Spain Authorizes Phase 3 Trial of Johnson & Johnson’s COVID-19 Vaccine
Spain’s health regulator, the Agency for Medicines and Health Products (AEMPS), has approved the second part of Johnson & Johnson (J&J)’s global phase 3 trial evaluating experimental vaccine JNJ-78436735.
The New Brunswick, N.J., drugmaker announced the beginning of dosing earlier this week, disclosing testing had begun in the UK.
The study, conducted in partnership with the UK’s National Institute for Health Research, will enroll up to 30,000 participants to assess whether a second dose of the vaccine leads to greater efficacy. The first part of the study, also enrolling 30,000 participants, is testing whether a single-dose regimen is effective.
In its statement, AEMPS said dosing will occur in nine hospitals. J&J is currently conducting phase 2 trials in Spain and will be rolling out further late-stage trial announcements in other countries.