NEW BRUNSWICK, N.J.,July 30, 2020/PRNewswire/ — Johnson & Johnson (NYSE:JNJ) (the Firm) this day announced that its lead vaccine candidate stable in opposition to an infection with SARS-CoV-2, the virus that causes COVID-19, in pre-clinical reviews. The tips, revealed inNature, display veil the Firm’s investigational adenovirus serotype 26 (Ad26) vector-based entirely vaccine elicited a sturdy immune response as demonstrated by “neutralizing antibodies,” successfully combating subsequent an infection and offering full or terminate to-full safety within the lungs from the virus in non-human primates (NHPs) within the pre-clinical see. In accordance with the strength of the recommendations, a Phase 1/2a first-in-human clinical trial of the vaccine candidate, Ad26.COV2.S, in wholesome volunteers,has now commenced inthe USAandBelgium.
“We’re furious to peep these pre-clinical files because they display veil our SARS-CoV-2 vaccine candidate generated a valid antibody response and offered safety with a single dose. The findings give us self belief as we development our vaccine development and upscale manufacturing in parallel, having initiated a Phase 1/2a trial in July as a arrangement to transfer correct into a Phase 3 trial in September,” acknowledgedPaul Stoffels, M.D., Vice Chairman of the Govt Committee and Chief Scientific Officer, Johnson & Johnson.
The sturdy Janssen COVID-19 clinical trial program, in conjunction with the Phase 1/2a clinical trial and the Phase 3 clinical trial program, will evaluate both one- and two-dose regimens of Ad26.COV2.S in parallel reviews. The Phase 1/2a trial will evaluate the protection, reactogenicity (expected reactions to vaccination, corresponding to swelling or soreness), and immunogenicity of Ad26.COV2.S in over 1,000 wholesome adults frail 18 to 55 years, to boot to adults frail 65 years and older. Planning moreover is underway for a Phase 2a see inthe Netherlands,SpainandGermanyand a Phase 1 see inJapan. For more files about these reviews, please visitwww.clinicaltrials.gov.
Because the Firm plans its COVID-19 Phase 3 clinical development program, discussions are underway with companions as a arrangement to open up a pivotal Phase 3 clinical trial of the single vaccine dose versus placebo in September, pending the duration in-between files of the Phase 1 and 2 trials and approval of regulators. Simultaneously, the Firm moreover is planning to open up a parallel Phase 3 clinical trial of a two-dose regimen versus placebo.
The Firm moreover will emphasize illustration of populations that had been disproportionately impacted by the pandemic as it designs and implements its COVID-19 Phase 3 trial program. Inthe USA, this might possibly consist of predominant illustration of Blacks, Hispanic/Latinx and members over 65 years of age.
The pre-clinical reviews were finished by researchers from Beth Israel Deaconess Clinical Heart (BIDMC) in collaboration with the Janssen Pharmaceutical Corporations of Johnson & Johnson and others as fraction of its ongoingcollaborationto plod up the event of a SARS-CoV-2 vaccine.
Dan Barouch, M.D., Ph.D., Director of the Heart for Virology and Vaccine Study at BIDMC and the Ragon Institute, acknowledged, “The pre-clinical files, generated in collaboration with the Johnson & Johnson team, highlights the functionality of this SARS-CoV-2 vaccine candidate. Furthermore, the recommendations suggest that antibody phases can also just wait on as a biomarker for vaccine-mediated safety.”
Within the reviews, researchers first immunized the NHPs with a panel of vaccine prototypes, and then challenged them with SARS-CoV-2 an infection. The scientists chanced on that, of seven vaccine prototypes tested within the see, Ad26.COV2.S (referred to within theNaturearticle as Ad26-S.PP), elicited the very top phases of neutralizing antibodies to SARS-CoV-2. The extent of antibodies correlated with the level of safety, confirming outdated observations and suggesting they is in general a doubtless biomarker for vaccine-mediated safety. The six NHPs that obtained a single immunization with Ad26.COV2.S confirmed no detectable virus within the decrease respiratory tract after exposure to SARS-CoV-2, and excellent surely one of six confirmed very low phases of the virus in a nasal swab at two time functions.
“As we collectively warfare this pandemic, we remain deeply committed to our blueprint of offering a stable and effective vaccine to the enviornment. Our pre-clinical results give us motive to be optimistic as we provoke our first-in-human clinical trial, and we are furious to enter the following stage in our research and development against a COVID-19 vaccine. All of us know that, if a hit, this vaccine will even be swiftly developed, produced on an amazing scale and delivered around the enviornment,” acknowledgedMathai Mammen, M.D., Ph.D., Global Head, Janssen Study & Mutter, LLC, Johnson & Johnson.
The Firm’s predominant responsibility is to offer sufferers, patrons and healthcare providers with products which might almost definitely well be as stable and effective as doubtless. Johnson & Johnson takes a proof- and science-based entirely, ethics- and values-driven technique to scientific safety, striking patient and person wellbeing firstly in its resolution making and actions, with an emphasis on transparency.
As Johnson & Johnson progresses the clinical development of SARS-CoV-2, the Firm continues to amplify manufacturing ability and is in packed with life discussions with global strategic companions to purple meat up worldwide receive admission to. Johnson & Johnson targets to meet its blueprint to offer bigger than one billion doses globally thru the course of 2021, offered the vaccine is stable and effective.
This project has been funded in total or in fraction with Federal funds from the Field of job of the Assistant Secretary for Preparedness and Response, Biomedical Evolved Study and Mutter Authority, beneath Diversified Transaction Settlement HHSO100201700018C.
For more files on Johnson & Johnson’s multi-pronged technique to combatting the pandemic, visit:www.jnj.com/coronavirus.
About Johnson & Johnson
At Johnson & Johnson, we reflect correct smartly being is the root of provocative lives, thriving communities and forward development. That’s why for bigger than 130 years, we now possess aimed to withhold other americans smartly at every age and every stage of lifestyles. This day, because the enviornment’s excellent and most broadly-based entirely healthcare company, we are committed to utilizing our attain and size for correct. We strive to make stronger receive admission to and affordability, receive fitter communities, and set a wholesome recommendations, body and atmosphere terminate by of each person, in each place. We’re mixing our heart, science and ingenuity to profoundly swap the trajectory of smartly being for humanity. Learn more atwww.jnj.com. Apply us at@JNJNews.
Regarding the Janssen Pharmaceutical Corporations
At Janssen, we’re making a future the set illness is a ingredient of the previous. We’re the Pharmaceutical Corporations of Johnson & Johnson, working tirelessly to affect that future a actuality for sufferers in each place by combating sickness with science, bettering receive admission to with ingenuity, and therapeutic hopelessness with heart. We focal level on areas of tablets the set we are able to affect the excellent distinction: Cardiovascular & Metabolism, Immunology, Infectious Ailments & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension. Learn more atwww.janssen.com. Apply us at@JanssenGlobal.
Stare to Merchants Relating to Ahead-Looking Statements
This press free up comprises “forward-taking a ogle statements” as outlined within the Deepest Securities Litigation Reform Act of 1995 in the case of development of doubtless preventive and treatment regimens for COVID-19. The reader is cautioned now not to rely on these forward-taking a ogle statements. These statements are in step with latest expectations of future events. If underlying assumptions display veil erroneous or identified or unknown dangers or uncertainties materialize, valid results can also fluctuate materially from the expectations and projections of the Janssen Study & Mutter LLC., and/or Johnson & Johnson. Dangers and uncertainties consist of, but are now not cramped to: challenges and uncertainties inherent in product research and development, in conjunction with the uncertainty of clinical success and of acquiring regulatory approvals; uncertainty of industrial success; manufacturing difficulties and delays; competition, in conjunction with technological advances, unusual products and patents attained by opponents; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory slip; changes in habits and spending patterns of purchasers of smartly being care providers; changes to suitable criminal guidelines and laws, in conjunction with global smartly being care reforms; and traits against smartly being care price containment. A extra checklist and descriptions of these dangers, uncertainties and other factors will even be chanced on in Johnson & Johnson’s Annual Document on Invent 10-K for the fiscal year endedDecember 29, 2019, in conjunction with within the sections captioned “Cautionary Present Regarding Ahead-Looking Statements” and “Merchandise 1A. Chance Factors,” and within the company’s most recently filed Quarterly Document on Invent 10-Q, and the company’s subsequent filings with the Securities and Replace Commission. Copies of these filings are on hand online atwww.sec.gov,www.jnj.comor on ask from Johnson & Johnson. None of the Janssen Pharmaceutical Corporations nor Johnson & Johnson undertakes to update any forward-taking a ogle statement because unusual files or future events or inclinations.
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