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EUA of J&J COVID-19 vaccine possible in February, Warp Speed’s Slaoui says

Dec 2, 2020 | 10:08 PM GMT

The Janssen unit of Johnson & Johnson could complete the U.S. government-supported Phase III trial of its COVID-19 vaccine candidate by January, and if it is successful receive emergency use authorization from FDA in February, Moncef Slaoui, Operation Warp Speed’s chief scientific adviser, said Wednesday.

More than 28,000 participants have been enrolled in the global 60,000-person trial, Slaoui said. He emphasized the potential benefit of the single dose regimen.

“The breakthrough that we hope with this vaccine is that it’s a one-shot vaccine with very fast efficacy,” Slaoui said. Hinting at concerns that some people may not return for second vaccinations in two-shot regimens, he noted that there will be “100% compliance” with a single dose vaccine.

J&J has committed about $604 million and Warp Speed has committed about $454 million to the Phase III ENSEMBLE trial.

In addition to the single-dose trial Slaoui referenced, J&J started in November a two-dose Phase III trial of JNJ-78436735 human serotype 26 adenovirus (Ad26).

Next up after J&J’s vaccine is AstraZeneca’s chimpanzee adenovirus vector vaccine, Slaoui said. AstraZeneca plc (LSE:AZN; NASDAQ:AZN), which is partnering with the University of Oxford to develop AZD1222 is conducting a 40,000-person Phase III trial supported by Warp Speed that is recruiting patients at 93 sites in the U.S. and 23 in South America. The trial is testing two full doses of the vaccine administered 28 days apart.

The Warp Speed-supported Phase III trial is separate from trials AstraZeneca conducted in the U.K. and Brazil in which efficacy was higher in a subset of participants who accidentally received a half-dose followed by a full dose.

Both AstraZeneca and J&J are likely to have final efficacy data “somewhere between very late in December and the middle of January,” Slaoui predicted.

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