J & J ’s COVID-19 Vaccine Will Enter Phase 3 Testing, the Fourth To Reach That Stage

Johnson &Johnson announced today (Sept. 23) that it is launching a large-scale Phase 3 test of its COVID-19 vaccine candidate, which was developed based on science supported by the National Institutes of Health. The vaccine, being tested through the company’s Janssen Pharmaceuticals arm, will be the fourth to enter late stage studies, following candidates from Moderna, Pfizer-BioNTech and AstraZeneca. Unlike those vaccine candidates, which all require two shots, J&J’s vaccine involves a single injection. That means it could require half the number of doses to immunize the same number of people. J&J’s study, named ENSEMBLE, will recruit 60,000 volunteers across eight countries—Argentina, Brazil, Chile, Columbia, Mexico, Peru, South Africa and the U.S. Given the data showing that some groups are more vulnerable to the effects of COVID-19, Dr. Paul Stoffels, chief scientific officer at J&J, said the company and its study leaders are focusing on ensuring that the study includes a diverse population of participants. The vaccine uses a weakened cold virus, called AD26, to deliver the COVID-19 virus’s genetic material to the right immune cells in the body. Those cells then process the viral material to train the immune system to recognize and destroy any similar incoming virus. Based on studies in hamsters and monkeys, the vaccine produced sufficient immune responses that could neutralize the virus in the lab, and early tests in people which began ...
Source: TIME: Health - Category: Consumer Health News Authors: Tags: Uncategorized COVID-19 Source Type: news

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Source: WBZ-TV - Breaking News, Weather and Sports for Boston, Worcester and New Hampshire - Category: Consumer Health News Authors: Tags: Boston News Covid-19 Boston, MA Health Healthcare Status Beth Israel Deacones Medical Center Coronavirus Johnson & Johnson Source Type: news
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 im...
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
NIH COVID-19 SIG Lecture Series NIAID has a long-standing dual mandate to maintain a robust portfolio of research in its key focus areas and to respond to emerging and re-emerging infectious diseases (EIDs). With this mandate, NIAID has also sought to improve EID-response preparedness, working in partnership with other U.S. government research entities, industry, academia, and international public-health organizations. This preparedness planning helped the institute respond rapidly to COVID-19. NIAID tapped existing coronavirus expertise and other assets to stand up research programs spanning basic virology and immunology ...
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