USA TODAY US Edition

Guide­line shift mis­in­ter­preted, CDC head says

- Con­tribut­ing: Jes­sica Flores, Ryan W. Miller, Wil­liam Atkin­son, The As­so­ci­ated Press Health · Public Health · Medicine · U.S. News · U.S. Centers for Disease Control · Redfield, New York · University of Miami · Philadelphia Union · United States of America · Johns Hopkins University · Minnesota · Montana · Utah · Wisconsin · Wyoming · New York County, NY · Brooklyn · Queens · Johnson & Johnson · Johnson · South Africa · Argentina · Brazil · Chile · Colombia · Mexico · Israel · Boston · U.S. Food and Drug Administration · New York City · Donald Trump · White House · Beth Israel Deaconess Medical Center

The di­rec­tor of the Cen­ters for Dis­ease Con­trol and Preven­tion said Wed­nes­day that since-re­versed changes to the agency’s test­ing guide­lines that drew sharp crit­i­cism last month from in­fec­tious dis­ease ex­perts were mis­in­ter­preted.

The CDC posted re­vised guide­lines in Au­gust that said asymp­to­matic peo­ple may not need a test – even if they’ve been ex­posed to the coro­n­avirus. The CDC on Fri­day walked back that re­vi­sion, re­in­forc­ing the need for all peo­ple who have been ex­posed to some­one with COVID-19 to get tested.

CDC head Dr. Robert Red­field told a Se­nate panel the changes in Au­gust “were not in­ter­preted in the man­ner in which we had in­tended them to be in­ter­preted.” Red­field said the Au­gust re­vi­sions were in­tended to “reen­gage the med­i­cal and pub­lic health com­mu­nity as part of test­ing so that there was a pub­lic health ac­tion that hap­pened as a con­se­quence of ev­ery test.”

The U.S. has more than 6.9 mil­lion cases and 201,000 deaths, ac­cord­ing to Johns Hop­kins Univer­sity data. Min­nesota, Mon­tana, Utah, Wis­con­sin and Wy­oming set records for new cases; Mon­tana had a record num­ber of deaths in a week.

Parts of NYC see virus uptick

Sev­eral neigh­bor­hoods have seen an uptick in cases that is caus­ing city of­fi­cials “sig­nif­i­cant con­cern.” New York’s health depart­ment iden­ti­fied mul­ti­ple neigh­bor­hoods in Brook­lyn and Queens that ac­count for 20% of all cases city­wide as of Sept. 19. The uptick in the ar­eas be­gan Aug. 1. “These in­creases could po­ten­tially evolve into more wide­spread com­mu­nity trans­mis­sion and spread to other neigh­bor­hoods un­less ac­tion is taken,” the depart­ment said.

Late-stage trial of sin­gle-shot vac­cine begins

The fi­nal stage of John­son & John­son’s trial for its vac­cine can­di­date, which would re­quire only one dose, was set to be­gin Wed­nes­day, the com­pany said. The trial will be one of the largest in the world, with 60,000 vol­un­teers in the U.S., South Africa, Argentina, Brazil, Chile, Colom­bia, Mex­ico and Peru. A few other com­pa­nies al­ready have can­di­dates in the fi­nal stage of trials to test whether they’re safe and ef­fec­tive, but those re­quire two shots. “A sin­gle-shot vac­cine, if it’s safe and ef­fec­tive, will have sub­stan­tial lo­gis­tic ad­van­tages for global pan­demic con­trol,” Dan Barouch, di­rec­tor of the Cen­ter for Vi­rol­ogy and Vac­cine Re­search at Beth Is­rael Dea­coness Med­i­cal Cen­ter in Bos­ton, who part­nered with John­son & John­son on the vac­cine, told The Wash­ing­ton Post.

FDA on emer­gency au­tho­riza­tion of vac­cine

The Food and Drug Ad­min­is­tra­tion is ex­pected to an­nounce a higher stan­dard for emer­gency au­tho­riza­tion of a vac­cine in an ef­fort to gain pub­lic trust, the New York Times and Wash­ing­ton Post re­ported. The new re­quire­ment would make it highly un­likely a vac­cine would be avail­able be­fore the Nov. 3 elec­tion.

Man­u­fac­tur­ers will have to fol­low par­tic­i­pants in Stage 3 clin­i­cal trials for at least two months af­ter they re­ceive a sec­ond shot. Sur­veys show many Amer­i­cans are skep­ti­cal a new vac­cine would be safe and ef­fec­tive, with as many as half the re­spon­dents say­ing they would not get the im­mu­niza­tion to­day.

The FDA granted emer­gency au­tho­riza­tion to hy­drox­y­chloro­quine and con­va­les­cent plasma, two treat­ments for the virus touted by Trump but ques­tioned by pub­lic health ex­perts. The vac­cine guide­lines, drafted by a team of ca­reer sci­en­tists at the FDA and be­ing re­viewed by the White House, could come as early as this week.

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