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J&J (JNJ) Expands BARDA Deal for COVID-19 Vaccine Development

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Johnson & Johnson (JNJ - Free Report) announced an expanded agreement with Biomedical Advanced Research and Development Authority (BARDA), part of U.S. Department of Health and Human Services, to support the next phase of development of its coronavirus vaccine candidate, JNJ-78436735. Per the latest deal, J&J will commit approximately $604 million and BARDA is putting in approximately $454 million to support J&J’s large pivotal phase III study, ENSEMBLE, on JNJ-78436735, which was initiated in September.

So far this year, J&J’s shares have risen 2.8% compared with the industry’s 1.1% increase.



In late October, J&J resumed recruitment in the ENSEMBLE study, which was paused earlier in the month. Dosing was paused in the ENSEMBLE study due to an unexplained illness observed in a study participant, which was probed by the ENSEMBLE independent Data Safety Monitoring Board (DSMB). The DSMB later recommended resuming trial recruitment as no clear cause of the illness was determined. It was also not clear whether the unexpected serious adversity was related to the vaccine shot.

The ENSEMBLE study is expected to enroll 60,000 adult participants and compare a single vaccine dose of JNJ-78436735 to placebo. It aims to enroll participants in Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa and the United States across more than 200 sites. The ENSEMBLE study has been initiated in collaboration with BARDA and National Institute of Allergy and Infectious Diseases (NIAID).

Other than J&J, Pfizer (PFE - Free Report) /BioNTech (BNTX - Free Report) , Moderna (MRNA) and AstraZeneca (AZN - Free Report) /Oxford University’s COVID-19 vaccine candidates are also in late-stage 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 shots of their respective candidates.

Last week, Pfizer/BioNTech released first interim datafrom a phase III study on their mRNA-based coronavirus vaccine candidate, BNT162b2, which showed that the candidate was more than 90% effective in preventing COVID-19. With Pfizer/BioNTech’s COVID-19 vaccine candidate proving to be 90% effective, the benchmark has been set quite high as other vaccine candidates will likely need to show similar safety and efficacy data as they compete for market share. 

J&J currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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