J&J kicks off fi­nal study of vac­cine in 60,000 vol­un­teers


John­son & John­son on Wed­nes­day kicked off a fi­nal 60,000-per­son trial of a sin­gle-shot COVID-19 vac­cine that po­ten­tially would sim­plify dis­tri­bu­tion of mil­lions of doses com­pared with lead­ing ri­vals us­ing two doses.

The com­pany ex­pects re­sults of the Phase III trial by year end or early next year, Dr. Paul Stof­fels, J&J's chief sci­en­tific of­fi­cer, said in a joint press con­fer­ence with of­fi­cials from the Na­tional In­sti­tutes of Health and the Trump ad­min­is­tra­tion.

Ri­val vac­cines from Moderna Inc, Pfizer Inc and As­traZeneca all re­quire two shots sep­a­rated by sev­eral weeks, which make them much more dif­fi­cult to ad­min­is­ter. "The ben­e­fits of a sin­gle-shot vac­cine are po­ten­tially pro­found in terms of mass im­mu­niza­tion cam­paigns and global pan­demic con­trol," Dr. Dan Barouch, a Har­vard vac­cine re­searcher who helped de­sign J&J's COVID-19 vac­cine, said in a tele­phone in­ter­view.

Stof­fels said J&J would pub­lish a de­tailed study pro­to­col for its phase 3 trial Wed­nes­day on the com­pany's web­site, join­ing the three other vac­cine mak­ers that have made these study plans avail­able in re­cent weeks af­ter calls for in­creased trans­parency in the tri­als. Stof­fels said J&J started the phase 3 trial af­ter see­ing pos­i­tive re­sults in its phase 1/2 trial in the United States and Bel­gium. The com­pany plans to re­lease those re­sults im­mi­nently. Stof­fels said the safety and level of pro­tec­tion in the study were on par with what was seen in the com­pany's an­i­mal stud­ies, and said the re­sults showed a sin­gle dose could of­fer suf­fi­cient pro­tec­tion "for a long time."J&J's late-stage trial will use as many as 215 sites in the United States, South Africa, Ar­gentina, Brazil, Chile, Colom­bia, Mex­ico and Peru. The com­pany plans to man­u­fac­ture as many as 1 bil­lion doses in 2021, and more af­ter that, Stof­fels said.

The goal of the trial is to test whether the vac­cine can pre­vent mod­er­ate to se­vere COVID-19 af­ter a sin­gle dose, but it will also look to see if the vac­cine can pre­vent se­ri­ous dis­ease re­quir­ing med­i­cal in­ter­ven­tion and whether it can pre­vent milder cases of the virus.

Stof­fels pre­dicts it will take six weeks to two months to en­roll the trial, and said the com­pany hopes to get an an­swer on whether the vac­cine works "around the end of the year or early next year." It is not clear how fast the com­pany could get reg­u­la­tory ap­proval, but J&J plans to man­u­fac­ture doses be­fore ap­proval, so it could start dis­tri­bu­tion quickly.

The trial will be over­seen by an in­de­pen­dent Data and Safety Mon­i­tor­ing Board (DSMB) that will re­view vac­cine safety and ef­fec­tive­ness. In the press con­fer­ence, Dr. Fran­cis Collins, di­rec­tor of the Na­tional In­sti­tutes of Health, said all three of the vac­cines be­ing or­ga­nized and sup­ported by the fed­eral gov­ern­ment's Op­er­a­tion Warp Speed - J&J's, Moderna's and As­traZeneca's - share a com­mon DSMB. Pfizer is run­ning its own trial and has a sep­a­rate DSMB, Collins said. J&J's trial is de­signed to test for a vac­cine that is 60%ef­fec­tive. In the study pro­to­col, that could be de­ter­mined af­ter 154 peo­ple be­came in­fected with the virus. Stof­fels said the com­pany will start count­ing cases of COVID-19 in­fec­tions within the study pop­u­la­tion 15 days af­ter in­di­vid­u­als are vac­ci­nated.

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