Several biopharma players are racing to deliver COVID-19 vaccines, and now Johnson & Johnson is revving up its plans for late-stage trials earlier than originally expected—and it's aiming far above the FDA's 50% efficacy bar for approval, executives said.
In a conference call Thursday, Johnson & Johnson chief scientific officer Paul Stoffels said the company has seen “strong” preclinical data, and it's now ready to kick off human testing next week.
A phase 1/2a study in more than 1,000 adults ages 18 to 55 will start by enrolling in Belgium next week and open to U.S. participants the week after. The study will also include an arm testing the vaccine in people 65 and older, Stoffels said. Human trials in the Netherlands, Spain, Germany and Japan will follow.
From there, J&J expects initial human results in September, and the drugmaker could start phase 3 efficacy testing the same month. “We could have data before the year ends” or early 2021, Stoffels said on Thursday’s call. Vaccinations could begin in early 2021 under that timeline.
J&J is working with its adenoviral vector platform that allows “rapid” development of new candidates, he told analysts Thursday. The company has already used the platform in RSV, Zika, HIV and Ebola and is confident in its safety profile, the exec said.
J&J's vaccines have already been administered in about 80,000 people, Stoffels said, and J&J's Ebola vaccine won European approval earlier this month.
In COVID-19, the company's vaccine elicited a “high level of protection” in preclinical studies, Stoffels said, but it's “difficult to extrapolate” how that will play in humans. He said the company is aiming for “significantly above 50%” efficacy, which is the requirement the FDA has set for potential approvals. J&J is instead aiming for 70% or 80% efficacy.
“Let’s hope we reach that, because that could create herd immunity” and “put a stop to the disease,” Stoffels said. An FDA expert recently said herd immunity would require a 70% of the population to receive a vaccine at least 70% effective.
At the same time, J&J is building up its manufacturing capacity with partners including Emergent BioSolutions and Catalent, aiming to produce 1 billion doses by the end of next year.