirus cases are surging around the country, with the US hitting a new record for hospitalizations on Saturday, much attention has focused on encouraging news about the efficacy of three vaccine candidates, and Pfizer's application to the Food and Drug Administration for emergency use authorization -- with a decision expected within weeks of a December 10 meeting of a key FDA committee.
But enormous logistical and readiness hurdles remain within the 50 states given their variations in geography and weather; the availability of doctors, nurses and pharmaceutical employees who must be recruited and trained to administer the vaccine; the need for vaccine education campaigns to reach skeptical Americans and even the variance in each state's level of preparedness to find and vaccinate the patients who need protection the most.
While delaying the transition, President Donald Trump hindered the ability of President-elect Joe Biden's team to get up to speed on the plans and remaining challenges of vaccine distribution. In the weeks since the election, Trump -- who has been mostly absent from public view -- has continued to falsely claim the country has turned the corner even as Covid-19 cases skyrocket, with last week's White House Thanksgiving proclamation encouraging Americans to "gather" despite the worsening pandemic.
The warring political parties in Congress, distracted by a presidential election that Trump has baselessly contested, have been unable to come to any sort of agreement about the size and the scope of the next emergency funding package related to Covid-19. The pressure should be on when lawmakers return to Washington this week. But they'll also have to move quickly to pass a spending package to avert a partial government shutdown by December 11, which could once again distract from the need for Covid-19 relief.
Members went on Thanksgiving recess amid dimming hopes of a deal even though millions of Americans are facing a December 26 cutoff of their emergency unemployment benefits and other financial protections that have helped guard against economic devastation as a result of the virus.
Congress' inability to act has left not only those jobless workers facing an end-of-the-year financial crash, but also many state officials worried about whether they will have the resources to train workers and effectively distribute a vaccine — from tracking and corralling patients back to get the second shot, as some of the vaccines require; to being able to procure enough dry ice and enhanced storage capabilities to keep it at the right temperatures once it is delivered. (Pfizer's Covid vaccine must be kept between about negative 60 and negative 80 degrees Celsius).
States need more money
The Association of State and Territorial Health Officials, in concert with the Association of Immunization Managers — whose members will handle many of the intermediary steps between the federal government's delivery of the vaccine and the point where it is injected in a patient's arm — told Congressional leaders last month that they will need $8.4 billion in the next coronavirus emergency aid package to handle some of those challenges.
In mid-October, the National Governors Association submitted a list of questions on behalf of both Democratic and Republican governors to the Trump administration detailing their unsettled queries about vaccine funding, allocation and supply chain requirements. The memo noted that "without additional state and local funding to implement COVID-19 vaccine plans, we will be hampered in what we can accomplish."
The federal government has provided $200 million to states for vaccine preparedness through the US Centers for Disease Control and Prevention.
And the Department of Health and Human Services told the National Governors Association that the next tranche of Covid vaccine readiness funding would be awarded by mid-December: $140 million to "expand this readiness work and fill initial gaps."
In that memo, HHS officials underscored that "most of the major costs of a vaccine campaign are already being covered," including the costs of the securing the vaccines themselves and "almost all transportation," as well as insurance reimbursements for providers and a federal fund that will cover the costs of vaccinating the uninsured.
But in response to governors' questions about whether there will be more funding to make sure they have enough "boots on the ground" to conduct the vaccinations, the department acknowledged that "existing clinical infrastructure will be heavily relied upon."
Some of the biggest ticket items included in the $8.4 billion request from the Association of State and Territorial Health Officials and the Association of Immunization Managers was $3 billion for workforce recruitment and training, $1.2 billion for cold supply chain management, $500 million for the modernization of the data capabilities for Immunization Information Systems, and $1 billion for the creation of additional vaccination sites that can accommodate safe social distancing as people line up to get the vaccine, as well as protection for health workers from the elements at outdoor sites.
The Washington Post reported this week that a health official in Maine is considering vaccination sites like heated fire stations and car washes to keep their health workers from having to conduct vaccinations in full personal protective gear out in the cold.
In September, Dr. Robert Redfield, the director of the CDC, told members of a Senate Appropriations subcommittee that states and jurisdictions would need between $5.5 and $6 billion to distribute and safely monitor the vaccine. At the time, Missouri Sen. Roy Blunt, a Republican, told Redfield that if the US were to have the vaccine but lacked either the plan or resources to distribute it, that would be a "huge failure on the part of the Congress to provide the resources that we know are going to be necessary."
But even the risk of that failure doesn't seem to have spurred Congress along any more quickly.
This past week, New York Gov. Andrew Cuomo highlighted the precarious financial predicament that states are facing with their coffers drained from expanding testing, tracing and other Covid-19-related costs this year.
"The current vaccine program that's on the table is going to have to be improved," Cuomo said during a news conference. "The states are broke because Washington never approved state and local funding."
When California Gov. Gavin Newsom outlined his state's vaccine distribution plans last week — including the state's continuing search for adequate storage units, an ample supply of dry ice, its efforts to obtain ultra low temperature freezers and "mini freezers" for smaller counties — he said the federal government needs to step up with much more financial support.
The difference in state capabilities and resources could also create major equity issues that Congress might need to help negate with additional funding.
State officials have expressed concerns to CNN that they do not yet know exactly when they will receive the vaccine or how much. And some are grappling with how to get the vaccine to rural populations without wasting precious doses if they must meet minimum order requirements from the vaccine manufacturers and discard unused vials after a limited amount of time.
A key panel considers which groups will get the vaccine first
The CDC's Advisory Committee for Immunization Practices (ACIP) has called an emergency meeting Tuesday so they can vote on recommendations for the first people to get a coronavirus vaccine, once one gets emergency authorization from the FDA.
While most agree that front-line health workers should be first in line, there are ongoing discussions about whether residents of nursing homes and long-term care facilities should also be included in the first round.
Dr. Celine Gounder, a member of Biden's coronavirus advisory board, said Saturday that "people who are doing things that we really can't function without" should receive the vaccine first.
"Doctors, nurses who are caring for patients in the hospital, including patients with coronavirus, should very much be among those first receiving the vaccine," Gounder told CNN's Boris Sanchez.
"Beyond that, there are other front-line workers, essential workers -- whether that's the people who are working in food and meat processing (or) people who are at the grocery store checkout counter."
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