番茄社区app

The Health and Human Services (HHS) department on Wednesday unveiled general outlines for how the first COVID-19 vaccine doses will be shipped and administered.

Developed with the Department of Defense (DOD), the addresses engagement with state and local partners and other stakeholders; distribution under a "phased allocation methodology" still to be developed; safe vaccine administration and availability of auxiliary supplies; and data gathering via information technology to track distribution and administration.

The strategy gives January 2021 as the target to begin distribution of an FDA-approved or authorized vaccine.

Also released Wednesday was a from the CDC to assist local, state, tribal and territorial partners in rolling out their COVID-19 vaccination programs.

The CDC handbook tracks different phases of vaccine dose availability, from the first "potentially limited" phase, to a second phase when a "large number of doses [are] available," to a third phase of "continued vaccination."

In the earliest phase of vaccine distribution, "vaccine efforts may focus on those ... providing critical care and maintaining societal functions, as well as those at highest risk for developing severe illness as a consequence of COVID-19," explained Robert Redfield, CDC director, on a call with reporters that included other federal health officials.

The playbook identifies healthcare personnel and other essential workers as among the "critical populations," although final decisions remain to be made by the CDC's Advisory Committee on Immunization Practices.

The playbook also encourages jurisdictions to establish a "COVID-19 Vaccination Program" implementation committee that includes representatives from local health departments, pharmacies, churches or other religious institutions, correctional facilities, educational agencies, and other stakeholders.

Additionally, the guidance includes three hypothetical scenarios for the first phase of distribution intended as exercises for any such committee to workshop or practice.

"CDC's goal, and that of the U.S. government, is to have enough COVID-19 vaccines for all people in the United States who wish to be vaccinated," Redfield stated. He added that the playbook will be updated as soon as new information -- for example, vaccination guidance for pregnant people or for children -- becomes available.

Both the HHS strategy document and the CDC playbook still lack many key details, such as who is to receive the first doses, or how exactly the particular vaccines will be transported from factories and warehouses to immunization sites. The latter is a special challenge given that federal officials promised to begin shipping doses the day after the FDA approves or authorizes a product.

Moreover, plans must be laid without knowing for sure what vaccine or vaccines will get the green light.

Paul Mango, HHS deputy chief of staff for policy, described the vaccine process as a "logistically complex undertaking" taking place in a "world of uncertainty."

"We don't know the timing of when we'll have a vaccine. We don't know the quantities. We don't know the efficacy of those vaccines," he said.

Mango pointed out that current vaccine candidates use different types of needles and syringes, as well as require different storage and dosing methods, all of which further complicate preparations.

Nevertheless, he declared, "we are prepared for all of those uncertainties."

Mango also echoed President Trump's goal that no American should "pay a single dime" for the vaccine and said "we're getting very close to that aspiration right now."

There are currently three , from AstraZeneca, Moderna, and Pfizer, in phase III clinical trials. Other companies are expected to in the next 30 days, while others are expected to kick off trials before the end of the year, with each candidate vaccine enrolling 30,000 participants per trial, explained U.S. Army Lt. Gen. Paul Ostrowski, director of supply, production, and distribution for .

Researchers anticipate that more than one vaccine will be approved by the FDA, either through a biologic license application or an emergency use authorization.

A 'Herculean Task'

The distribution of potentially six COVID-19 vaccines in the midst of a pandemic is a "Herculean task," said Ostrowski, and one that HHS lacks the personnel to manage on its own. The DOD's role in Operation Warp Speed will be to provide "the bandwidth and the enablers."

The DOD has the program management and contract expertise to ensure the government gets what it paid for from each of the vaccine developers, he said.

Additionally, the DOD will be responsible for logistics, such as securing supply chains for raw materials and other equipment associated with the vaccine.

Ostrowski outlined several key principles intended to guide the DOD's approach to administering and delivering COVID-19 vaccines including:

• Control: Ensuring that vaccines are distributed to the subset of the population prioritized to receive it at the earliest phase of distribution
• Visibility: Knowing where each vaccine is throughout the distribution chain
• Uptake: Identifying shortages or overages of vaccine and make certain that supply matches demand
• Traceability: Knowing which vaccine a person received, on what date, and at what facility; the ability to issue a reminder to that person, if necessary, regarding a second dose

Most of the vaccine candidates require two doses, Ostrowski explained. "We have to be able to... tell the person that we vaccinated, when it's time to come back in for the second shot," after the appropriate time period, likely 21 or 28 days.

And because a Pfizer vaccine cannot be substituted for Moderna's product, these details matter, he stressed.

Providers will need to know "what vaccine did a person receive, when did they receive it, and where did they receive it," Ostrowski stated.

All of this information must be traceable and requires the interoperability of public and private databases, so that if a person receives a vaccine in one state, and 28 days later needs to get the second dose in another location or state, they will have access.

The DOD is currently working to "allow those different databases to talk with one another through a data-link that we're developing and testing as we speak," Ostrowski said.

He also stressed that vaccine accessibility is paramount.

"We have to be able to go beyond the pharmacies, the hospitals and so forth to get after nursing homes; to get after meatpacking facilities; to get after those that are sheltered [at home]. We have to get this out to all four corners of this nation," he said.

Asked how soon a patient could receive the vaccine once the FDA has given the green light, Ostrowski said that a central distributor, , will move the vaccine "within a day or so" to administration sites.

As for Trump's aspiration that no American will pay out of pocket for the vaccine, Mango stressed that providers will still be paid for administering the vaccine by commercial insurers and Medicaid. For uninsured patients, a "sub-fund" of the Provider Relief Fund has been earmarked for the cost of administering these vaccines.

However, for full payment by Medicare, "there's a couple of complications," Mango acknowledged. Under current rules, a beneficiary might have to pay $3.50 out of pocket for the vaccine, but "we are working to eliminate that," he stated.

Ostrowski said contracts with vaccine manufacturers -- which so far haven't been made public -- are "releasable" to some degree and "will be made available at some point in time."

Comment