FDA Considering New Approach to Blood Donation by Gay and Bisexual Men

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Individuals within the challenge, referred to as the ADVANCE examine, answered a wide range of questions on their current, risk-related behaviors, similar to whether or not they had any new sexual companions or have been taking pre-exposure prophylactic medication, referred to as PrEP, that cut back the danger of H.I.V. an infection, mentioned Brian Custer, director of Vitalant Analysis Institute and principal investigator of the examine.

The members’ blood was additionally examined for H.I.V. and the antiretroviral medication utilized in PrEP.

The researchers have already shared an interim evaluation with the F.D.A. and may have the ultimate outcomes prepared earlier than the top of the yr, Dr. Custer mentioned. He declined to offer extra details about the preliminary findings, citing a confidentiality settlement with the F.D.A., however mentioned that he anticipated the outcomes to be informative for the company.

“I actually am assured that we now have essential data for the F.D.A. to have the ability to contemplate what a person, risk-based strategy to donor choice may appear to be,” he mentioned.

Susan Stramer, vice chairman for scientific affairs for the American Pink Cross, mentioned in an announcement that the examine was meant “to make blood donation a extra inclusive course of whereas sustaining the protection of the blood provide.”

“Whereas we now have not been notified by the F.D.A. regarding coverage modifications right now, the Pink Cross seems ahead to a future during which donation eligibility isn’t based mostly on sexual orientation, and extra wholesome people may give blood to assist sufferers in want,” she mentioned.

The present blood scarcity is tracked every day by America’s Blood Facilities, the commerce affiliation for 59 neighborhood services. On Wednesday, a few quarter of the facilities, or 16, had lower than a day’s provide readily available.

“On this post-pandemic setting, blood drives hosted by companies — specifically — haven’t returned to pre-pandemic ranges as the best way folks work has modified,” Nick Gehrig, the senior director for communications at Vitalant, mentioned in an e-mail.

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