J&J be­gins fi­nal-stage vac­cine test­ing

Four ex­per­i­men­tal virus shots have now en­tered Phase 3 test­ing in U.S.

The Standard (St. Catharines) - - BUSINESS - PETER LOF­TUS

John­son & John­son said Wed­nes­day it started a 60,000per­son clin­i­cal trial of its sin­gle­dose Covid-19 vac­cine on three con­ti­nents, be­com­ing the fourth ex­per­i­men­tal Covid-19 shot to en­ter fi­nal-stage test­ing in the U.S.

The New Brunswick, N.J., com­pany said it could learn piv­otal re­sults from the trial by early next year, which if pos­i­tive could lead to gov­ern­ment au­tho­riza­tion of the vac­cine for emer­gency use soon af­ter­ward. J&J aims to en­roll adult vol­un­teers in the U.S. and sev­eral other coun­tries, in­clud­ing Brazil and South Africa.

The trial fol­lows an ear­lier study in which the shot showed promis­ing re­sults. It will now test whether a sin­gle dose of J&J’S vac­cine can safely pro­tect peo­ple from Covid-19. U.S. gov­ern­ment agen­cies in­clud­ing the Na­tional In­sti­tutes of Health and the Depart­ment of Health and Hu­man Ser­vices are help­ing to fund the study, which is ex­pected to cost about $480 mil­lion.

A vac­cine that Moderna Inc. code­signed with the Na­tional In­sti­tute of Al­lergy and In­fec­tious Dis­eases started Phase 3 test­ing in July and has en­rolled nearly 26,000 peo­ple to­ward a goal of 30,000.

Pfizer Inc. and part­ner Biontech SE also started a Phase 3 trial of their vac­cine in July and have en­rolled nearly 32,000 to­ward a goal of 44,000. In­terim re­sults of the Moderna and Pfizer stud­ies could come as soon as Oc­to­ber, but pos­si­bly later, ac­cord­ing to com­pany ex­ec­u­tives.

As­trazeneca PLC, which li­censed a vac­cine from the Univer­sity of Ox­ford, started a 30,000-per­son Phase 3 trial in the U.S. in Au­gust but that study is on hold while an in­de­pen­dent com­mit­tee re­views a safety mat­ter.

J&J is col­lab­o­rat­ing with the U.K. gov­ern­ment for a sep­a­rate Phase 3 study to test a two-dose reg­i­men of the vac­cine.

Pub­lic-health of­fi­cials are count­ing on one or more of these vac­cines to pass muster in the large tri­als and be­come avail­able to help curb the coro­n­avirus pan­demic.

The vac­cine de­vel­op­ers have al­ready started man­u­fac­tur­ing doses that could be ready soon af­ter reg­u­la­tors clear a vac­cine for use.

“We want to do ev­ery­thing we can with­out sac­ri­fic­ing safety or ef­fi­cacy…to make sure that we end up with vac­cines that are go­ing to save lives,” NIH Di­rec­tor Fran­cis Collins said in a con­fer­ence call with re­porters.

J&J started work on its vac­cine ear­lier this year and in July started the first study in hu­mans in the U.S. and Bel­gium.

J&J Chief Sci­en­tific Of­fi­cer Paul Stof­fels said the vac­cine showed pos­i­tive in­terim re­sults in in­duc­ing im­mune re­sponses in the first study, and was gen­er­ally well-tol­er­ated.

Vac­cine re­cip­i­ents ex­pe­ri­enced cer­tain side ef­fects, in­clud­ing fever and flu­like symp­toms, which Dr. Stof­fels said weren’t un­usual for vac­cines. Dr. Stof­fels said full re­sults from the early-stage study would be pub­lished on­line im­mi­nently. In the Phase 3 study, some sub­jects will re­ceive the vac­cine, and others a placebo, and re­searchers will track whether the rates of symp­to­matic Covid-19 are lower among vac­ci­nated peo­ple than un­vac­ci­nated peo­ple.

J&J’S vac­cine is known as a vi­ral vec­tor shot be­cause it uses a mod­i­fied ade­n­ovirus—a virus that can cause the com­mon cold—to de­liver ge­netic in­struc­tions teach­ing the hu­man im­mune sys­tem to build a de­fense against the coro­n­avirus. The com­pany in Au­gust signed a $1 bil­lion con­tract with the fed­eral gov­ern­ment to sup­ply 100 mil­lion doses for the U.S., if the vac­cine proves suc­cess­ful in test­ing and gets au­tho­rized for use.

J&J ex­pects to pro­duce more than one bil­lion doses glob­ally dur­ing 2021.

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