The FDA ADVANCE study has been announced, which could lead to the outdated blanket blood donation ban for gay and bisexual men being eradicated. This has been announced in the same week that the United Kingdom announced a “landmark change” to its blood donation rules, which no longer require gay and bisexual men to abstain from sex.
In 2015, the FDA instated a new recommendation that said gay and bisexual men would have to adhere to a twelve month waiting period in which they would need to abstain from sex before they would be eligible to donate blood. This new recommendation was put into place in order to replace the lifetime prohibition on blood donation from gay and bisexual men originally imposed in 1983.
In April of this year, in response to the COVID-19 blood shortages, the FDA announced that it was loosening its recommendations for blood donations from gay and bisexual men, reducing the amount of time that these men should wait before they donate blood to three months, in hopes of mitigating a drastic drop in supply during the coronavirus pandemic.
But now, a pilot study named Assessing Donor Variability And New Concepts in Eligibility (ADVANCE), will be carried out by three of the largest blood centres in the US – Vitalant, OneBlood and the American Red Cross. Funded through a contract with the FDA, the ADVANCE study will work with LGBTQ+ community centers across the country and could possibly do away with the outdated blanket restrictions altogether.
According to the study’s website: “The purpose of the study is to determine whether a different donor deferral can be used at blood centres nationwide while maintaining the safety of the blood supply. For this to be possible, a change would need to be made to the donor history questionnaire, and this study is the first step in assessing the safety of a change.”
In this case, a single blood donation questionnaire “to assess risk factors that could indicate possible infection with a transfusion transmissible infection, including HIV” could then be used in place of a blanket restriction for gay and bisexual men.
LGBTQ+ centers across America will be assisting the blood centers in enrolling over 2,000 gay and bisexual men for the research, with results expected late next year. The results will be submitted to the FDA, which will then decide the next steps.