Single Dose of Johnson & Johnson COVID-19 Vaccine Candidate Demonstrates Strong Safety in Pre-clinical Research

Examine revealed in Nature reveals J&J’s investigational SARS-CoV-2 vaccine elicits a robust immune response that protects in opposition to subsequent an infection

First-in-human Section 1/2a scientific trial now underway in United States and Belgium; Section three scientific trial anticipated to start in September

NEW BRUNSWICK, New Jersey, July 30, 2020 /PRNewswire/ — Johnson & Johnson (NYSE: JNJ) (the Firm) at this time introduced that its lead vaccine candidate protected in opposition to an infection with SARS-CoV-2, the virus that causes COVID-19, in pre-clinical research. The info, revealed in Nature, present the Firm’s investigational adenovirus serotype 26 (Advert26) vector-based vaccine elicited a sturdy immune response as demonstrated by “neutralizing antibodies,” efficiently stopping subsequent an infection and offering full or near-complete safety within the lungs from the virus in non-human primates (NHPs) within the pre-clinical research. Primarily based on the energy of the information, a Section 1/2a first-in-human scientific trial of the vaccine candidate, Advert26.COV2.S, in wholesome volunteers, has now commenced in the US and Belgium.

“We’re excited to see these pre-clinical knowledge as a result of they present our SARS-CoV-2 vaccine candidate generated a robust antibody response and offered safety with a single dose. The findings give us confidence as we progress our vaccine improvement and upscale manufacturing in parallel, having initiated a Section 1/2a trial in July with the intention to maneuver right into a Section three trial in September,” mentioned Paul Stoffels, M.D., Vice Chairman of the Government Committee and Chief Scientific Officer, Johnson & Johnson.

The sturdy Janssen COVID-19 scientific trial program, together with the Section 1/2a scientific trial and the Section three scientific trial program, will consider each one- and two-dose regimens of Advert26.COV2.S in parallel research. The Section 1/2a trial will consider the security, reactogenicity (anticipated reactions to vaccination, comparable to swelling or soreness), and immunogenicity of Advert26.COV2.S in over 1,000 wholesome adults aged 18 to 55 years, in addition to adults aged 65 years and older. Planning is also underway for a Section 2a research in the Netherlands, Spain and Germany and a Section 1 research in Japan. For extra details about these research, please go to www.clinicaltrials.gov.

Because the Firm plans its COVID-19 Section three scientific improvement program, discussions are underway with companions with the target to begin a pivotal Section three scientific trial of the one vaccine dose versus placebo in September, pending the interim knowledge of the Section 1 and a pair of trials and approval of regulators. Concurrently, the Firm is also planning to begin a parallel Section three scientific trial of a two-dose routine versus placebo.

The Firm additionally will emphasize illustration of populations which have been disproportionately impacted by the pandemic because it designs and implements its COVID-19 Section three trial program. In the US, this would come with vital illustration of Blacks, Hispanic/Latinx and individuals over 65 years of age.

The pre-clinical research had been carried out by researchers from Beth Israel Deaconess Medical Heart (BIDMC) in collaboration with the Janssen Pharmaceutical Corporations of Johnson & Johnson and others as a part of its ongoing collaboration to speed up the event of a SARS-CoV-2 vaccine.

Dan Barouch, M.D., Ph.D., Director of the Heart for Virology and Vaccine Analysis at BIDMC and the Ragon Institute, acknowledged, “The pre-clinical knowledge, generated in collaboration with the Johnson & Johnson staff, highlights the potential of this SARS-CoV-2 vaccine candidate. Furthermore, the information recommend that antibody ranges could function a biomarker for vaccine-mediated safety.”

Within the research, researchers first immunized the NHPs with a panel of vaccine prototypes, after which challenged them with SARS-CoV-2 an infection. The scientists discovered that, of seven vaccine prototypes examined within the research, Advert26.COV2.S (referred to within the Nature article as Advert26-S.PP), elicited the best ranges of neutralizing antibodies to SARS-CoV-2. The extent of antibodies correlated with the extent of safety, confirming earlier observations and suggesting they might be a possible biomarker for vaccine-mediated safety. The six NHPs that obtained a single immunization with Advert26.COV2.S confirmed no detectable virus within the decrease respiratory tract after publicity to SARS-CoV-2, and solely certainly one of six confirmed very low ranges of the virus in a nasal swab at two time factors.

“As we collectively battle this pandemic, we stay deeply dedicated to our objective of offering a secure and efficient vaccine to the world. Our pre-clinical outcomes give us motive to be optimistic as we provoke our first-in-human scientific trial, and we’re excited to enter the following stage in our analysis and improvement towards a COVID-19 vaccine. We all know that, if profitable, this vaccine may be quickly developed, produced on a big scale and delivered all over the world,” mentioned Mathai Mammen, M.D., Ph.D., World Head, Janssen Analysis & Growth, LLC, Johnson & Johnson.

The Firm’s basic accountability is to supply sufferers, customers and healthcare suppliers with merchandise which might be as secure and efficient as doable. Johnson & Johnson takes an evidence- and science-based, ethics- and values-driven strategy to medical security, placing affected person and client wellbeing before everything in its resolution making and actions, with an emphasis on transparency.

As Johnson & Johnson progresses the scientific improvement of SARS-CoV-2, the Firm continues to extend manufacturing capability and is in lively discussions with international strategic companions to help worldwide entry. Johnson & Johnson goals to fulfill its objective to provide a couple of billion doses globally by means of the course of 2021, offered the vaccine is secure and efficient.

This venture has been funded in complete or partly with Federal funds from the Workplace of the Assistant Secretary for Preparedness and Response, Biomedical Superior Analysis and Growth Authority, underneath Different Transaction Settlement HHSO100201700018C.

For extra data on Johnson & Johnson’s multi-pronged strategy to combatting the pandemic, go to: www.jnj.com/coronavirus.

About Johnson & Johnson
At Johnson & Johnson, we imagine good well being is the muse of vibrant lives, thriving communities and ahead progress. That is why for greater than 130 years, now we have aimed to maintain individuals effectively at all ages and each stage of life. Right now, because the world’s largest and most broadly-based healthcare firm, we’re dedicated to utilizing our attain and measurement for good. We try to enhance entry and affordability, create more healthy communities, and put a wholesome thoughts, physique and atmosphere inside attain of everybody, in all places. We’re mixing our coronary heart, science and ingenuity to profoundly change the trajectory of well being for humanity. Be taught extra at www.jnj.com. Comply with us at @JNJNews.

Concerning the Janssen Pharmaceutical Corporations
At Janssen, we’re making a future the place illness is a factor of the previous. We are the Pharmaceutical Corporations of Johnson & Johnson, working tirelessly to make that future a actuality for sufferers in all places by preventing illness with science, enhancing entry with ingenuity, and therapeutic hopelessness with coronary heart. We give attention to areas of medication the place we will make the largest distinction: Cardiovascular & Metabolism, Immunology, Infectious Ailments & Vaccines, Neuroscience, Oncology, and Pulmonary Hypertension. Be taught extra at www.janssen.com. Comply with us at @JanssenGlobal.

Discover to Buyers Regarding Ahead-Wanting Statements

This press launch incorporates “forward-looking statements” as outlined within the Personal Securities Litigation Reform Act of 1995 relating to improvement of potential preventive and remedy regimens for COVID-19. The reader is cautioned to not depend on these forward-looking statements. These statements are primarily based on present expectations of future occasions. If underlying assumptions show inaccurate or identified or unknown dangers or uncertainties materialize, precise outcomes may differ materially from the expectations and projections of the Janssen Analysis & Growth LLC., and/or Johnson & Johnson. Dangers and uncertainties embody, however should not restricted to: challenges and uncertainties inherent in product analysis and improvement, together with the uncertainty of scientific success and of acquiring regulatory approvals; uncertainty of business success; manufacturing difficulties and delays; competitors, together with technological advances, new merchandise and patents attained by rivals; challenges to patents; product efficacy or security considerations leading to product recollects or regulatory motion; modifications in conduct and spending patterns of purchasers of well being care services and products; modifications to relevant legal guidelines and laws, together with international well being care reforms; and traits towards well being care price containment. An additional record and descriptions of those dangers, uncertainties and different components may be present in Johnson & Johnson’s Annual Report on Kind 10-Okay for the fiscal yr ended December 29, 2019, together with within the sections captioned “Cautionary Observe Relating to Ahead-Wanting Statements” and “Merchandise 1A. Threat Elements,” and within the firm’s most lately filed Quarterly Report on Kind 10-Q, and the corporate’s subsequent filings with the Securities and Change Fee. Copies of those filings can be found on-line at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. Not one of the Janssen Pharmaceutical Corporations nor Johnson & Johnson undertakes to replace any forward-looking assertion because of new data or future occasions or developments.

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SOURCE Johnson & Johnson

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