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J&J to Begin Human Study on Coronavirus Vaccine in July

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Johnson & Johnson (JNJ - Free Report) announced that it is speeding up the timeline for initiation of a phase I/II human clinical study on its vaccine candidate for COVID-19. It will now begin the phase I/II study in the second half of July rather than September, as announced earlier.

Strong preclinical data and positive feedback from regulatory authorities allowed J&J to accelerate the clinical study on the COVID-19 vaccine candidate, Ad26.COV2-S, recombinant

The phase I/II study will be conducted in 1045 healthy adults aged 18 to 55 years, plus adults aged 65 years and older and will be initiated in the United States and Belgium. J&J said that it is holding talks with the National Institutes of Allergy and Infectious Diseases to begin pivotal phase III studies on the candidate sooner than planned if data from the phase I/II study is positive.

J&J’s goal is to supply more than 1 billion doses of the vaccine globally if it proves to be safe and effective.

J&J looks confident of having the first batch of COVID-19 vaccine available for emergency use authorization, on a not-for-profit basis, by early 2021. It has established a new U.S. vaccine manufacturing facility and is in discussions with other potential partners to expand manufacturing capacity in Europe and Asia.

Shares of J&J were up 1.2% on Wednesday, in response to the news. This year so far, J&J’s shares have risen 1.4% against the industry’s 1% decline.

 

 

J&J is committed to invest more than $1 billion in partnership with Biomedical Advanced Research and Development Authority (BARDA) to co-fund vaccine research, development, and clinical testing.

J&J is one of the dozen companies that are developing a vaccine for the deadly coronavirus disease. Of these, Moderna (MRNA - Free Report) , Novavax (NVAX - Free Report) , Pfizer (PFE - Free Report) and its Germany-based partner BioNTech, AstraZeneca in partnership with Oxford University and Inovio Pharmaceuticals have initiated human/clinical studies on a coronavirus vaccine. Infact, Moderna expects to initiate a pivotal phase III study in July. AstraZeneca/Oxford University also expects to begin late-stage studies with 30,000 participants in a number of countries if data from the phase I/II study, expected to be released shortly, is successful.

Infact, per a New York Times report, published last week, J&J is one of the five companies, which the Trump administration has identified as part of the Operation Warp Speed (OWS) initiative to rapidly develop a vaccine for COVID-19. The other four companies are Moderna, Oxford University/AstraZeneca, Merck, and Pfizer. The report mentioned that the five companies will get extra federal funds, help to run their clinical studies and manufacturing assistance

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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