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AstraZeneca and Johnson & Johnson, vaccine trials are positioned to restart after being paused over potential safety concerns

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the staff of the Ridgewood blog

New Brunswick NJ, according to Johns Hopkins Center for Health Security two major vaccine trials, those of AstraZeneca and Johnson & Johnson, are positioned to restart after being paused over potential safety concerns. The AstraZeneca trial was paused on September 6th, but after independent monitoring of the adverse event several trial sites in other countries resumed later in September. The US FDA held off on restarting AstraZeneca trial sites in the US through October in order to further investigate the event with their own team. The Johnson & Johnson vaccine trial was paused on October 11 after a participant suffered a stroke. This adverse event was also independently reviewed and a final report was sent to the US FDA that recommends the vaccine trial continue. The Johnson & Johnson trial can start re-enrolling participants as early as next week. This vaccine is of particular interest to many since it is a one-dose vaccine which would greatly simplify the process of quickly inoculating millions of people. The AstraZeneca vaccine has already shown promising preliminary results and seems to produce an immunogenic response in elderly participants as well as in younger ones. It is important that any eventual vaccine can produce immunogenic responses in the eldery, in children, and in those with underlying conditions. The Pfizer vaccine has begun to enroll a cohort of children between the ages of 12-18 to test its efficacy in this age group. 16- and 17-year-old volunteers are the first to be enrolled in this study, with researchers soon looking to enroll their younger peers.

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Johnson & Johnson Temporarily Pauses COVID-19 Vaccine Candidate Clinical Trial

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the staff of the Ridgewood blog

New Brunswick NJ, At Johnson & Johnson has temporarily paused further dosing in all our COVID-19 vaccine candidate clinical trials, including the Phase 3 ENSEMBLE trial, due to an unexplained illness in a study participant. The participant’s illness is being reviewed and evaluated by the ENSEMBLE independent Data Safety Monitoring Board (DSMB) as well as our internal clinical and safety physicians.

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New Jersey’s Johnson & Johnson Launches Phase 3 trials for Potential Coronavirus Vaccine

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the staff of the Ridgewood blog

NEW BRUNSWICK NJ,  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.

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Johnson & Johnson Announces Phase 1 clinical for Lead Vaccine Candidate for COVID-19

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the staff of the Ridgewood blog

NEW BRUNSWICK NJ,  Johnson & Johnson (NYSE: JNJ) (the Company) today announced the selection of a lead COVID-19 vaccine candidate from constructs it has been working on since January 2020; the significant expansion of the existing partnership between the Janssen Pharmaceutical Companies of Johnson & Johnson and the Biomedical Advanced Research and Development Authority (BARDA); and the rapid scaling of the Company’s manufacturing capacity with the goal of providing global supply of more than one billion doses of a vaccine. The Company expects to initiate human clinical studies of its lead vaccine candidate at the latest by September 2020 and anticipates the first batches of a COVID-19 vaccine could be available for emergency use authorization in early 2021, a substantially accelerated timeframe in comparison to the typical vaccine development process.

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Johnson & Johnson To Appeal Flawed Opioid Judgment in Oklahoma

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the staff of the Ridgewood blog

NEW BRUNSWICK NJ, Johnson & Johnson (NYSE: JNJ) and its Janssen Pharmaceutical Companies today announced they will appeal the $572 million civil judgment entered in Cleveland County District Court in the State of Oklahoma’s lawsuit against opioid manufacturers. The Company is confident it has strong grounds to appeal this decision.

The judgment disregards the Company’s compliance with federal and state laws, the unique role its medicines play in the lives of the people who need them, its responsible marketing practices and that since launch, DURAGESIC®, NUCYNTA® and NUCYNTA® ER have accounted for less than one percent of total opioid prescriptions in Oklahoma as well as the United States.

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