FDA rec­om­mends do­nated blood be tested for Zika virus

Mary­land urged to be­gin screen­ings within 12 weeks

Baltimore Sun - - FRONT PAGE - By Mered­ith Cohn

As Zika in­fec­tions con­tinue to spread around the na­tion, the U.S. Food and Drug Ad­min­is­tra­tion rec­om­mended Fri­day that all do­nated blood and blood com­po­nents soon be tested for the mos­quito-borne virus.

Test­ing of the blood sup­ply al­ready has be­gun in Florida and in Puerto Rico, which is par­tic­u­larly hard-hit by the Zika out­break. The FDA rec­om­mended 11 other states be­gin test­ing in the next month and the rest of the coun­try — in­clud­ing Mary­land — be­gin test­ing within12 weeks.

A unit of in­fected blood was found in re­cent weeks in Florida and re­moved from the sup­ply, Dr. Peter Marks, direc­tor of the FDA’s Cen­ter for Bi­o­log­ics Eval­u­a­tion and Re­search, said in a call with re­porters Fri­day.

“At this time, the rec­om­men­da­tion for test­ing the en­tire blood sup­ply will help en­sure that safe blood is avail­able for all in­di­vid­u­als who might need trans­fu­sion,” Marks said.

Zika will be added to a list of nine other con­tam­i­nants, an­ti­bod­ies or viruses, in­clud­ing HIV and hep­ati­tis, that blood banks and groups such as the Amer­i­can

Red Cross must test for when they ac­cept a do­na­tion of whole blood, plasma or platelets.

The FDA es­ti­mates that about 1 mil­lion units of blood are do­nated a month na­tion­wide. The cost of adding Zika tests isn’t known, but FDA of­fi­cials called the move es­sen­tial be­cause the prob­lems caused by the virus are so se­ri­ous and sci­en­tists con­tinue to learn about other ef­fects.

“There is still much un­cer­tainty regarding the na­ture and ex­tent of Zika virus trans­mis­sion,” Marks said.

The guid­ance ex­pands the FDA’s rec­om­men­da­tion ear­lier this year that ar­eas with ac­tive Zika virus trans­mis­sion screen whole blood and its com­po­nents for Zika.

The pri­mary con­cern about the virus is the risk to the fe­tuses of preg­nant women and women who plan to be­come preg­nant. Zika is known to cause mi­cro­cephaly, which stunts the brains and skulls of fe­tuses in in­fected women. But other brain dam­age and other im­pacts on ba­bies, as well as on adults, are be­ing in­ves­ti­gated.

“The sit­u­a­tion is quickly evolv­ing, and new sci­ence is com­ing out ev­ery day, and it makes sense that the FDA is­sued this guid­ance out of an abun­dance of cau­tion,” said Dr. Leana Wen, Bal­ti­more’s health com­mis­sioner. “The po­ten­tial con­se­quences are dev­as­tat­ing to the un­born child.”

What’s more, Zika has been found in se­men for up to six months, rais­ing con­cerns at the FDA that men car­ry­ing the virus could in­fect po­ten­tial blood donors.

Marks said only about 20 per­cent of peo­ple in­fected with Zika ex­hibit symp­toms, which include fever and rash. That means many peo­ple who might be in­fected and haven’t been tested could do­nate tainted blood un­know­ingly, he said.

There have been 77 cases of Zika in Mary­land, all of them re­lated to travel. Na­tion­ally, there have been 2,517 cases of Zika re­ported to the U.S. Cen­ters for Dis­ease Con­trol and Pre­ven­tion, in­clud­ing more than 40 cases of Zika at­trib­uted to lo­cal mos­quito bites in Florida. There have been 9,011 cases in U.S. ter­ri­to­ries in­clud­ing Puerto Rico.

Peo­ple who know or be­lieve they are in­fected with Zika should wait 120 days, or un­til their symp­toms re­solve, which­ever is longer, be­fore do­nat­ing blood, the FDA said.

Donors who test pos­i­tive for viruses are no­ti­fied di­rectly by the blood col­lec­tion agen­cies, said Christo­pher Gar­rett, spokesman for the state De­part­ment of Health and Men­tal Hy­giene.

The agen­cies also need to re­port the cases to the health de­part­ment.

An­drew Pekosz, a pro­fes­sor in the de­part­ments of molec­u­lar mi­cro­bi­ol­ogy and im­munol­ogy, and en­vi­ron­men­tal health sci­ences the Johns Hop­kins Uni­ver­sity’s Bloomberg School of Pub­lic Health, said the new guide­lines are timely — and nec­es­sary.

“It seems there have been a sig­nif­i­cant amount of cases that they should re­ally be ac­count­ing for this in the screen­ing process,” he said.

The Aedes ae­gypti mos­quito has been the pri­mary car­rier and most ef­fi­cient trans­mit­ter of Zika, Pekosz said. Out­side of Florida and other South­ern states, the risk of in­fec­tion is far lower, he said.

Mary­land isn’t likely to see many cases of lo­cal in­fec­tion be­cause the Aedes al­bopic­tus mos­quito, also known as the Asian tiger mos­quito, is more preva­lent in the state.

Be­cause of the lower risk, and be­cause blood dona­tions typ­i­cally dip at the end of the sum­mer, he said area res­i­dents should con­sider do­nat­ing now.

“It cer­tainly shouldn’t de­ter do­nat­ing,” Pekosz said.

“In fact, it’s one of those times peo­ple should think about go­ing in and do­nat­ing blood.”

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