Federal officials will lay out more details about the approval process of the COVID-19 vaccine and detail the logistics behind its distribution during a "Vaccine Summit" at the White House Tuesday. President Donald Trump also plans to issue an executive order that Americans be first in line for the vaccine before other nations.
Senior administration officials said the summit is being held by Operation Warp Speed, a joint initiative of the departments of Health and Human Services (HHS) and Defense (DOD), to instill confidence in Americans around the vaccine’s development and distribution plans.
The event itself has been steeped in politics. (Stat reported that Pfizer and Moderna—both undergoing regulatory review for their vaccines—declined invitations. Meanwhile, President-elect Joe Biden was reportedly left off the guest list.)
It also comes amid questions about how quickly states will actually get the vaccine. As The Washington Post reported, while Trump administration officials initially said 300 million or so doses of vaccine would be delivered immediately after emergency use approval and before the end of 2020, current plans call for availability of 35 million to 40 million doses. The Trump administration recently outlined a goal of vaccinating 100 million people with the COVID-19 vaccine by the end of February, which would be enough to reach all healthcare workers and the country’s at-risk population.
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However, it also could offer a more detailed glimpse at how the first doses of the vaccine will ultimately make it to patients. Here's a rundown of what we know so far about the distribution process:
Allocating to the states
As soon as the emergency use authorization is granted, Moncef Slaoui, M.D., chief adviser to Warp Speed, recently told reporters, the initiative will start to distribute 6.4 million doses to states, cities and several federal agencies such as the DOD, the Federal Bureau of Prisons and the Department of Veterans Affairs.
Senior administration officials said Tuesday they'd likely ship about half of that immediately to ensure that everyone who gets the first dose of the vaccine will have a second dose available within 21 days of getting the initial dose.
After the initial push, there will be a continuous flow of vaccines going out to states each week. Slaoui said that more doses could be available once a vaccine being pursued by Johnson & Johnson is approved.
Warp Speed has designated certain allocations to the 64 jurisdictions, including U.S. territories and islands. Each of those jurisdictions has already enrolled thousands of vaccinators who are registered to give the vaccine after being trained, proving they meet cold storage requirements, and getting linked through Warp Speed's IT system.
Both Pfizer and Moderna’s vaccines will require two doses for someone to get fully vaccinated. Pfizer’s vaccine requires ultra-cold storage while Moderna’s candidate can be stored in a regular refrigerator.
As doses come out of the fill-and-finish facility designated for Warp Speed, they will be tracked with an IT system, a senior administration official said. At the direction of the state, vaccination sites can order product and Warp Speed will direct Pfizer or Moderna to distribute the vaccine. If it's a Moderna vaccine, that will be handled through McKesson. If it is a Pfizer vaccine, Pfizer will distribute the vaccine itself.
Both of those will use some combination of UPS and FedEx to ship the doses directly to the points of vaccination.
Paying for the vaccines
Senior administration officials reiterated that every dose is already paid for as part of its advance purchase agreements, including syringes, needles and swabs needed to vaccinate as well as the dry ice needed to keep the vaccines in cold storage.
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"No American will have to pay a penny out of his or her own pocket to get vaccinated. It will be absolutely co-pays, deductibles or co-insurance associated with this," a senior administration official said.
When the vaccines get to the vaccination site, those administering the vaccine will bill Medicare or Medicaid, or commercial payers. If a person is uninsured, the Provider Relief Fund through the CARES Act will be covering the cost of that at the Medicare reimbursement rate. Those sites that are vaccinating will bill approximately $20 to $25 per injection in reimbursement for distributing the vaccine.
International distribution
The executive order to be signed by Trump Tuesday will require the U.S. government-secured COVID-19 vaccines to go to Americans first, senior administration officials said
The order also tasks the state department, the U.S. Agency for International Development, the U.S. AID Finance Corporation and the Export–Import Bank of the U.S. to collaborate with HHS to work with partners and ally countries in need of vaccines, senior administration officials said.
That means working with allies that can afford to directly procure vaccines to ensure they have access to the private markets. It also means working with low- and middle-income countries, based on their need, to help them get the vaccine.