FDA halts vac­cine trial in Bay Area

San Francisco Chronicle Late Edition - - BAY AREA - By Catherine Ho

Bay Area re­searchers who had been poised to start en­rolling pa­tients in a coronaviru­s vac­cine trial have sus­pended those plans af­ter the vac­cine de­vel­op­ers and fed­eral reg­u­la­tors halted the trial in the United States over safety con­cerns.

Phase 3 tri­als for the vac­cine, made by the drug com­pany As­traZeneca and Ox­ford

University — con­sid­ered one of the front­run­ners in the race for a vac­cine — were tem­po­rar­ily halted world­wide Sept. 6 af­ter a par­tic­i­pant in the United King­dom de­vel­oped a neu­ro­log­i­cal ill­ness. The tri­als, which are be­ing con­ducted in a num­ber of coun­tries, re­sumed shortly af­ter in Bri­tain, South Africa and Brazil. But the U.S. Food and Drug Ad­min­is­tra­tion has not al­lowed the study to restart in the United States.

It is un­clear if, or when, the FDA may de­cide whether to re­sume the U.S. por­tion of the trial. Nei­ther the FDA nor As­traZeneca would say why other coun­tries have re­sumed the tri­als and the U.S. has not, each di­rect­ing the ques­tion at the other. An FDA spokes­woman said the agency can­not com­ment on the sta­tus of an in­ves­ti­ga­tional new drug ap­pli­ca­tion. As­traZeneca said it is work­ing with the FDA and the agency will de­cide when the U.S. trial can re­sume.

The devel­op­ment comes at a time of height­ened con­cerns that fed­eral coronaviru­s poli­cies are be­com­ing in­creas­ingly politi­cized as the na­tional elec­tion nears. From the ap­point­ment of controvers­ial pol­icy re­searcher Scott At­las to the pres­i­den­tial coronaviru­s task force, to the in­con­sis­tent mes­sag­ing around masks and test­ing guid­ance from the

CDC, public health ex­perts are in­creas­ingly con­cerned that de­ci­sions that should be driven purely by sci­ence are now in­flu­enced by po­lit­i­cal mo­tives. Con­cerns es­ca­lated Wed­nes­day, when Pres­i­dent Trump called new, stricter FDA guide­lines for au­tho­riz­ing vac­cines “a po­lit­i­cal move” and said the White House might not ap­prove them.

In the case of the As­traZene

ca trial, FDA pru­dence could be per­ceived as a pos­i­tive.

“There is height­ened in­ter­est and scru­tiny about COVID vac­cines, so from a public per­spec­tive I can see how an event such as this could raise some con­cern,” said Dr. Bali Pu­len­dran, an im­mu­nol­o­gist at Stan­ford Health Care. “But, es­sen­tially, all the ap­pro­pri­ate steps are be­ing taken. The FDA is do­ing a thor­ough in­ves­ti­ga­tion and the trial is be­ing halted for that pur­pose . ... I’m glad it was early on and the trial was halted as we find out what’s go­ing on with this.”

As­traZeneca has paused and restarted its global tri­als twice, each time af­ter a U.K. par­tic­i­pant de­vel­oped an un­ex­plained neu­ro­log­i­cal ill­ness. One par­tic­i­pant de­vel­oped symp­toms of trans­verse myeli­tis, a rare and se­ri­ous con­di­tion in­volv­ing in­flam­ma­tion of the spinal cord. The con­di­tion was di­vulged in a July in­for­ma­tion sheet, a doc­u­ment given to po­ten­tial par­tic­i­pants to in­form them of pos­si­ble risks. It is un­clear if the prob­lem was caused by the vac­cine, or if the symp­toms de­vel­oped in­de­pen­dently.

Ex­perts say it is not un­com­mon in large clin­i­cal tri­als for some par­tic­i­pants to ex­pe­ri­ence an ad­verse event, or harm­ful re­ac­tion, af­ter re­ceiv­ing an ex­per­i­men­tal vac­cine or medicine. It is also not un­usual for reg­u­la­tors in one coun­try to pause and re­sume a trial there, while reg­u­la­tors in an­other coun­try con­tinue putting it on hold while they in­ves­ti­gate safety con­cerns. In a way, they said, it is re­as­sur­ing reg­u­la­tors are tak­ing se­ri­ously their role to closely ex­am­ine safety. It may just be a mat­ter of time be­fore the FDA al­lows the tri­als to re­sume here.

“This is good news in the sense that it indi­cates the sys­tem is work­ing,” said Dr. Richard Feachem, a pro­fes­sor of epi­demi­ol­ogy and bio­statis­tics at UCSF. “There was an ad­verse event, the trial was halted, the case was in­ves­ti­gated. The U.K. reg­u­la­tor said con­tinue, carry on. The U.S. reg­u­la­tors are still in­ves­ti­gat­ing. So this is rou­tine.”

Two San Fran­cisco sites were plan­ning to be­gin en­roll­ment for the trial: Zucker­berg San Fran­cisco Gen­eral Hos­pi­tal and Bridge HIV, a re­search unit within the San Fran­cisco De­part­ment of Public Health. Each planned to en­roll 250 par­tic­i­pants. Both have put their par­tic­i­pa­tion on hold un­til the FDA de­cides it is safe to pro­ceed. Nei­ther San Fran­cisco site had en­rolled any pa­tients at the time the U.S. tri­als were halted.

“We hope to have more in­for­ma­tion soon,” said a state­ment from the San Fran­cisco COVID Com­mand Cen­ter. “Safety is our num­ber one pri­or­ity and we will not be mov­ing for­ward with next steps un­til we have ap­proval from the U.S. FDA and Data and Safety

Mon­i­tor­ing Board to pro­ceed.”

The Data and Safety Mon­i­tor­ing Board is an in­de­pen­dent panel of ex­perts that reviews data from clin­i­cal tri­als for safety. The board in­cludes ex­perts in the field that do not have ties to the drug’s spon­sors.

Sut­ter East Bay AIDS Cen­ter, part of Alta Bates Sum­mit Med­i­cal Cen­ter in Oak­land, was also con­sid­er­ing en­rolling 500 pa­tients in the trial. The cen­ter has not yet en­rolled par­tic­i­pants and is await­ing in­for­ma­tion from the FDA and As­traZeneca about ef­forts to re­sume the U.S. trial be­fore fi­nal­iz­ing its de­ci­sion on whether to par­tic­i­pate, a Sut­ter of­fi­cial said.

The trial was slated to en­roll 30,000 peo­ple across 80 U.S. sites. At the time the U.S. tri­als were paused, the vac­cine had been ad­min­is­tered to some pa­tients at other U.S. sites, but not at the San Fran­cisco sites.

The As­traZeneca vac­cine is one of 10 vac­cines that are in Phase 3 tri­als glob­ally, the last stage be­fore the FDA can con­sider whether it is safe and ef­fec­tive for wide­spread use. Phase 3 tri­als are when vac­cines get tested on tens of thou­sands of peo­ple — com­pared to the dozens or hundreds of peo­ple dur­ing Phases 1 and 2. John­son & John­son, Moderna and Pfizer are also de­vel­op­ing vac­cines that are in Phase 3.

Bay Area par­tic­i­pants are be­ing re­cruited in at least two other Phase 3 vac­cine tri­als. Pfizer, which is part­ner­ing with Ger­man com­pany BioNTech, last month be­gan en­rolling Kaiser Per­ma­nente mem­bers in North­ern Cal­i­for­nia. And John­son & John­son on Wed­nes­day an­nounced plans to en­roll pa­tients for its Phase 3 trial, in­clud­ing at two Bay Area sites — Stan­ford University Med­i­cal Cen­ter in Palo Alto and the VA Med­i­cal Cen­ter in San Fran­cisco. Stan­ford and the VA are ten­ta­tively sched­uled to be­gin en­roll­ment Sept. 30 and Oct. 19, re­spec­tively, ac­cord­ing to John­son & John­son.

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