Johnson & Johnson Initiates Pivotal Global Phase 3 Clinical Trial of Janssen ’s COVID-19 Vaccine Candidate

NEW BRUNSWICK, N.J., September 23, 2020 – Johnson &Johnson (NYSE: JNJ) (the Company) today announced the launch of its large-scale, pivotal, multi-country Phase 3 trial (ENSEMBLE) for its COVID-19 vaccine candidate, JNJ-78436735, being developed by its Janssen Pharmaceutical Companies. The initiation of the ENSEMBLE trial follows positive interim results from the Company’s Phase 1/2a clinical study, which demonstrated that the safety profile and immunogenicity after a single vaccination were supportive of further development. These results have been submitted to medRxiv and are due to be published online imminently. Based on these results and following discussions with the U.S. Food and Drug Administration (FDA), ENSEMBLE will enroll up to 60,000 volunteers across three continents and will study the safety and efficacy of a single vaccine dose versus placebo in preventing COVID-19.Johnson &Johnson has continued the scaling up of its manufacturing capacity and remains on track to meet its goal of providing one billion doses of a vaccine each year. The Company is committed to bringing an affordable vaccine to the public on a not-for-profit basis for emergency pandemic use and anticipates the first batches of a COVID-19 vaccine to be available for emergency use authorization in early 2021, if proven to be safe and effective. Johnson &Johnson will develop and test its COVID-19 vaccine candidate in accordance with high ethical standards and sound scientific...
Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Our Company Source Type: news

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Conclusions Genomics will continue to drive advances in CVD prevention and management, and equitable progress is imperative. Nursing should leverage the public's trust and its widespread presence in clinical and community settings to prevent the worsening of CVD disparities among African Americans.
Source: Journal of Cardiovascular Nursing - Category: Nursing Tags: ARTICLES: Precision Health in Cardiovascular Conditions Source Type: research
Background Cardiovascular disease is a significant health problem in the United States, attributed to more than 30% of all deaths annually. Anxiety has been associated with cardiovascular disease risk and is thought to be associated with cardiovascular disease risk through inflammatory pathways. Objective The purposes of this study were to examine the relationship between anxiety and systemic inflammation in individuals at risk for cardiovascular disease and to determine if single-nucleotide polymorphisms (SNPs) associated with inflammation moderate this relationship. Methods A secondary analysis was cond...
Source: Journal of Cardiovascular Nursing - Category: Nursing Tags: ARTICLES: Precision Health in Cardiovascular Conditions Source Type: research
Conclusions Young adults are not armed with the accurate knowledge to make informed choices about using e-cigarettes. E-cigarette users are understudied and tend to value appearance and physical sensation over health. Social norms related to e-cigarette use are linked to perception of identity and the current technology-focused culture.
Source: Journal of Cardiovascular Nursing - Category: Nursing Tags: ARTICLES: Literature Review Source Type: research
NEW BRUNSWICK, N.J., April 21, 2021 – Johnson &Johnson (the Company) today announced publication in the New England Journal of Medicine of primary data from the Phase 3 ENSEMBLE clinical trial for its single-dose COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson &Johnson (Janssen). The publication of the primary analysis follows the topline efficacy and safety data announced in January, showing the trial met all primary and key secondary endpoints, and found that the Johnson &Johnson single-dose COVID-19 vaccine prevented hospitalization and death across all study participants...
Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Our Company Source Type: news
NEW BRUNSWICK, N.J., February 28, 2021 – Johnson &Johnson (NYSE: JNJ) (the Company) today announced that the U.S. Centers for Disease Control and Prevention’s (CDC) Advisory Committee on Immunization Practices (ACIP) has recommended the first single-shot COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson &Johnson, for individuals 18 years of age and older under the Emergency Use Authorization (EUA) issued by the U.S. Food and Drug Administration (FDA). “For more than 130 years, Johnson &Johnson has come to the aid of people during times of crisis, and we believe tod...
Source: Johnson and Johnson - Category: Pharmaceuticals Source Type: news
NEW BRUNSWICK, N.J., February 27, 2021 – Johnson &Johnson (NYSE: JNJ) (the Company) today announced that the U.S. Food and Drug Administration (FDA) has issued Emergency Use Authorization (EUA) for its single-dose COVID-19 vaccine, developed by the Janssen Pharmaceutical Companies of Johnson &Johnson, to prevent COVID-19 in individuals 18 years of age and older. This decision was based on the totality of scientific evidence, including data from the Phase 3 ENSEMBLE study that demonstrated the vaccine was 85 percent effective in preventing severe disease across all regions studied, and showed protection agains...
Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Our Company Source Type: news
NEW BRUNSWICK, N.J., February 26, 2021 – Johnson &Johnson (NYSE: JNJ) (the Company) today announced that the U.S. Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) unanimously voted to recommend Emergency Use Authorization (EUA) for the Company’s single-shot COVID-19 vaccine candidate for adults 18 and older, developed by the Janssen Pharmaceutical Companies of Johnson &Johnson. The vote was based on a totality of scientific evidence provided by the Company, including efficacy and safety data from the Phase 3 ENSEMBLE trial. “We are ext...
Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Our Company Source Type: news
NEW BRUNSWICK, N.J., February 4, 2021 – Johnson &Johnson (NYSE: JNJ) (the Company) today announced that Janssen Biotech, Inc., has submitted an application to the U.S. Food and Drug Administration (FDA) requesting Emergency Use Authorization (EUA) for its investigational single-dose Janssen COVID-19 vaccine candidate. The Company’s EUA submission is based on topline efficacy and safety data from the Phase 3 ENSEMBLE clinical trial, demonstrating that the investigational single-dose vaccine met all primary and key secondary endpoints. The Company expects to have product available to ship immediately followin...
Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Innovation Source Type: news
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 COV...
Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Our Company Source Type: news
Discussions with the FDA are ongoing to define the required data set for filing Janssen’s Ebola vaccine regimen under the FDA’s Animal Rule licensure pathway. About Janssen’s Ebola Vaccine Regimen The Janssen investigational preventive Ebola vaccine regimen (Ad26.ZEBOV, MVA-BN-Filo) utilizes a viral vector strategy in which viruses – in this case adenovirus serotype 26 (Ad26) and Modified Vaccinia Virus Ankara (MVA) – are genetically modified so that they cannot replicate in human cells. In addition, these vectors are modified to safely carry the genetic code of an Ebola virus protein in order...
Source: Johnson and Johnson - Category: Pharmaceuticals Tags: Innovation Source Type: news
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