Playing capture-up in the race to build a coronavirus vaccine, Johnson & Johnson explained Thursday it now expects to commence a late-phase study of its vaccine applicant in September.
The phase III study would adhere to the phase I human trial that J&J options to commence this 7 days with far more than 1,000 individuals in the U.S. and Belgium.
“Our original information on the phase I will be available 2nd 50 % of September, which will grow to be the foundation for a phase III study. And that will start off mid-to-stop September,” J&J Main Scientific Officer Paul Stoffels explained through a publish-earnings conference connect with.
J&J’s coronavirus vaccine is based on the identical technologies it used to make its experimental Ebola vaccine, which was provided to persons in the Democratic Republic of Congo in late 2019. It involves combing genetic product from the coronavirus with a modified adenovirus that is recognized to trigger typical colds in people.
The timeline laid out by Stoffel “could empower the drugmaker to produce preliminary phase III final results by the stop of this 12 months or early up coming,” BioPharma Dive explained.
J&J is a single of at least five drugmakers operating with the U.S. federal government to commence late-phase testing of their experimental coronavirus photographs by this drop. But according to Reuters, it has been lagging guiding corporations these types of as Moderna, Pfizer, and AstraZeneca.
The Fda has explained it wants to see a vaccine that lessens the chance of infection or COVID-19 ailment by at least 50% as opposed to placebo. In accordance to Stoffel, J&J is anticipating its vaccine could lessen the chance by 70% to eighty%.
“Potentially aiding J&J transfer speedily is its expectation that its vaccine can be presented as a single shot, alternatively than the two-dose regimen used by Moderna, Pfizer, and many others,” BioPharma Dive explained.
J&J declared the new timeline for its vaccine after reporting that its 2nd-quarter income slid 35% from a 12 months earlier as the coronavirus pressured hospitals to postpone elective surgeries, hitting the company’s professional medical unit business enterprise really hard.