GEORGETOWN, May 6 (WNM/Johns Hopkins Center for Health Security) - As the interest in the widespread use of serological tests for SARS-CoV-2 increases, conversations around the use of official documentation of immunity status as a basis for resuming social activity continue. These so-called “immunity passports/certificates” pose a variety of technical, social, ethical, and legal issues.
A commentary published in The Lancet addresses some of these challenges. The author, Dr. Alexandra Phelan highlights technical barriers, including uncertainty regarding the degree and duration of immunity conferred by SARS-CoV-2 infection and the impact of false positive and negative test results (https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(20)31034-5/fulltext).
Additionally, a variety of social and economic factors could introduce incentive for individuals to deliberately infect themselves or introduce opportunity for corruption and increased socioeconomic inequities. Legal barriers, including ensuring appropriate protections of individuals, regardless of immune status or the presence of risk factors such as age or underlying health conditions, and “immunity passports would risk enshrining such discrimination in law.”
Beyond the national scale, the use of immunity to determine eligibility for international travel could pose challenge both in terms of the health benefit (considering the technical challenges of administering and interpreting the tests) and discriminatory impact. Dr. Phelan argues that there is a fundamental difference between “immunity passports” based on infection, as would currently be the case for SARS-CoV-2, and those based on vaccination, such as for yellow fever. In the absence of a SARS-CoV-2 vaccine, an “immunity passport” would only incentivize infection.
The US FDA revised its policy regarding the use of serological tests. In light of the increased number and availability of serological tests in the United States, the FDA announced that companies developing serological tests are now required to seek Emergency Use Authorization (EUA) for the tests, which will include submitting relevant validation data (https://www.fda.gov/news-events/fda-voices/insight-fdas-revised-policy-antibody-tests-prioritizing-access-and-accuracy). The FDA also published minimum performance standards for serological tests, both sensitivity and specificity, to ensure appropriate levels of accuracy. The FDA also published EUA submission templates for both commercially developed serological tests and those developed at CLIA-certified laboratories. The goal of the policy change is to increase oversight and, therefore, the quality of available serological tests.