Playing catch-up in the race to develop a coronavirus vaccine, Johnson & Johnson said Thursday it now expects to begin a late-stage study of its vaccine candidate in September.
The phase III study would follow the phase I human trial that J&J plans to begin this week with more than 1,000 participants in the U.S. and Belgium.
“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,” J&J Chief Scientific Officer Paul Stoffels said during a post-earnings conference call.
J&J’s coronavirus vaccine is based on the same technologies it used to make its experimental Ebola vaccine, which was provided to people in the Democratic Republic of Congo in late 2019. It involves combing genetic material from the coronavirus with a modified adenovirus that is known to cause common colds in humans.
The timeline laid out by Stoffel “could enable the drugmaker to deliver preliminary phase III results by the end of this year or early next,” BioPharma Dive said.
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. But according to Reuters, it has been lagging behind companies such as Moderna, Pfizer, and AstraZeneca.
The FDA has said it wants to see a vaccine that reduces the risk of infection or COVID-19 disease by at least 50% versus placebo. According to Stoffel, J&J is expecting its vaccine could reduce the risk by 70% to 80%.
“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,” BioPharma Dive said.
J&J announced the new timeline for its vaccine after reporting that its second-quarter profit slid 35% from a year earlier as the coronavirus forced hospitals to postpone elective surgeries, hitting the company’s medical device business hard.