The University of Oxford is ready to launch a phase 3 trial in Brazil of AstraZeneca (AZ)’s COVID-19 vaccine candidate, considered by the World Health Organization (WHO) to be the frontrunner in the research race.
The vaccine is currently being studied in the UK in a phase 2/3 trial, in which more than 4,000 participants are enrolled and an additional 10,000 are anticipated to sign up, the university said. It’s also being studied in a phase 1/2 South African study.
“AZ certainly has a more global scope at the moment in terms of where they’re planning their vaccine trials,” said WHO Chief Scientist Soumya Swaminathan. “I think there is an advantage, really, for companies to look at mechanisms where you could actually plan to do clinical trials in multiple countries, in multiple settings, and WHO would be very happy to facilitate that kind of approach.”
Swaminathan said that Moderna’s vaccine hopeful, mRNA-1273, is not far behind AZ’s candidate and is likely to enter phase 3 trials in mid-July. There are currently 17 vaccine candidates in clinical trials and an additional 132 candidates still in the preclinical stage, according to WHO data.
Oxford’s phase 3 study, the first COVID-19 vaccine trial in Latin America, will enroll 5,000 volunteers across the country, with vaccinations in Sao Paulo, Rio de Janeiro and a site in northeastern Brazil, the university said, following the Brazilian government’s approval of the trial at the beginning of next month.
The study is being run with support from AstraZeneca, which is licensing the vaccine, and which has already hashed out a local vaccine production deal between Brazil’s Ministry of Health and the drugmaker’s Brazilian arm. — James Miessler