John­son & John­son says it will en­roll 60,000 par­tic­i­pants in the next stage of its COVID-19 vac­cine trial, mak­ing it the largest in the U.S.

Santa Fe New Mexican - - FRONT PAGE - By Carl Zim­mer and Katie Thomas

The fever­ish race for a coro­n­avirus vac­cine got an in­fu­sion of en­ergy Wed­nes­day as John­son & John­son an­nounced that it has be­gun the fi­nal stage of its clin­i­cal tri­als, the fourth com­pany to do so in the United States as the coun­try hits a grim mile­stone of 200,000 deaths from the pan­demic.

John­son & John­son is a cou­ple of months be­hind the lead­ers, but its ad­vanced vac­cine trial will be by far the largest, en­rolling 60,000 par­tic­i­pants. The com­pany said it could know by the end of this year if its vac­cine works.

Its vac­cine has po­ten­tially con­se­quen­tial ad­van­tages over some com­peti­tors and uses a tech­nol­ogy that has a long safety record in other vac­cines. Their vac­cine could re­quire just one shot in­stead of two — im­por­tant con­sid­er­ing that the en­tire pop­u­la­tion of the world needs vac­ci­na­tion. And it does not have to be kept frozen as it is de­liv­ered to hos­pi­tals and other places where it will be given to pa­tients, sim­pli­fy­ing the lo­gis­tics of hun­dreds of mil­lions of doses.

“Big news,” Pres­i­dent Don­ald Trump tweeted about the trial Wed­nes­day morn­ing. “@FDA must move quickly!” he added, re­fer­ring to the Food and Drug Ad­min­is­tra­tion, which over­sees vac­cine ap­proval.

The pres­i­dent has re­peat­edly claimed that a vac­cine will be ready be­fore Elec­tion Day and urged fed­eral reg­u­la­tors to act quickly to ap­prove one, rais­ing fears that they will bow to the pres­sure and rush their vet­ting process. The fed­eral gov­ern­ment’s Op­er­a­tion Warp Speed pro­gram has in­vested more than $10 bil­lion in pri­vate com­pa­nies’ coro­n­avirus vac­cines to date, in­clud­ing about $1.5 bil­lion to John­son & John­son.

Fac­ing crit­i­cism over se­crecy, sev­eral com­pa­nies — in­clud­ing John­son & John­son on Wed­nes­day — have re­leased the de­tailed blue­prints of their tri­als, which are typ­i­cally con­sid­ered pro­pri­etary. The FDA is ex­pected this week to re­lease stricter guide­lines out­lin­ing the cri­te­ria it will use to vet clin­i­cal trial data.

Never in his­tory has a vac­cine been tested and man­u­fac­tured so quickly — in months in­stead of years. Right be­hind John­son & John­son are Sanofi and No­vavax, which may prove just as good or bet­ter than the lead­ing con­tenders.

“We need mul­ti­ple vac­cines to work,” said Dr. Dan Barouch, a vi­rol­o­gist at Beth Is­rael Dea­coness Med­i­cal Cen­ter who led the de­vel­op­ment of the tech­nol­ogy used in John­son & John­son’s trial. “There are 7 bil­lion peo­ple in the world, and no sin­gle vac­cine sup­plier will be able to man­u­fac­ture at that scale.”

John­son & John­son’s ad­vanced trial, known as a Phase 3 trial, started Mon­day. At a news con­fer­ence, Dr. Paul Stof­fels, the com­pany’s chief sci­en­tific of­fi­cer, said the com­pany might be able to de­ter­mine by the end of the year if the vac­cine is safe and ef­fec­tive. The com­pany will soon be post­ing a man­u­script on­line with data from the ear­lier phases of its tri­als, he said.

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