Johnson & Johnson’s COVID-19 vaccine candidate enters phase 3 trial
The investigational vaccine produced positive interim results in the company’s 1/2a clinical study, which showed that the safety profile and immunogenicity after a single vaccination were supportive of further development.
Johnson & Johnson announced the launch of its large-scale, global phase 3 trial for its COVID-19 vaccine candidate (JNJ-78436735) today in a press release. The vaccine, also known as Ad26.COV2.S, is being developed by its Janssen Pharmaceutical Companies.
The phase 3 trial will enroll up to 60,000 volunteers aged 18 years and older across 3 continents and will evaluate the safety and efficacy of a single vaccine dose compared with placebo in preventing COVID-19. The trial will include significant representation from those that are over the age of 60 years and will include individuals with and without comorbidities associated with an increased risk for progression in severe COVID-19. Read the study protocol here.
For further detail and additional trial coverage, visit Drug Topics
Contemporary OB/GYN Senior Editor Angie DeRosa gets insight on the current state of COVID-19 from Christina Han, MD, division director of maternal-fetal medicine at the University of California, Los Angeles, and member of its COVID-19 task force. Han is an active member of the Society for Maternal-Fetal Medicine and discusses the issues on behalf of SMFM.
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