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2 years ago-Biopharma Group
2 years ago-BioGenes GmbH

J&J, on the cusp of starting coronavirus vaccine trials, sets high bar for success

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Johnson & Johnson plans to start the first human study of its experimental coronavirus vaccine on July 22, and expects a late-stage trial could begin as early as mid-September if initial data prove positive.The timeline, set out by J&J’s top scientist Paul Stoffels on a Thursday call with investors, is sped up from initial expectations laid out by the company and could enable the drugmaker to deliver preliminary Phase 3 results by the end of this year or early next.J&J is currently discussing with regulators the shape of its Phase 3 study. Stoffels, however, said he expects the company’s vaccine to significantly surpass the bar for effectiveness set out by the Food and Drug Administration, an assumption that will factor into the trial’s design.

J&J is one of at least five drugmakers working with the U.S. government to begin late-stage testing of their experimental coronavirus shots by this fall.

Moderna, long the front-runner in the U.S., is set to be first, with a Phase 3 study of 30,000 people scheduled to begin July 27. Pfizer and AstraZeneca could follow in July or August, with J&J and Novavax trailing a month or two behind.

Yet J&J, banking on technology proven in its recently cleared Ebola vaccine, expects to quickly have the data it needs to make its vaccine available. If everything goes to plan — hardly a guarantee in vaccine development — J&J could feasibly meet the aggressive 12- to 18-month timeline set out by the U.S. government in its “Operation Warp Speed” project.

First, however, will be a Phase 1/2a study of its vaccine that will enroll roughly 1,000 healthy adults in the U.S. and Belgium. J&J is also planning to conduct a Phase 1 study in Japan, and a Phase 2 study in the Netherlands, Spain and Germany, Stoffels said.

Potentially helping J&J move quickly is its expectation that its vaccine can be given as a single shot, rather than the two-dose regimen used by Moderna, Pfizer and others. Moderna’s vaccine, for example, is administered via two shots spaced four weeks apart.

Stoffels said a booster shot might eventually be needed for its vaccine, but likely one or two years after the first dose, citing J&J’s experience with its vaccine technology in Ebola and other infectious diseases.

J&J could have initial data from its Phase 1/2a test by mid-September, clearing the way for the Phase 3 to begin soon after should results show the vaccine to be safe and potentially effective.

Stoffels believes his company’s vaccine could substantially surpass the minimum standard the FDA said would need to be met before it cleared any shot for widespread use. In guidance released last month, the regulator said it wants to see a vaccine that reduces the risk of infection or COVID-19 disease by at least 50% versus placebo.

J&J is expecting its vaccine could be even better, in the range of 70% to 80%, Stoffels said, although it’s not clear what goal J&J would choose for its Phase 3 study.

The company has conducted preclinical studies in animals of its vaccine and expects to soon publish results from a non-human primate challenge study in a major medical journal.

The updates on J&J’s vaccine plans came during a second quarter earnings call Thursday. The pharma reported an 11% year-over-year drop in sales during the three-month period from April to June, driven principally by weak performance from its medical device business.

Pharmaceutical sales rose slightly, by 2.1% over last year’s mark. While the effects of the COVID-19 pandemic on J&J’s drug business were not as severe, company officials did note lower use of physician-administered drugs.

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