Operation Warp Speed expects to distribute 6.4M COVID-19 doses 24 hours after FDA approval

The U.S. federal government aims to distribute 6.4 million doses of a COVID-19 vaccine to states 24 hours after it gets emergency approval, and officials are in the midst of dry runs to prepare for the shipments, officials said Tuesday.

The White House’s Operation Warp Speed, a joint initiative between the departments of Health and Human Services (HHS) and Defense that aims to distribute the vaccine, gave an update to reporters Tuesday on the initial allocations of a vaccine. The update comes as emergency approval from the Food and Drug Administration (FDA) could come in the middle of December.

“Allocation numbers went to 64 jurisdictions and five agencies last Friday,” said Gen. Gustave F. Perna, chief operating officer of Operation Warp Speed. “Each received their allocation of the vaccine so they can plan and figure out where they want the vaccine to be distributed to.”

HHS Secretary Alex Azar said the allocations are based on the per capita population of each state for residents 18 years and older and not based on COVID-19 cases.

Azar said COVID-19 caseloads weren’t a factor since the virus is spreading rampantly across the country.

“We thought that would be the fairest approach, most consistent,” he said.

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Providers can enroll to receive doses of the vaccine to be distributed, and Operation Warp Speed has reached deals with retail pharmacy chains such as CVS to get doses. There won’t be a limit to the number of providers that can enroll in a state.

“We are not constrained by numbers,” Perna said of the government’s distribution efforts to states.

The government aims to distribute 6.4 million doses of a vaccine 24 hours after the FDA grants an emergency use authorization (EUA). It will then distribute more doses every week.

States and the federal government are right now going through rehearsals and dry runs to figure out how the initial distributions will work, Perna said. The goal to distribute 40 million doses of a vaccine by the end of the year is still in mind, he added.

Currently, Pfizer is the only drugmaker to apply for emergency approval, but Moderna could apply soon for its own vaccine candidate. AstraZeneca announced positive results from its overseas COVID-19 vaccine trials and could use international data to seek FDA approval.

An FDA advisory committee will review Pfizer’s vaccine Dec. 10, and an EUA could come soon after that meeting.

Pfizer’s vaccine candidate, which the company said was 95% effective, must be stored in an ultra-cold unit and kept at minus 80 degrees Celsius.

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The manufacturer aims to distribute 975 doses of its vaccine in ultra-cold units that resemble pizza boxes to providers and pharmacies. A provider will have 20 days to distribute the doses, which must be thawed out to be used.

If states plan the right locations and personnel that need to get vaccinated, “975 doses is very doable within 20 days,” Perna said.

Moderna’s vaccine, which is 94% effective in interim results, can be stored in a regular refrigerator and will last for 30 days.

It remains unclear who will get the first doses. The Centers for Disease Control and Prevention’s Advisory Committee on Immunization Practices will vote on who should get the first doses after a vaccine gets an EUA. The panel has said it is considering several groups to get scarce doses: healthcare workers, essential workers and people in high-risk health categories or 65 years and older.

But the decision will ultimately be up to governors, Azar said.

“They will decide whom the vaccine is given to,” he said. “We hope recommendations will carry weight with them.”