Azar expects 40M COVID-19 vaccine doses ready to distribute by end of December

Department of Health and Human Services Secretary Alex Azar expects 40 million doses of Pfizer and Moderna’s COVID-19 vaccines will be ready for distribution by the end of December as providers must gear up now to allocate the doses.

Azar gave an update on vaccine distribution as part of Operation Warp Speed on Wednesday. His remarks come as both Pfizer and Moderna have reported high efficacy for their COVID-19 vaccine candidates of more than 90%, and both are expected to seek emergency approval from the Food and Drug Administration (FDA) soon.

Officials with Warp Speed, a Trump administration program that has funded the research and manufacturing of vaccine doses, laid out the process for how a vaccine will initially be distributed after the FDA extends an emergency use authorization.

“We will begin distribution of the vaccine within 24 hours after [the] vaccine is approved,” said General Gustave Perna, chief operating officer of Warp Speed.

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The operation is working with 64 jurisdictions that include regions and cities that will get the initial allocations, which will vary based on population. The initiative had invested in manufacturing doses of six vaccine candidates before they were even approved to be ready with some initial doses once one or more gets approved.

The federal government is working with the jurisdictions to enroll providers to help distribute the vaccine. Only providers who have enrolled in the distribution program can qualify to get the vaccine.

Warp Speed emphasized that states also need to sign data use agreements to share data on vaccine use. 

"We must be able to see who got their first dose, where they got their first dose and what vaccine they received as their first dose," Perna said. "We need to make sure we can do the same for the second dose that we are sending out."

But there are some major challenges with the distribution itself.

Both Pfizer and Moderna’s vaccines will require two doses a month apart to ensure protection. Pfizer’s vaccine must be stored at minus 70 degrees Celsius in an ultra-cold freezer, and Moderna’s vaccine can be stored in a normal refrigerator for 30 days.

Pfizer’s vaccines can be thawed and stored in a normal refrigerator for five days before expiring.

Perna said states are working on establishing the right techniques, and procedures are in place to ensure providers have the correct amount of vaccine on hand for allocation and the rest stay in ultra-cold storage.

He added that states have been working to identify all ultra-cold storage facilities in the country to boost capacity.

“Don’t be afraid of the refrigeration requirements,” Perna said.

Pfizer has also said that distributors and providers can use dry ice to keep the vaccines cold. The drugmaker said last week that it expects to produce up to 50 million vaccine doses by the end of 2020 and 1.3 billion doses next year.

Perna couldn’t say whether Moderna’s vaccine would be more widely distributed since it has less burdensome logistical challenges because of the cold storage requirements.

“We are going to wait for the science to lay some things out for us, and then we will execute the plans that the jurisdictions have established,” he said.

Pfizer announced Wednesday that it plans to submit its vaccine for emergency approval from the FDA soon after full results from the phase 3 clinical trial showed 95% efficacy.

Moderna has not announced a plan to submit to FDA but recently announced its interim trial results show efficacy of 94%.