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The Trump administration announced it will stop withholding portions of its COVID-19 vaccine supply for second doses, and instead free up all available doses so that states can vaccinate people ages 65 and over, as well as adults under 65 with comorbid conditions.

"We're telling states today that they should open vaccinations to all of their most vulnerable people. That is the most effective way to save lives now," said Department of Health and Human Services (HHS) Secretary Alex Azar during a Tuesday press conference.

Azar pointedly blamed the states' restrictive eligibility criteria for delays in vaccine rollout, claiming that some states "heavy-handed micromanagement of this process has stood in the way of vaccines reaching a broader swath of the vulnerable population more quickly."

Azar stressed that the administration is "100% committed" to ensuring that every person in the U.S. who receives a first dose also gets a second.

The administration initially withheld vaccine doses in order to ensure that sufficient doses would be available for recipients to receive a second dose within the appropriate time frame, and it plans to adhere to the already established protocols for delivery of second doses -- 21 days for the Pfizer/BioNTech vaccine and 28 days for the Moderna's.

"Based on the science and evidence we have, it is imperative that people receive their second doses on time...ignoring that [science] would be reckless," Azar said. (For more, see "Can Second Doses Be Delayed?")

While the administration's change in strategy put forward by President-elect Joe Biden, Azar framed the announcement as part of a pre-planned transition, triggered by having met certain benchmarks outlined in the vaccine playbook released in September 2020.

Azar said that in the 4 weeks since vaccine distribution started, the Operation Warp Speed team has gained confidence in the infrastructure it developed, and vaccines have been delivered to more than 14,000 locations "essentially without a hitch."

The nation recently averaged 700,000 reported vaccinations per day and 9 million first vaccine doses have been administered in total, he stated, adding that "we are on track to hit 1 million per day in a week to 10 days time." In addition, 95% of long-term care facilities will have "first visits" with vaccine doses by the end of next week.

Now that the vaccine supply exceeds that of the priority populations eligible to receive it -- frontline healthcare workers and residents of long-term care facilities -- Azar said it was time to broaden the scope of eligible recipients, and to expand the number and type of delivery sites. He outlined the administration's plans to carry out the following actions:

• Direct states to expand the populations eligible to receive COVID vaccine doses to those ages ≥65 and those ages <65 with comorbidities as validated by medical documentation (the latter will be determined by state governors)
• Direct states to "expand the channels and access points for administering vaccines" to pharmacies, community health centers, and other sites
• Release "the entire supply" of available vaccines to be ordered by states
• Change how vaccine doses are allocated to states beginning in 2 weeks time

Azar said there was never any argument for making sure that all healthcare providers were vaccinated before allowing other vulnerable populations access. "States should not be waiting to complete 1A priorities," he said referring to healthcare workers and long-term care facility residents, "before proceeding to broader categories of eligibility... Moving on to broader populations when supply meets demand was always part of the recommendations the CDC had provided to states."

He applauded Gov. (D-Conn.) and Gov. (R-W.V.) who took similar actions in expanding vaccine access and "demonstrated real success."

With regard to expanding the sites where vaccines can be administered, Azar said that it made sense to focus on hospitals for distribution when the primary populations being vaccinated were healthcare workers, but it's now time to equip other sites to help deliver vaccine shots.

He urged states to allow pharmacies, community health centers, and "mass vaccination sites" to help boost vaccine administration. Last week, the administration announced that pharmacies enrolled in a government partnership (19 pharmacy chains and associations) could be used to give vaccine shots. Through this partnership, states can allocate vaccines directly to pharmacy partners to administer vaccines to eligible populations and ultimately the general public, according to Azar.

The administration also is leveraging federally qualified health centers to help with vaccination efforts, he added, noting that states have "ample funding" to support this work and through congressional legislation.

Azar stated that with the steady pace of production, the federal government is able to ship doses that had been withheld and replace those with the vaccine doses coming from the manufacturing lines. If a production "glitch" were to occur, Azar said that new production of vaccine would go towards completing the obligation to adults waiting for a second dose to ensure they received it within the appropriate time frame, and the delivery of first doses would be delayed.

Finally, Azar outlined the reallocation of vaccine doses to those states that are most effective in administering them, based on self-report, and to those states with the greatest numbers of adults who are over age 65. In 2 weeks, allocations will no longer be determined simply by a state's population but by the percentage of vaccines administered compared to the allocation a state received, he explained.

"This new system gives states a strong incentive to ensure that all vaccinations are being promptly reported, which they're currently not, and...to ensure doses are going to work...protecting people, rather than sitting on shelves or in freezers," Azar stated.

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