Posted on January 13, 2021 at 8:44 AM
by Arthur Caplan, PhD
There is general agreement that the rollout of vaccines in the United States has been a dismal failure. Too many doses are in warehouses, not nearly enough in arms. And too much confusion exists about prioritizing those in need versus allowing institutions and vaccination sites discretion to decide how best to use their supplies.
Given these challenges, what lessons can be drawn about vaccination policy going forward?
Drawing up priority lists without attention to logistics—where vaccine is being given– is confusing in terms of maximizing protection, vaccines in arms or following guidance as to priorities. Where vaccine is available, what is required to store them and how much effort is required to redeploy supply is just as important as setting priority lists as to who gets vaccinated.
Establishing priority groups is valuable and important, but it’s a balancing act between so diligently enforcing the categories to the letter that following the rules grinds rollout to a halt vs. people viewing them as such a barrier to speedy rollout that states/institutions/sites are tempted to abandon them and make allocation a free-for-all. Moreover, some discretion and judgement has to be allowed and supported to grapple with unexpected supply shifts.
Policy is needed for dealing with surplus, both unexpected on site, predictable due to refusals or oversupply and how to manage surplus between institutions. Redistribution requires ability to expeditiously move vaccine or recipients between locations and strong partnerships as well as communication and record-keeping between state and county and city health departments and health systems or other entities administering doses such as pharmacies and private practices.
Better to use vaccine in someone rather than waste it but safety requires being able to follow up with them for second doses, adverse events both short and long-term.
The private sector will drive vaccine distribution nationally and internationally as soon as government purchases are done. Guidance for this next phase and how it will be enforced is not clear.
Overcoming vaccine distrust and refusal is just as important as supplying vaccine.
Vaccinating politicians and their families and staff in the name of cementing trust in vaccines is ludicrous. Refusal will become an increasingly huge challenge unless serious, data-driven efforts are made to respond.
The US government will soon face a decision about sharing vaccine supply with poor nations and when. Otherwise they will get next to nothing. Some nations will ask for philanthropy from private companies to help buy vaccine on the open market but will resist disclosing their allocation plans as a cost of continuing to do business there.
The rich, the connected, celebrities and athletes will continue to finagle their way toward better access unless there are strict penalties imposed.
Altering dosing regimens including using half-doses and delayed dosing and switching between products to stretch coverage are all experiments that must be organized and presented as such to patients and studied carefully. Consent ought to be obtained.
It is unethical not to unblind vaccine trials when vaccines are approved for EUA or licensed.
It is likely that new vaccine trials will be initiated in poor nations lacking availability of any EUA or licensed vaccines even if this smacks to many of exploitation and regardless of the ability to conduct complex trials or generalize from them.
Distribution of vaccines primarily through big box stores or pharmacy chains will lead to confusion and maldistribution. These outlets are already overwhelmed during Covid with manpower issues, drug shortages, overworked pharmacists and long lines.
Future vaccine trials will not rely on large, randomized RCTs when EUA or licensed vaccines are available. They will use more surrogate end-point antibody markers top show equivalence and more real-world evidence to gain licensure.
Competition among approved vaccines will lead to market driven pricing and access late this year. We need to be planning ahead for additional vaccines with very different efficacy or safety profiles than those currently authorized and thinking about strategies to deploy various vaccines equitably, optimally, and in ways that maintain public support.
Our existing health care infrastructure is already unable to keep up with the pace of vaccines becoming available, a problem that will only increase as rollout expands to larger populations and more doses become available. Need more attention to purpose-built mass vaccination clinics!
Far greater federal guidance and collaboration is required for vaccine rollout activities, avoiding the fragmented, 50-state approach that we’re seeing currently (mirroring what we saw with testing). Current approach means that states are each required to reinvent the same systems and processes (appointment scheduling, e.g.), there is huge variation in how states are performing so far. And they need more money!