Johnson & Johnson launched the phase 3 trial for its experimental COVID-19 vaccine Sept. 23, testing the single-shot candidate's effectiveness in preventing COVID-19 against a placebo.
The trial will include 60,000 participants in the U.S., Mexico, Argentina, Brazil, Chile, Colombia, Peru and South Africa.
The vaccine candidate uses an adenovirus, which creates coronavirus proteins within the body that could prepare the immune system to fend off COVID-19. Adenovirus vaccines do not need to be stored in frozen settings, unlike most of the other vaccines in testing phases across the U.S.
"This pivotal milestone demonstrates our focused efforts toward a COVID-19 vaccine that are built on collaboration and deep commitment to a robust scientific process," Johnson & Johnson CEO Alex Gorsky said in a news release. "We are committed to clinical trial transparency and to sharing information related to our study, including details of our study protocol.”
Johnson & Johnson's vaccine candidate is the fourth to enter phase 3 testing in the U.S. The one Moderna is developing with the National Institute of Allergy and Infectious Diseases and the one Pfizer is developing with BioNTech both entered phase 3 testing in July. The vaccine AstraZeneca is developing with the University of Oxford began phase 3 testing in August, but it is currently paused as its safety is reviewed.
Johnson & Johnson said it is scaling up its production capacity for the vaccine and remains prepared to manufacture 1 billion doses of the vaccine each year.