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Image courtesy of the Office of Gov. Andrew M. Cuomo, taken from the New York State Department of Health draft COVID-19 vaccination administration program.
Image courtesy of the Office of Gov. Andrew M. Cuomo, taken from the New York State Department of Health draft COVID-19 vaccination administration program.

Cuomo addresses coronavirus vaccine

Sun, Oct 18th 2020 03:45 pm

Announces draft New York state COVID-19 vaccination administration program intended to ensure a safe & effective vaccine is administered to all residents who want one

Proposed vaccine prioritization matrix plans for high-risk populations and essential health care workers to receive vaccination first; draft vaccination administration program available here

Gov. Andrew Cuomo on Sunday announced the New York State Department of Health has released a draft COVID-19 vaccination administration program that serves as an initial framework for ensuring the safe and effective distribution of a COVID-19 vaccine in New York.

The draft program was developed in consultation with leading clinical and public health experts, and requires collaboration and partnership with local departments of health, community partners and organizations, and the federal government.

Given the many unknowns at this point in the vaccine development process, the draft New York state COVID-19 vaccination administration program is designed to be flexible and account for multiple variables and scenarios regarding vaccine availability, timeline for vaccine approval, delineation of federal and state responsibilities, funding, supply chain needs, and allocation requirements.

"We are coming up with a plan on many presumptions. We don't know how many doses we're going to get. We don't know what vaccine we're going to get. We don't know when we're going to get it. The state will have a statewide vaccination plan. We will do it in concert with the federal government. The federal government is in charge of producing the actual vaccine and distributing the vaccines," Cuomo said. "States cannot do this on their own. Period. This is a massive undertaking. This is a larger operational undertaking than anything we have done under COVID to date. This is a more complicated undertaking and task. And we need the federal government to be a competent partner with this state and with every state."

Following the determination that the vaccine is safe and effective, the draft vaccination program prioritizes vaccination recipients based on science, clinical expertise, and public health. The plan puts forward the following proposed prioritization matrix to ensure those most at risk and essential workers are priority recipients, with particular attention paid to those living in communities with highest COVID-19 prevalence.

 

 

High COVID-19 Prevalence in Geographic Area

Low COVID-19 Prevalence in Geographic Area

High Risk Populations/

Essential Health Care Workers

Priority 1

Priority 2

Lower Risk Populations/

Other Essential Workers

Priority 3

Priority 4

General Population

 

Priority 5

Priority 6

 

Within each phase, the draft plan puts forward the following proposed additional prioritization phases to be used based on vaccine availability and vaccination rates:

 

Phase 1

  • Health care workers (clinical and nonclinical) in patient care settings (ICU, ED, EMS top priority)
  • Long-term care facility workers who regularly interact with residents
  • Most at-risk long-term care facility patients

Phase 2

  • First responders (fire, police, national guard)
  • Teachers/school staff (in-person instructions), child care providers
  • Public health workers
  • Other essential frontline workers that regularly interact with public (pharmacists, grocery store workers, transit employees, etc.) or maintain critical infrastructure
  • Other long-term care facility patients and those living in other congregate settings
  • Individuals in general population deemed particularly high risk due to comorbidities and health conditions

Phase 3

  • Individuals over 65
  • Individuals under 65 with high-risk

Phase 4

  • All other essential workers

Phase 5

  • Healthy adults and children

 

The draft New York State COVID-19 vaccination administration program was prepared by the state Department of Health and is subject to change based on future details expected from the federal government. The draft plan outlines:

  • Guiding principles to be adhered to throughout the vaccine process
  • Key assumptions, unknowns and variables that may impact vaccine planning
  • Measures to ensure vaccine safety and effectiveness, both pre- and post-administration
  • Expertise to guide vaccine distribution and implementation
  • A vaccine prioritization matrix based on clinical guidance
  • A process for efficient vaccine distribution and delivery
  • Measures to train, register, deploy and support providers to administer the vaccine
  • A data and IT infrastructure to coordinate and monitor all aspects of the vaccine program
  • A public education and community outreach campaign to build trust and inform the public
  • A vaccine central command center to manage the entire vaccine program
  • A budget and procurement process to obtain necessary supplies and equipment

A press release said, “The draft New York State COVID-19 vaccination administration program responds to the fact that there are still myriad unknowns about the federal government's vaccine development process and plan, including its timing, allocation, quantities, prioritization, distribution, administration and monitoring post-administration. To date, the federal government has not clearly delineated the roles and responsibilities between the federal and state government, outlined how the vaccine will be funded or reimbursed, and provided other key details that will be required before New York can finalize plans for a vaccine program.”

National Governors Association Submits List of Questions to Trump Administration on Effective Implementation of COVID-19 Vaccine

The National Governors Association, chaired by Cuomo, sent a list of questions to the Trump administration seeking clarity on how to most effectively distribute and administer a COVID-19 vaccine.

A press release said, “The distribution and implementation of the vaccine is a massive undertaking that cannot be managed without significant logistical coordination, planning and financial assistance between states and the federal government.”

The list of questions – which were submitted from Republican and Democratic governors from around the country – covers funding for the administration of a vaccine, allocation and supply chain, and communication and information requirements.

"The National Governors Association, which I chair, sent a letter to the president of the United States last week. We asked to meet with the president to discuss how this is supposed to work between the federal government and the states," Cuomo said. "We are now releasing a compilation of questions from governors all across the country, Democratic and Republican, saying to the White House: How is this going to work? We need to answer these questions before the vaccine is available so that we are ready to go and no one is caught flat-footed when the time comes to vaccinate people."

The list of questions NGA gathered from the nation's governors is available below:

Funding for Vaccine Administration

  • Will there be funding allocated to states to assist with distribution of the vaccine and other vaccine efforts?
  • Without additional state and local funding to implement COVID-19 vaccine plans, we will be hampered in what we can accomplish. When can we expect more definitive information about resources related to this response?
  • What are the plans for any federal contracts and/or additional funding to support "boots on the ground" to vaccinate in tiers 2 and beyond?
  • How will vaccine administration costs be covered for people who are uninsured?
  • Will the federal government be setting guidelines around allowable vaccine administration costs for those with health insurance (whether that is state insurance, Medicaid, Medicare, CHIP, or some other state-funded health insurance)?
  • How will funding/reimbursement for vaccines be handled?
  • We understand that the vaccine will initially be provided at no cost, as was remdesivir. However, states now must pay for remdesivir on the commercial market. How long will the federal government commit to providing the vaccine to states cost-free?

Allocation and Supply Chain

  • How will the vaccine be allocated to states? What formula will be used?
  • How will the vaccine be distributed? What mechanism will the federal government use?
  • Can the administration provide more guidance on what prioritization requirements will be a condition of vaccine release and to what extent will states have latitude to guide these decisions?
  • Are any further PREP Act changes anticipated beyond authorizations for pharmacists and interns to administer vaccine?
  • How is CDC planning to manage vaccine distribution to federal entities such as federal prisons, the VA and other federal organizations? Will these entities receive a vaccine supply directly from the CDC or will states manage it?
  • Similarly, when can states expect guidance from the federal government on the states' responsibility to vaccinate federal employees (e.g., who is vaccinating National Guard, USPS employees, FBI, etc.).
  • How will tribal sovereignty be respected? The CDC sent a template asking how many vaccine doses need to be sent to each IHS/tribal health facility rather than asking states where each tribe wants their vaccine doses sent (which could be one of those facilities, a DOH public health office, a private provider that they'd like to contract with, etc.).
  • What will be the national strategy for vaccine prioritization when supply is short?
  • How will management of supplies (i.e. needles, syringes, alcohol pads, band aids, etc.) work?
  • Will there be further guidance documents on handling ultra-cold vaccine (i.e. thawing, storage after thawing, reconstitution, etc.)?
  • We are aware of concerns that there is already a shortage of dry ice, which is being used to store the ultracold storage vaccines during the clinical trials.
  • If that is true, does that shortage impact plans for shipping of ultracold storage vaccine using dry ice and containers that could store the vaccine for up to a week?
  • If there is a shortage of dry ice, does this change the guidance to states to not purchase additional ultracold storage freezers?
  • We also need guidance on redistribution of ultracold storage vaccines. If they will come in 1,000 dose shipments as indicated by the federal government, we likely will need to distribute them further in our rural areas. What will the guidelines be to do that without compromising the vaccine?
  • How long will the product be viable outside of the original packaging that the 1,000 doses will be shipped in? Can/will smaller volume packaging be provided in the shipment as well?
  • What will the federal guidance be on subprioritization among the initial priority groups since there will not be enough vaccine at first for even health care workers as a group?

Communication and Information Requirements

  • There has been some indication that large pharmacy chains and possibly interstate health care systems will register directly with the federal government. We need the specific details since many of them are also reaching out to the states. This affects our targeted enrollment of these stakeholders to onboard as COVID-19 vaccine providers. When can we expect clarification on which stakeholders will contract directly with the federal government?
  • Will there be coordinated multistate process for monitoring vaccination effects (adverse effects, lack of immunity responses, etc.) to ensure early warning signs are identified as quickly as possible?
  • Will the federal government provide current/real time information about tribal nations enrolling with the CDC for direct shipments, versus enrolling through the state?
  • Can the administration provide more information around long-term care facilities? Specifically, are they planning to mandate vaccines in nursing homes through CMS? For example, will the use of vaccines be connected to continued Medicaid funding? If so, when would such requirements take effect?
  • Is the federal government going to request that states report personally identifiable COVID vaccine data? We have concerns that this may create a lack of trust and discourage people from getting vaccinated.
  • What is the state's role in safety monitoring after people have been vaccinated?
  • How many states are using VAMS as their immunization information system (IIS)?
  • Will states share their micro-prioritization within Phase 1b?
  • What communication/messaging materials have been developed?
  • How will complex scientific data be messaged and shared publicly? What type of educational material, and in what languages, will be developed?
  • What information will be shared publicly on each approved vaccine? How will transparency be ensured?
  • CDC is planning to require reporting to the IIS within 24 hours of administration of the vaccine. We know for flu vaccine there is a dramatic lag in data coming in – how will COVID-19 vaccine data reporting be any different?

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