J&J eyes late-stage study start of COVID-19 vaccine in September

Johnson & Johnson disclosed alongside its second-quarter earnings call on Thursday that it hopes to begin a late-stage study of its COVID-19 vaccine candidate Ad26.COV2-S in late September, ahead of its previous schedule. The company is in talks with the US National Institutes of Health to bring forward the start of the trial, although chief financial officer Joseph Wolk cautioned that "the science still has to play out."

On Thursday, Johnson & Johnson also indicated that it aims to start a Phase I trial of the recombinant vaccine in Belgium on July 22. That study will include more than 1000 participants, primarily between the ages of 18 and 55 years, although the company also plans to include a cohort of people who are 65 or older in the early-stage trial. "We're going to try to target the most vulnerable population," Wolk remarked, adding "it's going to be far-reaching in terms of the demographic makeup and we are very optimistic that that will yield good results."

Initial Phase I data

Chief scientific officer Paul Stoffels said "our initial data on the Phase I will be available second half of September, which will become the basis for a Phase III study, and that will start mid-to-end September." He added that the drugmaker is also planning a Phase II trial in the Netherlands, Spain and Germany. The company has previously said it was committed to supplying more than 1 billion doses of the vaccine worldwide in 2021.

Earlier this week, Moderna released emerging Phase I data showing that its experimental coronavirus vaccine mRNA-1273 induced "robust" antibody as well as T-cell responses in all 45 participants, with "no trial-limiting safety concerns." The company said it would be starting a late-stage trial on July 27. If the vaccine remains on track, Moderna stated that it will be able to deliver "approximately 500 million doses per year, and possibly up to 1 billion doses per year," beginning in 2021.

Meanwhile, recent reports have hinted at "positive news" expected soon, possibly as early as Thursday, for AstraZeneca and the University of Oxford's COVID-19 vaccine candidate AZD1222. The Lancet recently confirmed that data from a Phase I trial of AZD1222 will be published in the journal on July 20.

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