Johnson & Johnson (JNJ – Free Report) announced an expanded agreement with the Biomedical Advanced Research and Development Authority (BARDA), part of the US Department of Health and Human Services, to support the next phase of development of its coronavirus vaccine candidate, JNJ -78436735. Under the latest agreement, J&J will commit approximately $ 604 million and BARDA will invest approximately $ 454 million to support J&J’s large pivotal Phase III study, ENSEMBLE, on JNJ-78436735, which launched in September.
So far this year, J&J shares have risen 2.8% from the industry’s 1.1% increase.
At the end of October, J&J resumed recruiting for the ENSEMBLE study, which had been discontinued earlier in the month. Dosing was discontinued in the ENSEMBLE study due to unexplained illness observed in one study participant, which was investigated by the ENSEMBLE Independent Data Safety Oversight Board (DSMB). The DSMB subsequently recommended resuming trial recruitment as no clear cause of the disease was determined. It was also not clear whether the unexpected severe adversity was related to the vaccine.
The ENSEMBLE study is expected to enroll 60,000 adult participants and compare a single dose of JNJ-78436735 vaccine to placebo. It aims to register participants in Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa and the United States at more than 200 sites. The ENSEMBLE study was initiated in collaboration with BARDA and the National Institute of Allergies and Infectious Diseases (NIAID).
Other than J&J, Pfizer (PFE – Free report) / BioNTech (BNTX – Free report), Moderna (ARNM) and AstraZeneca (AZN – Free Report) / The University of Oxford’s COVID-19 vaccine candidates are also in advanced development. While J&J is testing a single dose of its COVID-19 vaccine candidate, Pfizer / BioNTech, AstraZeneca / Oxford University and Moderna are testing two injections of their respective candidates.
Last week, Pfizer / BioNTech released the first interim data from a Phase III study of their mRNA-based coronavirus vaccine candidate, BNT162b2, which showed the candidate to be over 90% effective in prevention of COVID-19. With Pfizer / BioNTech’s COVID-19 vaccine candidate found to be 90% effective, the benchmark has been set quite high as other vaccine candidates will likely have to present similar safety and efficacy data as they compete market share.
J&J currently has a Zacks # 3 (Hold) rank. You can see The full list of current Zacks # 1 Rank (Strong Buy) stocks here.
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