The Department of Health and Human Services (HHS) on Wednesday revealed a summary of how the first doses of the COVID-19 vaccine will be sent and administered.
Developed with the Ministry of Defence (DOD), the four-party strategy deals with the participation of state and local partners and other stakeholders; distribution according to a “step-by-step allocation methodology” that has not yet been developed; Safe management of vaccines and availability of auxiliary supplies; and generation of knowledge collection data to track distribution and management.
The strategy sets a January 2021 purpose to begin distribution of an FDA-approved or approved vaccine.
On Wednesday, he also published an interim manual of the CDC’s COVID-19 immunization program to local, state, tribal, and territorial partners implementing its COVID-19 immunization programs.
The CDC handbook tracks the other aspects of vaccine dose availability, from the first “potentially limited” matrix to a time when “a large number of doses are available”, to a third of “continuous vaccination”.
At the earliest stage of vaccine distribution, “vaccination efforts can focus on oneArrays . . . they provide extensive care and social functions, as well as those most at risk of serious illness as a result of COVID-19,” explained Robert Redfield, director of the CDC, in a call with journalists that included other federal fitness officials.
The manual identifies fitness care personnel and other essential staff as “critical populations,” final decisions remain to be made through the CDC’s Immunization Practice Advisory Committee.
The manual also encourages jurisdictions to identify a committee to implement the “COVID-19 vaccination program” which includes representatives of local fitness services, pharmacies, churches or other devout institutions, correctional institutions, educational agencies and other stakeholders.
In addition, the consultant includes 3 hypothetical scenarios for the first distribution that claim to be trainings for that committee in the workshop or practice.
“The purpose of the CDC, and that of the U. S. government, has not been a problem. USA, it’s having enough COVID-19 vaccines for everyone else in the U. S. But it’s not the first time They need to be vaccinated,” said Redfield, who added that the manual will be up-to-date as new data – for example, vaccination tips for pregnant or young women – are available.
The HHS strategy paper and the CDC handbook still lack many key details, such as who gets the first doses or how accurately express vaccines will be transported from factories and warehouses to vaccination sites. The latter is a specific challenge given that federal officials have promised to start sending doses the day after the FDA approves or approves a product.
In addition, plans will have to be made without knowing for sure which vaccines will receive the green light.
Paul Mango, deputy chief of HHS policy staff, described the vaccination procedure as a “logistical commitment” that takes a position in a “world of uncertainty. “
“We don’t know when we’re going to get a vaccine. We don’t know the quantities. We don’t know the effectiveness of those vaccines,” he said.
Mango noted that existing vaccine applicants use other types of needles and syringes, as well as other dosing and garage methods, which further complicate preparations.
However, he said, “we are prepared for all these uncertainties. “
Mango also echoed President Trump’s purpose of no American “paying a penny as a bachelor” for the vaccine and said that “we are approaching that aspiration right now. “
Lately there are 3 candidate vaccines, from AstraZeneca, Moderna and Pfizer, in Phase III clinical trials. Other companies are expected to begin Phase III trials within the next 30 days, while others are expected to publish trials before the end of the year. with the candidate vaccine recruiting 30,000 participants according to the trial, said U. S. Army Lieutenant General Paul Ostrowski, Oconsistent’s director of acquisition, production and distribution with Warp Speed.
Researchers expect the FDA to approve more than one vaccine, either through a biological license application or an emergency use authorization.
A herculean task
The distribution of potentially six COVID-19 vaccines amid a pandemic is a “hercúle task,” Ostrowski said, and that HHS has no responsibility to administer it alone. The role of the DOD in Operation Warp Speed will be to supply. “bandwidth and facilitators. “
The DOD has the experience in program control and hiring to make sure the government gets what it paid for from vaccine developers, he said.
In addition, the Department of Defense will be guilty of logistics, such as securing chains for raw fabrics and other vaccine-related appliances.
Ostrowski defined several key principles for DOD consultants to administer and administer COVID-19 vaccines, including:
Most vaccine applicants require two doses, Ostrowski explained. “We’ll have to be able to array . . . tell the user that we have been vaccinated, when it is time to return for the time of the vaccine, after the right period, probably 21 or 28 days. “
And since a Pfizer vaccine is replaced through Moderna’s product, the main points matter, he said.
Providers will want to know “what vaccine a user won, when they won it, and where they won it,” Ostrowski said.
All this data must be traceable and require the interoperability of public and usual databases, so that if a user obtains a vaccine in one state and, 28 days later, wants to obtain the dose of the moment in some other position or state, have access to it.
The DOD is running lately to “allow those other knowledge bases to talk to others through a knowledge link we are creating and testing as we speak,” Ostrowski said.
He also said vaccine accessibility is paramount.
“We want to go beyond pharmacies, hospitals, etc. to take on nursing homes, to take on meat packaging facilities; to attack those who stay [at home]. We want to take this to the 4 corners of this nation,” he said.
When asked how temporarily a patient can get the vaccine once the FDA gives the go-ahead, Ostrowski said a central distributor, McKesson, will move the vaccine “in about a day” to delivery locations.
As for Trump’s aspiration that no American will pay out-of-pocket for the vaccine, Mango is under pressure that providers will continue to pay for the administration of the vaccine through ad insurers and Medicaid. For unsafe patients, a “sub-background” the prices of administration of these vaccines.
However, for full Medicare payment, “there are some complications,” acknowledged Mango. Under existing rules, a beneficiary would possibly have to pay $ 3. 50 out of pocket for the vaccine, but “we’re getting there,” he said.
Ostrowski said contracts with vaccine brands, which have so far not been made public, are “liberable” to some extent and “will be available at some point. “
Shannon Firth reports on fitness policy as a correspondent for MedPage Today in Washington since 2014 and is a member of Enterprise
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