The National Governors Association, chaired by New York State Governor Andrew M. Cuomo, today sent a list of questions to the Trump Administration seeking clarity on how to most effectively distribute and administer a COVID-19 vaccine. 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,” Governor 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.”
In his press briefing on COVID-19 in the state, Cuomo commented, “The 36 questions from the Governors sent to the White House basically are asking, ‘How does this work. We understand the concept but how does it work?’ Some of the questions: How will the vaccine be allocated to states? What formula is used – in other words, are you going to allocate it by infection rate? Are you going to allocate it by number of cases of COVID? Are you going to allocate it by population? Who determines how many each state gets – what’s the basis that you using.
“Is there a national strategy on the prioritization – in other words, the federal government going to say, ‘I think nursing homes should get it first. I think nurses should get it first. I think doctors should get it first. I think anybody over 70 should get it first.’ Is the federal government going to do that prioritization? Can they tell us if they’re going to condition the release of vaccines, right? The vaccines are controlled by the federal government. Are they going to turn around and say, ‘Well we won’t give you the vaccines, New York State, California unless you do X Y Z.’ And can we know that now? Is there multi-state coordination? On our own, during COVID we coordinated with the Northeastern states to New Jersey, Connecticut, et cetera. Is there a multi-state coordination piece here, or is everybody on their own? Am I my responsible for all of New York and there’s no connection to New Jersey and there’s no connection to Connecticut, there’s no connection to Pennsylvania?
“And who is going to pay to do this? New York State is already $50 billion in debt between state and local governments. And they have not passed legislation on the state and local relief. If the state has a deficit and the local governments have a deficit, we can’t fund essential workers. That’s who gets cut when you cut state and local governments. And now you’re going want undertake this vaccination program, which frankly requires more essential workers, not less? And they’re talking about a vaccine possibly in December. We’re here in October – this is just a few weeks to plan in this massive undertaking. Let’s learn the lessons from the past seven months. Otherwise, we’re going to relive the nightmares that we have lived through, right? Let’s not repeat the mistakes of March, April, May….
“We can’t go through that same confusion again. It’s not a question of knowing what to do. It’s a question of knowing how to do it. We know what we need to do. We need to control the virus, we need to take more tests, now we need to do vaccines. We know what we need to do. How do you do it? How do you do it – the devil’s in the details. How do you administer 40 million vaccines in the State of New York. That’s the trick. Everybody agrees with the concept. “Yes, vaccinate everyone.” Got it. How? How?
“And that’s the art form of government by the way and that’s what separates words from action and rhetoric from results and talk from competence – how do you do it? And that’s what we have to focus on now and that’s what the governors are saying to the federal government. Why? Because the way the federal government has structured it, the states are in charge of the doing. This person got to the COVID situation, he said, ‘It’s up to the Governors. It’s up to the states’. I don’t even know how that works by the way. It’s a nationwide problem. 50 states have it. But it’s not a federal response? The federal response is, ‘It’s up to you. You take charge, Governor. But I’m right behind you -go get ’em, tiger.’ Yeah, thank you very much. So again, I’m sure what the federal government is talking about is we’ll approve the vaccines, we’ll appropriate the vaccine, we then deliver them to the state. You figure out how to do it. Who pays? Insurance companies? What happens for the uninsured people? How do I keep dosages cold, – 80-degrees? Well, those are details. No. That’s the difference between life and death in a situation like this. And that’s where we have to get.”
Cuomo added, “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 vaccines and distributing the vaccines so the State’s position is we have to wait for the federal government to provide us the vaccines, what is the schedule, how many, etcetera…
“We believe there’s going to be questions about the safety of the vaccine, so we put together a special New York task force team of experts. I’m going to ask them to review any vaccine before I recommend it to the people of the state. I think that will give people added surety in the vaccine. But, we are coming up with a plan on many presumptions. We don’t really 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. So this is all preliminary. But, we would prioritize the vaccinations. The prioritization would be based on risk and essential workers would have a priority and people at risk would be prioritized and we’d set up a matrix on that regards, by that regards, and there’d be several phases to the administration of the actual doses. We’re working with our health care partners all across the state. This is going to be a massive undertaking, hospitals, urgent care facilities , primary care facilities, pharmacies, local departments of health, mobile units, mass vaccination sites.”
Here is the list of questions NGA gathered from the nation’s governors:
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 sub-prioritization among the initial priority groups since there will not be enough vaccine at first for even healthcare workers as a group?
Communication and Information Requirements
- There has been some indication that large pharmacy chains and possibly interstate healthcare 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 multi-state 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?