There is a staggering amount of public/private coordination required for COVID-19 vaccination, certainly in a country the size of the US, with, perhaps, wartime levels of cooperation and logistics required.
A high level of collaboration has already emerged, said Winston Kirton and Reed Stephens from the global law firm of Winston & Strawn, who have gauged the current level of preparedness in the US for a pandemic vaccination response.
“The response is definitely progressing in the right direction but there are some areas where more work needs to be done, which is not surprising given how the situation is continually evolving.
“Firstly, the government needs to make sure there is increasing buy-in from the majority of the public in terms of willingness to take at least one of the vaccines that has been offered and then that they complete the course of treatment, otherwise we are going to see an erratic level of effectiveness for the vaccines.
“It is not as simple as people getting one shot because the first two vaccines that appear to be lined up for emergency use authorization (EUA) require two doses and there is some time in between each dose,” said Stephens.
An education effort needs to be ramped up, added the legal expert.
The US Department of Health and Human Services (HHS) has been taking a lead role in educating the US public about the vaccine candidates and the vaccine distribution process. “I would expect that it would continue in that role of coordinator of the education effort and that hopefully money would be spent to provide resources at the state and local level to help those government authorities also give consistent messages about the vaccines, how they will be distributed and what steps the public need to take,” continued Stephens.
Herculean level of coordination required
Also needing sustained and increasing attention is the process of taking the fully manufactured vaccines to the actual patient – an important inflection point, he said, in terms of any discussion around US vaccination campaign preparedness.
The GAO, an arm of the US federal government, published a report at the end of last month, noted Stephens, that raised concerns about whether or not the level of coordination between the federal government and the state and local governments has been as robust as it needs to be.
“There has been a lot of coordination between the federal government and the vaccine manufacturers on the process of funding the development of the vaccines [and getting the required level of doses manufactured]. The question now is whether [the plan to] get the finished product to individual patients at the scale of tens of millions of people has been fully fleshed out.”
Vaccination distribution in the US is expected to start almost immediately after formal authorizations for the COVID-19 vaccines are granted.
“The US federal government outlined, in its distribution plans published in November, that it intends on flipping an on-switch on the distribution process the same day the authorizations are granted. There is no intention of having any lag as regards initiating the process – the question is going to be whether or not the logistics will be as smooth as we hope.”
But how well versed is the US in delivering vaccines at this scale?
“The US government has experience in addressing pandemic risk over the past 10 to 15 years. A number of risks have emerged and have been identified over that period from H1N1 to Ebola to MERS and Zika, so the federal government certainly has a track record; the question is whether all that experience and resources are going to be brought to bear at the scale required to vaccinate tens of millions of people against such a highly contagious virus as coronavirus. It is, to a large extent, unprecedented,” he reiterated.
It is not accidental that the US Department of Defense is very involved in this process, remarked Kirton.
“The military is in a position, if you will, to understand and manage logistics on a large scale. That is a component, if levelled appropriately and levelled to its fullest, can be beneficial to the whole process,” he added.
Recording patient data
There are challenges involved in recording patient data in the US, say the legal specialists.
There is no national registry.
States have always been charged with tracking vaccinations among their residents through immunization information systems. Previous attempts to establish a federal registry have been undermined by campaigners arguing against personal health information being centralized under the federal government.
“We don’t have a national identifying database of our citizens in terms of easy identification and tracking of individuals. Our political system has been very resistant to the idea of that sort of citizenship database so it is going to require a lot of coordination, it is going to take some effort to achieve standardization across all the main state jurisdictions to keep track of vaccinations and adverse effects,” commented Kirton.
All the states were asked to submit distribution and tracking plans to the federal government at the end of October. “The general public does not know where those plans are at, what they include, and to what point you can coordinate one state versus another. What we do know though, right now, it is incumbent on the states, who are at the point of use, to come up with a plan. The states will have to make best case efforts to understand who is being vaccinated as well as in following up on any adverse effects that may be related to individual vaccinations, and then build a bridge between state and federal databases to allow tracking of all this information,” he said.
The vaccine manufacturers, of course, will still be in the process of gathering data, to track information such as adverse effects and other related data, so they can continue to develop out those vaccines, he stressed.
“But the coordinated effort is going to have to be top notch, and it is going to have to deliver,” added Kirton.
Securing delivery of vaccines
Looking at the risk environment around the transportation of vaccines, delivery to the point of care, he said the initial phase should see a paramount level of control.
A company like Pfizer is incredibly sophisticated in terms of the security process and the type of security that is implemented around transportation and monitoring, etc., said Kirton.
“What I am hearing is that Pfizer is going to forego using the US government’s logistics and supply chain network and use its own. What that is telling us is that Pfizer is fully confident in its established supply chain protocols for delivery of the vaccines to the various states. It has been dealing with high value asset medicines for the longest time. It has systems in place like GPS to pinpoint, in real time, exactly where the product is. I imagine that it is using such technology to capture any potential variability in storage conditions in transit as well.”
While there are always going to be bad actors trying to crack into the system along with counterfeiters trying to infiltrate it, there has already been significant collaboration between the federal government and drug manufacturers, with a lot of investment in technology, to enhance the supply chain security and ensure robust validation of third parties, said Kirton.
Big Pharma has also invested deeply in cross-border security in terms of beefing up supply chain networks, he added.
Weighing in on this aspect, Stephens said: “We do see that Interpol is warning governments globally about the risk of fake vaccines, fraud, and criminal diversions. There are all sorts of opportunities out there, which is why it is going to be so important the government authorities in the US have a strong, coordinated and consistent public education message about the vaccination distribution process, where people should go to get the authorized vaccines and what they should be looking for in terms of legitimacy and validity.”
Litigation risk
There is always going to be some risk in terms of litigation around patient outcomes, and that applies to the COVID-19 vaccination campaign in the US, continued Stephens.
“From a political standpoint, there are still a lot of balls in the air about what kind of immunity all the relevant parties are going to have granted to them by the government. There are certain protections that are already in place. They are not going to be end to end, there is still medical judgement in play here. But I do think there is a real desire by important stakeholders in the US to shield manufacturers from that kind of risk. However, as you can see from our opioid litigation over the past several years, there are a lot of different participants in the pharmaceutical distribution chain in the US, and they cannot all be protected from litigation risk.”
