Johnson & Johnson 121 Jahre Erfahrung

John­son & John­son Announ­ces Sin­gle-Shot Jans­sen COVID-19 Vac­ci­ne Can­di­da­te Met Pri­ma­ry End­points in Inte­rim Ana­ly­sis of its Pha­se 3 ENSEMBLE Tri­alVac­ci­ne Can­di­da­te 72% Effec­ti­ve in the US and 66% Effec­ti­ve Over­all at Pre­ven­ting Mode­ra­te to Seve­re COVID-19, 28 Days after Vac­ci­na­ti­on
85% Effec­ti­ve Over­all in Pre­ven­ting Seve­re Dise­a­se and Demons­tra­ted Com­ple­te Pro­tec­tion Against COVID-19 rela­ted Hos­pi­ta­liz­a­ti­on and Death as of Day 28
Pro­tec­tion Against Seve­re Dise­a­se Across Geo­gra­phies, Ages, and Mul­ti­ple Virus Vari­ants, inclu­ding the SARS-CoV‑2 Vari­ant from the B.1.351 Lineage[1] Obser­ved in South Afri­ca 
Sin­gle-shot com­pa­ti­ble with stan­dard vac­ci­ne dis­tri­bu­ti­on chan­nels pro­vi­des important tool in pan­de­mic set­ting
[1] The B.1.351 lineage also known as 501Y.V2 vari­ant and 20H/501Y.V2 (form­er­ly 20C/501Y.V2) is a vari­ant of SARS-CoV‑2, the virus that cau­ses COVID-19

NEW BRUNSWICK, N.J., Janu­a­ry 29, 2021 – John­son & John­son (NYSE: JNJ) (the Com­pa­ny) today announ­ced topli­ne effi­cacy and safe­ty data from the Pha­se 3 ENSEMBLE cli­ni­cal tri­al, demons­tra­ting that the inves­ti­ga­tio­nal sin­gle-dose COVID-19 vac­ci­ne in deve­lo­p­ment at its Jans­sen Phar­maceu­ti­cal Com­pa­nies met all pri­ma­ry and key secon­da­ry end­points. The topli­ne safe­ty and effi­cacy data are based on 43,783 par­ti­ci­pants acc­ruing 468 sym­pto­ma­tic cases of COVID-19. 

The Pha­se 3 ENSEMBLE stu­dy is desi­gned to eva­lua­te the effi­cacy and safe­ty of the Jans­sen COVID-19 vac­ci­ne can­di­da­te in pro­tec­ting mode­ra­te to seve­re COVID-19, with co-pri­ma­ry end­points of 14 days and 28 days fol­lowing vac­ci­na­ti­on. Among all par­ti­ci­pants from dif­fe­rent geo­gra­phies and inclu­ding tho­se infec­ted with an emer­ging viral vari­ant, Janssen’s COVID-19 vac­ci­ne can­di­da­te was 66% effec­ti­ve over­all in pre­ven­ting mode­ra­te to seve­re COVID-19, 28 days after vac­ci­na­ti­on. The onset of pro­tec­tion was obser­ved as ear­ly as day 14. The level of pro­tec­tion against mode­ra­te to seve­re COVID-19 infec­tion was 72% in the United Sta­tes, 66% in Latin Ame­ri­ca and 57% in South Afri­ca, 28 days post-vaccination. 

“John­son & John­son embar­ked on the glo­bal effort to com­bat the COVID-19 pan­de­mic a year ago, and has brought the full for­ce of our capa­bi­li­ties, as well as tre­men­dous public-pri­va­te part­ners­hips, to enab­le the deve­lo­p­ment of a sin­gle-shot vac­ci­ne. Our goal all along has been to crea­te a simp­le, effec­ti­ve solu­ti­on for the lar­gest num­ber of peop­le pos­si­ble, and to have maxi­mum impact to help end the pan­de­mic,” said Alex Gorsky, Chair­man, Board of Direc­tors and Chief Exe­cu­ti­ve Offi­cer, John­son & John­son. “We’re proud to have reached this cri­ti­cal mile­stone and our com­mit­ment to address this glo­bal health cri­sis con­ti­nues with urgen­cy for ever­yo­ne, everywhere.”

Pre­ven­ti­on of seve­re dise­a­se; pro­tec­tion against COVID-rela­ted hos­pi­ta­liz­a­ti­on and death
The vac­ci­ne can­di­da­te was 85 per­cent effec­ti­ve in pre­ven­ting seve­re dise­a­se across all regi­ons stu­di­ed,[i] 28 days after vac­ci­na­ti­on in all adults 18 years and older. Effi­cacy against seve­re dise­a­se incre­a­sed over time with no cases in vac­ci­na­ted par­ti­ci­pants repor­ted after day 49. 

The Jans­sen COVID-19 vac­ci­ne can­di­da­te demons­tra­ted com­ple­te pro­tec­tion against COVID-rela­ted hos­pi­ta­liz­a­ti­on and death, 28 days post-vac­ci­na­ti­on. The­re was a clear effect of the vac­ci­ne on COVID-19 cases requi­ring medi­cal inter­ven­ti­on (hos­pi­ta­liz­a­ti­on, ICU admis­si­on, mecha­ni­cal ven­ti­la­ti­on, extra­cor­po­re­al mem­bra­ne oxy­ge­na­ti­on (ECMO), with no repor­ted cases among par­ti­ci­pants who had recei­ved the Jans­sen COVID-19 vac­ci­ne, 28 days post-vaccination. 

“The­se topli­ne results with a sin­gle-shot COVID-19 vac­ci­ne can­di­da­te repre­sent a pro­mi­sing moment. The poten­ti­al to signi­fi­cant­ly redu­ce the bur­den of seve­re dise­a­se, by pro­vi­ding an effec­ti­ve and well-tole­ra­ted vac­ci­ne with just one immu­niz­a­ti­on, is a cri­ti­cal com­po­nent of the glo­bal public health respon­se,” said Paul Stof­fels, M.D., Vice Chair­man of the Exe­cu­ti­ve Com­mit­tee and Chief Sci­en­ti­fic Offi­cer, John­son & John­son. “A one-shot vac­ci­ne is con­si­de­red by the World Health Orga­niz­a­ti­on to be the best opti­on in pan­de­mic set­tings, enhan­cing access, dis­tri­bu­ti­on and com­pli­an­ce. Eigh­ty-five per­cent effi­cacy in pre­ven­ting seve­re COVID-19 dise­a­se and pre­ven­ti­on of COVID-19-rela­ted medi­cal inter­ven­ti­ons will poten­ti­al­ly pro­tect hund­reds of mil­li­ons of peop­le from serious and fatal out­co­mes of COVID-19. It also offers the hope of hel­ping ease the huge bur­den pla­ced on health­ca­re sys­tems and communities.” 

In the stu­dy, the defi­ni­ti­on of seve­re COVID-19 dise­a­se inclu­ded labo­ra­to­ry-con­fir­med SARS-CoV‑2 and one or more of the fol­lowing: signs con­sis­tent with seve­re sys­temic ill­ness, admis­si­on to an inten­si­ve care unit, respi­ra­to­ry fail­u­re, shock, organ fail­u­re or death, among other fac­tors. Mode­ra­te COVID-19 dise­a­se was defi­ned as labo­ra­to­ry-con­fir­med SARS-CoV‑2 and one or more of the fol­lowing: evi­dence of pneu­mo­nia, deep vein throm­bo­sis, short­ness of breath or abnor­mal blood oxy­gen satu­ra­ti­on abo­ve 93%, abnor­mal respi­ra­to­ry rate (≥20); or two or more sys­temic sym­ptoms sug­ges­ti­ve of COVID-19.

Pro­tec­tion was gene­ral­ly con­sis­tent across race, age groups, inclu­ding adults over 60 years of age (N= 13,610), and across all vari­ants and regi­ons stu­di­ed, inclu­ding South Afri­ca whe­re near­ly all cases of COVID-19 (95%) were due to infec­tion with a SARS-CoV‑2 vari­ant from the B.1.351 lineage[ii].

Mul­ti-con­ti­nent Stu­dy Pro­vi­des Cli­ni­cal Data on Mul­ti­ple Emer­ging Viral Muta­ti­ons
The ENSEMBLE stu­dy results inclu­de effi­cacy against new­ly emer­ging strains of coro­na­vi­rus, inclu­ding some high­ly infec­tious vari­ants pre­sent in the US, Latin Ame­ri­ca and South Afri­ca. The Pha­se 3 ENSEMBLE tri­al is being con­duc­ted at the height of the COVID-19 pan­de­mic in eight coun­tries and three regi­ons, at a time when dise­a­se spread has acce­le­ra­ted throughout the world resul­ting in peop­le having incre­a­sed expo­sure to the virus.

“The­se results are a tes­ta­ment to the extra­or­di­na­ry efforts of ever­yo­ne invol­ved in our COVID-19 vac­ci­ne can­di­da­te cli­ni­cal pro­gram, and we are extre­me­ly gra­te­ful to the cli­ni­cal tri­al staff and tri­al par­ti­ci­pants for their inva­lu­able con­tri­bu­ti­ons,” said Mat­hai Mam­men, M.D., Ph.D., Glo­bal Head, Jans­sen Rese­arch & Deve­lo­p­ment. “Chan­ging the tra­jec­to­ry of the pan­de­mic will requi­re mass vac­ci­na­ti­on to crea­te herd immu­ni­ty, and a sin­gle-dose regi­men with fast onset of pro­tec­tion and ease of deli­very and sto­rage pro­vi­des a poten­ti­al solu­ti­on to reaching as many peop­le as pos­si­ble. The abi­li­ty to avoid hos­pi­ta­liz­a­ti­ons and deaths would chan­ge the game in com­ba­ting the pandemic.”

Tri­al par­ti­ci­pants of the pha­se 3 ENSEMBLE stu­dy con­ti­nue to be fol­lo­wed for up to two years for assess­ments of safe­ty and effi­cacy. The­re­fo­re, the­se data may be updated based on ongo­ing ana­ly­sis. The com­pre­hen­si­ve avail­ab­le data set will be sub­mit­ted to a peer-review­ed jour­nal in the com­ing weeks.

Pha­se 3 ENSEMBLE Stu­dy Safe­ty Data
The ana­ly­sis inclu­ded a con­cur­rent review of the avail­ab­le Pha­se 3 ENSEMBLE stu­dy safe­ty data by the Data and Safe­ty Moni­to­ring Board (DSMB), an inde­pen­dent group of experts, that did not report any signi­fi­cant safe­ty con­cerns rela­ting to the vac­ci­ne. A review of adver­se events indi­ca­ted that a sin­gle-dose of Janssen’s COVID-19 vac­ci­ne can­di­da­te was gene­ral­ly well-tolerated. 

The safe­ty pro­fi­le was con­sis­tent with other vac­ci­ne can­di­da­tes using Janssen’s AdVac® tech­no­lo­gy among more than 200,000 peop­le to date. Over­all fever rates were 9% and Gra­de 3 fever 0.2%. Over­all serious adver­se events (SAEs) repor­ted were hig­her in par­ti­ci­pants who recei­ved pla­ce­bo as com­pa­red to the acti­ve vac­ci­ne can­di­da­te. No ana­phy­la­xis was observed.

Jans­sen Vac­ci­ne Can­di­da­te Access and Dis­tri­bu­ti­on
The Com­pa­ny is com­mit­ted to brin­ging an afford­a­ble COVID-19 vac­ci­ne on a not-for-pro­fit basis for emer­gen­cy pan­de­mic use, pen­ding regu­la­to­ry authorizations. 

In addi­ti­on, the Jans­sen vac­ci­ne can­di­da­te is com­pa­ti­ble with stan­dard vac­ci­ne dis­tri­bu­ti­on chan­nels. If aut­ho­ri­zed, Janssen’s sin­gle-dose vac­ci­ne can­di­da­te is esti­ma­ted to remain sta­ble for two years at ‑20°C (-4°F), at least three mon­ths of which can be at tem­pe­ra­tures of 2–8°C (36°F–46°F). The Com­pa­ny will ship the vac­ci­ne using the same cold chain tech­no­lo­gies it uses today to trans­port other inno­va­ti­ve medicines.

The Com­pa­ny intends to file for U.S. Emer­gen­cy Use Aut­ho­riz­a­ti­on (EUA) in ear­ly Febru­a­ry and expects to have pro­duct avail­ab­le to ship immedia­te­ly fol­lowing aut­ho­riz­a­ti­on. It expects to share more infor­ma­ti­on on spe­ci­fics of deploy­ment as aut­ho­riz­a­ti­ons are secu­red and con­tracts are fina­li­zed. The Company’s anti­ci­pa­ted manu­fac­tu­ring time­li­ne will enab­le it to meet its 2021 sup­ply com­mit­ments, inclu­ding tho­se signed with governments and glo­bal orga­niz­a­ti­ons.

Pha­se 3 ENSEMBLE Stu­dy Design 
The Pha­se 3 ENSEMBLE stu­dy is a ran­do­mi­zed, dou­ble-blind, pla­ce­bo-con­trol­led cli­ni­cal tri­al desi­gned to eva­lua­te the safe­ty and effi­cacy of a sin­gle-dose vac­ci­ne ver­sus pla­ce­bo in adults 18 years old and older. 

The ENSEMBLE stu­dy was desi­gned to eva­lua­te the safe­ty and effi­cacy of the Jans­sen vac­ci­ne can­di­da­te in pro­tec­ting against both mode­ra­te and seve­re COVID-19 dise­a­se, with assess­ment of effi­cacy as of day 14 and as of day 28 as co-pri­ma­ry endpoints.

Pha­se 3 ENSEMBLE Stu­dy Demo­gra­phics
The tri­al, con­duc­ted in eight coun­tries across three con­ti­nents, inclu­des a diver­se and broad popu­la­ti­on inclu­ding 34% (N= 14,672) of par­ti­ci­pants over age 60. 

The stu­dy enrol­led 44% (N=19,302) of par­ti­ci­pants in the United Sta­tes, 41% (N=17,905) in Cen­tral and South Ame­ri­ca (Argen­ti­na, Bra­zil, Chi­le, Colom­bia, Mexi­co, Peru) and 15% (N=6,576) in South Africa. 

For­ty-five per­cent of par­ti­ci­pants are fema­le, 55% male.

Among par­ti­ci­pants glo­bal­ly, 59% are White/Caucasian; 45% are His­pa­nic and/or Latinx; 19% are Black/African Ame­ri­can; 9% are Nati­ve Ame­ri­can and 3% are Asi­an. In the United Sta­tes, 74% are White/Caucasian; 15% are His­pa­nic and/or Latinx; 13% are Black/African Ame­ri­can; 6% are Asi­an and 1% are Nati­ve American.

For­ty-one per­cent of par­ti­ci­pants in the stu­dy had comor­bi­di­ties asso­cia­ted with an incre­a­sed risk for pro­gres­si­on to seve­re COVID-19 (over­all 41%), obe­si­ty (28.5%), type 2 dia­be­tes (7.3%), hyper­ten­si­on (10.3%), HIV (2.8%); also other immu­no­com­pro­mi­sed par­ti­ci­pants were in the study.

Janssen’s Vac­ci­ne Tech­no­lo­gy 
The inves­ti­ga­tio­nal Jans­sen COVID-19 vac­ci­ne can­di­da­te lever­a­ges the Company’s AdVac® vac­ci­ne plat­form, which was also used to deve­lop and manu­fac­tu­re Janssen’s Euro­pean Com­mis­si­on-appro­ved Ebo­la vac­ci­ne regi­men and con­struct its Zika, RSV, and HIV inves­ti­ga­tio­nal vac­ci­ne candidates. 

The Jans­sen AdVac® viral vec­tor tech­no­lo­gy can indu­ce potent and long-las­ting humo­ral and cel­lu­lar immu­ne respon­ses, enab­ling the pur­su­it of vac­ci­nes for dise­a­se tar­gets that are cur­r­ent­ly unpre­ven­ta­ble or untreatable.

John­son & John­son con­ti­nues to deve­lop and test its COVID-19 vac­ci­ne can­di­da­te in accordance with ethi­cal stan­dards and sound sci­en­ti­fic princi­ples. The Com­pa­ny is com­mit­ted to trans­pa­ren­cy and sharing infor­ma­ti­on rela­ted to its ongo­ing cli­ni­cal stu­dies – inclu­ding the ENSEMBLE stu­dy pro­to­col.

ENSEMBLE has been fun­ded in who­le or in part with Federal funds from the Office of the Assi­stant Secreta­ry for Pre­pa­red­ness and Respon­se, Bio­me­di­cal Advan­ced Rese­arch and Deve­lo­p­ment Aut­ho­ri­ty (BARDA), under Con­tract No. HHSO100201700018C, and in col­la­bo­ra­ti­on with the Natio­nal Insti­tu­te of All­er­gy and Infec­tious Dise­a­ses (NIAID), part of the Natio­nal Insti­tu­tes of Health (NIH) at the U.S. Depart­ment of Health and Human Ser­vices (HHS).

Jans­sen has worked with BARDA sin­ce 2015 on inno­va­ti­ve solu­ti­ons for influ­en­za, che­mi­cal, bio­lo­gi­cal, radia­ti­on and nuclear thre­ats and emer­ging infec­tious dise­a­ses such as Ebo­la. In Febru­a­ry 2020, Jans­sen and BARDA began work on the deve­lo­p­ment of a COVID-19 vac­ci­ne based on Janssen’s AdVac® technology.

The Jans­sen Phar­maceu­ti­cal Com­pa­nies ent­e­red into a col­la­bo­ra­ti­on with the Beth Isra­el Deaco­ness Medi­cal Cen­ter (BIDMC) to sup­port the deve­lo­p­ment of the pre­ven­ti­ve vac­ci­ne can­di­da­te for COVID-19. 

Janssen’s COVID-19 vac­ci­ne pro­gram has been desi­gned to be tho­rough and dri­ven by sci­ence. As such, the Com­pa­ny is also inves­ti­ga­ting immu­ne respon­ses for dif­fe­rent doses and dosing regi­mens as well as stu­dy­ing a two-dose regi­men of its COVID-19 vac­ci­ne can­di­da­te for effi­cacy in the Pha­se 3 ENSEMBLE 2 study.

For more infor­ma­ti­on on the Company’s mul­ti-pron­ged approach to hel­ping com­bat the pan­de­mic, visit: www.jnj.com/coronavirus.

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About John­son & John­son
At John­son & John­son, we belie­ve good health is the foun­da­ti­on of vibrant lives, thri­ving com­mu­nities and for­ward pro­gress. That’s why for more than 130 years, we have aimed to keep peop­le well at every age and every sta­ge of life. Today, as the world’s lar­gest and most broad­ly-based health­ca­re com­pa­ny, we are com­mit­ted to using our reach and size for good. We stri­ve to impro­ve access and afforda­bi­li­ty, crea­te healt­hi­er com­mu­nities, and put a healt­hy mind, body and envi­ron­ment wit­hin reach of ever­yo­ne, ever­y­whe­re. We are blen­ding our heart, sci­ence and inge­nui­ty to pro­found­ly chan­ge the tra­jec­to­ry of health for huma­ni­ty. Learn more at www.jnj.com. Fol­low us at @JNJNews.

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