On Wednesday, leaders of the Infectious Diseases Society of America (IDSA) and the HIV Medicine Association (HIVMA) sent a letter to the National Institutes of Health Director Francis Collins, MD, PhD, and officials of “Operation Warp Speed,” a U.S. Department of Health and Human Services initiative requesting that trials for COVID-19 vaccines be inclusive of people with HIV.
This letter was sent after the National Institute of Allergy and Infectious Diseases and Moderna Phase 3 trial began their investigational vaccine on Monday.
This trial is looking at enrolling 30000 volunteers, and the participant criteria excludes people with HIV but allows other participants with preexisting conditions.
The letter asserts that no medical justification exists for excluding treated people with HIV from the trial.
“To build trust among those highly impacted communities and avoid policies that can compromise the success of these trials, people with HIV or medically at-risk populations and community representatives must be involved from the start in the design of COVID-19 clinical trials and not just brought in at the end of study development to help recruit participants,” the letter stated.
The letter notes that hesitancy to accept a successful vaccine candidate already stands as a potentially significant challenge to an immunization campaign, with polling showing just half of all Americans–and smaller percentages of Latinx and Black Americans–planning to get a vaccine against the coronavirus disease when one becomes available.
Their exclusion, however, has the potential to limit access to approved vaccines against the coronavirus among whom it has not been tested and to limit acceptance of a vaccine among communities excluded from input in its development.
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