Johnson & Johnson said Thursday that late-stage clinical trials for its coronavirus vaccine are now fully enrolled, and expects to release initial data on the shot’s effectiveness by the end of January.
The company said roughly 45,000 participants in several countries have now signed up to receive the pharmaceutical company’s vaccine, which is being developed along with its medical research and development subsidiary, Janssen.
“Given the high incidence of COVID-19 among the general population in the countries where the trial is being conducted, this number of participants will be sufficient to generate the data needed to determine the efficacy and safety of the Company’s investigational COVID-19 vaccine candidate,” the company said in a statement.
Unlike the other leading vaccine candidates — including Pfizer-BioNTech, which has been approved for use in several countries, and Moderna, which is nearing approval in the United States and Canada — Johnson & Johnson’s shot only requires a single dose.
Initial trials of the vaccine showed that 98 per cent of participants had developed antibodies against COVID-19 nearly a month after receiving the shot.
Phase 3 trials for the vaccine began in September, with an initial goal of testing 60,000 volunteers. The trials are being conducted in the U.S., South Africa, Argentina, Brazil, Chile, Colombia, Mexico and Peru.
Health Canada began conducting a rolling review of Johnson & Johnson’s vaccine at the end of November, meaning it will look at the company’s data as it is submitted throughout the Phase 3 trial process. The application was accepted based on the strong results seen in early trials.
Johnson & Johnson said Thursday that if the current trial proceeds on schedule and further proves the vaccine is safe and effective, it expects to apply to the U.S. Food and Drug Administration for emergency use in February. Other applications will be made to more countries “in parallel,” the company said.
Canada has signed a deal with Johnson & Johnson to receive up to 38 million doses of its vaccine if it is approved for use.View link »