Vaccine Documentation Will Be Important But A Hodgepodge

by John J. Cohrssen and Henry I. Miller: Few could have imagined a year ago that by now our world would be so profoundly changed by a pandemic that has killed more than 300,000 Americans; been confirmed in over 16 million; gone undiagnosed in scores of millions more; and caused debilitating, persisting symptoms in many who have “recovered.” Certainly, no credible drug manufacturer would have claimed that a new vaccine for this emerging infectious disease could go through all phases of drug development and reach marketing approval within the space of 11 months. Even with the first COVID-19 vaccine having been approved for emergency use by the Food and Drug Administration and being administered, challenges remain to keep track of those who have been vaccinated, and for vaccinees to verify their immunization.

With the growth of individuals’ immunity to COVID-19 through vaccination, persons who have gotten the shots could receive opportunities unavailable to those who have not. A recent Sky News poll in the United Kingdom found that 54% of the population believe that it would be acceptable to limit air travel only to people who have been vaccinated; that 36% believe that public transport should be similarly limited; access to restaurants, 39%, and to cinemas, 44%.

Vaccination will become mandatory under certain circumstances. Various employers could require their employees or customers to be vaccinated, and schools could require staff and students to. Qantas Airlines intends next year to require proof of vaccination for Australians traveling internationally. The airline industry more broadly is finalizing a requirement that passengers present documentation of COVID-19 vaccination. The International Air Transport Association recently announced that it is in the final stages of developing the IATA Travel Pass, a digital document to confirm vaccination or a negative coronavirus test result, in order both to make air travel safer and to encourage the public to fly.

Ideally, each vaccinated person would receive a secure, unique COVID-19 “immunity passport” of some kind, but in the real world, with vaccinations about to rev up rapidly, there is no secure national, state, or other identity card available to reflect immunization status. A recent Wall Street Journal article discussed the legal issues involved in such documentation, noting that some experts “see pitfalls in creating a distinction between vaccinated and non-vaccinated individuals, as well as issues around data protection, privacy rights and forgery.” It brought up another, practical complication – “some groups who might make use of greater freedoms the most, such as young people, aren’t scheduled to be vaccinated for months.”

There is no single database that could easily be adapted to reflect the immunization status of all U.S. citizens or residents. Vaccination programs are run by state governments that will be responsible for COVID-19 vaccinations in ways similar to their oversight of other immunizations. States have their own systems for tracking vaccine administration information. For COVID-19 vaccinations, the Centers for Disease Control and Prevention (CDC) has a list of information it wants states to provide to the CDC for monitoring the program. In addition to the immunization information, it requests the recipient’s name, address, and date of birth. Some states are objecting to this identifiable information, fearing that it might be inappropriately used for immigration enforcement or other purposes. Moreover, the collection of personally identifiable information could discourage undocumented persons from seeking vaccination.

Without some sort of government-authorized immunization passport or an accessible national database, the documentation of immunization will necessarily rely on what is available, which isn’t much. In the United States, by default it likely will be the vaccine record that will be given to every vaccinated person and will contain details of the vaccine received and a reminder of the date for the second dose. The United Kingdom has created a similar COVID vaccine card that includes the name of the vaccine, date(s) administered, and batch number. However, the U.K. government has said that it is not an “immunity passport,” nor are there plans for such a document.

For airlines that require vaccine confirmation, reliance on the vaccine record may be relatively secure, inasmuch as a falsified record could trigger penalties for document fraud. Similar criminal charges might arise if a forged or improper vaccine record were presented for immigration purposes, while the use of a vaccine record for purposes not subject to government authority might be more susceptible to abuse.

It is reasonable to expect that the need for proof of vaccination will diminish as we reach the roughly 70% vaccination penetration needed to achieve so-called “herd immunity” – the point at which the coronavirus has difficulty finding new susceptible hosts and the pandemic subsides. Meanwhile, documentation of vaccination will have to rely on the available, rather than the ideal; the honesty of those using it; and the possible penalties for those who abuse it.
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John J. Cohrssen is an attorney who served in senior positions for White House agencies, including the office of Vice President Dan Quayle. Henry I. Miller, a physician and molecular biologist, is a senior fellow at the Pacific Research Institute. He was the founding director of the FDA’s Office of Biotechnology.

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